Thursday November 9, 10:56 am Eastern Time
SOURCE: Biogen, Inc.
PARIS, Nov. 9 /PRNewswire/ -- Biogen (Nasdaq: BGEN - news) today said that a press release issued yesterday by Serono was an inaccurate and misleading summary of a decision made several weeks ago in The Netherlands relating to a local advertisement for AVONEX® (Interferon beta-1a). The decision was made by the Dutch pharmaceutical industry board and relates only to the Netherlands. Biogen also said the Serono release seeks to promote Serono's product in a misleading fashion and that Biogen is considering appropriate legal action to correct defamatory statements in the Serono release.
Mark Leuchtenberger, Biogen's Vice President-International, said, "This inaccurate and misleading statement is another misguided attempt by Serono to attack AVONEX®, the worldwide leader in multiple sclerosis (MS) therapy, and to promote Rebif®, its own interferon product. It comes on the heels of Serono's continued failure to enter the U.S. MS market with Rebif®." The U.S. Food and Drug Administration has officially determined that Rebif® is not clinically superior to AVONEX and has rejected Serono's application for approval of Rebif®.
More than 93,000 patients are currently being treated with AVONEX®, while Serono claims that a maximum of 24,000 patients have been treated at some time, including clinical trials, with Rebif®. AVONEX® has shown unsurpassed efficacy in two successful large Phase III clinical studies where it was effective on all recognized endpoints, including disability progression, relapse rates, and various brain parameters, and most recently showed a 44 percent reduction in the rate of disease progression. In a similar study, which has not been published, Rebif® failed to produce equivalent results.
Biogen said it had successfully challenged Serono this week in The Netherlands, where the Dutch pharmaceutical board forbade Serono from using one of its product advertisements. Biogen had also been previously successful in challenging other Serono campaigns in The Netherlands, the United Kingdom, Germany and Switzerland, where Serono was using misleading claims.
Biogen said that Serono's press release regarding the recent action in The Netherlands was deliberately misleading because:
Biogen, Inc., winner of the U.S. National Medal of Technology, is a biopharmaceutical company principally engaged in discovering and developing drugs for human healthcare through genetic engineering. Headquartered in Cambridge, MA, the Company's revenues are generated from international sales of AVONEX® (Interferon beta-1a) for treatment of relapsing forms of multiple sclerosis, and from the worldwide sales by licensees of a number of products, including alpha interferon and hepatitis B vaccines and diagnostic products. Biogen's research and development activities are focused on novel products to treat inflammatory and autoimmune diseases, neurological diseases, cancer, fibrosis and congestive heart failure. The Company maintains active clinical research programs in protein therapeutics, small molecules, genomics and gene therapy. For copies of press releases and additional information about the Company, please consult Biogen's Homepage on the World Wide Web at http://www.biogen.com .
AVONEX® (Interferon beta-1a) is a registered trademark of Biogen, Inc. AVONEX® is approved in the U.S. and in most other countries around the world for the treatment of relapsing forms of multiple sclerosis. Rebif® is a registered trademark of Serono, Inc.
SOURCE: Biogen, Inc.