BioConnect Ireland Medtech R&D
Collaborating to Compete Medtech R&D-Can campus capabilities meet company challenges?
Radisson Blu Hotel, Galway
26th September at 2.30pm
Register online at:
BioConnect Ireland is pleased to announce that the online registration for the third event of 2012 is now open.
The Radisson Blu Hotel in Galway City is the venue for our Collaborating to Compete event which looks at Medtech R&D and explores if campus capabilities can meet company challenges.
The medical device industry continues to be robust even during these most challenging economic times. The number and calibre of research groups in Irish Research Institutes that are relevant to the Medtech sector has increased over the last decade. There are also a number of government funding incentives for companies to collaborate with research institutes.
We will hear from a number of research groups that cater for the Medtech sector and from company executives who have worked in collaboration with academic research groups.
So, whether you are a company interested in accessing expertise and resources to develop new and improved products, processes, services, and generate new knowledge and know-how or a researcher with expertise or technology that has commercial applications, then this event is for you.
Who should attend?
Executives from emerging and established medical technology companies
Universities and researchers looking to commercialize technologies/research capability
Venture capital, private equity and institutional financial firms
Business and Product Development Professionals
Research and Development Professionals
Biomedical and Research Students
When: Wednesday September 26th 2012 at 2.30pm
Where: Radisson Blu Hotel Galway Directions and Map >>
Lough Atalia Road, 5 minutes walk from Eyre Square
2.30 Registration/Tea/Coffee and Networking
Research Centres outline their R&D capability relevant to the Medtech Sector.
4.00 Panel Discussion:
Medtech executives discuss their experiences of collaborating with research institutes in Ireland
4.45 Open Mike:
A series of short (3 minute) presentations from BioConnect Ireland members introducing themselves and their activities to the network
5.00-6.00 Network reception
Register online at:
THANKS TO OUR SPONSORS,
FOUNTAIN HEALTHCARE PARTNERS,
THIS EVENT IS FREE TO ATTEND BUT REGISTRATION IS REQUIRED
Ireland's medical technology sector profile
Ireland's medical technology sector has evolved into one of the leading clusters for medical device and diagnostic products globally.With exports to the value of ?7.2bn, and 250 companies involved in developing, manufacturing and marketing a diverse range of products and services from disposable plastic and wound care products to precision metal implants including pacemakers to micro-electronic devices, orthopaedic implants, diagnostics, contact lenses and stents.
Pressures on healthcare systems have resulted in a greater focus on enhanced efficacy of treatments and cost reduction. There is no sense of complacency across the sector in Ireland where industry and Government alike are constantly looking for new ways to enhance competitiveness, develop new capabilities and ultimately generate new sustainable growth.
A recent report published by Forfás entitled 'Health LifeSciences in Ireland - an Enterprise Outlook' concludes that Ireland is well positioned to take advantage of global trends in the sector including convergence products and devices, functional foods, and remote diagnostics and healthcare delivery. It concludes that relevant R&D investment combined with our ICT and engineering capabilities will serve us well as we shift towards increasingly innovative and research intensive activities.
Some key Irish Medtech facts/ figures:
There are currently 250 medical technology companies in Ireland, exporting ?7.2b worth of product annually and employing 25,000 people - the highest number of people working in the industry in any country in Europe, per head of population.
Exports of medical devices and diagnostics products now represent 8% of Ireland's total merchandise exports; and growth prospects for the industry globally remain good.
Many of the world's top medical technology companies have invested significantly in Ireland and a number of exciting, research-based, indigenous companies are emerging and competing internationally.
50% of the companies in the sector are indigenous (ref Enterprise Ireland)
The Irish government has identified the medical technology sector as one of the key drivers of industrial growth for the future and provides a wide range of supports to encourage and foster this growth.
The medical technology industry in Ireland is changing from being prominently manufacturing to being more complex and driven by R&D. It now involves intensive collaboration between a broad range of partners, including research institutions, clinicians, manufacturing companies and government agencies..
Some key European facts/ figures:
There are almost 22,500 medical technology companies in EU, employing nearly 500,000 employees, with annual sales of ?95 billion*.
The medical technology industry produces over 500,000 individual products, in 10,000 generic groups*.
80% of medical technology companies are SMEs*.
In excess of ?7.6 billion euro is invested in R&D by medical technology companies annually*.
A new European medtech patent is filed every 38 minutes* .
Ireland is well placed to capitalise on the growing global market for medical technology products and services. The challenge is to continue to develop
and integrate the broad range of strategic competencies and support systems that will enable this island to compete as a mature, high value added economy, with innovation at its core.
*Sources: Eucomed and OECD 2010; European Patent Office 2006
Lilly to Invest 330 Million (Euro) in New Biopharmaceutical Facility in Cork
27th of February 2012
State-of-the-art commercialisation and manufacturing plant will require 200 employees when fully operational.
Cork, Ireland, 27th February 2012-- Minister for Jobs, Enterprise and Innovation Richard Bruton TD today announced that Eli Lilly and Company, a global leader in biopharmaceuticals, is to invest ?330 million in a brand-new facility at its Kinsale campus in Cork. The investment will expand the Kinsale site's existing biopharmaceutical mission with the establishment of an additional world-class commercialisation and manufacturing facility.
The new facility, when fully operational, will require up to 200 highly skilled employees. In addition, a further 300 construction jobs will be created on the site during building works. IDA Ireland worked closely with Lilly to attract this investment to Ireland.
The planned 240,000-square-foot biopharmaceutical commercialisation and manufacturing facility announced today will further enhance the company's ability to bring treatments for illnesses such as cancer and diabetes to patients worldwide. This is the second large investment Lilly has made at its Kinsale site in recent years. In 2006, the company announced a ?300 million investment in its first biopharmaceutical manufacturing and new-product commercialisation facility at its Kinsale campus, which came on-stream in 2010.
Speaking at the announcement, Minister Bruton said: "The Action Plan for Jobs, which the government published recently, outlined a range of measures which we will take in 2012 to target the high-end manufacturing and health/life sciences sectors for further growth and also to deepen and develop the impact of multinational companies in Ireland. Today's announcement-that this world-leading company is making a substantial investment in expanding its facility in Kinsale with the creation of up to 200 permanent jobs-shows what is possible in these areas.
"The Government is determined to ensure that more announcements like this become real in the coming years", Bruton added. "By implementing the Action Plan for Jobs, we can support more businesses, rebuild the economy and create the jobs we so badly need".
Ed Canary, General Manager of the Kinsale site, said: "This investment is an endorsement of the Lilly Kinsale site's success in developing a biopharmaceutical business in recent years and demonstrates our ability to rise to that challenge. This is in no small part due to the site's excellent performance record, the talent of the workforce, and the support from IDA Ireland.
"In the past five years, we have hired and trained some highly talented people and now have a technical talent base and capability in biopharmaceutical commercialisation and manufacturing that makes us a very attractive company for highly skilled people", Mr. Canary added.
The strategic importance of the investment for the corporation was emphasised by Paul Ahern Ph.D., Senior Vice President - Global API and Dry Product Manufacturing. "This investment is part of Lilly's planned growth strategy and proof of our confidence in Lilly's pipeline of new products, many of which are derived from biotechnology".
Maria Crowe, President of Global Manufacturing Operations for Lilly, who also attended the announcement, complimented the Irish government for its long-established pro-business environment and support of the pharmaceutical sector in Ireland through its science and technology policies. "We in Lilly have seen this reflected in our deep and productive relationships with organisations such as the IDA and Irish academic institutions. The output from this commitment to education is also reflected in the excellent candidates who apply to join our company, many of whom have gone on to careers at Lilly operations across the globe".
Commenting on the announcement, IDA Ireland CEO Barry O'Leary said: "I would like to congratulate Lilly's Irish management and staff on this achievement. It is a great success story for the Kinsale site and an excellent addition to the south west region. This investment demonstrates Lilly's enduring commitment to Ireland and further evidence that Ireland continues to position itself as a leading location of choice for the commercialisation and manufacturing of biopharmaceuticals".
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.ie
About Lilly in Ireland
Lilly has been in Ireland for over 30 years and now employs around 700 people in four operations; in Kinsale, Cork City, Sligo and Dublin, involved in bulk pharmaceutical (API), biopharmaceutical manufacturing, animal vaccines, financial shared services, marketing and sales.
Eli Lilly S.A. - Irish Branch, based in Dunderrow, Kinsale,first established a manufacturing presence in Ireland in 1981 and manufactures the active ingredients for a number of Lilly's most important medicines, including Alimta®, Evista®, Strattera®, and Zyprexa®. To date, over ?1 billion has been invested in the Kinsale facility. In 2006, Lilly commenced the construction of a biopharmaceutical development and manufacturing facility in Kinsale. The facility, which is completing its start-up, employs 140 people and is scheduled to manufacture commercial product by late 2013.
The products from Kinsale are shipped to finishing plants around the world, where they are converted to final-dosage forms such as tablets, capsules, or injectibles.
BioMarin to Acquire Pfizer's manufacturing facility in Cork
Acquisition will lead to over 100 jobs in the next five years
Cork, 23rd June, 2011 - Minister for Jobs, Enterprise and Innovation, Richard Bruton T.D., today welcomed the announcement that BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) has reached agreement with Pfizer to acquire its manufacturing facility in Shanbally, Cork. BioMarin, a California headquartered company, plans to create over 100 high quality jobs in the next 5 years with the support of Government through IDA Ireland.
The company is investing $48.5 million to purchase the Shanbally plant, a 133,000 sq.ft. bulk biologics manufacturing facility. Biomarin focuses on the treatment of rare diseases and has a number of new product candidates in late stage development. The company plans to occupy the Shanbally plant in a phased transition with substantial manufacturing activities being tied to results of its ongoing Phase 3 clinical study for N-acetylgalactosamine 6-sulfatase (GALNS) for the treatment of Mucopolysaccharidosis IVA (MPS IVA, also known as Morquio A Syndrome). It is anticipated that the facility will be licensed for GALNS production by 2015.
Welcoming today's announcement Minister Bruton said "If we are to get out of the crisis we're in, one crucial aspect of this will be to build on our traditional strengths as an economy. The pharmaceutical industry has developed into a particular strength of the Irish economy in recent years: most of the world's leading companies in the field have a presence here and we have developed an industry which plays a global role out of all proportion to the size of our economy.
"However it is crucial that we continue to set and meet ever more ambitious targets in this area. With the right policies success can breed more success, and I am determined that we must build on our strengths in this sector and today's very welcome announcement to create further jobs and get our country back to work".
Jean Jacques Bienaimé, Chief Executive Officer of BioMarin stated, "The new plant in Shanbally greatly expands our manufacturing capacity to accommodate our growing commercial portfolio and advancing clinical programs."
Mr. Bienaimé continued, "The new facility in Shanbally also diversifies our manufacturing risk and provides us with an attractive business environment. The facility is state-of-the-art, utilizing disposable technology and flexibly designed to run either fed batch or perfusion processes. This gives us tremendous latitude for the types of products that can be produced at the plant and allows us to focus efforts on the technical transfer of our next commercial product into the facility."
Commenting on the announcement IDA Ireland CEO, Barry O'Leary, said, "This is a strategically important development for BioMarin as it is the first time the company has placed internal biopharmaceutical production activities outside of the US. It is also the next phase in BioMarin's expansion into Ireland's Life Sciences industry, following the establishment of an international Supply Chain and Logistics presence in Dublin earlier this year. The decision to acquire the Shanbally plant is a significant endorsement of Ireland's wealth of talent and expertise."
"Ireland has a long, successful track-record of attracting significant pharmaceutical investment from multinationals. We have established Ireland as the second largest Development and Manufacturing (D&M) location in the world for Biopharmaceuticals, after the US. I am delighted to welcome BioMarin, a leading global biopharmaceutical company, to Ireland and look forward to working closely with the company as it develops its operations here", concluded Mr. O'Leary.
Welcoming BioMarin's decision, Pfizer's Vice President, External Supply OpU, Dr Paul Duffy said: "We are very pleased to have successfully found a buyer for the Shanbally site, especially another new manufacturing investor locating in Ireland's growing biopharmaceutical hub. Finding buyers for sites is a challenging endeavour and the IDA played a crucial role in working with us to attract potential acquirers for the facility. I wish to thank them for the key support they have provided throughout this process. Above all else I wish to acknowledge our colleagues in Shanbally and their dedication to their work and continued focus throughout the sale process. Their enthusiasm, talent and capabilities are second to none and I wish them every future success".
It is expected that the acquisition will close around September 2011, provided pre-sale conditions are met, and subject to consultation approx 65 Pfizer employees will have departed the business at that point. In the intervening months Pfizer will be working with recruiting companies in an on-site Careers Matching Programme to support the transition from Pfizer for those for which no alternative opportunities within the Pfizer network are available.
BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company's product portfolio comprises four approved products and multiple clinical and pre-clinical product candidates. Approved products include Naglazyme® (galsulfase) for mucopolysaccharidosis VI (MPS VI), a product wholly developed and commercialized by BioMarin; Aldurazyme® (laronidase) for mucopolysaccharidosis I (MPS I), a product which BioMarin developed through a 50/50 joint venture with Genzyme Corporation; Kuvan® (sapropterin dihydrochloride) Tablets, for phenylketonuria (PKU), developed in partnership with Merck Serono, a division of Merck KGaA of Darmstadt, Germany; and FirdapseT (amifampridine), which has been approved by the European Commission for the treatment of Lambert Eaton Myasthenic Syndrome (LEMS). Product candidates include GALNS (N-acetylgalactosamine 6-sulfatase), which is currently in Phase III clinical development for the treatment of MPS IVA, amifampridine phosphate (3,4-diaminopyridine phosphate), which is currently in Phase III clinical development for the treatment of LEMS in the U.S., PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase), which is currently in Phase II clinical development for the treatment of PKU, BMN 701, a novel fusion protein of insulin-like growth factor 2 and acid alpha glucosidase (IGF2-GAA), which is currently in Phase I/II clinical development for the treatment of Pompe disease, and BMN 673, a poly ADP-ribose polymerase (PARP) inhibitor, which is currently in Phase I/II clinical development for the treatment of genetically-defined cancers.
Pfizer is Ireland's largest pharmaceutical employer and investor. The company employs over 4,000 people at locations in Cork, Dublin, Kildare and Limerick and is engaged in a range of manufacturing, commercial and financial/shared services activities. In May 2010 as part of its global plant network strategy announcement Pfizer advised that it would be exiting its operations at Shanbally, but would be seeking to sell the site and preserve roles.
Announcement from BioConnect Ireland
BioConnect Ireland invites you to:
"Inventing - The Future
" The Changing Face of IP Portfolio Management for Companies, Colleges and Competitiveness
When: March 7th 2012 at 2.30pm
Where: The Davenport Hotel, Merrion Square, Dublin 2
Register for this free event at: www.biotechnologyireland.com
Dr Deirdre Leane, President IP Navigation Europe
"Patent monetisation - unlocking the value of your assets"
Dr John Scanlan, Director of Commercialisation, NUI Maynooth
"IP Commercialisation Strategies"
Our Open Mike (3 minute) Presenters are:
Mark Gorman - Barr Pomeroy Tax Advisors
Jim Ryan - Circa Group Europe
Fred Logue - New Morning IP
Tim Yeomans - Shannon ABC
Neil Thomas - Ventac Partners
Stephen Murray- Grant Thornton
Paul Dunne- Aptuit LLC
The following organisations have attendees registered for this event:
Abbott, AER Sustainable Technology Ltd, Allergy Standards Ltd, Aptuit LLC, Argutus Medical Ltd., Arthur Cox, Athlone Institute of Technology, Babelfish Consulting, Barr Pomeroy Tax Advisors, Beasley & Associates, Biocroi Ltd, ByrneWallace, Circa Group Europe, CloudCORE - Dublin City University, Consultant, Cromsource, Cruickshank IP Attorneys, Davy, Decromo Consulting, Deloitte, Dept of Agriculture, Food and the Marine, DFMG Solicitors, Dublin City University, Enterprise Ireland, Focus Diagnostics, FRKelly, Grant Thornton, Health Research Board (FP7), HKPB scientific Ltd, IDA Ireland, Invent DCU, IPNav, IPS&E, Irish Exporters Association, Irish Medicines Board, Java Clinical, Kentz, Kora, Life Science, Life Science Recruitment, Life Science Ventures, Maclachlan & Donaldson, Murgitroyd & Company, New Morning IP, Novartis Ireland Ltd, NovaUCD, NUI Maynooth, Oncomark, Pall Biopharma, Pall Life Sciences, Royal College of Surgeons in Ireland, Saltigo GmbH, Science Foundation Ireland, Shannon ABC, Technology Transfer Office, TCD, Thrombogenics, TNT Express, Trinity College Dublin, University of Limerick, University College Dublin, Udaras na Gaeltachta, Ventac Partners, World Courier.
BioConnect Ireland is sponsored by: Enterprise Ireland, RFT Group, Seroba Kernel
Register for this free event at: www.biotechnologyireland.com
Registration will close on 6th March at 4pm.
KCI to Expand Product Portfolio Through Acquisition of TechniMotionT Patient Handling Technologies
Released : 10th January 2011
Kinetic Concepts, Inc. announced the acquisition of substantially all of the assets and intellectual property of TechniMotion Medical, an Austin, Texas-based company that designs and develops innovative and ergonomic patient handling systems for acute and post-acute patient care.
SAN ANTONIO-(BUSINESS WIRE)- Kinetic Concepts, Inc. (NYSE:KCI) today announced the acquisition of substantially all of the assets and intellectual property of TechniMotion Medical, an Austin, Texas-based company that designs and develops innovative and ergonomic patient handling systems for acute and post-acute patient care.
Among other innovations, TechniMotionT products include patient lifts that enable out-of-bed transfers, seated transfers, and basic sit-to-stand maneuvers in a more comfortable and natural position, and a reclining bedside chair that allows bed transfers to be performed over the patient's mattress.
The products, which promote safe patient handling, will be marketed through KCI's Therapeutic Support Systems (TSS) division. TSS provides a portfolio of beds, mattress replacement systems, and other products for wound care, bariatric care and critical care settings.
"The novel systems from TechniMotion are a natural fit to our suite of products that are focused on providing a continuum of care and improved patient outcomes," said Steve Seidel, Global President, Therapeutic Support Systems. "Unlike other patient lifts for instance, TechniMotion's lift provides greater patient comfort and can be handled by just one caregiver, potentially reducing the risk of injury and bringing real efficiencies to the hospital and home care setting."
The medical lift market is approximately $220 million annually in the United States, with significant future growth opportunity.
The initial launch of the products is expected this summer.
Forward Looking Statements
This press release contains forward-looking statements regarding management's estimated market size for the medical lift market in the U.S. as well as KCI's expectations for TSS product availability in the U.S. medical lift market. Forward-looking statements may contain words such as believes, expects, anticipates, estimates, projects, intends, should, seeks, future, continue, or the negative of such terms, or other comparable terminology. Forward-looking statements are subject to risks, uncertainties, assumptions and other factors that are difficult to predict and that could cause actual results to vary materially from those expressed in or indicated by them. In particular, our ability to recognize sales and profitability from our TSS products in the U.S. market is subject to all the risks associated with the commercialization of products based on innovative technologies in new markets, including a lack of acceptance of our products or services by customers targeted by KCI, changes in business strategy, the introduction of competing products or technologies by other companies and other factors beyond our control. Additional risks and factors are identified in KCI's filings with the U.S. Securities Exchange Commission (the SEC), including its Annual Report on Form 10-K for the fiscal year ending December 31, 2009, and Quarterly Reports on Form 10-Q for the quarters ended September 30, 2010, June 30, 2010 and March 31, 2010, which are available on the SEC's Web site at http://www.sec.gov. KCI undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.
Abbott Receives CE Mark Approval for World's First Drug Eluting Bioresorbable Vascular Scaffold for Treatment of Coronary Artery Disease
Date: January 10, 2011
- Abbott's Newest Innovation Can Treat a Patient's Blocked Heart Vessel and Then Dissolve, Leaving the Patient's Vessel Free of a Permanent Metallic Implant
- Abbott will Continue to Conduct Additional Trials to Further Study the Device in Expanded Populations, Including a 500-Patient Trial in Europe
- Full Commercial Launch in Europe is Planned by End of 2012
Abbott Park, Illinois (NYSE: ABT) - Abbott announced today that it has received CE Mark approval for the world's first drug eluting bioresorbable vascular scaffold (BVS) for the treatment of coronary artery disease. Abbott's BVS device restores blood flow by opening a clogged vessel and providing support to the vessel until the device dissolves within approximately two years, leaving patients with a treated vessel free of a permanent metallic implant. Abbott's BVS device will be commercialized under the brand name ABSORBT.
"The CE Mark approval for ABSORB in Europe is a significant accomplishment that validates the impressive clinical results that have been observed with this device," said Patrick W. Serruys, M.D., Ph.D., professor of interventional cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, the Netherlands. "Abbott's ABSORB has the potential to change the way patients with coronary artery disease are treated, as it does what no other drug eluting coronary device has been able to do before - completely dissolve and potentially restore natural vessel function in a way not possible with permanent metallic implants."
ABSORB is made of polylactide, a proven biocompatible material that is commonly used in medical implants such as resorbable sutures. Since a permanent metallic implant is not left behind, a patient's vessel treated with ABSORB may ultimately have the ability to move, flex and pulsate similar to an untreated vessel. Restoration of these naturally occurring vessel functions, or vascular restoration therapy (VRT), is one of the features that makes ABSORB a significant innovation for patients in the treatment of coronary artery disease. In addition, continuing research indicates that the need to administer long-term dual anti-platelet therapy to patients may be reduced because the temporary scaffold is completely resorbed.
"Our ABSORB technology has the potential to revolutionize the treatment of coronary artery disease - with the prospect for positive therapeutic outcomes resulting from its unique ability to treat a blocked vessel, potentially restore natural vessel function and disappear within approximately two years after implant," said Robert B. Hance, senior vice president, vascular, Abbott. "Receiving CE Mark is a significant milestone on the path to providing patients with new treatment options for coronary artery disease. Abbott is committed to building the clinical and economic benefits of this therapy in anticipation of making it widely available in Europe by the end of 2012."
CE Mark approval for ABSORB in Europe was supported by data from the ABSORB clinical trials, which included patient follow-up out to three years. To further study the device in an expanded population, Abbott plans to initiate a randomized, controlled clinical trial in Europe later this year. The study will enroll approximately 500 patients at 40 centers throughout Europe and will compare ABSORB to Abbott's XIENCE PRIME, which, together with XIENCE V, is the market-leading drug eluting stent system in Europe. The trial will provide additional data to support European commercialization and reimbursement activities. A global trial, including the U.S. and other geographies, is planned for later this year.
In addition to clinical trial product, ABSORB will be made available in select sizes to a limited number of centers in Europe later this year and into 2012. This will enable physicians in these centers to increase their clinical experience with the technology and to continue to develop the therapy. A full-scale European commercial launch of ABSORB with a broad size matrix is planned by the end of 2012.
About the ABSORB Clinical Trials
The ABSORB trial is the world's first clinical trial evaluating a drug eluting BVS for coronary artery disease, and Abbott is the only company with long-term, four-year clinical data on a complete patient set evaluating the safety and performance of a drug eluting BVS. The ABSORB trial is a prospective, non-randomized (open label), two-phase study that enrolled 131 patients from Australia, Belgium, Denmark, France, the Netherlands, New Zealand, Poland and Switzerland. Key endpoints of the study include assessments of safety - major adverse cardiac events (MACE) and treated-site thrombosis rates - at 30 days and at six, nine, 12 and 24 months, with additional annual clinical follow-up for up to five years, as well as an assessment of the acute performance of the BVS device, including successful deployment of the system. Other key endpoints of the study include imaging assessments by angiography, intravascular ultrasound (IVUS), optical coherence tomography (OCT), and other state-of-the-art invasive and non-invasive imaging modalities at six, 12 and 18 months and at two, three and five years.
Results from the first stage of the ABSORB trial with 30 patients demonstrated that Abbott's BVS successfully treated coronary artery disease and was resorbed into the walls of treated arteries within approximately two years. Patients in this first stage of the ABSORB trial experienced no blood clots (thrombosis) out to four years and no new MACE between six months and four years (3.4 percent at four years).
Nine-month results from the 101 patients enrolled in the second stage of the ABSORB trial showed that the MACE rate remained consistent at 5.0 percent at nine months. There were no reports of blood clots in any of the 101 patients at nine months.
The ABSORB EXTEND trial is a single-arm study that will evaluate patients at up to 100 centers in Europe, Asia Pacific, Canada and Latin America. The trial will enroll approximately 1,000 patients with more complex coronary artery disease.
Abbott's bioresorbable technology delivers everolimus, an anti-proliferative drug. Everolimus is developed by Novartis Pharma AG and is licensed to Abbott by Novartis for use on its drug eluting vascular devices. Everolimus has been shown to inhibit treated-site neointimal growth in the coronary vessels following vascular device implantations, due to its anti-proliferative properties.
About the ABSORB Bioresorbable Vascular Scaffold
ABSORB is made of polylactide, a proven biocompatible material that is commonly used in medical implants such as resorbable sutures. The device is designed to restore blood flow by opening a clogged vessel and providing support to the vessel. Once the vessel can remain open without the extra support, ABSORB is designed to slowly metabolize and eventually be resorbed by the body. Since a permanent implant is not left behind, a vessel treated with ABSORB may ultimately have the ability to move, flex and pulsate similar to an untreated vessel. Restoration of these naturally occurring vessel functions, or vascular restoration therapy (VRT), is one of the features that makes ABSORB a significant innovation for patients in the treatment of coronary artery disease. ABSORB is currently under development and is not available for sale in the United States.
IDA Ireland End of Year Statement 2010
IDA Ireland End of Year Statement 2010
IDA Ireland wins significant increase in new jobs from Foreign Direct Investment in 2010
Ireland continued in 2010 to win significant foreign direct investment. Most encouraging is the substantial increase in the scale of these investments from many of the world's leading companies. In the past year the job numbers within investments secured show a marked increase, with the average employment per investment double the 2009 level. Export led growth is feeding through in the employment portfolio of IDA's clients, which created almost 11,000 new jobs in 2010, significantly up on the previous year's total of 4,615.
