Biogen Idec, Inc., an international biotechnology company, engages in the development, manufacture, and commercialization of new therapies. The company creates new standards of care in oncology, neurology, immunology and other specialty areas of unmet medical needs.
Products
The company has five main products: AVONEX; RITUXAN; TYSABRI; FUMADERM; and ZEVALIN.
AVONEX (interferon beta-1a)
AVONEX is approved worldwide for the treatment of relapsing forms of multiple sclerosis, or MS, and is the most prescribed therapeutic product in MS worldwide. MS is a progressive neurological disease in which the body loses the ability to transmit messages along nerve cells, leading to a loss of muscle control, paralysis and, in some cases, death. AVONEX is on the market in 70 countries. AVONEX is the prescribed therapeutic product for the treatment of MS worldwide with approximately 135,000 patients using AVONEX. The company has also extended the Controlled High Risk AVONEX Multiple Sclerosis Prevention Study In Ongoing Neurological Surveillance, or CHAMPIONS. In November 2006, the company launched AVONEX in Japan, following the approval of the Japanese Ministry of Health, Labour and Welfare of AVONEX for the prevention of MS relapse.
RITUXAN (rituximab)
RITUXAN is approved worldwide for the treatment of relapsed or refractory low-grade or follicular, CD20-positive, B-cell non-Hodgkin’s lymphomas, or B-cell NHLs. In 2006, the U.S. Food and Drug Administration, or FDA, approved RITUXAN for three additional uses in NHL. In February 2006, the FDA approved the RITUXAN supplemental Biologics License Application, or sBLA, for use of RITUXAN, in combination with methotrexate, for reducing signs and symptoms in adult patients with moderately-to-severely active rheumatoid arthritis, or RA, who have had an inadequate response to one or more tumor necrosis factor, or TNF, antagonist therapies. The company is in the process of working with Genentech and Roche on the development of RITUXAN in additional oncology and other indications. RITUXAN is the trade name for the compound rituximab in the U.S., Canada and Japan. MabThera is the trade name for rituximab in the European Union, or EU.
RITUXAN in Oncology: RITUXAN is the oncology therapeutic in the United States and has had approximately 960,000 patient exposures worldwide. RITUXAN is administered as outpatient therapy by personnel trained in administering chemotherapies or biologics. RITUXAN is unique in the treatment of B-cell NHLs due to its specificity for the antigen CD20, which is expressed only on the surface of normal B-cells and malignant B-cells. Stem cells (including B-cell progenitors or precursor B-cells) in bone marrow lack the CD20 antigen. This allows healthy B-cells to regenerate after treatment with RITUXAN and to return to normal levels within several months.
The company, along with Genentech and Roche, is also conducting a multi-center global Phase III registrational study in patients with relapsed chronic lymphocytic leukemia, or CLL, comparing the use of fludarabine, cyclophosphamide and RITUXAN together, known as FCR, versus fludarabine and cyclophosphamide alone.
TYSABRI (natalizumab)
TYSABRI is approved for the treatment of relapsing forms of MS. Under the terms of a collaboration agreement with Elan Corporation plc, or Elan, the company is solely responsible for the manufacture of TYSABRI, and collaborates with Elan on the product’s marketing, commercial distribution and on-going development activities. The company, along with Elan, has completed three Phase III studies of TYSABRI in Crohn’s disease. The three completed Phase III studies are known as ENACT-2 (Evaluation of Natalizumab as Continuous Therapy-2), ENACT-1 (Evaluation of Natalizumab as Continuous Therapy-1), and ENCORE (Efficacy of Natalizumab for Crohn’s Disease Response and Remission).
ZEVALIN (ibritumomab tiuxetan)
The ZEVALIN therapeutic regimen, which features the ZEVALIN antibody, is a radioimmunotherapy that is approved for the treatment of patients with relapsed or refractory low-grade, follicular, or transformed B-cell NHL, including patients with RITUXAN refractory NHL. ZEVALIN is approved in the EU for the treatment of adult patients with CD20-positive follicular B-cell NHL who are refractory to or have relapsed following RITUXAN therapy. The company sells ZEVALIN to Schering AG for distribution in the EU.
