Biogen, Inc. (NASDAQ/BGEN) today said Serono’s recently released six-month data are “an incomplete measure giving a snapshot view of a serious disease that must be treated over the long-term.” Biogen also said that it is not surprised by today’s announcement and continued to express strong belief Serono’s assertions about the data are misleading.
Burt Adelman, M.D., Biogen’s Vice President of Medical Research, said, “The findings announced today provide only limited data to compare AVONEX® (Interferon beta-1a) and Rebif® (Interferon beta-1a). Importantly, data describing each drug’s effect on disability progression and their safety profiles are missing. It is remarkable Serono did not present the actual clinical data from the study. Previously submitted data from Serono’s Phase III clinical study was not sufficient to enable the FDA to approve Rebif for sale in the U.S. There is a wealth of data from well-designed clinical trials that define the risks and benefits of these two products. These data announced today do not change this perspective.
“MS is a life-long disease, we do not believe that a six-month data snapshot is adequate to
determine the risk-to-benefit ratio of a drug that will be taken for years.
“AVONEX® (Interferon beta-1a) has been demonstrated to have important and clinically meaningful effects on relapse rate, as well as progression of disability; these actions are recognized by people with MS and their physicians.
“Hopefully, individuals with MS and their physicians won’t be misled by incomplete pieces of data released to provide commercial, rather than scientific, advantage. We are confident in the FDA’s high scientific standards and the agency’s ability to carefully evaluate clinical data to assure that the purpose and incentives of the Orphan Drug Law are fulfilled.”
AVONEX is the most prescribed treatment for MS worldwide. It was launched in the U.S. in 1996 and later in Europe for the treatment of relapsing forms of MS to slow the accumulation of physical disability and to decrease the frequency of clinical exacerbations. More than 100,000 patients worldwide are now on AVONEX therapy, which is marketed internationally in more than 65 countries.
The most common side effects associated with AVONEX treatment are flu-like symptoms, muscle ache, fever, and chills. Other common side effects seen, but not statistically different between AVONEX and control groups, were headache, pain and asthenia (weakness). These side effects usually go away within a day after the injection and occur less often as the treatment continues. AVONEX should be used with caution in people with depression and people with seizure disorders. AVONEX should not be used by pregnant woman. People with cardiac disease should be closely monitored. Routine periodic blood chemistry and hematology tests are recommend during treatment with AVONEX.
In addition to historical information, this press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Reference is made in particular to statements regarding speculation on the likely view of Serono’s data by the FDA and the implications for the marketplace. These statements are based on the Company’s current beliefs and expectations as to such future outcomes. Factors which could cause actual results to differ materially from the Company’s current expectations include the risk that submitted or longer-term data may be different than announced data, or that the FDA may apply it’s standards differently than expected as well as the other risks and uncertainties described from-time-to-time in the Company’s periodic reports filed with the Securities and Exchange Commission.
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 ( Prescribing Information ). 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.
Rebif® (Interferon beta-1a) is the registered trademark of Serono.