Angiotech Pharmaceuticals Inc. and partner Boston Scientific Corp. late Thursday afternoon received approval for the Taxus Express2 paclitaxel-eluting coronary stent system.
Angiotech, of Vancouver, British Columbia, licensed the coating for the product to Boston Scientific, of Natick, Mass. The product uses Angiotech's paclitaxel-coated stent technology to prevent cardiac restenosis - the re-clogging of surgically cleared arteries.
The approval was based in part on pivotal trial data reported in September by Boston Scientific at the Transcatheter Cardiovascular Therapeutics meeting in Washington. Findings showed that treatment with the stent resulted in a target lesion revascularization rate of 3 percent in the Taxus group, compared to 11.3 percent in the control group (p<0.0001).
Boston Scientific said it plans to launch the product in the U.S. immediately and has inventory in all sizes. The company said it has about 225,000 units of the stent available for sale.
It heads into the market in direct competition with another stent called Cypher, developed by Miami Lakes, Fla.-based Cordis Corp., a subsidiary of Johnson & Johnson.
The Taxus product, which incorporates the Express2 coronary stent on the Maverick balloon catheter as its platform, has an approved shelf-life of six months and all seven stent lengths were approved: 8 mm, 12 mm, 16 mm, 20 mm, 24 mm and 28 mm. Also, diameters between 2.5 mm and 3.5 mm were approved, and the 3.5-mm version is authorized for treatment of vessels up to 3.75 mm in diameter.
Boston Scientific launched the Taxus system in Europe and other international markets in February of last year and has achieved positions of between 60 percent and 70 percent and beyond in many of those markets.
The Taxus stent initially will be priced at $2,950.
For Angiotech, sales of the product will supplement an already rich balance sheet. Last fall, a follow-on public offering generated gross proceeds to the company of C$295 million (US$218.75 million) through the sale of 5 million common shares at $43.75 apiece. (See BioWorld Today, Sept. 29, 2003.)
Beyond its alliance with Boston Scientific, Angiotech has partnered its technology with another stent developer, Bloomington, Ind.-based Cook Inc. That paclitaxel-eluting coronary stent is in four clinical trials. An unpartnered product, Paxceed, is an injectable paclitaxel formulation in clinical development for rheumatoid arthritis and psoriasis.
On Friday, Angiotech's stock (NASDAQ:ANPI) gained $1.07 to close at $26.25. The company's shares also trade on the Toronto Stock Exchange.