Barry O'Leary, CEO IDA Ireland
. World's leading multinationals and emerging companies increase investment in Ireland
. Almost 11,000 jobs created - export led recovery leads to new jobs
. Employment per investment double 2009 level
. Companies investing in Ireland for first time up 20%
. RD&I investment of over ?500million
Foreign Direct Investment (FDI) in Ireland increased significantly in 2010, despite global economic uncertainty. IDA has continued to increase the number of companies investing in Ireland for the first time while encouraging existing operations to expand and diversify their operations here. Amongst those investing in Ireland for the first time in 2010 were D&B, Telefonica, Warner Chilcott, LinkedIn, EA, Riot Games, Webroot, FC Stone, Spencer Stuart, Fi-Tek, Genband, Synchronoss, Aspect, Streamserve and IIR.
Despite the turbulent global economy in which, according to the OECD, foreign direct investment declined by 8% and with increased competition for FDI, IDA secured 126 investments. IDA client companies created almost 11,000 new jobs in 2010, well in excess of 2009's outcome of 4,615 jobs. Many of IDA's existing and new clients are actively recruiting in Ireland, including HP, Accenture, Citi, Google, Facebook, Eli Lilly and MSD.
. Almost 11,000 new jobs created
. A total of 126 foreign direct investments won
. 47 companies investing in Ireland for the first time, up 20% on 2009
. Investment in Research, Development and Innovation (RD&I) over ?500million
. 62% of investments from existing companies
. Over 60% of corporation tax in Ireland paid by IDA clients
. Exports from IDA client companies account for over 75% of total Irish exports
. Renewed investment in manufacturing partly due to Ireland's improving competitiveness
. Strong growth in employment intensive services investments
Welcoming the results, the Minister for Enterprise, Trade and Innovation, Batt O'Keeffe TD said, 'Despite the period of global recession over the past two years our value proposition to multinational firms either operating here or choosing to hub in Ireland for the first time remains one of the strongest in the world.'
'The combined influence of Ireland's increased competitiveness, commitment to our 12.5% corporate tax rate, and quick and decisive measures taken by the Government to combat the challenging economic situation has resulted in an excellent flow of foreign direct investment.'
'The pre-crisis levels of investment are coming from our traditional markets of North America, mainland Europe and the United Kingdom, as well as from new high-growth markets.'
'It is clear from these results that the Government's investment strategy for science, technology and innovation is the right one to create high-quality jobs and support export-led economic recovery.'
'Crucially, the Government has resourced the State's enterprise and innovation agencies, including IDA Ireland, under the four year plan for economic recovery to meet their job creation targets and accelerate our return to sustainable economic growth,' said Minister O'Keeffe.
IDA Ireland CEO, Barry O'Leary said, 'Ireland continued in 2010 to win significant foreign direct investment. Most encouraging is the substantial increase in the scale of these investments from many of the world's leading companies. In the past year the job numbers within investments secured show a marked increase, with the average employment per investment double the 2009 level. Export led growth is feeding through in the employment portfolio of IDA's clients, which created almost 11,000 new jobs in 2010, significantly up on the previous year's total of 4,615.'
Export led economic recovery
It is generally accepted that Ireland's economic recovery will be export led. Economic forecasts project strong growth in Ireland's position, with the ESRI estimating Irish exports to grow 7.5% in 2010 and 5.5% in 2011. IDA clients account for over 75% of total Irish exports. The growth and development of multinationals, with their strong focus on high value goods and services exports is fundamental to the Irish economy and is an essential component of Ireland's economic recovery.
In March 2010, IDA published its strategy for the forthcoming decade, Horizon 2020. This presents our view of how the environment in which we operate will change over the next ten years, and the opportunities for FDI created by global trends. Horizon 2020 sets out our targets for the 5 year period to 2014, as well as the direction IDA will take in the pursuit of these goals. Today's results provide strong grounds to be confident that IDA will achieve its 5 year targets.
Existing Clients and their Transformation
Transformation of clients' operations and activities in Ireland is a core element of Horizon 2020. In keeping with IDA's focus on transformation within its client companies it has been encouraging to see that a large number of existing clients announced expansion and diversification investments. These involved skills uplift, technology uplift, RD&I in product and process, and energy initiatives or taking on new mandates in order to increase their Irish operations' strategic importance within their parent corporations.
Companies that announced expansion and diversification investments in 2010 included, HP, SAP, Google, PayPal, eBay, AOL, Gala Games, Kellogg's, Kostal, Eli Lilly, MSD, Stream Global Services, ServiceSource, Salesforce.com, Hertz and Accenture. International Financial Services firms expanding include Zurich, Axa, Citi, State Street, UnitedHealth Group, Allianz and Generali.
Manufacturing is a core strategic pillar of the Irish economic landscape. With a strong base of many of the world's leading multinationals with significant manufacturing operations in Ireland including Intel, Analog Devices, EMC, Abbott, Medtronic, Boston Scientific, Liebherr, Kostal, J&J and Pfizer located here, manufacturing will continue to remain an integral part of Ireland's FDI portfolio. With our improving competitiveness, Ireland continued to attract manufacturing investments during 2010 including Warner Chilcott, MCI, Merit Medical, Hollister, Yves Rocher, Lufthansa Technik, Goodman Medical, Zeus, Valeo and Freund.
Research, Development & Innovation (RD&I)
2010 saw IDA win a number of high-value RD&I projects for Ireland with over ?500million in new RD&I investment secured. RD&I plays a strategic role as part of Ireland's FDI landscape embedding existing employment and setting the groundwork for increased future employment. Among the companies that announced RD&I investments in 2010 included IBM (Smarter Cities), United Technologies Research Centre (Renewable Energies), Alcatel-Lucent /Bell Labs, HP Galway, Biotrin, and Accenture's Global Analytics Centre.
Science Foundation Ireland (SFI) initiatives have enhanced the research environment for international investors, many of whom are collaborating with SFI funded initiatives.
CAO choices and future job opportunities
Foreign Direct Investment is constantly evolving, particularly due to the development of new technologies and business models. Employment opportunities will continue to be provided by multinationals for individuals who have appropriate skills. At a time when parents and students are examining the best prospects for their future and where long term employment opportunities exist, the data overwhelmingly suggests that meaningful opportunities continue to arise in sectors such as information technology, digital media, advanced manufacturing, lifesciences, medical technologies, international financial services and internationally traded services. IDA client companies are actively recruiting candidates who are technology competent with engineering, mathematics, science and international financial and multi-lingual skills.
Ireland's relative FDI position
During the year IBM's 2010 Global Locations Trends report ranked Ireland 1st globally for jobs by inward investment per capita, injecting renewed confidence in Ireland's reputation for FDI. The IBM report also enhanced Ireland's position with top 10 global rankings for both jobs in R&D and jobs in business support services.
Also in 2010, the IMD World Competitiveness Yearbook, for the key measures influencing foreign direct investments, ranked Ireland;
. 1st for corporate taxes
. 4th for the availability of skilled labour
. 4th for being open to new ideas
. 6th for labour productivity
. 7th for the availability of financial skills
. 7th for the flexibility and adaptability of people
These are critical criteria for multinationals making mobile investment decisions.
Irish competitiveness improved significantly in 2010. Business costs including energy, private rents, office rents, services, construction and labour have all become more competitive. Both gas and electricity prices are now below the Euro average, and the cost of living has also fallen. Office rents have decreased sharply - typically up to 40%, whilst the EU has forecast that from 2008 to 2012, Ireland's labour costs will have improved 13% relative to the EU (27) average. The improvement in competitiveness is helping secure new FDI for Ireland and a continuing focus on improving competitiveness is essential.
National Infrastructure Developments
Ireland's infrastructure has improved significantly in recent years, enhancing our attractiveness as an FDI location. Improved road access to Gateway locations, EirGrid is building an East-West electricity interconnector to ensure security of supply and provide an export outlet for any excess energy, new ESB Telecoms and Hibernia (Project Kelvin) international telecoms infrastructure, and the completion of Dublin Airport's Terminal 2 opening the possibility of new direct access to existing and growth markets, are creating a positive impact. Dublin's Port Tunnel enhances the transportation of goods and also facilitates linking the International Financial Services Centre to Dublin airport in a mere 20 minute commute. Other infrastructural improvements include major rail investments with a suite of new rolling stock, extension of the light rail network in Dublin, and enhanced frequency and shorter inter-city journey times are enhancing Ireland's attractiveness as an FDI location.
Horizon 2020 sets out to achieve a challenging target of securing 50% of investments outside Dublin and Cork. It is encouraging to see companies investing in key regional locations, such as Warner Chilcott (200 jobs, Dundalk), Global Indemnity (30 jobs, Cavan), MCI (50 jobs, Manorhamilton, Co Leitrim), United Health (200 jobs, Letterkenny), Zeus (75 jobs, Letterkenny), Elanco/Eli Lilly (ongoing investment in Sligo vaccine facility), Freund (25 jobs, Tullamore), Valeo (R&D investment at Tuam, Co Galway), Hollister (200 jobs, Ballina, Co Mayo), Merit Medical (100 jobs, Galway), EA (200 jobs, Galway), Stream Serve (20 jobs, Galway), Lumension (20 jobs, Galway), Synchronoss (Galway), IIR (50 jobs, Galway), Genband (100 jobs, Galway), Aspect (Galway), HP (105 jobs, Galway), Goodman Medical (115 jobs Galway), Enercon (30 jobs, Tralee), Straker (25 jobs, Tralee) and Citi (Waterford). Cork investments included Eli Lilly (100 jobs), United Technologies Research Centre (37 jobs), Otterbox (50 jobs), PAS Technologies and Yves Rocher.
Horizon 2020 sets a target that 20% of Greenfield investments by 2014 will be secured from growth markets. This emphasis on growth markets has led IDA, in recent months, to open a new office in Singapore, a second office in China (Shenzhen) and plans to open a second office in India (Bangalore) in early 2011, complementing the opening of offices in Shanghai and Mumbai in recent years.
IDA will continue its transformation journey to increase the effectiveness and efficiency of the agency while continuously reviewing and amending its operational foot-print both domestically and internationally.
Employment Portfolio and Transformation
IDA Ireland client companies created 10,897 new jobs in 2010, significantly up on the previous year's level.
Our strategy includes winning as many new jobs as possible each year and giving equal priority to maintaining existing jobs. We recognise that job losses occur every year for a variety of reasons including changing competitiveness, competition from sister sites, product and technology lifecycles or global location rationalisation as a result of mergers and acquisitions.
To address the need to maintain jobs in Ireland, IDA is actively encouraging its clients to strongly engage in transformation initiatives, and is assisting them in programmes to:
- improve company-wide competitiveness
- enhance use of new technologies
- grow the skills of the business
- engage in research, development & innovation
- develop new business processes
- make company operations more energy efficiency
There is a requirement to have a constant agenda to support clients improve and invest to transform their Irish operations to ensure jobs can be maintained and losses minimised.
In 2010, 9,545 jobs were lost by IDA supported companies leaving an overall increase in IDA's employment portfolio of 1,352. A number of the job losses arose from the implementation of job reductions announced in the first half of 2009.
FDI Impact on Economy
IDA supported companies directly employ c.139,000 people with a total impact of 240,000 jobs in the Irish economy, and account for ?110bn or over 75% of total Irish exports (goods and services). These companies contribute over ?19 billion in direct expenditure to the Irish economy.
FDI Outlook and Ireland's Reputation
The global outlook for FDI in 2011 remains challenging but a continuing focus on improving competitiveness will place Ireland in a favourable position to win further significant FDI and contribute strongly to Ireland's export led economic recovery. Significant FDI wins in 2010 have built a strong momentum for investment which will be carried through in 2011. It is encouraging to note that many investments secured last year will be recruiting this year, feeding further employment-growth in IDA's portfolio. IDA's focus will continue to be on high end manufacturing, global services and RD&I across a wide range of sectors. In particular ICT, Digital Media, International Financial Services, Internationally Traded Services, Lifesciences and Cleantech are poised for further growth.
Restoring Ireland's reputation in the international media will be a key priority in 2011 and IDA will work closely with all relevant stakeholders in Team Ireland. Ireland's value proposition which includes our talent pool, attractive corporation tax regime, strong track record of FDI companies and technological capability remains strongly attractive to many of the world's leading multinationals and emerging companies.
To position Ireland in the global business community IDA commenced a new marketing campaign in North America in Q4 2009. During 2010 we built upon this campaign extending its reach to Europe and India. It is critically important that Ireland's investment message is carried in international media, and media interviews with global business channels such as CNBC, Bloomberg and Fox have been a feature of our marketing effort.
IDA Ireland CEO, Barry O'Leary concluded 'There has never been greater need for increased levels of FDI. As a nation, and leveraging the assets and capability of Team Ireland, we are well capable of continuing to attract and increase the level of inward investment in Ireland. It is particularly encouraging, against the backdrop of last year, that IDA secured investments from 47 companies establishing a presence in Ireland for the first time, with a further 79 investments from existing companies already here. The level of confidence demonstrated by overseas investors in Ireland ensures we will remain one of the leading locations in the world for foreign direct investment.
The international FDI community continues to have confidence in Ireland. We too should be confident in our ability to secure increased levels of investment. Our enhanced competitiveness means Ireland is winning more FDI business, which is contributing significantly to Ireland's export led economic recovery.'
