Tuesday January 9
Source: PR Newswire
CAMBRIDGE, Mass., Jan. 9 /PRNewswire/ -- Biogen, Inc. (Nasdaq: BGEN) said today it expects the number of drugs in its clinical pipeline to double during 2001 and that it currently has 20 projects in its research pipeline. James C. Mullen, Biogen's President and Chief Executive Officer, made the statement at the annual J.P. Morgan Chase H&Q Lifesciences Conference held today in San Francisco, CA.
Mr. Mullen said that Biogen has completed dosing all patients in its Phase III trials of AMEVIVE(TM) (alefacept) in chronic plaque psoriasis and expects to have data from these trials by mid-year. Pending successful conclusion of the trials, the Company anticipates product registration and launch in the second half of 2002. Biogen also expects to report Phase II results from studies of ANTEGREN(R) (natalizumab) in multiple sclerosis (MS) and Crohn's disease during the first quarter of 2001. The ANTEGREN program is being conducted in collaboration with Elan Pharmaceuticals, Inc.
Three drugs are scheduled to enter the clinic this year. They are Adenosine A1 antagonist for congestive heart failure, soluble lymphotoxin beta receptor for autoimmune diseases and interferon beta gene therapy for glioma.
Mr. Mullen presented a strategic overview of Biogen's plans to grow from its current status as a single-product company into an integrated, global, multi-product organization. The Company will announce results for the full year and fourth quarter 2000 on January 17, 2001.
"We have a major challenge ahead of us, and one we are confident of achieving," Mr. Mullen said. "Since the introduction of AVONEX(R) (Interferon beta-1a) to the U.S. marketplace in 1996, Biogen has completed its initial mission of becoming an integrated, global biopharmaceutical company. This has given us a firm base supported by three pillars - strong commercial leverage, a dynamic product pipeline and a strategic research program that builds on our historical excellence in biology to allow us to maximize the potential of the genomics revolution. It also helps us to continue to deliver value to our investors.
"Last year, we announced more data about AVONEX, our lead proprietary product, than in any year since product launch. All of it reinforced the unique utility of this product in the treatment of MS."
AVONEX is the world's leading MS therapy, with more AVONEX sold throughout the world than all other MS drugs combined. Mr. Mullen also said that the global commercial models the company has initiated to support AVONEX would serve as a basis for AMEVIVE and other drugs in the product pipeline.
Mr. Mullen said the Company is enthusiastic about the introduction of AMEVIVE. "The psoriasis marketplace is the kind Biogen understands. There are many parallels to the MS marketplace back in 1996 when we launched AVONEX - a large, underserved patient population and a medical community that is close-knit and tightly focused. Existing therapies are expensive and have a lot of unwanted side effects. We plan to register and launch concurrently throughout the world, thus capturing maximum value for the drug - just as we did with AVONEX. We have a lot of experience with this kind of business model and anticipate equal success in the psoriasis marketplace as we have achieved in the neurology marketplace."
Mr. Mullen also said that Biogen is uniquely positioned to capitalize on the new technologies coming out of the human genome project. "There is more than one way to capitalize on the riches coming out of this research," he said. "You can call it 'push' vs. 'pull' or 'datamining' vs 'biomining.' Now that so much information is available about the human genome, we believe that companies like Biogen, with our extraordinary depth of experience and understanding of biology, will be able to use a 'pull' or biomining strategy to identify selective genes and apply our knowledge of biological systems to enhanced target identification and drug development."
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.
In addition to historical facts, this press release contains forward- looking statements that involve risks and uncertainties that could cause actual results to differ materially from those reflected in the forward- looking statements. Reference is made in particular to statements regarding the number of products anticipated to enter clinical trials in 2001, the Company's expectations with respect to AMEVIVE(TM) and registration and launch of the product and the Company's plans and belief as to its ability to achieve its strategic goals. Factors which could cause actual results to differ materially from the Company's current expectations include the risk that the Company will encounter one or more technical hurdles associated with new drug development or that problems or delays may arise during preparations for or the conduct of clinical trials, or that results of clinical trials may be different than those seen in earlier stage or smaller trials or in preclinical work as well as the other risks and uncertainties associated with drug development and commercialization described in the Company's periodic reports filed with the Securities and Exchange Commission. Drug development involves a high degree of risk. Success in early stage clinical trials or preclinical work does not ensure that later stage or larger scale clinical trials will be successful.
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
Source: Biogen, Inc.
Contact: Media Contacts: Kathryn R. Bloom, Director of Communications, 617-679-2851, or Investment Community Contact: Elizabeth Woo, Associate Director, Investor Relations, 617-679-2812, both of Biogen