Thursday, August 14, 2008

Boston Scientific stock drops after WSJ data review

By Mass High Tech Staff

Natick-based medical device maker Boston Scientific Corp. saw its stock drop five percent to $12.69 per share in early trading after an independent review, performed by the Wall Street Journal, said it found serious flaws in clinical data analysis for one of the company’s top selling products.

According to the WSJ review paper, its research found that the Boston Scientific (NYSE: BSX) cardiac stent Taxus Liberte would have not passed muster under “common standards.”

Already approved outside the U.S., the device is awaiting approval from the U.S. Food and Drug Administration (FDA) based on the study data submitted in 2006.

The statistical methods used in the trial were the unofficial standards used by other medical device firms, including Medtronic Inc. and Abbott Laboratories, for measuring the safety and effectiveness of stents, Boston Scientific stated.

In February, Boston Scientific was ordered by a U.S. District Court jury in Marshall, Texas, to pay $431 million to Bruce Saffran for patent infringement from the company’s Taxus Liberte and Taxus Express coronary stents. Saffran did not request any injunction preventing Boston Scientific from selling the two Taxus stents, however, according to Boston Scientific.

Late last year, Boston Scientific garnered approval of its Taxus coronary stent in Europe for patients with diabetes. Officials of the life sciences company said at the time that the European approval expanded its Taxus product for more uses than any other drug-eluting stent on the market. Stents are devices used to prop open arteries for patients with coronary artery disease..

Boston Scientific reported a net loss of $495 million on revenue of $8.4 billion for 2007.