Full Description
Biogen Idec Inc. (BIIB.O) (Nasdaq)
Biogen Idec Inc. is engaged in the development, manufacturing, and commercialization of therapies. The Company’s products address diseases such as multiple sclerosis, non-Hodgkin’s lymphoma (NHL), rheumatoid arthritis (RA), crohn’s disease (CD) and psoriasis. The Company has four products: AVONEX (interferon beta-1a), RITUXAN (rituximab), TYSABRI (natalizumab) and FUMADERM (dimethylfumarate and monoethylfumarate salts). AVONEX is used in the treatment of relapsing forms of multiple sclerosis (MS). RITUXAN is one of the selling oncology therapeutics. In the United States, RITUXAN is approved for NHL. TYSABRI is approved for the treatment of relapsing forms of MS. FUMADERM acts as an immunomudulator. The Company also has product candidates, such as BG-12, which is a oral fumarate; ANTI-CD80 monoclonal antibody (MAb)(galiximab); ANTI-CD23 MAb (lumiliximab); Humanized Anti-CD20 MAb (ocrelizumab), Lixivaptan, an oral compound for the potential treatment of hyponatremia, and ADENTRI, which is an adenosine A1 receptor antagonist, being developed under a licensing agreement with CV Therapeutics, Inc.
AVONEX
The Company markets and sells AVONEX for the treatment of relapsing MS. AVONEX is a recombinant form of a protein produced in the body by fibroblast cells in response to viral infection. AVONEX has been shown in clinical trials in relapsing MS both to slow the accumulation of disability and to reduce the frequency of flare-ups. AVONEX is approved to treat relapsing forms of MS, including patients with a first clinical episode and magnetic resonance imaging (MRI) features consistent with MS. AVONEX is on the market in over 70 countries. The Company has extended the five-year study known as CHAMPIONS for an additional five years.
RITUXAN
In the United States RITUXAN is approved for NHL for the treatment of patients with relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent; treatment of patients with previously untreated diffuse large B-cell, CD20-positive, NHL, or DLBCL, in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy regimens; for the treatment of patients with previously untreated follicular, CD20-positive, B-cell NHL in combination with CVP (cyclophosphamide, vincristine and prednisone) chemotherapy, and the treatment of patients with non-progressing (including stable disease), low grade CD20-positive, B-cell NHL, as a single agent, after first line CVP chemotherapy. RITUXAN, in combination with methotrexate, is also approved for reducing signs and symptoms in adult patients with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.
In the United States, the Company in collaboration with Genentech Inc. is engaged in the continued development of RITUXAN. Genentech provides the support functions for the commercialization of RITUXAN in the United States and has worldwide manufacturing responsibilities. Outside the United States, F. Hoffman-La Roche Ltd. (Roche) markets and sells RITUXAN, except in Japan where RITUXAN is co-marketed by Zenyaku Kogyo Co. Ltd. (Zenyaku) and Chugai Pharmaceutical Co., Ltd. (Chugai), an affiliate of Roche.
TYSABRI
In January 2008, the Company and Elan Corporation plc (Elan) announced the Food and Drug Administration of United States (FDA’s) approval of a supplemental biologics license application (sBLA), for use of TYSABRI for inducing and maintaining clinical response and remission in adult patients with moderately to severely active CD with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-alpha.
Under the terms of the Company’s collaboration agreement with Elan Corporation plc (Elan) the Company is solely responsible for the manufacture of TYSABRI, and it collaborates with Elan on the product’s marketing, commercial distribution and on-going development activities. In the United States, the Company sells TYSABRI to Elan who sells the product to third party distributors. Elan and the Company co-market the product.
FUMADERM
The Company has acquired the right to distribute FUMADERM in Germany from Fumedica GmbH. FUMADERM acts as an immunomodulator and is approved in Germany for the treatment of severe psoriasis.
The Company competes with EMD Serono, Pfizer, Merck Serono, Bayer Schering Pharma AG, Novartis AG, Teva Neuroscience, Inc., Sanofi-Aventis, Bayer Healthcare Pharmaceuticals, Millennium Pharmaceuticals, Inc., Cephalon, GenMab, Centocor, Inc., Abbott Laboratories, Amgen, Inc., Wyeth Pharmaceuticals, Inc., Bristol-Myers Squibb Company and Genentech.