IDA IRELAND INDICATORS
Indicator 2010 Value
JOBS CREATED 10,897
TOTAL NUMBER OF INVESTMENTS APPROVED 126
NEW CLIENTS 47
EXISTING CLIENTS, of which 79
No. of Expansion Projects 42
No. of Research, Development & Innovation Projects 37
% of Investments locating outside Greater Dublin and Cork 37%
% of Jobs locating outside Greater Dublin and Cork 45%
Investment in Research, Development & Innovation Projects c.?500m.
Annual Corporate Tax Payments of IDA Client Companies ?2.4 billion (est)
NOTE: Corporation Tax data refers to year 2009.
Top 10 Medical Device Companies: 2010
The top 10 medical device companies all boasted billions in sales in 2009. Johnson and Johnson, a giant in the pharma sector, proved its dominance in the device world, bringing in close to $30 billion last year. While other big players like Siemens, GE and Philips have made their marks in non-medical industries, they still rank among the biggest medical device makers in the space. Well known but smaller outfits like Medtronic and Boston Scientific also our made the list.
The list was compiled with information from Medical Products Outsourcing Magazine, as well as the individual company's annual reports.
1. Johnson & Johnson
2. Siemens Healthcare
3. GE Healthcare
5. Baxter International
6. Philips Healthcare
7. Abbott Laboratories
8. Boston Scientific
10. Becton Dickinson
SFI welcomes Government's commitment to scientific research
Monday, July 26th 2010: Science Foundation Ireland (SFI) has welcomed today's announcement by An Taoiseach Brian Cowen T.D. of Infrastructure Investment Priorities 2010-2016, the Government's ?39.43billion revised capital investment programme.
Welcoming the six-year plan, Director General of SFI, Professor Frank Gannon, said "The Government's announcement unambiguously reaffirms the central role that research and development is playing in our economic rejuvenation, in fostering academic-enterprise collaboration on these shores, and in enhancing Ireland's efforts of becoming an international innovation hub.
Professor Gannon added: "The investment of ?2.4billion for Science, Technology and Innovation programmes will enable SFI and others to deliver on the sustained progress collectively achieved in partnership with Government, agencies, industry and the academic community over the past decade. The funding will assist in retaining and attracting world-class researchers and foreign direct investment, as well as developing Ireland's indigenous hi-tech sector. A capital injection of this magnitude represents perhaps the clearest signal to date - to the myriad of interested parties here and abroad - of Ireland's commitment to re-establishing competitiveness and growth and to attaining excellence, through targeted investment in scientific and engineering research."
Note: Infrastructure Investment Priorities 2010-2016 is available at http://www.finance.gov.ie/viewdoc.asp?DocID=6403
Partnership between Cleveland Clinic and Irish companies could lead to major jobs boost
23rd March, 2010
THE CLEVELAND Clinic is one of the great American medical institutions and a beacon of progress, according to US President Barack Obama, who visited it last year and described it as a model of top class care at an affordable price.
The clinic has also one of the biggest innovation centres in the world for medical devices, a sector which is of increasing importance to Ireland and which has been a rare success story in recent years.
Its head of innovation, Dr Brian Griffin, is an Irish-born cardiologist who will speak at the National Healthcare Conference on Thursday at the Burlington Hotel. He will outline 10 of the most important medical device innovations this year.
His presentation on innovation is topical given that the Government's Innovation Taskforce argues strongly for investment in research and development that can be led to the development of products which will create employment in Ireland.
In that regard Dr Griffin will have a good news story for delegates. The Cleveland Clinic has begun a partnership approach with the burgeoning Irish indigenous medical devices sector.
A delegation from the clinic, including Dr Griffin, was given a tour by Enterprise Ireland last year of some of the country's indigenous medical device manufacturers.
"Ireland has been very successful in recruiting the biggest and best of the medical devices companies and are beginning to leverage that into spin-off companies," he said.
"I was amazed at the sophistication of some of the companies involved in Galway and Dublin. I was unaware of how sophisticated some of these smaller companies which had started off as large companies have become."
He singled out Creganna, a medical devices manufacturer in Galway city, as a prime example of an innovative Irish company.
Cleveland's chief executive, Dr Toby Cosgrove, came to Ireland last year to meet Taoiseach Brian Cowen and to brief him on their Irish plans.
Cleveland is now anxious to team up with Irish companies. The clinic has been given a grant to carry out medical innovations by the state of Ohio from funds raised out of a class action suit against tobacco companies operating in the US.
The clinic is using the money to grant-aid start-up companies to pursue their innovation on campus. "We are interested in having Irish companies who want to do their international development here," he said, adding that one such company has already taken up the offer. The clinic is also hoping that some American companies can carry out their non-US development work in Ireland.
Cleveland has also been negotiating with an Irish company to set up a 24-hour call centre which would be accessible for US patients.
"I left Ireland in the 1980s and the country is immeasurably better off
than it was then," remarked Dr Griffin. "Ireland is a very driven society. I
don't see it going back to being a backwater. I see good times ahead for Ireland."
The clinic has also linked up with the Royal College of Surgeons of Ireland (RCSI) and its Centre of Innovation in Surgical Technology (CIST), which is aiming to commercialise and patent medical devices.
Cleveland and the RCSI are looking to move forward together on six different projects. They are collaborating on new areas of surgery and medical devices, and CIST will carry out clinical trials and design evaluations of their devices. Possible start-ups could emerge out of this on both sides of the Atlantic.
CIST head of innovation Derek Young, who will also speak at the conference, said the aim was to have a central hub for ideas whereby technicians can link up with medical staff to bring innovative proposals to fruition.
CIST has 46 different medical devices for which it is currently building prototypes or going through the latter stages of development. Two in particular, a new ureteral catheter and a bone displacement device, are in the late stages of development.
"We have all the expert advice we need in this country. We don't need to look elsewhere," he said.
"We have been traditionally very manufacturing orientated in the medical device sector. The switch that has emerged is that research and development can be done here. The potential is there to harness our own ideas on our own doorstep," he added.
TURNING IDEAS INTO REALITY: EXAMPLES OF MEDICAL DEVICE INNOVATIONS IN RECENT YEARS
Continuous-flow ventricular assist devices: Tiny devices weighing 85g surgically attached alongside the heart that quietly and effectively take over the pumping duties of the organ.
Forced exercise to improve motor function in patients with Parkinson's disease: Pedalling at 90rph on a tandem bike to dramatically improve the motor functioning of patients with Parkinson's disease.
Fertility preservation through oocyte cryopreservation: A rapidly improving technology that allows the eggs of a healthy woman to be safely frozen and stored, ready to be thawed and fertilised at a later date.
Outpatient diagnosis of sleep-related breathing disorders: Self-contained reliable at-home sleep-monitoring devices for the screening, diagnosing and treatment of sleep-related breathing disorders.
Medtronic Gets FDA Nod For Complete SE Vascular Stent System
Medtronic has received FDA approval for the Complete SE Vascular Stent System to be used for the treatment of peripheral arterial disease (PAD) in the iliac arteries, major blood vessels within the pelvis that supply blood to the lower extremities.
Medtronic Complete SE Vascular Stent System features several advances, including a dual-deployment delivery system with a triaxial design. The new delivery system is made up of an inner shaft, a retractable sheath and a stabilizing sheath that reduces friction and allows the retractable sheath to move back freely. This decreases the amount of force required to deploy the stent, thereby making deployment easy and precise.
Medtronic said that in other areas of company's PAD clinical research program, physicians are progressing with enrollment in two additional indication-specific trials, one investigating the use of the Complete SE stent for the treatment of superficial femoral artery stenoses, and the other studying the balloon-expandable Assurant Cobalt stent in treating iliac artery disease.
According to the Peripheral Arterial Disease Coalition, PAD of the lower extremities affects approximately eight million people in the US, although many patients are unaware of their condition or the seriousness of it. PAD results in a two- to six-fold increase in cardiovascular mortality and an increased risk of amputation, disability and diminished quality of life. It often signals atherosclerosis in the heart and the brain, the PAD Coalition reports.
Robert Molnar, MD of Michigan Vascular Research Center in Michigan, said: "The Complete SE Vascular Stent System provides physicians with a new treatment option that offers significant benefits for patients with narrowed iliac arteries due to peripheral vascular disease. The system enables highly accurate stent placement in the iliacs, reducing the likelihood of stent 'jumping,' which we commonly see during deployment with the use of many self-expanding stent systems."
Sean Salmon, vice president and general manager of Coronary and Peripheral, part of the CardioVascular business at Medtronic, said: "FDA approval of the Complete SE Vascular Stent System for a peripheral indication marks a successful milestone in our PAD clinical research program.
"Following our acquisition of Invatec, this approval augments Medtronic's offerings in a large and growing market where patients are significantly under-diagnosed and could benefit from expanded treatment options."
Abbott Acquires Facet Biotech
Abbott, a global health care company into discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostic, has acquired Facet Biotech to strengthen its pharmaceutical pipeline in immunology and oncology.
The acquisition provides Abbott with a biologic intended to treat multiple sclerosis (MS) and compounds that complement its existing diverse oncology program.
The new Abbott compounds include daclizumab, a Phase II investigational biologic intended to treat MS that is expected to move into Phase III development in the second quarter 2010.
The final step in the acquisition process was a short-form merger of Amber Acquisition, a wholly-owned subsidiary of Abbott, with and into Facet Biotech. As a result of the merger, all outstanding shares of Facet common stock not tendered in the cash tender offer (other than those as to which holders properly exercise dissenters' rights) were converted into the right to receive $27 per share in cash, without interest and subject to any required withholding taxes.
John Leonard, senior vice president of global pharmaceutical research and development at Abbott, said: "Facet's depth of biologics experience and sophisticated antibody engineering platforms complement Abbott's current R&D programs in oncology, immunology and other therapeutic areas."
Facet Biotech was launched in December 2008 as a spin-off from PDL BioPharma.
Boston Scientific to Immediately Resume Distribution Of COGNIS(R) CRT-Ds And TELIGEN(R) ICDs in the U.S.
Boston Scientific Corporation (NYSE: BSX) announced that it has received U.S. Food and Drug Administration (FDA) clearance for the two validated manufacturing changes affecting all of its cardiac resynchronization therapy defibrillators (CRT-Ds) and implantable cardioverter defibrillators (ICDs), and that it will immediately resume distribution of its COGNIS® CRT-Ds and TELIGEN® ICDs. The Company is positioned to fully meet customer demand for COGNIS and TELIGEN within 24 hours. COGNIS and TELIGEN represent virtually all of the Company's defibrillator implant volume in the United States.
On March 15th and 16th the Company submitted the two manufacturing changes to the FDA for the following CRT-D and ICD product families: COGNIS, TELIGEN, CONFIENTT, LIVIANT, PRIZMT, RENEWAL® and VITALITYT. Solely on its own initiative, the Company has conducted an internal review of manufacturing and other changes for these products, as well as the associated regulatory submissions. The review found a few additional instances where the Company did not submit the appropriate documentation for validated manufacturing changes for CONFIENT, LIVIAN, PRIZM, RENEWAL and VITALITY. The Company has now submitted this documentation and is working closely with the FDA to secure clearances to return CONFIENT, LIVIAN, PRIZM, RENEWAL and VITALITY -- the earlier generations of the Company's CRT-D and ICD products -- to market as soon as possible in the United States. These products may continue to be implanted in geographies outside the United States.
The Company's pacemakers and other products were not affected by the ship hold and product removal actions. Geographies outside the United States were never affected and remain unaffected by these actions.
"We are pleased that the FDA has cleared the manufacturing changes, and that we are again able to offer COGNIS and TELIGEN to U.S. patients and physicians," said Ray Elliott, President and Chief Executive Officer of Boston Scientific. "We are committed to doing the right thing every time, and we acted voluntarily, swiftly and appropriately to ensure compliance with all regulatory requirements. Our entire sales force is energized and hard at work!"
The Company is evaluating the impact of the ship hold and product removal actions on its financial results and will provide an update with the release of its first quarter earnings. These recent actions may have a material impact on the Company's previously issued guidance, including revenue, operating profit and cash flows for the first quarter and full year of 2010.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding our regulatory approvals, internal systems and processes, product performance and availability, and financial results. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.
Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and, future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this document.
Source: Boston Scientific Corporation
HKPB Scientific to create 200 new jobs in Nenagh
UL biotech spinout to create 200 new Nenagh jobs
A spinout biotechnology company from the University of Limerick is set to create up to 200 new jobs over the next five years through opening a new facility in Co Tipperary.
HKPB Scientific is set to locate its new plant at the Lisbunny Industrial Estate in Nenagh on the site of the former Aventis plant.
HKPB produces products such as a pioneering form of bone cement, which is used in procedures including hip replacements. It has also developed a coating technology that will prevent the spread of the MRSA bug.
Nenagh offers potential for companies
Labour MEP Alan Kelly made the HKPB Scientific jobs announcement today.
"I am delighted to have attracted a company of this quality to Nenagh. They are creating the type of jobs we need, high-value, export led jobs that will boost the entire regional economy," Kelly said.
