Cook has restructured its license agreement with Angiotech regarding drug-eluting medical devices. The license agreement signed by Cook and Angiotech in 1997 has been amended to accommodate Cook’s decision to focus its product development efforts under the license on peripheral vascular and gastrointestinal drug-eluting medical devices.
Under the terms of the agreement, Angiotech has agreed to pay Cook $25 million and to grant the company the right to use distributors for licensed products. In exchange, Cook agreed to a termination of its rights under the license agreement in the coronary vascular field of use. Angiotech also has granted Cook a multi-year extension in the peripheral vascular and gastrointestinal fields of use.
“We are very pleased with the terms of the agreement,” said Kem Hawkins, president of Cook Incorporated. “This restructuring allows Cook to focus more of its resources on developing new and innovative therapies for patients suffering from peripheral vascular disease.”
On July 28 2004, Cook announced plans for the Zilver PTX peripheral stent trial, the US’s first non-coronary drug-eluting stent study. Cook’s DESTINY trial (Drug-Eluting StenT IN the SFA/Fempop ArterY) is the first clinical investigation approved by the US Food and Drug Administration to study the effectiveness of a drug-eluting stent for a peripheral artery. The DESTINY trial will investigate the use of the Zilver PTX paclitaxel-eluting stent in the above-the-knee femoropopliteal artery. It will be conducted initially at 10 US medical facilities and will enroll 60 patients, with an expanded trial likely pending further FDA review. Cook expects to enroll the first patient in this trial by mid-October.
“This is one of the most anticipated trials in years,” said the DESTINY trial’s national principal investigator Dr Michael Dake, Chief of Cardiovascular and Interventional Radiology at Stanford University School of Medicine. “There is tremendous investigator enthusiasm for DESTINY to determine if benefits comparable to those achieved in patients with coronary lesions can be obtained by translating similar drug-eluting stent technology to symptomatic individuals with peripheral arterial disease.”