News
PPD invests E14 million and will create up to 250 jobs at new facility
02/03/2010 13:15
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.
Further Information
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.
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Lake Region Medical Acquires Brivant Medical; Merged Companies Strategically Aligned for Global Competitive Edge
21/02/2010 20:55
U.S. parent company sees growth, jobs in Galway's guidewire medical device maker New Ross, Co Wexford, Ireland - July 27, 2009 - Lake Region Medical, Ltd., a subsidiary of the closely-held Lake Region Medical in Chaska, Minnesota (USA), today announced that it has acquired Brivant Medical, based in Galway, Ireland. The acquisition was effective July 23, 2009. Terms were not disclosed. Both the American and Irish companies are global OEM leaders for medical device guidewires and related products for minimally-invasive cardiac surgery and other procedures. Lake Region Medical has been doing business in New Ross, Ireland, as Lake Region Medical Ltd., since 1994, while the U.S. parent company with more than 1,500 employees globally, has more than 50 years experience in the medical device arena. It was recently named one of the Top 10 medical device companies based in the Twin Cities by the Minneapolis- St. Paul Business Journal (July 3, 2009). Brivant Medical and Lake Region Medical Ltd., currently employ approximately 800 people at the two locations in Ireland. Spokespersons for both Brivant Medical and Lake Region Medical said the new acquisition will preserve - and ultimately expand - jobs at the company sites in Galway, New Ross, and Chaska, Minnesota, a suburb of the Twin Cities (and a northern metropolitan area that is a hotbed of medical device manufacturing and innovation in the states). Complementary alignment will enhance global initiatives and expedite time to market. The newly aligned companies complement each other and will allow Lake Region Medical a greater global competitive edge in the medical device and equipment market valued at US$246B by 2011. Brivant Medical's expertise, technology, research and development, operations, and product portfolio readily strengthen Lake Region Medical's presence in the interventional guidewire marketplace. The acquisition will enhance the company's global expansion initiatives and expedite time to market for both Lake Region Medical and Brivant Medical products. 'Lake Region Medical will build upon Brivant Medical's R&D, technological innovations and streamlined processes to deliver a wide range of OEM steerable guidewires for use in interventional cardiology and peripheral applications,' said Joseph F. Fleischhacker, Lake Region Medical CEO. 'Its reputation for exemplary customer service and Brivant Medical's high-quality solutions, hard working employees, and geographic base will extend Lake Region Medical's ability to deliver current - and new - industry-leading products and services to the medical device industry.' 'Lake Region Medical's industry leadership position in guidewire technology, along with its longevity in the business and highly productive culture, makes it the ideal company to purchase Brivant Medical,' said Henry Lupton, Brivant Medical CEO. 'Lake Region Medical's global reach, scale and widely recognized OEM brand provide the solid foundation to advance Brivant Medical's innovative technology.' 'Based on performance, Brivant Medical has a very stable and capable management team,' said Ron Von Wald, Global Marketing Director. 'Lake Region Medical not only purchased Brivant Medical for its assets, but also for its outstanding personnel at all levels of the organization.' Von Wald said the only Brivant Medical management change is that the team will now report directly to John Harris, who has been promoted to the position of Vice President of Outside of US Operations. About Lake Region Medical www.lakeregionmedical.com Lake Region Medical, based in Chaska Minnesota, USA, was founded in 1947 and is a global leader in OEM devices, supplying the world's largest medical device companies. Lake Region Medical specializes in minimally invasive devices for cardiovascular, endovascular and neurovascular applications and serves all major markets worldwide. Its subsidiary, Lake Region Medical Ltd., has operated in Ireland since 1994. Its facility in New Ross, County Wexford is considered to be one of the largest guidewire manufacturing operations in the world, shipping products to locations worldwide. With the Brivant Medical acquisition, Lake Region Medical employs more than 800 people in Ireland. About Brivant Medical www.brivant.com Brivant Medical, based in Galway, Ireland, is a market leader in the design, development and manufacture of interventional OEM guidewires and medical devices for use in Interventional Cardiology and Peripheral applications. It also provides contract manufacturing and design services. Brivant Medical offers CE approved and 510(k) registered OEM interventional guidewires providing solutions from design through validation, manufacturing and delivering sterile, labelled devices to the customer, ready for clinical use. Brivant Medical was established in November 2000 with the purpose of designing and manufacturing OEM guidewires and medical devices for the international market place. The company was founded by experienced industry managers who have a broad range of engineering, clinical and operations expertise.
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Tactx acquisition beefs up Creganna's medical device capabilities
21/02/2010 20:43
January 2010Creganna 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.
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Abbott Gets European Approval For New Ovarian Cancer Diagnostic Test
19/01/2010 15:03
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.
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Boston Scientific Initiates Patient Enrollment In WallFlex Biliary RX Stent Study
19/01/2010 14:52
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.
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Abbott Presents Positive Three-Year Data On Bioabsorbable Stent Technology
18/11/2009 11:14
November 2009
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."
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Abbott's Xience Prime, Xience V Obtain Additional CE Markings
04/11/2009 10:11
November 2009
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."
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Medtronic Catapults Into Transcatheter Valve Market With Billion-Dollar Buys
02/11/2009 13:56
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.
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Irelands newest pharmaceutical devices company, Blue Box Sensors spun out of NUI Maynooth
13/10/2009 10:39
July, 2009
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.
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Eight of the world's 10 largest medical device companies are located in Ireland
11/10/2009 13:52
July, 2009
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.
Research-led Innovation
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.
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1millionEuro to attract world-class researchers to Ireland (SFI)
30/09/2009 17:43
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."
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Business Achievers Award for Crospon
24/09/2009 12:25
December, 2008
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.
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Medtronic move to Galway from the US
22/09/2009 16:13
May, 2008
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.
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Tánaiste announces major expansion of Cook Medical in Limerick with 200 new jobs and ?25 million investment
21/09/2009 21:50
May, 2008
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."
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Tax report will help attract skills and R&D Investment here in Ireland
19/09/2009 14:11
September, 2009
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
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Bio Medical Research Ltd - back on track
18/09/2009 12:04
February, 2008
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.
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Covidien Ltd.'s shareholders approve a plan to change Covidien's place of incorporation from Bermuda to Ireland
17/09/2009 09:37
May, 2009
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.
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Cappella Inc. secures 17.3 million dollar series C Investment
09/09/2009 08:46
June 2009
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.
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Creganna snaps up assets of Swedish firm
08/09/2009 10:30
February, 2009
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.
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Boston Scientific Cork 21.7 million Euro RD&I investment (to develop next generation neurovascular products)
07/09/2009 10:10
July, 2009
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
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Amarin receives special protocol assessment
07/05/2009 16:01
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.
About AMR101
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
years.
About Hypertriglyceridemia
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.
About Amarin
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
development.
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
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Parexel's cancellations double as profit growth stalls
28/04/2009 16:08
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.
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