"Nenagh offers unrivalled potential for companies and it baffles me how the Government can allow facilities such as Lisbunny lie idol and fall into disrepair, when there are innovation led, high-potential businesses such as HKPB looking for a base," he added.
"We are talking about a pioneering company that is founded and run by highly educated young Irish people and they should stand as a symbol of what is required to get this county back on its feet.
"Companies such as HKPB offer Nenagh sustainable growth into the future and I expect to see a great deal of jobs coming to the town as a result of this announcement, both directly and indirectly."
Producing in-demand products
"We are going back to basics and producing something that's in high demand," explained HKPB's CFO David O'Flynn.
"The company is delighted to have chosen Nenagh as the next step in our growth. We hope to link up with other business in the area and build a network of mutually beneficial partnerships," he added.
HKPB has strategic links with the University of Limerick, Institute of Technology Tralee and the Royal College of Surgeons in Dublin.
PPD invests E14 million and will create up to 250 jobs at new facility
March 1st 2010
Athlone, Co. Westmeath, Taoiseach Brian Cowen today opened PPD's new contract research facility, which will include an analytical testing laboratory. The new facility will create up to 250 high value positions for Ph.D.-level students, analytical laboratory staff and other clinical development professionals. PPD are investing up to ?14 million in the new facility which is supported by the Irish Government with the aid of IDA Ireland.
The analytical facility will conduct testing for clinical and commercial programs spanning all phases of drug development. The lab will allow the company to continue to serve its growing client base in Europe, Middle East and Africa (EMEA) and to win business in this region. It represents PPD's initial investment toward further expansion of its contract research operations in the country.
PPD is a leading global contract research organisation (CRO) providing discovery and development services to pharmaceutical, biotechnology, medical device companies and academic and government agencies. Clients include almost all of the world's top 50 pharmaceutical companies and more than 250 biotechnology/small pharmaceutical and medical device companies.
Speaking at the opening of the new facility, Taoiseach, Brian Cowen said, 'I am delighted to be here in Athlone today for the opening of PPD's new contract research facility which will create up to 250 high quality jobs in the biotech and pharmaceutical sectors. PPD is a most welcome addition to the Midlands Life Science's cluster and I look forward to a long lasting and mutually beneficial relationship between PPD and this region.'
'The decision by PPD to locate this world class operation here is of great significance to this region and to Ireland as a whole. This is a strategic win for Ireland and is in keeping with the Government's policy on building the 'Smart Economy.' PPD's presence here represents a valuable contribution to the local economy and I look forward with eager anticipation to the growth and development of PPD's Irish operation.'
Speaking at the opening,General David L. Grange, chief executive officer of PPD, said, 'PPD will benefit from Athlone's business-friendly climate and close proximity to the Athlone Institute of Technology, which offers qualified scientists and laboratory professionals. The Irish Government has provided strong support for our expansion, and we appreciate its continuing support as we continue to expand our Irish operations.'
PPD has applied to the Irish Medicines Board (IMB) for manufacturer licenses to support both investigational medicinal products and marketed products and laboratory certifications for quality control of medicinal products. As of March 1, PPD's license applications have been assessed, and the quality system and premises inspected by the IMB. The progression of PPD's applications are under active consideration by the IMB.
PPD is a leading global contract research organisation, celebrating 25 years of providing discovery and development services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organisations. With offices in 40 countries and more than 10,500 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and commitment to quality to help clients and partners maximise returns on R&D investments that accelerate the delivery of safe, effective therapeutics.
Contract Research Organisations (CRO) provide product development services to the pharmaceutical, biotechnology and medical device industries. Development services include drug testing, data analysis, reporting and consulting services to move a drug in development through the necessary regulatory requirements that must be met to seek approval for marketing a drug to the public.
Tactx acquisition beefs up Creganna's medical device capabilities
Creganna of Galway, Ireland, recently completed an acquisition that expands its technologies and services for minimally invasive medical delivery and access devices.
On Jan. 4, Creganna acquired Avalon Medical Services Pte. Ltd., which did business at Tactx Medical Inc. of Campbell, Calif. Terms were not disclosed. Together, Creganna and Tactx had 2009 sales exceeding $100 million.
Now known as Creganna-Tactx Medical, the company employs more than 800 and operates manufacturing facilities in Galway; Campbell; Marlborough, Massachusetts; Plymouth, Minnesota; and Singapore.
Prior to the acquisition, Creganna employed 550 and Tactx 270.
"This move represents a key step in Creganna's vision to build a leading global medical technology company," Helen Ryan, Creganna-Tactx Medical CEO, said in a statement.
Creganna-Tactx exhibited this week at the Medical Design & Manufacturing West trade show in Anaheim.
Abbott Gets European Approval For New Ovarian Cancer Diagnostic Test
Abbott has received European approval for a new diagnostic tool, which studies show, can aid in determining the risk of whether a pelvic mass is benign or malignant. It is now available in Europe.
This blood test is expected to help in the assessment of epithelial ovarian cancer. This immunoassay, which will run on Abbott's Architect systems, is the first automated HE4 test available in the world, claims the company.
Research has shown that this novel diagnostic marker, combined with other tests such as the CA125 assay, can aid in measuring the risk of epithelial ovarian cancer in pre- and post-menopausal women who have a pelvic mass.
Michael Warmuth, senior vice president of diagnostics at Abbott, said: "The ability of this test to help physicians predict whether a pelvic mass is benign or malignant is an important development for both patients and physicians. Abbott's Architect HE4 test will aid physicians in determining the most appropriate treatment for their patients."
Abbott partnered with Fujirebio Diagnostics in the development of the assay. The test is now available in several European countries, as well as in some countries in Asia Pacific and Latin America. The Architect HE4 Assay was recently submitted to the FDA for 510(k) clearance.
Boston Scientific Initiates Patient Enrollment In WallFlex Biliary RX Stent Study
Boston Scientific has reported that the first patient has been enrolled in a clinical trial to evaluate its WallFlex Biliary RX fully covered stent, for the treatment of benign bile duct strictures.
The multi-center, prospective study plans to enroll 187 patients at 11 centers worldwide over the next 18 months.
The trial will evaluate the removal of the stents from patients with benign bile duct structures as well as the effectiveness of temporary stenting for long-term, benign biliary stricture resolution. The study will include patients with bile duct strictures associated with post liver transplant anastomosis, prior abdominal surgery such as cholecystectomy and chronic pancreatitis.
The WallFlex Biliary RX Stent will remain in the patients four to 12 months depending on the nature of the stricture. Patients will be followed for five years after stent removal.
The Stent is constructed of braided, platinum-cored Nitinol wire (Platinol Wire) and features three key components, radial force to help maintain duct patency and resist migration, flexibility to aid in conforming to tortuous anatomies and full-length radiopacity to enhance stent visibility under fluoroscopy.
The Stents have received FDA clearance and CE Mark approval and are indicated for the palliative treatment of biliary strictures produced by malignant neoplasms. The company said that the safety and effectiveness of the system for use in the vascular system have not been established.
Abbott Presents Positive Three-Year Data On Bioabsorbable Stent Technology
Initiates large-scale international trial
Abbott has announced three-year data from the first 30 patients in the first phase of the ABSORB clinical trial, demonstrating that its fully bioabsorbable drug eluting coronary stent successfully treated coronary artery disease and was absorbed into the walls of treated arteries.
Patients in this first phase of the ABSORB trial experienced no stent thrombosis out to three years and no new major adverse cardiac events (MACE1) between six months and three years (3.6% at three years). These results were presented at the 2009 American Heart Association's Scientific Sessions.
Abbott is also initiating a large-scale trial called ABSORB EXTEND, which will enroll approximately 1,000 patients from up to 100 centers in Europe, Asia Pacific, Canada and Latin America. ABSORB EXTEND is a single-arm study designed to further evaluate the performance of Abbott's proprietary fully bioabsorbable stent technology. The study will enroll patients with more complex coronary artery disease and is slated to begin enrolling before the end of the year.
Abbott also announced that patient enrollment is complete for the second phase of the ABSORB trial. The second phase of the ABSORB clinical trial enrolled 101 additional patients from 12 centers in Europe, Australia and New Zealand, and incorporated device enhancements designed to improve deliverability and vessel support.
Abbott's bioabsorbable everolimus eluting coronary scaffold is made of polylactide, a proven biocompatible material that is commonly used in medical implants such as absorbable sutures. As with a metallic coronary stent, Abbott's bioabsorbable technology is designed to restore blood flow by propping open a clogged vessel, and to provide support until the blood vessel heals. Unlike a metallic stent, however, a bioabsorbable scaffold is designed to be slowly metabolized by the body and is completely absorbed over time.
Charles Simonton, divisional vice president of medical affairs and chief medical officer at Abbott Vascular, said: "Abbott continues to make advancements with its promising bioabsorbable technology. The second phase of the ABSORB trial enrolled very quickly, which is a testament to the excitement among the clinical community around the potential shown with this technology. We look forward to starting the ABSORB EXTEND trial to further evaluate promising attributes of our fully bioabsorbable technology in a broader patient population."
Abbott's Xience Prime, Xience V Obtain Additional CE Markings
For the treatment of patients with diabetes
Abbott has announced that Xience Prime everolimus eluting coronary stent system and the Xience V everolimus eluting coronary stent system have received additional new CE Markings covering the treatment of patients with diabetes.
In addition to diabetes, Xience Prime and Xience V also received CE Mark for expanded indications to treat patients that have complex disease, including dual vessels, small vessels. The expanded indications for Xience Prime and Xience V are based on randomized clinical trial data from the SPIRIT family of trials that support the safety and performance of the stents in these patient subgroups.
Both Xience Prime and Xience V leverage the outcomes from the extensive body of clinical evidence from the SPIRIT family of clinical trials. Most recently, data from the company's SPIRIT IV trial comparing Xience V to the taxus express paclitaxel-eluting coronary stent system were presented at the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting in September 2009.
Charles Simonton, divisional vice president of medical affairs and chief medical officer of Abbott Vascular, said: "This expanded indication further confirms Xience Prime and Xience V as important options for physicians who are treating patients with diabetes. The deliverability of both devices provides physicians with confidence to easily reach the lesion site."
Medtronic Catapults Into Transcatheter Valve Market With Billion-Dollar Buys
The firm announced Feb. 23 that it will acquire CoreValve for $700 million, plus milestone payments, and earlier-stage Israeli firm Ventor Technologies for $325 million.
The deals are not a big surprise. Medtronic made its plans public last year to enter the nascent transcather aortic valve space, which some analysts project could become a billion-dollar-plus worldwide market in five years.
While the device giant already has some intellectual property covering percutaneous delivery of aortic heart valves, Medtronic was still years away from getting a product into pivotal trials on its own.
With CoreValve, whose CEO Daniel Lemaitre is a former Medtronic senior VP, and Ventor, Medtronic will be in a better position to compete with Edwards LifeSciences, which up until now has been the largest company with a transcather aortic valve.
CoreValve Ahead In Europe, Behind In U.S.
The purchase of privately-held CoreValve immediately makes Medtronic the market leader in Europe for minimally invasive aortic valves. CoreValve's ReValving percutaneous valve, inserted via the femoral artery, controls about 56% of the approximately $80 million-$100 million market against its only competitor, Edwards' Sapien.
But Medtronic will likely still lag well behind Edwards in the U.S., where transcatheter valves have yet to reach the market.
Edwards aims to complete enrollment of its 1,040-patient FDA pivotal trial this year and to launch Sapien in the U.S. before the end of 2011 (though some analysts believe 2012 is more realistic), whereas Medtronic projects a U.S. launch of its first transcatheter aortic valves - an offering each from the CoreValve and Ventor portfolios - in 2014.
The CoreValve deal includes plans for two $75 million milestone payments. The first is contingent on investigational device exemption approval for ReValving's approximately 1,100-patient pivotal U.S. trial by March 2010. The second depends on the product generating at least $150 million in revenue in Europe by December 2012.
Despite its market leadership in Europe, ReValving is only marginally profitable for CoreValve because the firm relies so heavily on third-party distributors. Medtronic does not immediately plan to adjust distribution channels for the valve, though a direct sales operation will be established over the longer term, according to Medtronic spokesman Daniel Beach.
"They have done an excellent job of building the necessary infrastructure to educate physicians and a lot of that is done through their distribution," he said in an interview. Physician education "is going to be as valuable to the long-term future of the transcatheter valve segment as the refinement of the technology."
Medtronic Gains Two Valve-Delivery Approaches
The deal for privately-held Ventor does not include milestone payments. But Medtronic says it plans to hit the ground running in initiating a U.S. pivotal trial for the investigational stage firm's Embracer transapical-delivered valve.
"Our focus for the moment is that we have an IDE approved as rapidly as possible," Beach said.
To compete with Edwards on all fronts, the goal is to launch Embracer domestically alongside ReValving in 2014, he explained.
Edwards' Sapien is available in Europe using two delivery approaches. It can be inserted transfemorally, beginning with an incision in the groin, or transapically, via a small incision in the rib cage. The former is performed primarily by interventional cardiologists and the latter by cardiac surgeons. Edwards' intricately designed U.S. trial is evaluating both approaches.
With ReValving limited to transfemoral delivery, Medtronic's ability to access the transapical market through Ventor is important, particularly since about 70% of patients needing valve replacements have anatomies that don't make them candidates for the femoral approach, Beach explained.
