Collaborations Bolster the Company's Pipeline Development Efforts
Updated 5:08 PM ET October 10, 2000
CAMBRIDGE, Mass., Oct. 10 /PRNewswire/ -- Biogen, Inc. (NASDAQ:BGEN) today reported financial results for the third quarter of 2000. For the three months ended September 30, 2000, the Company reported net income of $68,381,000, an increase of 10 percent compared to the same period in 1999 resulting in $0.44 per share. Revenues for the quarter were $233,754,000, up 12 percent over the third quarter of last year.
James C. Mullen, Biogen's President and Chief Executive Officer, said, "With its proven results and broad-based efficacy, AVONEX(R) remains the worldwide drug of choice among people with multiple sclerosis (MS) and their physicians. This quarter, we saw global product revenue growth of 18 percent year-over-year.
"More than 93,000 patients worldwide now use AVONEX. It is the only MS treatment that has demonstrated proven results across a broad range of meaningful clinical measures. As we learn more about AVONEX, the unique benefits it brings to people with MS expand. At the end of September, our landmark CHAMPS trial was published in the New England Journal of Medicine, showing that early treatment with AVONEX significantly reduced the rate at which individuals at high-risk for MS develop clinically definite multiple sclerosis (CDMS). Treatment with AVONEX in this group of patients reduced the rate of development of CDMS by 44 percent versus treatment with placebo and reconfirmed the significant effect on brain inflammation, with a 91 percent reduction in the volume of MRI lesions. We are now in the process of a global registration for this additional indication.
"In addition, the positive results seen in primary progressive MS, a very aggressive form of the disease, are very encouraging. These results, combined with the effects previously seen with AVONEX in slowing the decline in physical and cognitive abilities, reducing relapse rate, and slowing the atrophy of brain tissue, clearly distinguish AVONEX from other therapies available for this debilitating disease.
"We continue with aggressive development of our pipeline products. We completed accrual for the Phase III trial of AMEVIVE(TM) months ahead of schedule, and if all goes well we are on track to file for regulatory filing in the second half of 2001. These Phase II data show that AMEVIVE is the first disease-modifying agent for the treatment of psoriasis that has a long duration of effect and is well tolerated. Phase III studies are ongoing to further demonstrate the efficacy and safety of AMEVIVE in this population. We also expect to bring three new programs into the clinic next year: ADENTRI(TM) for acute and chronic congestive heart failure, LT beta-receptor for autoimmune diseases, and interferon beta gene therapy for glioma. In addition, we expect to begin Phase III trials of ANTEGREN(R) in MS and Crohn's disease in the second half of next year, pending successful completion of the Phase II trials.
"During the past quarter, we intensified our investment in the important new platform technology of genomics and expanded our long-term pipeline capabilities and basic research programs with several collaborative agreements. These include the Elan collaboration, a multi-year research and development collaboration with Eos Biotechnology in the area of breast cancer, and a multi-product gene-therapy development and commercialization collaboration with Targeted Genetics."
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 plans for future regulatory filings and commencement of clinical trials. These statements are based on the Company's current beliefs and expectations as to such future outcomes. Drug development involves a high degree of risk. Success in early stage clinical trials does not ensure that later stage or larger scale clinical trials will be successful. Factors which could cause actual results to differ materially from the Company's current expectations include the risk that a particular product may not show therapeutic effect or an acceptable safety profile in subsequent trials or may not meet applicable regulatory standards, or that problems or delays may arise in preparation for or during clinical trials or in the course of the development, testing or manufacturing of the product.
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 U.S. and European 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) is a registered trademark of Biogen, Inc. AMEVIVE(TM) (alefacept) and ADENTRI(R) (adenosine A1 antagonist inhibitor) is a trademark of Biogen, Inc. ANTEGREN(R) (natalizumab) is a registered trademark of Elan Corporation. AVONEX(R) is approved in the U.S. and in most other countries around the world for the treatment of relapsing forms of multiple sclerosis.
NOTE: The Company's earnings conference call for the third quarter will
be broadcast via the Internet at 5:00 p.m. EST on Tuesday, October 10,
2000, and will be accessible through the investor relations section of
Biogen's homepage, http://www.biogen.com.