Our product pipeline is one of the most robust in the industry, with 13 programs in Phase II clinical trials or later, seven of which are Phase III programs. The company’s core therapeutic areas include neurology, oncology and immunology, and, with the acquisition of Syntonix, we expanded our expertise into hemophilia. This robust and diverse pipeline is a testament to the dedication, inspiration and hard work of scientists who strive to create meaningful therapeutic advancements for patients.
- TECFIDERA® (dimethyl fumarate) – an oral multiple sclerosis therapy approved in the United States, Canada, Australia and European Union. TECFIDERA has been proven to significantly reduce important measures of disease activity, including relapses and development of brain lesions, as well as to slow disability progression over time, while demonstrating a favorable safety and tolerability profile.
The most common adverse events (AEs) associated with TECFIDERA were flushing and gastrointestinal (GI) events (i.e., diarrhea, nausea, abdominal pain, upper abdominal pain). Overall, clinical trial discontinuations due to flushing (3%) and GI events (4%) were low.
Mean lymphocyte counts decreased during the first year of treatment and then remained stable. There were no opportunistic infections in TECFIDERA-treated patients and no overall increased risk of serious infections.
- TYSABRI® (natalizumab) - approved in more than 65 countries. TYSABRI is approved in the United States as a monotherapy for relapsing forms of MS, generally for patients who have had an inadequate response to, or are unable to tolerate, an alternative MS therapy. In the European Union, it is approved for highly active relapsing-remitting MS (RRMS) in adult patients who have failed to respond to beta interferon or have rapidly evolving, severe RRMS.
TYSABRI has advanced the treatment of MS patients with its established efficacy. Data from the Phase 3 AFFIRM trial, which was published in the New England Journal of Medicine, showed that after two years, TYSABRI treatment led to a 68 percent relative reduction (p<0.001) in the annualized relapse rate when compared with placebo and reduced the relative risk of physican disability progression by 42-54 percent (p<0.001).
The company co-promotes the product with Elan Pharmaceuticals, Inc.
- AVONEX® (interferon beta-1a IM) - approved in more than 90 countries, AVONEX has more than 15 years of clinical experience in more than 388,000 patients worldwide and 1.4 million years of patient experience. It is a treatment for patients with clinically isolated syndrome (CIS) with a high risk for developing clinically definite multiple sclerosis (CDMS). It is also approved for relapsing forms of MS.
- RITUXAN® (rituximab) - the world’s first licensed monoclonal antibody therapy for the treatment of certain B-cell non-Hodgkin's lymphomas (NHL). RITUXAN is also indicated for moderately-to-severely active rheumatoid arthritis. In addition, RITUXAN, in combination with glucocorticosteroids, is approved for the treatment of Wegener’s Granulomatosis and Microscopic Polyangiitis in adults. Genentech and Biogen collaborate on Rituxan in the United States, and Roche markets MABTHERA® in the rest of the world, except Japan, where RITUXAN is co-marketed by Chugai and Zenyaku Kogyo Co., Ltd.
- FUMADERM® - marketed in Germany, FUMADERM is indicated for the treatment of moderate-to-severe psoriasis.
FAMPYRA® (prolonged-release fampridine tablets) is a treatment indicated to improve walking in adult patients with multiple sclerosis (MS) who have walking disability. Biogen has a license from Acorda Therapeutics, Inc to develop and commercialize FAMPYRA in all markets outside the United States. In the U.S this prolonged-release fampridine tablet formulation was developed and is being commercialized by Acorda under the name AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg. FAMPYRA is the first treatment that addresses the unmet medical need of walking improvement in MS with demonstrated efficacy in adults with MS. FAMPYRA can be used alone or in combination with disease modifying therapies, including immunomodulatory drugs. In clinical trials, patients responding to FAMPYRA had an average increase in walking speed of 25 percent and FAMPRYA was shown to provide a clinically meaningful improvement in walking.
For further information on FAMPYRA in your country please click here.