With smaller valve designs, the proportion of patients who are candidates for the percutaneous femoral artery procedure will substantially increase. But, Beach said, "Even when the devices get smaller, which they will with our planned second- or third-generation transfemoral approaches, there is still going to be at least 20% of the market that is going to need the transapical approach."
Farther back in Ventor's pipeline is a transfemoral valve technology that Medtronic plans to integrate with CoreValve intellectual property as well as Medtronic IP - providing a next-generation transfemoral product down the road, Beach noted.
The transcatheter aortic valve technology from CoreValve and Ventor also complements Medtronic's Melody transcatheter pulmonary valve, which is available outside the United States and slated to debut domestically by 2010.
Deals Validate Market, But Challenges Remain
While market analysts agree that Medtronic's move puts more pressure on Edwards, they generally also see it as a positive sign for the market.
For Edwards, "We see Medtronic's deals as more validation than increasing competitive risk," writes Morgan Stanley's David Lewis in a Feb. 23 research note. "This is a large market. Edwards has plenty of resources in valves ... to compete, and remains 2-3 years ahead in the U.S."
Wachovia's Larry Biegelsen points out that Edwards and Medtronic already compete in the surgical valve arena, where Edwards maintains a leadership position and where Medtronic has recently lost some market share. This "suggests to us that Edwards can compete effectively versus Medtronic," he writes Feb. 23.
But how the minimally invasive aortic heart valve market will play out is far from clear, particularly in the U.S., where the path to approval is perilous.
Edwards' PARTNER U.S. pivotal trial required a redesign mid-stream, causing the company to delay its target launch date from 2009 to 2011. And some cardiologists say the company will be challenged to get good enough mortality data to convince FDA of success in every arm of the pivotal trial.
Patients in the arm comparing transapical delivery and open surgery have a relatively large number of comorbidities, making it difficult to reach a statistically significant result, some point out. Also, a PARTNER U.S. investigator has voiced concerns that the mortality endpoint will be tough to reach in the arm comparing transfemoral valve delivery with drug therapy.
Medtronic will not be immune to clinical development challenges, either. "It is going to be necessary to develop an awful lot of clinical evidence for these valves," spokesman Beach acknowledged.
Further, the different product platforms each have inherent plusses and minuses. The ReValving device is ahead in the European market primarily because it is has a smaller profile compared with Sapien, and, thus, can be used in a greater number of transfemoral procedures. Edwards is developing a smaller diameter version of Sapien that it plans to have ready in Europe in 2010.
Both CoreValve's and Ventor's products are built on a nitinol stent frame, whereas Sapien has a stainless steel foundation. Nitinol allows the products to be self-expanding and to be retracted and repositioned during valve delivery. But FDA's prior experience with nitinol stents has led the agency to take extra care in checking for the likelihood of stent fractures, a matter that may be contributing to delays in getting the ReValving U.S. trial up and running.
The picture could become cloudier before it gets clearer as other big players enter the space. St. Jude Medical announced earlier this year its plans to initiate transcatheter aortic valve trials. While Johnson & Johnson also is developing transcatheter valves, some market watchers speculate that J&J could eventually seek to buy Edwards.
The Medtronic deals, says J.P. Morgan analyst Michael Weinstein in a Feb. 23 note, increase Edwards' "scarcity value, as its Sapien platform now represents the only remaining late-stage asset available for other players eyeing an entry."
That said, Weinstein doesn't expect an acquisition of Edwards to be considered until mid-2010 at the earliest, when there could be more clarity on the outcome of the Sapien pivotal trial.
Irelands newest pharmaceutical devices company, Blue Box Sensors spun out of NUI Maynooth
NUI Maynooth has today announced the latest spin out from the University. Based on patented technology by Prof John Lowry, head of Chemistry Dept, Blue Box Sensors Ltd will manufacture devices that can track levels of chemicals in the brain in real time over the course of weeks or even months. The sensors offer fresh insights into the workings of the brain and stand to improve preclinical research and drug discovery for a range of diseases including Alzheimer's, Parkinson's and schizophrenia.
Speaking at the announcement, Prof Lowry explained how he started developing the sensors; "my initial aim was to develop electrodes to investigate and study the brain. Over the last few years, the focus has been on designing the chemistry of the surface of the electrode, to give selectivity for the molecule to be measured and validating the approach".
According to John Scanlan, Director of Commercialisation at NUI Maynooth, the commercial potential of the sensor technology is already apparent, with interest being expressed from a number of leading pharmaceutical companies. "The management team we have pulled into Blue Box Sensors have been involved in selling the technologies that this sensor technology will replace," he commented. "They are close to the market, close to the customers and know the demand potential". He believes the company will grow organically, working towards building up a reputation within the industry and regulators, with the aim of replacing the standard practice of microdialysis which is limited by not being real-time and by not being as sensitive.
Their eyes are also on a powerful stamp of approval, according to Scanlan. "The ultimate goal would be to have it FDA approved so that the FDA request data from Blue Box sensors, in the knowledge that the sensors provide the best data," he says.
The sensor devices will be manufactured in Galway.
Prof Lowrys original research was funded by Science Foundation Ireland and the commercialisation activity funded by Enterprise Ireland.
Eight of the world's 10 largest medical device companies are located in Ireland
Eight of the world's 10 largest medical device companies are located in Ireland, with Europe's premier cluster of device companies based in the Galway region.
Examples of global companies with substantial operations include Abbott, Bayer, Becton Dickinson, Boston Scientific, Johnson & Johnson, Guidant, Medtronic and Stryker. The sector employs over 26,000 people in 130 companies and generates sales in excess of 6 billionEuro annually, with annual growth approaching 16 per cent. Over half of the medical technologies companies based in Ireland have dedicated R&D facilities.
This continued investment has stimulated the emergence of an indigenous cluster of over 100 innovation-led companies along the entire Medtech value chain - from R&D intensive technologies, to proprietary products, contract design and manufacturing, packaging and sterilisation. This has positioned Ireland as a world-class centre of excellence for medical devices.
The Irish Government has committed to an 8.2 billionEuro investment in science and technology research up until 2013, funding centres of excellence like the 15 millionEuro Regenerative Medicine Institute (REMEDI), a world-class biomedical research centre focusing on gene therapy and stem cell research, and the 23 millionEuro Biomedical Diagnostics Institute (BDI), a multidisciplinary research institute focused on the development of next generation biomedical diagnostic devices.
Royal College of Surgeons in Ireland (RCSI) Colles Institute currently consists of three centres: the National Surgical Training Centre (NSTC) which provides education and training programmes in Ireland; the Centre for Innovation in Surgical Technology (CIST) which develops and commercialises surgical technology ideas from industry, clinicians, or researchers; and the Centre for Clinical Research and Development (CCR&D) which provides clinical research services to industry, clinicians and researchers.
Key Characteristics and Growth Areas
- Cardiovascular: 80 per cent of global stent production is carried out in Ireland, with significant investment by Abbott, Boston Scientific, Guidant and Medtronic. The Galway Medical Devices Centre of Excellence (GMedTech) is actively focused on cardiovascular research in four key research topics: abdominal aortic aneurysms; cranial aneurysms; coronary artery disease and the venous system. Other areas of research include the human musculoskeletal system, dentistry, urology and reconstructive surgery.
- Orthopaedics: Ireland hosts manufacturing facilities by industry leaders Stryker, J&J, DePuy and, most recently, a 50 millionEuro investment by Zimmer.
- Diagnostics: Six of the top 7 global diagnostics companies are located in Ireland, including Abbott Diagnostic and Beckman Coulter.
1millionEuro to attract world-class researchers to Ireland (SFI)
Minister Lenihan announces funding of almost 1millionEuro to attract world-class researchers to Ireland at the launch of the Science Foundation Ireland Annual Report 2008
Ireland continues to attract world-class researchers through SFI investment" - Lenihan
The Minister for Science, Technology & Innovation Mr. Conor Lenihan TD today (September 30th 2009) announced funding of almost 1mEuro to attract world-class researchers to Ireland through Science Foundation Ireland's Walton Visitor Programme. The Minister made the announcement at the launch of SFI's Annual Report for 2008.
Minister Conor Lenihan said "I am delighted that through the Science Foundation Ireland Walton Programme, Ireland is able to further enhance our reputation as a location for high-quality scientific research. With this funding of nearly 1mEuro, 16 top-class researchers have chosen to come to Ireland to carry out research with some of the world-class people we have here. Their collective efforts will benefit Irish industry and strengthen our connections with the international research community across the globe."
In launching the 2008 SFI Annual Report, Minister Lenihan said "By directly supporting 2,812 researchers and collaborating with over 300 companies SFI is playing a key role in the Irish economy and in the Government's strategy to build a Smart Economy."
"The Government, through SFI, is helping to further embed existing firms in the Irish economy as well as being a major magnet of attraction for the IDA in their efforts to secure additional foreign investments and growing employment opportunities in Ireland."
"The importance of SFI to our economy was further recognised by Government during 2008 when the SFI remit was also formally extended to include sustainable energy and energy-efficient technologies." the Minister added.
Chairperson of SFI, Professor Pat Fottrell, speaking on the SFI Annual Report's publication, remarked: "2008 was, in many respects, a defining year in SFI's journey to date. The year was one in which the importance of science, R&D, and investment in innovation was brought sharply into focus not just in Ireland, but globally too. The proposition that economic recovery is best initiated by having a sound and flourishing research base was one that gained currency over this period, and has been reflected, for example most notably, in subsequent investment by President Obama's administration. Also the positive endorsement of SFI's activities by Indecon International Economic Consultants in its 'Value for Money' report on SFI was independent, authoritative confirmation that we are on the right track and recording meaningful and measurable progress of benefit to Ireland".
Speaking on the SFI E.T.S. Walton Visitor Programme, Director General of SFI, Professor Frank Gannon said "Our host institutions around the country look forward to welcoming leading researchers from the UK, USA, Belgium, Germany, France, Singapore and Russia. Such a wealth of research talent coming to Ireland is of immense benefit to our own pool of researchers, and significantly raises our international standing."
Business Achievers Award for Crospon
Crospon, a medical device developer based in Galway, has won a Connaught Business Achievers Award for 2008 in the 'Ones to Watch' category. Now in its 15th year, the Ulster Bank Business Achievers Awards aims to reward success at a provincial level before finalists go forward to an all-island awards ceremony. The regional winners were announced at a reception held on Wednesday 3 December at the Clayton Hotel, Galway.
Crospon Limited develops leading edge, minimally invasive medical devices for monitoring, diagnosis and therapy in the areas of endocrinology and gastroenterology.
Commenting, John O'Dea, CEO Crospon Ltd said, "We are absolutely delighted to have won the 2008 'Ones to Watch' Business Achievers Award for Connaught. The quality of the other companies on the shortlist underlines the merit of the Ulster Bank Business Achievers Awards. As a company, we will be looking forward to the national awards and hope to represent Connaught with distinction."
The company also announced that it has completed an additional ?500,000 funding round. This follows on from the announcement earlier this year of the completion of a ?3million round of financing.
Crospon secured an initial ?2.3 million seed funding secured in June 2007. This additional funding will be primarily used for the completion of development, manufacturing startup, and preparation to market the company's EndoFLIP® system that is used to enhance diagnosis and assist in the surgical treatment of gastroesophageal reflux disorder (GERD). The company also launched a new EndoFlip website http://www.endoflip.com. The EndoFlip® system is the first of a range of products the company plans to bring to market.
In November, Crospon and HP's Smart Drug Delivery Patch was listed in Popular Science's magazines annual 'Best of What's New' for 2008. The Patch technology was one of just 11 detailed in the Health category.
Medtronic move to Galway from the US
Medtronic annoucned plans for wordwide cuts in their staffing, in 2008. Up to 1,100 jobs worldwide are expected to go, which is almost 3% of it's workforce. Thankfully this comes with a good note for Jobs in Galway, as Medtronic are moving their endovascular manufacturing operation from Santa Rosa, California, USA to Galway . The endovascular division makes stent grafts to treat aortic abdominal aneurysms. It is also moving some of it's operations (diagnostic and cardiac rhythm disease management) to Holland.
Medtronic specialises in medial technology for chronic diseases. They manufacture products and therapies and services to alleviate pain and enhance peoples lives. Each year over 6 million people world wide use Medtronics services in the treatment of heart disease, diabetes and vascular illnesses.
Tánaiste announces major expansion of Cook Medical in Limerick with 200 new jobs and ?25 million investment
Cook Ireland Limited
Irish Facility to be the sole global manufacturing site for new stent product
Tánaiste and Minister for Enterprise, Trade and Employment Mary Coughlan TD today (30th September 2008) announced that Cook Medical, one of the world's largest privately held medical device companies, is to invest ?25 million, with the support of Government through IDA Ireland, in the expansion of its medical devices manufacturing and services facility - Cook Ireland Limited - in Limerick. The investment will add 200 high quality jobs over the next five years. It will also establish the Limerick operation as the sole global manufacturing site for Cook's new drug eluting stent, Zilver PTX, for the treatment of peripheral arterial disease. This is the first time such a stent will be manufactured in Ireland.
