Swiss Court Issues Injunction Prohibiting Serono From Misleading Publicity on "EVIDENCE" Study
CAMBRIDGE, Mass., June 22 /PRNewswire/
-- Biogen, Inc. (Nasdaq: BGEN) today said that Serono continues to make
misleading claims of superior efficacy in comparison to Biogen's multiple
sclerosis (MS) drug, AVONEX(R) (Interferon beta-1a), the world's leading
treatment for the disease. Biogen also said that the Serono announcement
adds nothing new in advancing the understanding of the progression of the
disease. These data presented are based on a study that lacks scientific
rigor and presents an incomplete measure of a serious disease that must
be treated over the long-term. Yesterday a court in Geneva, Switzerland,
the worldwide headquarters of Serono, issued an injunction forbidding Serono's
continued misleading presentation of their data related to the "EVIDENCE"
study. That court determined that Serono's claims about relapses
and brain lesions are misleading, and specified that criminal penalties
could apply to further violations.
Serono has touted dramatic numbers ("a 90 percent greater odds of remaining relapse-free") instead of reporting what are actually very small numeric differences. The actual differential is less than 12 percentage points: 74.9% of patients on Rebif(R) were relapse free and 63.3% of patents on AVONEX were relapse free. It is crucial to recognize that the validity of relapse-related statistics is seriously compromised by Serono's short-term "snapshot" approach that accentuates random relapses unrelated to treatment effects.
The FDA previously rejected Serono's application for marketing approval in the U.S. In response to ongoing attempts to gain approval, the FDA has maintained its position that the Rebif(R) data fail to demonstrate clinical superiority to AVONEX(R).
"We can only hope that neither individuals with MS, nor their physicians will be misled by these data released to further commercial, rather than scientific, goals," said Burt Adelman, M.D., Biogen's Vice President of Medical Research. "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 Act are fulfilled."
"Serono's comparative trial is an open-label, short-term marketing-oriented effort that we believe will not survive the rigors of scientific scrutiny," Dr. Adelman continued. "Serono has focused on comparing only one aspect of MS over an extremely short period of time in a disease that has a complex, multi-faceted course of progression that happens over a long period of time," he said.
Biogen noted that well-designed Phase III clinical trials conducted over the past eight years do not support Serono's new claims about Rebif. Moreover, Biogen's AVONEX has clearly demonstrated its efficacy in slowing the progression of disability and in reducing the frequency of relapses. Biogen said data that differ dramatically from the well-established body of evidence must be seriously questioned.
"There is a wealth of data from well-designed clinical trials that define the risks and benefits of MS products. Serono's recently announced data do not change this perspective. Specifically, AVONEX has been demonstrated to slow the progression of disability in relapsing MS. Slowing the progression of disability is the more meaningful measurement of this long-term chronic disease. If Serono wanted a scientifically sound comparative trial, rather than a marketing study, they would have selected this more meaningful endpoint of disability progression. They did not," Dr. Adelman said.
The Serono study design is flawed for the following reasons:
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, as well as statements regarding the anticipated commencement
date of Phase III clinical trials of ANTEGREN. These statements are
based on the Company's current beliefs and expectations as to such future
Factors which could cause actual results to differ materially from the Company's current expectations include, with respect to the statements regarding the Serono data, the risk that submitted or longer-term data may be different than announced data, or that the FDA may apply its standards differently than expected and, with respect to the statements regarding ANTEGREN(R), the risk that unexpected delays may arise as well as in each case 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(R) (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(R) (Interferon beta-1a) and ANTEGREN(R) (natalizumab) are registered trademarks of Biogen, Inc. Rebif(R) (Interferon beta-1a) is the registered trademark of Serono.
SOURCE Biogen, Inc.
Web Site: http://www.biogen.com.