BB&T and Staff Reports

Neovacs (Paris) and Biomedical Diagnostics (BMD; Marne La Vallee, France) have won financing of €7.9 million ($11 million) for the Tracker theranostics program – tharanostics meaning a pairing of a diagnostic test with a therapeutic – in this case for treatment of rheumatoid arthritis.

The funding, from OSEO Innovation (Maisons-Alfort, France), combines a grant of €2.5 million ($3.5 million) with a loan of €5.4 million ($7.5 million) to validate the diagnostics tools developed by BMD and to test a therapeutic solution developed by Neovacs based on anti tumor necrosis factor (TNF) monoclonal antibodies.

The prevalent therapeutic used to treat rheumatoid arthritis, anti-TNF monoclonal antibodies progressively is neutralized by the antibodies it induces, leading to resistance or intolerance to the treatment, which renders it ineffective over time and in some cases toxic.

A recent study in the UK found that more than one-fourth of patients abandon this class of medication within 15 months.

More than 5 million people in Europe and the U.S. are diagnosed with rheumatoid arthritis which advances to become a disabling condition for 30% of this patient population within 10 years of diagnosis.

The two partners will use the OSEO funding to evaluate the neutralizing antibodies using BMD tests and determine a treatment strategy using a range of therapeutics from Neovacs involving active anti-TNF immunization.

Spun off from the Pierre and Marie Curie University (Paris) in 1993 by one of France's most eminent immunologists and AIDS experts, Professor Daniel Zagury, Neovacs holds a patent portfolio of therapeutic vaccines for the treatment of AIDS, cancer and auto-immune and allergic diseases.

In July 2007 Neovacs received a €13 million ($18.3 million) investment from the Novartis Venture Fund and a second investment from Truffle Capital of €4 million ($5.6 million), an investor and majority shareholder since 2003.

BMD specializes in the production and marketing of in vitro diagnostics based on technology from Luminex (Oosterhout, the Netherlands), a multiplex platform that combines flow cytometry, microspheres, lasers, and digital signal processing.

BMD is targeting the emerging theranostics market, with the aim of personalizing medications by identifying appropriate biomarkers to indicate the progression, or regression under treatment, of a disease.

BMD said this market totaled $5.4 billion in 2005 and is expected to grow to $21.2 billion by 2012.

4,300 exhibitors expected at MEDICA

The annual MEDICA trade fair is widely known as the world's largest medical exposition, but the 4,300 exhibitors expected at the 40th rendition of the event, scheduled for Nov. 19-22 at the fairgrounds in Dusseldorf, Germany, is mind-boggling nevertheless.

In addition to the aforesaid exhibitors who will be highlighting their products and services in exhibit hall after exhibit hall across the sprawling fairgrounds, MEDICA 2008 will feature two major congresses, an ancillary program and numerous special events, according to the organizer, Messe Dusseldorf.

Exhibit categories at MEDICA will include electromedical and laboratory equipment, medical technology, diagnostics, pharmaceuticals and medical supplies as well as physiotherapy and orthopedic technology, communication and information technology, facility management, clothing, medical furniture, and equipment and building technology.

The exhibits will be complemented by the MEDICA Physiotherapy Forum; MEDICA MEDIA, a telemedicine forum; MEDICA MEET-IT, a user forum for IT solutions; MEDICA VISION, presentations of research institutes); the MEDICA Congress and the German Hospital Conference.

A special feature will be two U.S. pavilions, organized by Messe Dusseldorf North America. In one of the pavilions, laboratory equipment, reagents, in vitro/in vivo diagnostics, devices, systems and pharmaceuticals will be presented, while the other Pavilion will feature medical technology and electromedical equipment.

Singapore groups establish Asia MEDTECH

The first Asia MEDTECH 2009 conference will be held in Singapore next March to catalyze the medical equipment manufacturing sector in Singapore and the region, positioning the industry to capitalize on the $336 billion global medical devices market, its organizers said.

The Singapore Precision Engineering & Tooling Association (SPETA), organizer of the event, said the conference would enable the precision engineering sector in the region to adapt and ride the wave of the global boom in the medical device market.

MEDTECH 2009 will be held from March 25-28 at the Singapore Expo. The event is held in collaboration with the Singapore Economic Development Board, International Enterprise Singapore and SPRING Singapore.

The organizers said that to date, 17 leading global med-tech companies have set up more than 20 commercial-scale manufacturing facilities in Singapore. "Coupled with rising global sourcing needs from multinational corporations, a perpetual upward demand for reliable production and assembly of complex components [has] been created within the medical device supply chain," SPETA said.

It added that Singapore's precision engineering industry players, numbering some 2,700 companies, "are solution providers with strong design, prototyping, production and supply chain management capabilities."