Cook Ireland Limited established in the National Technology Park, Limerick, in 1996 where it currently employs 480 people in the production of devices for a range of medical areas including urology, gastroenterology, women's health and surgery. A number of European management roles are housed at the facility and the diverse range of manufacturing and services activities performed there include customer services, sales support, marketing, production, regulatory, distribution and R&D.
The Tánaiste, welcoming the investment, said "Today's news is another fantastic development for the thriving medical technology industry in Ireland. This is the 10th significant investment by a multinational company from the medical technologies sector in Ireland since the beginning of this year."
"It is superb news for the staff and management of Cook Ireland. The Irish facility has secured the manufacturing investment for a leading-edge product and will result in 200 new jobs in the company. Cook is a great company and its medical device products are at the forefront of technology. Since establishing in Limerick in 1996, the operation has seen continuous development well beyond its original mandate and this investment will add further strategic value and importance to the facility. The company has also undertaken collaborative R&D with University of Limerick and Dublin Institute of Technology, an area in which this Government is fully supportive'" the Tánaiste concluded.
Bill Doherty, Vice President of Cook's European business said "The Limerick facility's successful track-record in implementing and delivering a variety of projects over the past 12 years was a significant factor in Cook's decision to undertake this strategic investment at the site. As the investment forms part of our company's future international growth plans, it is essential that we have confidence in the ability of the chosen location to deliver to the strict deadlines and exacting quality standards required. We have that confidence in the Limerick team. In addition, our experience in Limerick demonstrates Ireland's ability to provide the right people - highly skilled and adaptable which are needed for the next phase of our development."
Tax report will help attract skills and R&D Investment here in Ireland
Our aim should be to foster a self-sustaining innovation ecosystem, writes RAY O'NEILL
BEYOND THE headline grabbers the report of the Commission on Taxation contains several recommendations that will impact positively on Ireland's ability to develop a balanced and sustainable approach to innovative, high-value economic activity.
First item of interest is a proposal to put in place a new system of tax incentives to increase the attractiveness of Ireland as a location for individuals with specific skills that Ireland cannot immediately provide. A 25 per cent tax credit on salary for three years is proposed.
It might be seen as unfortunate that Ireland cannot provide all the high skills that industry requires, but it is only realistic to recognise there are specific skills deficits in the short term in areas of strategic importance, and that some importation of talent is required.
A second set of important recommendations are aimed at supporting new businesses.
The third point is the proposal that the 25 per cent tax credit on research and development should continue, but that companies should have the option to offset credits against employer PRSI. The rationale is to make Ireland a more attractive location for multinational companies interested in pursuing R&D.
In 2008, ?2.6 billion was spent on research, development and innovation activities in Ireland. This represents 1.7 per cent of GNP or 1.4 per cent of GDP, which compares poorly with a 2.25 per cent GDP average for OECD countries. Of that sum, ?1.6 billion is invested by firms carrying out R&D in Ireland. Just under ?1 billion is derived from Government, EU and other non-profit sources.
The ?1 billion is invested by agencies such as Science Foundation Ireland and Enterprise Ireland, and lags the OECD average in this sphere by about 0.1 per cent of GNP (about ?150 million).
The main value of this funding is in developing genuinely new ideas, in training innovative thinkers and researchers, and ensuring Ireland has the internal capacity to understand and benefit from scientific and technological progress worldwide. It is a central factor in attracting high value foreign direct investment. Such investment includes companies such as IBM, De Puy and AON, so there is hard evidence that the strategy is bearing fruit.
Despite these successes, investment in R&D in the business sector (?1.6 billion in 2008) provides cause for reflection. It represents only 58 per cent of the OECD average expenditure. Over 70 per cent of the business spend on R&D is by foreign-owned companies.
Ireland's prosperity depends on further development of high value activities including high quality manufacturing, international services and associated R&D.
Our aim should be to foster a self-sustaining innovation ecosystem for small and large firms, while partnering with government agencies and universities. The Medtech approach in Switzerland is an interesting model that Ireland might learn from. Medtech is an umbrella body with members in private and public institutions, from industry, research and regulatory bodies. Medtech focuses on consolidating a network approach to improving healthcare and biomedical products and international awareness of them.
Most of these elements are present here in sectors including ICT, biopharma and biomedical devices. But our approach is less co-ordinated than that of the Swiss. Changes in this area proposed by the commission are a positive move that will help promote a healthy innovation ecosystem - and they should be adopted.
Ray O'Neill is vice-president for research at NUI Maynooth
Bio Medical Research Ltd - back on track
Getting BMR back on track after its US disaster was top priority for chief executive Trish Smith, and now company growth is high on her agenda.
When Trish Smith joined Galway firm Biomedical Research (BMR) as chief executive almost five years ago, the company was in a perilous state.
After building a solid business for its Slendertone toning devices, BMR had hit a major hurdle when its entry into the US market was wiped out by cheap and ineffective imports. By the time the imports were regulated, consumers had lost faith in the devices.
The episode cost BMR dearly, and the firm almost went to the wall before getting new investment. Smith, who is a qualified cardiologist, led a turnaround of the firm - in the process generating lots of headlines about BMR getting in shape, slimming down and toning up.
In the past year, however, she has found that growing a company and keeping profits up can be just as challenging as rescuing it from financial crisis. BMR had sales of about ?57 million last year, up from ?50.2million in 2006, but operating profits dipped to ?5 million from ?6.2million.
It's still a healthy figure, but Smith doesn't like to see the figure ''trending in the wrong direction'' and is determined to reverse the slide. Her to-do list for this year includes expansion into new markets, new Slendertone product ranges, and ambitious plans for the other side of BMR's business, a German-based medical devices unit called Neurotech.
Smith said that last year was ''a tale of two businesses'', with some distribution issues affecting Slendertone, while Neurotech performed very strongly. The Slendertone devices stimulate muscles to create the same effect as exercise, although Smith is aware that people are sceptical.
''The first question everyone asks about Slendertone is: does it work? Well, of course it works. We wouldn't be able to sell it as a medical device if it didn't. You can't make outrageous claims if you are regulated by the FDA [the Food and Drug Administration in the US]."
Re-entering the US market been a big part of Smith's focus and, in 2006, BMR bought back the US distribution rights to Slendertone from an American partner. The firm decided to sell direct to consumers, mainly through so-called 'infomercials', but by the second half of 2006, it decided that was not the best approach for the business.
''People don't expect to see a premium brand with solid R&D behind it advertised on direct TV," Smith said. "Dealing direct through infomercials was limiting our prices and was too complicated. It just had too many pitfalls."
BMR decided on a shift to ''a more familiar European retailing strategy'' for Slendertone, and has invested heavily in building relationships with retailers, according to Smith.
''Last year was a year of investment and there has been a lot of care and nurturing required," she said. Smith now spends about one week a month in the US and also spends a lot of time on video conferences to keep track of the other 24 markets where Slendertone devices are sold.
''Our core European markets are very strong - all our European markets had double-digit growth last year," she said, attributing the rise to increased distribution and better awareness of the products.
''We also added a couple of significant new markets in 2007. "We got Korean regulatory approval at the beginning of the year and launched about March. The brand does very well in Korea, and premium brands like ours do well in the Middle East too."
Smith expects some growth in the Japanese market this year, after the launch of the new Slendertone System range was delayed last year.
''It has been a solid brand [in Japan] since 2005, but we didn't get to launch the System range in 2007. That will start in March this year."
The episode highlighted for Smith the downside of dealing with distributors, rather than selling directly and retaining full control.
''We had put a lot of work into the launch in the second half of 2007 and our operating profits would have been a lot healthier if that had happened. But, with Korea and Japan, we will be in a very solid position by the end of 2008."
While the developments in the US and Japan caused the dip in profits, Smith said she was not disappointed with BMR's performance last year. "I firmly believe that we have the right strategy. Things may take us a little bit longer, but it is about diligence and discipline and making sure that money is invested appropriately," she said. The funding for BMR's turnaround came from Bank of Scotland (Ireland), which injected ?13 million into the business in 2003.
Some individual private investors also backed the firm in 2005 and, in 2006, it raised an ?8 million loan to fund the buyback of the US distribution rights and the growth of the American business.
The company's accounts show that the ?8 million is due to be paid back next year and Smith said the firm would have ''no problem'' doing so. In the past year, she has used some of the money to build her management team, hiring a new operations manager, chief financial officer, marketing director, head of IT and US vice president.
''It has taken a long time, but we have the jigsaw pieces in place," she said. "I am delighted with the team - that was the big win of 2007."
In total, BMR employs 236 people, with the group headquarters and Slendertone business based in Galway and the Neurotech business based in Germany. Almost 150 of the staff work for Neurotech, which is more labour-intensive than Slendertone. While Slendertone is a consumer business, Neurotech makes medical devices that stimulate damaged muscles and help manage pain.
''The medical devices business is absolutely flying. It has grown very dramatically, with a 21 per cent increase in revenues last year," said Smith.
Most of Neurotech's growth came in Germany and ''internationalisation'' is one of Smith's main priorities for 2008. "We are having conversations with prospective partners in the US and are dealing with a couple of candidates. One of them in particular would be a very good partner - we could sell their products in Europe, and they could sell ours in the US."
Neurotech is also expanding its research and development (R&D) efforts and looking at opportunities in orthotics and bracing, according to Smith. "It is a much easier business [than Slendertone] in some ways. It is more stable than consumer electronics and you can be very clear about what your investment will deliver."
If Neurotech can strike the right deal in the US, it would ''signal a new era for that business'', Smith said. "I'm desperate for Neurotech to become an international business and a lot of hard work has gone into it. It could be a very strong European business in the US."
On the Slendertone side, Smith wants to build the retail operation in the US, aiming for ''steadier growth''. Where the firm once used celebrity endorsements, she is much keener on getting sports scientists, personal trainers and physiotherapist to back Slendertone.
She has high hopes for the System range, which comes with an iPod-style controller with rechargeable batteries. It can be plugged into a range of Slendertone devices, including shorts or a miniskirt. "It is a brilliant innovation. All women are bothered about saggy bottoms. It's difficult to train those muscles - and age doesn't help."
The firm is also considering a product to tone facial muscles. ''That is a premium opportunity for Slendertone," Smith said. "Muscle atrophy does cause changes to facial appearance, and we need to collect clinical evidence to back up the design of a product for the facial muscles."
BMR is also investing in its ecommerce strategy and hopes to build its sales over the internet. Smith said that Tom Kirwan, the chairman of BMR, had been very supportive throughout the turnaround and growth, as had Enterprise Ireland and Udaras na Gaeltachta.
''It is hard and challenging at times, and it can be a rollercoaster ride when you are dealing with distributors," she said. "There are still a couple of jobs to do on both sides of the business."
She has scaled back her expectations for the business somewhat and said previous forecasts of sales of ?100 million by 2009 were ''probably over-optimistic''. In stead, sales will be ''over the ?60 million mark'' this year, and ''significantly over'' that if its new strategy in the US pays off.
While this year marks the fifth anniversary of the Bank of Scotland (Ireland) rescue package, Smith said that BMR had no plans ''right now'' for a trade sale or flotation.
''We have enough to do," she said, adding that an option such as a flotation on the Alternative Investment Market (AIM) in London ''would muddy the waters'' for the firm's growth strategy.
So, if Smith's ultimate message is that using BMR's products ''should be a pleasure, rather than a chore'', could she say the same about running the company? ''Most of the time. Unless you're sat in an airport with a delay for hours that you weren't expecting," she said, laughing.
Covidien Ltd.'s shareholders approve a plan to change Covidien's place of incorporation from Bermuda to Ireland
Covidien, parent of St. Louis-based Mallinckrodt Inc., cited tax and legislative reasons for wanting to move the country of incorporation.
The company pointed to the "possible adoption of various legislative and regulatory proposals in the United States" including "proposals introduced in the U.S. to limit tax treaty benefits to companies that are domiciled and tax resident in countries that do not have tax treaties with the U.S., and potential federal and state legislative proposals that would deny government contracts to such companies."
"If enacted, we determined that these proposals, due to their potentially wide-ranging scope, could have a material and adverse impact on the company and its shareholders," the company said.
Covidien said it selected Ireland because it has conducted business there for nearly 30 years and has 6 facilities and 2,000 employees there. The company also liked that Ireland "enjoys strong relationships as a member of the European Union," and that it's an English-speaking nation.
Covidien, formerly known as Tyco Healthcare, operates Covidien Imaging Solutions, also known as Mallinckrodt, which is located in St. Louis and provides medical imaging technology and pharmaceuticals. It was spun off from Tyco International Ltd. in 2007.
With 2008 revenue of nearly $10 billion, Covidien has 1,500 employees in St. Louis, more than 2,500 in Missouri and more than 41,000 employees worldwide.
Cappella Inc. secures 17.3 million dollar series C Investment
New and existing investors complete a $17.3 million Series C investment
Experienced medical device executive, Dr Art Rosenthal, appointed as CEO
Aggressive launch of SideguardTM Sidebranch stent in EU following recent CE Marking
Expansion of management team, R&D and manufacturing capacity in Galway, Ireland
Cappella, Inc. (Cappella) announced today (15th June, 2009) that it has completed a $17.3 million Series C investment, led by new investors, Fountain Healthcare Partners and Mitsui & Co. Venture Partners (MCVP). Enterprise Ireland also participated in this round alongside Cappella's existing investors, Polytechnos Partners and ACT Venture Capital.
