A Medical Device Daily

Biosensors International Group (Singapore) said it has successfully defended against legal claims and defeated a request for an injunction request brought against it in the Netherlands by Angiotech Pharmaceuticals (Vancouver, British Columbia) and Boston Scientific (Natick, Massachusetts).

The company said the result of the court's decision to deny the claims and injunction allows it to continue the production of the Axxion drug-eluting stent (DES) in the Netherlands, with distribution throughout Europe and other parts of the world where regulatory approval for the device has been secured.

The legal action, which commenced on Dec. 9 in The Hague, the Netherlands, claimed that the Axxion stent infringes on European patent No. 0706376, which is jointly owned by Angiotech and the University of British Columbia (also Vancouver).

Boston Scientific is the exclusive licensee of the patent for cardiovascular medicine, which encompasses, among other things, claims describing a stent that uses a composition of paclitaxel and a polymeric coating as a drug carrier.

Biosensors said the judge in the case ruled that its Axxion DES does not infringe the European patent.

Yoh-Chie Lu, chairman and CEO of Biosensors, said, “The decision of the Dutch court enables us to continue to sell the Axxion DES and to pursue our business model.“ He said the introduction and rollout of Axxion in Europe “has been an important step for Biosensors as it has allowed us to build our sales and marketing infrastructure, initiate market share and develop the necessary systems for the eventual launch of our flagship BioMatrix DES.“

Biosensors' European subsidiary, Occam International (Eindhoven, the Netherlands), received European marketing approval for the Axxion stent last summer (Medical Device Daily, July 13, 2005). The Axxion DES is a polymer-free system that incorporates Biosensors' Calix stent delivery system and the drug paclitaxel, which is directly coated on the stent over a layer of glycocalix, a substrate designed to improve biocompatibility of the metal stent surface after the drug is released.

The technology is licensed exclusively by Occam from a privately held company in Germany that is a manufacturer of ultra-thin coatings that according to Biosensors, “set unsurpassed standards of efficiency, hemocompatibility and biocompatibility.“

Lu noted that the legal action only involved the Axxion product and does not relate to the company's BioMatrix DES, which is expected to receive CE-mark approval in the first half of 2006. He said the BioMatrix “features a fully biodegradable polymer and our own proprietary drug, and we plan for it to drive our growth in the coming years.“

The BioMatrix DES system incorporates the company's proprietary anti-restenotic drug, Biolimus A9, bioresorbable polymer, S-Stent and stent delivery catheter, all of which have been developed in-house.

Askion to produce device for EOS

Electro-Optical Sciences (EOS; Irvington, New York), a company focused on designing and developing a non-invasive, point-of-care instrument to assist in the early diagnosis of melanoma, said it has entered into an agreement with Askion (Gera, Germany) for the production of EOS's MelaFind hand-held imaging device.

The agreement calls for Aakion to produce MelaFind imaging devices for EOS to be used in the company's pivotal trial, which is expected to be conducted at more than 20 clinical study sites in the U.S. The purpose of the pivotal trial is to establish the safety and efficacy of MelaFind in the imaging of suspicious skin lesions.

Financial terms of the agreement were not disclosed.

“This agreement is an important milestone for EOS and is a significant step in our pre-commercialization process,“ said Joseph Gulfo, president and CEO of EOS. “2006 will be an exciting year for EOS as we conduct our clinical trials and anticipate PMA approval and commercialization of MelaFind in 2007.“

Gerald Wagner, PhD, acting chief operating officer and member of EOS's board of directors, said, “I have had first-hand dealings with Askion management and personnel for 15 years since my days at Bayer Diagnostics and Agfa. Askion has a solid reputation for top-quality production and manufacturing.“

EOS started as a part of Agfa-Gevaert AG in 1991, mostly with employees from the former Carl Zeiss Jena.

The MelaFind product features a hand-held imaging device that emits multiple wavelengths of light to capture images of suspicious pigmented skin lesions and extract data. The data are then analyzed against EOS's database of melanomas and benign lesions in order to provide information to the physician and produce a recommendation of whether the lesion should be biopsied.

AMRI agrees to buy Hungarian firm

Albany Molecular Research (AMRI; Albany, New York) said it has signed a stock purchase agreement to acquire privately held drug discovery service company ComGenex (Budapest, Hungary).

Founded in 1992, ComGenex provides contract chemistry services to the pharmaceutical and biotechnology industries, and possesses what AMRI termed “unique technologies for the rational design of chemical libraries for lead generation.“

Specifically, the company integrates parallel synthesis with computational chemistry to create unique small molecules with drug-like characteristics. It also has developed novel applications in the areas of chemical genomics and target identification.

In 2005, ComGenex generated about $8.5 million in contract revenue. The company and its subsidiaries currently have 119 employees, including 88 scientific and technical staff.

Thomas D'Ambra, PhD, chairman, president and CEO of AMRI, said, “The acquisition of ComGenex further expands AMRI's global chemistry services platform. This combination creates an immediate presence in Europe in a EU member state with a significantly lower cost structure than Western European countries, while maintaining access to a comparable talent pool not only in Hungary, but all of Europe and neighboring regions.“

D'Ambra said, “Along with [our] offerings in the U.S., Singapore and India, this move represents another step in the diversification and globalization of AMRI's brand among technologies, geographic access and a range of different cost structures.“

Subject to customary closing conditions, the transaction is expected to be completed by the end of 1Q06.

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