FDA Lifts Boston Scientific Warning Letter Restrictions On PMA Approvals
Full article reprinted from "The Gray Sheet" - October 27, 2008
Boston Scientific anticipates FDA approval of its Express SD renal stent, among other products, now that the agency has lifted the restrictions on Class III device approvals imposed by a 2006 company-wide warning letter.
Full article reprinted from "The Gray Sheet" - October 27, 2008
FDA Lifts Boston Scientific Warning Letter Restrictions On PMA Approvals
FDA informed the company Oct. 21 "that we were in substantial compliance with its quality systems regulations and that the agency has agreed to remove their restrictions imposed by the corporate warning letter related to Class III product approvals and certificates to foreign governments," CEO Jim Tobin told investors during the firm's Oct. 22 earnings call.
However, the letter "remains in place pending final remediation of some [medical device reporting] filing issues, which we are actively working with FDA to resolve," Tobin said.
The next day, Boston Scientific announced FDA approval of its Wallstent carotid stent system. The company plans to launch the device immediately.
The firm had already begun to receive approvals for Class III products in recent weeks, however, signaling progress on the warning letter front - including market go-ahead for its Taxus Express 2 Atom and Taxus Liberté paclitaxel-eluting stents (1"The Gray Sheet" Oct. 13, 2008, In Brief).
In addition to the Express SD renal stent, Boston Scientific notes that products on tap for FDA approval as a result of its progress with the warning letter include its Apex angioplasty balloon catheter.
Express SD would be the only stent labeled for renal use on the U.S. market, if approved. Boston Scientific announced in May it had submitted two-year data on Express SD in renal patients. While there were two stents, Medtronic's Bridge and Cordis' Palmaz, approved in 2002 for a renal indication, neither are marketed in the U.S. Abbott also is pursuing development of a renal stent. The firm began enrollment of a pivotal trial of its Rx Herculink Elite in September 2007 (2"The Gray Sheet" Oct. 1, 2007, In Brief).
Cardiac Rhythm Management Sales Up 11% In Q3
Boston Scientific's cardiac rhythm management business was a bright spot for the firm in the third-quarter, advancing 11% from last year to $572 million, the firm reported. The total includes a 13.7% jump in sales of implantable cardioverter defibrillators to $423 million.
Boston Scientific received "more than a dozen major CRM approvals in 2008," Tobin noted. These included the Cognis cardiac resynchronization therapy defibrillator and Teligen implantable cardioverter defibrillator, launched in Q3.
Meanwhile, revenue from drug-eluting stents declined 12% to $396 million for the quarter, due in part to increased competition. The firm stresses that while sales of its flagship Taxus drug-eluting stent have dropped, it has retained U.S. market share leadership of 45% by distributing Promus, a private-label version of Abbott's Xience drug-eluting stent. The firm's overall drug-eluting stent sales included $271 million from Taxus and $125 million from Promus, approved in July.
Boston Scientific estimates that Abbott and Johnson & Johnson/Cordis each control about 22% of the U.S. DES market, while Medtronic has 11%. However, Abbott estimates its domestic market share percentage is between 25% and 30%.
Overall, Boston Scientific reported corporate sales of $1.98 billion for the third quarter, down 3% on a reported basis, or 6% at a constant currency basis.
$334 Million Charge For Patent Case
The firm's reported net loss of $62 million in Q3 reflects a $334 million pre-tax charge relating to a stent patent infringement ruling in favor of J&J/Cordis.
In late September, a federal court ruled that Boston Scientific and Medtronic had infringed J&J/Cordis' Palmaz patent, and ordered the companies to pay, respectively, $703 million and $521 million in damages and pre-trial interest.
The company is appealing the award and does not expect the case to be resolved for at least a year. Tobin noted that J&J also is appealing two patent cases that came out in favor of Boston Scientific.
- Brooke McManus
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