Proceeds will be used to finance the launch of Cappella's proprietary SideguardT Sidebranch stent for the treatment of Bifurcated Vascular Disease in Europe and to advance key R&D programs in Galway on additional applications of Cappella's technology in Complex Coronary Artery Disease (CAD).
Commenting on this financing, Dr. Art Rosenthal, Cappella's recently appointed CEO, said 'This funding will allow us to expand our pipeline, to supplement on-going clinical studies and to successfully launch our first product, the SideguardTM Sidebranch stent. We believe our proprietary products will treat many types of bifurcation disease, including Left Main Bifurcation Disease. In 2008, this was a $1.0 billion worldwide market and it is growing annually'.
Dr Rosenthal previously served as Chairman and CEO of Labcoat Ltd. and as Chief Scientific Officer of Boston Scientific Corporation. Cappella has also appointed additional senior management to lead European sales and manufacturing activities.
Dr Ena Prosser of Fountain Healthcare Partners commented 'We are delighted to invest in Cappella at a very strategic point in the company's development. From our perspective, Cappella have a differentiated product offering for the treatment of coronary heart disease. Cappella's impressive management team and top-class scientific advisory board will drive rapid adoption of the SideguardT Sidebranch stent in Europe and its successful clinical development in the US'.
Masashi Kiyomine, Principal at Mitsui & Co. Venture Partners, commented: 'We are very pleased to have co-led this important round of financing for Cappella, to support the global commercial success of the SideguardT Sidebranch stent. With an experienced management team led by Dr. Rosenthal, we believe Cappella is ideally positioned to become the leading provider of innovative solutions for the treatment of bifurcation vascular disease - an area of high unmet medical need'.
Dr Wolfgang Oster, Managing Partner at Polytechnos Venture Partners and Chairman of Cappella's Board, noted: 'As founding investors of Cappella, we are delighted to close this substantial round of finance for a company which we believe has the potential to lead the field of bifurcation devices. The commercial expertise which the new investors bring to the table in Europe, US and Japan is reassuring and will help to accelerate the company's marketing efforts of its device portfolio. Importantly, the continued participation of our syndicate partners, in particular ACT Venture Capital, in our common cause was a prerequisite to get the company to this exciting value inflection point. '
In addition to Dr Wolfgang Oster, Dr Art Rosenthal and Dr Ena Prosser, other Board seats will be held by Masashi Kiyomine, MCVP, Dr Ascher Shmulewitz company co-founder, Cappella's Vice Chairman Charlie Glass of ACT Venture Capital and Dirk Kanngiesser, Polytechnos Venture Partners.
About Cappella Inc
Cappella, Inc. ('Cappella' or the 'Company') is a medical device company that is developing novel solutions for the treatment of Complex Coronary Artery Disease (CAD) and specifically bifurcation vascular disease. The Company's initial product is the SideguardTM Sidebranch stent. This technology addresses an unmet medical need in CAD. The company was founded in 2004 by Antonio Columbo, M.D., Chief of Invasive Cardiology at San Raffaele Hospital in Milan, Italy, and Ascher Shmulewitz, M.D., Ph.D., a cardiologist, medical device entrepreneur and founder of NeoVision, Xcardia and Labcoat Ltd., and established its headquarters in Galway, with the backing of Polytechnos Venture Partners and ACT Venture Capital. The SideguardTM Sidebranch stent is an anatomically shaped self-expanding coronary stent that utilizes a unique peel-away delivery system. Both the stent and this delivery system were developed by Cappella Medical Devices Ltd. The unique delivery technology overcomes a number of delivery problems associated with existing nitinol stents, including reduced profile and improved placement accuracy over traditional delivery systems. Cappella Medical Devices Ltd., Galway, Ireland is the R&D and manufacturing subsidiary of Cappella Inc.
Creganna snaps up assets of Swedish firm
The Galway-based company, which has annual revenues of more than 50 million Euro and employs about 500 people, has bought the technology and patents of Micromuscle. While the Swedish firm had raised significant venture capital funding it sought voluntary liquidation after a venture capitalist withdrew from the company.
The terms of the acquisition are not known, but Creganna will retain some Micromuscle technical staff and is working with the company's customers on development projects. Creganna makes devices used in minimally-invasive surgery, while Micromuscle has technology to control the movement of devices and the release of drugs.
Alan Crean, director of business development at Creganna, described Micromuscle as ''the perfect fit'' for the company.
Founded in 1979,Creganna has expanded both organically and through acquisitions. Its previous deals include the buyout of Screentech Medical, a Wicklow company, for 4 million Euro in 2006.
Creganna has generated profits of more than 4 million Euro annually in recent years, but last year re-registered as an unlimited firm, meaning that it does not have to file public accounts. The company is owned by its founders and Altaris Capital Partners, a New York private equity firm which has a 29 per cent stake.
Helen Ryan, chief executive of Creganna, said recently that maintaining the company's growth rate was ''the top challenge'' for 2009.
''There are some indicators that a number of companies are slowing the pace of projects due to funding constraints, and this, in turn, may slow our growth rate," she said.
Boston Scientific Cork 21.7 million Euro RD&I investment (to develop next generation neurovascular products)
Tánaiste and Minister for Enterprise, Trade and Employment Mary Coughlan TD today (Thursday 9th July 2009) announced that Boston Scientific Corporation (BSC), which specialises in medical devices for use in minimally invasive procedures, is to invest ?21.7 million in a Research, Development and Innovation (RD&I) initiative at its site in Cork, with the support of the Government through IDA Ireland.
The investment reflects the enhanced capability of the Cork site for the development of next generation products to treat neurovascular diseases of the brain - including coils, intracranial stent delivery systems and access devices - and the research laboratory infrastructure to facilitate their path to commercialisation.
This investment is closely aligned to BSC's corporate strategy of building a robust pipeline of RD&I projects across all of its businesses designed to maintain and extend its current market leadership positions, and drive profitable, sustainable growth. In 2009, BSC expects that more than a third of its revenue will come from new product introductions.
An Tánaiste, welcoming the initiative, said "Boston Scientific employs 5,000 people in Ireland. This investment by BSC, a renowned global corporation and a reference life science company in Ireland, is an enormous boost of confidence in the talent at its Cork site. It further endorses Ireland's capability to support next generation research, development and innovation at the vanguard of minimally invasive products. BSC has contributed very significantly to the Cork local economy since its establishment in 1998. This latest initiative will further enhance the site's reputation within the parent corporation."
Mark Paul, President of Boston Scientific's Neurovascular business, said "The performance and success of our Cork site gave us the confidence that this is the correct setting and timing for this strategic investment. The Irish Government's foresight to create centres of excellence is a cogent strategy that is attractive to industry. The commitment to RD&I, through the involvement of both the Government and IDA Ireland, has resulted in a growing international reputation for success in the development of new leading-edge products. The investment we are announcing today will continue to strengthen our Company globally. We appreciate the support of IDA for this initiative."
The Irish Government's foresight to create centres of excellence is a cogent strategy that is attractive to industry. The commitment to RD&I, through the involvement of both the Government and IDA Ireland, has resulted in a growing international reputation for success in the development of new leading-edge products. The investment we are announcing today will continue to strengthen our Company globally. We appreciate the support of IDA for this initiative.
Mark Paul, President of Boston Scientific's Neurovascular business
Amarin receives special protocol assessment
AGREEMENT FROM THE FDA FOR PHASE 3 CARDIOVASCULAR TRIAL
DUBLIN, Ireland, May 6, 2009 - Amarin Corporation plc (NASDAQ: AMRN) today
announced that it has reached agreement with the U.S. Food and Drug Administration
(FDA) under a Special Protocol Assessment (SPA) for its planned Phase 3 registration
clinical trial of AMR101 (ethyl-EPA) in patients with hypertriglyceridemia, or very high
triglyceride levels. The SPA is a written agreement between the Company, as the trial's
sponsor, and the FDA regarding the design, endpoints, and planned statistical analysis of
the Phase 3 trial to be used in support of a New Drug Application (NDA).
Thomas Lynch, Chairman and Chief Executive Officer of Amarin, commented
"Receiving FDA agreement on the Phase 3 trial represents an important milestone for
Amarin. We now look forward to commencing this Phase 3 trial shortly."
Pursuant to the SPA, the Phase 3 trial will be a multi-center, placebo-controlled,
randomized, double-blind, 12-week study to evaluate the efficacy and safety of two doses
of AMR101, a prescription grade Omega-3 fatty acid, in patients with fasting triglyceride
levels of ?500 mg/dL (the AMR101 MARINE Study). The primary endpoint in the trial
is the percentage change in triglyceride level from baseline to week 12. Following
completion of the 12-week double-blind treatment period, patients will be eligible to
enter a 40-week, open-label, extension period.
The trial is expected to enroll approximately 240 patients, with enrolment planned to
commence in mid-2009. The trial will be conducted in centers throughout North and
Central America, Europe, India and South Africa. The Company plans to use the results
of this Phase 3 registration trial as the basis for the submission of an NDA to the FDA.
In addition to the AMR101 MARINE study, Amarin is also planning to conduct a Phase
3 trial with AMR101 in patients with high triglyceride levels (?200 mg/dL and ?500
mg/dL) who are on statin therapy.
Amarin has worked closely with its Cardiovascular Advisory Group in designing these
trials. The Advisory Group, consisting of leading experts in the field of cardiovascular
disease research and development, comprises: Dr. Harold Bays, Medical Director and
President of Louisville Metabolic and Atherosclerosis Research Center; Professor Philip
Calder, Nutritional Immunology at the University of Southampton, UK; Dr. Michael
Criqui, Professor and Chief, Division of Preventive Medicine, in the Department of
Family and Preventive Medicine at the University of California, San Diego School of
Medicine; Dr. Meredith Hawkins, Professor of Medicine and Director of the Global
Diabetes Initiative at the Albert Einstein College of Medicine in New York; Dr. Sotirios
Tsimikas, Professor of Medicine and Director of Vascular Medicine at the University of
California, San Diego and Dr. Anthony Wierzbicki, Consultant in Chemical
Pathology/Metabolic Medicine at Guy's and St Thomas' Hospitals NHS, UK.
AMR101 is an ultra-pure ethyl ester of eicosapentaenoic acid (ethyl-EPA). Amarin has
developed a substantial body of data on AMR101 to date. Amarin has previously
investigated AMR101 in central nervous system (CNS) disorders in several double-blind,
placebo-controlled studies, including Phase 3 trials in Huntington's disease. Over 900
patients have received AMR101 in these studies, with over 100 receiving continuous
treatment for one year or more. In all studies performed to date, AMR101 has shown a
very good safety profile.
Numerous independent studies have demonstrated the safety, tolerability and efficacy of
ethyl-EPA in lowering plasma triglycerides in patients with high triglyceride levels of
varying degrees of severity. In Japan, an ethyl-EPA prescription product has been
approved for the treatment of hyperlipidemia and has been on the market for seventeen
Hypertriglyceridemia refers to a condition in which patients have high blood levels of
triglycerides and is associated with increased risk of heart disease. It is one component of
a range of lipid disorders collectively referred to as dyslipidemia. The overall
dyslipidemia population in the U.S. is believed to be in excess of 100 million, with over
10 million of those diagnosed with hypertriglyceridemia.
Amarin is a late-stage biopharmaceutical company with a focus on cardiovascular
disease. Amarin's programs capitalize on its lipid science expertise and the known
therapeutic benefits of Omega-3 fatty acids in treating cardiovascular disease. Amarin's
lead product candidate is AMR101, a prescription grade Omega-3 fatty acid comprising
not less than 96% ultra-pure ethyl eicosapentaenoic acid (EPA), which is entering Phase
3 clinical trials for the treatment of hypertriglyceridemia. The pipeline also includes
proprietary next-generation lipid candidates, currently at preclinical stages of
Amarin has a range of clinical and preclinical stage compounds to treat central nervous
system (CNS) disorders, including Huntington's disease, myasthenia gravis, Parkinson's
disease and epilepsy, all of which are available for partnering. Amarin is listed in the
U.S. on the NASDAQ
Parexel's cancellations double as profit growth stalls
Parexel's cancellations double as profit growth stalls
By Nick Taylor, 28-Apr-2009
Related topics: Clinical Development, Phase I-II, Phase III-IV
Parexel posted a doubling in cancellations in Q3 of its fiscal year, with profits remaining flat as an eight per cent boost in service revenue was offset by higher operating expenses.
Contract research organisations (CRO) have been hit hard by project cancellations, with PPD and Kendle recording unprecedented levels, and Parexel has also suffered.
Parexel's cancellations rose to $95.8m (?73.5m) in Q3, up from $49.5m in 2008, and new business remained flat at around $425m. These figures are indicative of the challenges facing CROs but Josef von Rickenbach, Parexel's CEO, is positive about the results.
He said: "The company's positive quarterly results were a clear reflection of the determined focus by our employees to control costs and achieve both our financial and operational targets.
"I am proud of our staff's ability to grow service revenue and expand operating margins in today's challenging environment. In addition, we were able to generate a very respectable level of new business wins in the quarter, despite some market headwinds."
The financial market has responded favourably to the results, which included an increase in profit forecasts for 2009 that helped the company's share price gain 15 per cent.