SPETA said that programs such as the Supplier Development Initiative have encouraged supplier companies to enhance their capabilities and establishes business linkages with larger precision engineering companies. The MedTech Capability Development Program by SPRING Singapore also has encouraged capability development projects in the areas of process improvement, product development and certification to meet the increasing demand for innovation and efficiency for med-tech customers.

Asia MEDTECH 2009 will comprise an exhibition, the Asia MEDTECH 2009 seminar, as well as GATE09 (Global-Asia Trade Exchange) Medical Technology, a business-matching platform for the medical technology sector.

Some 150 exhibiting companies are expected to participate and showcase their component manufacturing capabilities for some 8,000 medical devices ranging from simple bandages and spectacles, through implantable devices, equipment to screen and diagnose disease and health conditions, to the most sophisticated diagnostic imaging and minimal invasive surgery equipment.

Four country pavilions from Singapore, Malaysia, South Korea and the U.S. will be featured.

Swedish region in PACS contract

Sectra (Link ping, Sweden) said it has signed a five-year contract with Sweden's Region Sk ne regarding a digital solution for managing and archiving radiology images (PACS). With this order, Sectra said it would replace existing systems at the university hospitals in Malmo and Lund.

The initial order value amounts to SEK 30 million.

"With this new, common digital solution for managing radiology images, we are taking an important step towards more efficient cooperation and use of resources within the radiology operations in our region," says Hans Stridbeck, regional chief medical officer.

The agreement includes an option to connect the other radiology departments as well as nuclear medicine and cardiology imaging units in the region to the central backbone solution that Sectra is establishing with Region Sk ne.

"Region Sk ne's procurement is the largest in Sweden this year for IT systems for radiology departments," said Marie Ekstr m, president of Sectra's medical operations in Scandinavia. "The need for systems that facilitate cooperation and communication is substantial and the holistic approach taken by Region Sk ne for the IT structure of radiology operations is a model for other care providers."

Region Sk ne, a regional public body responsible for health, medical and dental services, includes 10 hospitals that conduct more than 900,000 radiology examinations annually. All the hospitals in the region are already are operating with Sectra's system for managing radiology information.

Region Sk ne also recently ordered an IT solution, Master Examination Index, from Sectra that enhances the efficiency of radiology cooperation within and outside the region.

Roche amends UPL agreement

Roche Diagnostics (Penzberg, Germany) and Exiqon (Vedbaek, Denmark, a provider of gene expression analysis products, reported that they have signed an amendment to their 2005 license and distribution agreement for the Universal ProbeLibrary (UPL), based on Exiqon's Locked Nucleic Acid (LNA) Oligonucleotides.

Roche's exclusive rights to sell and distribute the ProbeLibrary products are extended on a co-exclusive basis. In addition, Roche obtains co-exclusive rights to use the UPL for the development and manufacturing of its new line of RealTime ready qPCR assays. With the RealTime ready assay line, Roche Applied Science will offer a fully customizable portfolio of validated target specific gene expression assays for quantitative PCR in single assay format and multi-well plate format, pre-plated in 96- and 384-well qPCR plates for the LightCycler System.

"This agreement allows us to continue our successful business with the Universal ProbeLibrary products," said Manfred Baier, head of Roche Applied Science, a business area within Roche Diagnostics. "We will address the current need for increased speed and flexibility in biomedical research providing customized on demand supply of single assays and ready-to-use qPCR panels for virtually every gene of the human genome and other important organisms."

He added, "The Universal ProbeLibrary products supplement our broad existing portfolio of RealTime PCR products in the best possible way."

Czech Republic office for Averion

Averion International (Southborough, Massachusetts), an international clinical research organization (CRO) specializing in oncology, cardiovascular diseases and medical devices, said it has further strengthened its European operations by opening an office in the Czech Republic.

"Averion continues to expand its European footprint to meet the needs of our clients," said CEO Markus Weissbach, MD, PhD. "In the heart of Central Eastern Europe, the Czech Republic offers a strong clinical trial environment with large patient populations and well qualified investigators in a broad range of indications. These critical factors are top priorities for our clients and they are vital to the successful conduct of international trials."

The Czech Republic office, located in Prague, is led by Dr. Libor Hubacek, country manager for Averion, which he joins with more than 10 years of experience in monitoring, submissions and management of clinical trials in the Czech Republic, with particular expertise in arterial hypertension, oncology, renal impairment, pulmonology, urinary tract infection, atherosclerosis, diabetes mellitus, cystic fibrosis and others.

Averion's European operations are headquartered in Basel, Switzerland. It has additional U.S. offices in California, Maryland and New York; and international offices in France, the Netherlands, the UK, Poland, Russia, Israel, Germany, Austria, Ukraine and the Czech Republic, along with operation centers in Slovakia and Hungary and research partnerships in India, Asia and South America.

50 positions cut at Q-Med

Q-Med (Uppsala, Sweden) said that as part of the company's push to focus resources on the aesthetics business, personnel reductions would be made at its facility in Uppsala.

