Boston Sci Promus Element stent approved in Europe
By Susan Kelly
CHICAGO, Nov 2 (Reuters) - Boston Scientific Corp (BSX.N) on Monday said it received regulatory approval to sell its new Promus Element drug-eluting stent in Europe, replacing the Promus stent it co-markets with Abbott Laboratories (ABT.N).
The company said it will immediately begin selling the stent in the European Union. A supply agreement with Abbott Laboratories (ABT.N) permitting Boston Scientific to sell Abbott's original Promus stent in the European Union is set to expire on Nov. 21.
"We expect Promus Element to be highly competitive and believe BSX will expand its European Promus market share," said Sanford Bernstein analyst Derrick Sung in a note to clients. Promus has a roughly 9 percent share in Europe and about 25 percent in the United States, he said.
Leerink Swann analyst Rick Wise said investors were anxious about whether the approval would occur before the distribution arrangement with Abbott expired. "This is an important psychological and financial positive for the company and the stock," he said.
The original Promus is Abbott Laboratories' (ABT.N) popular Xience stent sold under the Promus brand name, with Abbott receiving about 40 percent of the profit. Stents are wire-mesh tubes inserted into clogged heart arteries to help prop them open after they have been cleared of blockages.
With Promus Element, Boston Scientific will manufacture the product, which features a new platinum-chromium design and catheter delivery system, and keep all of the profit.
"The timing should allow Boston Scientific to smoothly transition its Promus business to Promus Element, although we expect certain countries like France to require additional data for approval," said Wachovia analyst Larry Biegelsen.
For the U.S and Japanese markets, Boston Scientific's co-marketing agreement with Abbott on the original Promus is good through June 2012.
Boston Scientific said it anticipates U.S. Food and Drug Administration approval for Promus Element in 2012. It is currently studying the product in a pivotal trial called Platinum designed to support its U.S. and Japanese regulatory applications.
The Platinum trial completed enrollment of 1,532 patients in September at more than 140 sites worldwide.
Boston Scientific, which also sells the Taxus stent system worldwide, is also studying a Taxus Element stent in a trial called Perseus, which completed enrollment in October 2008 and will report primary endpoint data at the American College of Cardiology conference in March.
The company said it expects Taxus Element to receive European approval in the second quarter of 2010 and U.S. approval in 2011.
Promus Element is coated with the drug everolimus to prevent clots from reforming in the artery, while Taxus Element is coated with the drug paclitaxel.
Boston Scientific competes against Medtronic Inc (MDT.N) and Johnson & Johnson (JNJ.N), in addition to Abbott, in the nearly $5 billion worldwide stent market.
Shares of Boston Scientific fell 2 cents to $8.10 in afternoon trading on the New York Stock Exchange. (Reporting by Susan Kelly, editing by Dave Zimmerman)