Q-Med has decided to focus on the aesthetics business, so sales and marketing of Hospital Healthcare products will be done via partners and there will be no further in-house development of new products within that area.

The company said this change "leads to redundancies at [our] facility in Uppsala. Despite the fact that Q-Med assesses that some of these redundancies can be absorbed by the aesthetics business, approximately 50 . . . workers in Uppsala will need to leave the company." The company has about 700 employees overall, about 500 at Uppsala.

Q-Med primarily manufactures medical implants, the majority of which are based on the company's NASHA technology for the production of stabilized non-animal hyaluronic acid.

The product portfolio today contains Restylane for filling lines and folds, contouring and creating volume in the face, Macrolane for body contouring, Durolane for the treatment of osteoarthritis of the hip and knee joints, Deflux for the treatment of vesicoureteral reflux (VUR, a malformation of the urinary bladder) in children, and Solesta for the treatment of fecal incontinence.

Sales are made through the company's own subsidiaries or distributors in more than 70 countries.

Biggest RIS/PACS contract for Sectra

Sectra (Link ping, Sweden) said the Department of Health, Social Services and Public Safety in Northern Ireland would implement an integrated solution for managing radiology information and images (RIS/PACS) provided by the company through a 10-year agreement. Sectra said the contract is valued at GBP 30 million and represents its largest order to date.

The solution will be used throughout the entire public healthcare system in Northern Ireland.

The company noted that there is growing demand for efficient, integrated RIS/PACS solutions that enable sharing of information and reading of images generated at several hospitals.

"This major project is unique in the way it links together so many hospitals for a totally seamless workflow of images and information throughout their entire public healthcare system," says Jan Wolffram, managing director of Sectra in the UK and Ireland.

Northern Ireland has about 1.8 million inhabitants and nearly 1 million radiology examinations are carried out every year. The installation includes some 25 hospitals, organized in five trusts.

Sectra develops IT systems and products for radiology, mammography and orthopedic departments. More than 950 hospitals worldwide use the system, together performing in excess of 45 million radiology examinations annually.

The company was founded in 1978 and has its roots in the Link ping Institute of Technology. Sectra has offices in 11 countries and operates through partners worldwide.

bioMérieux in pact with ProteoSys

bioMérieux (Marcy l'Etoile, France) reported signing a license and development agreement with ProteoSys (Mainz, Germany) for Annexin 3, which will be used to develop a urine-based, confirmatory diagnostic test for prostate cancer.

After a research phase, the new test should be developed on the VIDAS platform, which is one of the most widely installed automated immunoassay instruments in the world.

Financial details of the agreement were not disclosed.

Annexin 3, also known as ANXA 3, was discovered by ProteoSys. Studies have shown that ANXA 3 quantification in urine is a novel, non-invasive test with high specificity for prostate cancer. The ANXA 3 test is expected to be used to provide better identification of patients with a high probability of prostate cancer, thereby reducing the number of unnecessary biopsies.

The first phase of research is beginning at bioMérieux, which will be followed by the development of a diagnostic test for the VIDAS platform. While the confirmatory diagnostic application on VIDAS will be the initial focus, bioMérieux said it also is considering the development of treatment decision and prognostic applications for ANXA 3.

The ANXA 3 test will be complementary to the tPSA and FPSA tests available on the company's VIDAS platform.

Cook Medical expanding Irish plant

The Irish government said last month that Cook Medical (Bloomington, Indiana) would generate 200 new jobs through the expansion of its manufacturing plant in the city of Limerick.

Cook Medical, which already has nearly 500 employees in Limerick making devices for use in urology, gastroenterology and women's health, will invest €25 million ($35.79 million) in the facility expansion.

In a statement, Deputy Prime Minister Mary Coughlan hailed the news as "another fantastic development for the thriving medical technology industry in Ireland."

Cook reportedly plans to make Limerick the sole global manufacturing site for its new Zilver PTX stent to treat peripheral artery disease.

The U.S. firm, which has facilities in North America, Europe, Asia and Australia, had 2007 revenues of $1.25 billion.

Regulatory approvals

A sampling of regulatory approvals in Europe reported in the past month:

  • ITGI Medical (Or Akiva, Israel) reported that its second heterologous tissue-covered stent, AneuGraft, has received CE-mark approval. AneuGraft is a stent completely covered with a heterologous tissue, designed to set a barrier between the coronary blood vessel wall and its lumen. It is intended for use in tortuous vessels. The stent is mounted on a delivery system designed to improve navigability of the stent in tortuous vessels.
  • Nicast (Lod, Israel), a developer of medical devices made from its electrospinning technology, reported the receipt of the CE mark for its flagship product, the AVflo artificial vascular graft. The device is intended to help end-stage renal failure patients who must undergo hemodialysis treatment three or more times a week. AVflo enables hemodialysis to continue without further disturbance to the veins and arteries in the patient's arms already severely damaged by the habitual needle punctures required by the treatment, Nicast said.

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