FUMADERM (dimethylfumarate and monoethylfumarate salts)
FUMADERM was acquired with the purchase of Fumapharm AG, or Fumapharm, in June 2006. FUMADERM acts as an immunomudulator and has been approved in Germany for the treatment of severe psoriasis. The product has been in commercial use in Germany for approximately eleven years and is the most prescribed oral systemic treatment for severe psoriasis in Germany.
BG-12
BG-12 is a second-generation oral fumarate with an immunomodulatory mechanism of action. The company completed a Phase 2b clinical study of BG-12 in patients with relapsing-remitting MS in October 2005. In January 2006, the company announced that this study had its achieved its primary efficacy endpoint. Based on the results of the Phase 2 study, the company announced that it initiated a Phase 3 program of BG-12 in MS in January 2007. Fumapharm has also completed a small Phase III study of BG-12 in psoriasis.
ANTI-CD80 Antibody/(galiximab)
The CD80 antigen is expressed on the surface of follicular and other lymphoma cells, and is also known as B7.1. The company completed a Phase IIa study designed to evaluate the anti-CD80 antibody that was developed using Primatized antibody technology in patients with non-Hodgkin’s lymphoma. The antibody was well tolerated, with observation of clinical responses in patients treated with higher doses. Based on the results of the Phase IIa study, the company announced that it initiated a Phase III study of the antibody in front line non-Hodgkin’s lymphoma in combination with RITUXAN and standard chemotherapy in January 2007.
ANTI-CD23 Antibody/(lumiliximab)
The CD23 antigen is expressed on the surface of mature B-cells and other immune system cells, and is also known as Fc epsilon RII. The company has completed a Phase IIa study designed to evaluate the anti-CD23 antibody that it developed using Primatized antibody technology in patients with chronic lymphocytic leukemia, or CLL.
Other Research and Development Programs
The company intends to focus research and development efforts on finding novel therapeutics in areas of high unmet medical need. Its main focus areas are in oncology, neurobiology and autoimmune disease.
Oncology
M200 (volociximab), a chimeric monoclonal antibody directed against alpha5 beta1 integrin, shown to inhibit the formation of new blood vessels necessary for tumor growth, in collaboration with PDL BioPharma, Inc., or PDL; CNF2024, a totally synthetic, orally bioavailable heat shock protein 90 inhibitor, acquired with the purchase of Conforma Therapeutics Corporation, or Conforma; and a maytansinoid-conjugated monoclonal antibody directed against CRIPTO, a novel cell surface signaling molecule that is over-expressed in solid tumors.
Autoimmune and Inflammatory Diseases
A new humanized anti-CD20 antibody targeting B-cell disorders for a range of indications, and a BR3 protein therapeutic as a potential treatment for disorders associated with abnormal B-lymphocyte activity, in separate collaborations with Genentech; and a soluble form of the lymphotoxin beta receptor, which targets RA and other autoimmune diseases.
Neurobiology
In collaboration with Vernalis plc, BIIB014, formerly V2006, the main compound in Vernalis’ adenosine A2A receptor antagonist program, which targets Parkinson’s disease and other central nervous system disorders; in collaboration with PDL, daclizumab, a humanized monoclonal antibody that binds to the IL-2 receptor on activated T cells; in collaboration with UCB S.A., or UCB, CDP323, an orally active small molecule alpha-4 integrin inhibitor expected to enter Phase II clinical trials in MS in 2007; Neublastin, a protein therapeutic that appears to maintain the viability and physiology of peripheral sensory neurons.
Emerging Therapeutic Areas
Aviptadil, a peptide hormone in licensed from mondoBIOTECH AG, or mondo, for pulmonary arterial hypertension; and FIX:Fc, a Factor IX fusion protein acquired with the purchase of Syntonix Pharmaceuticals Inc., or Syntonix, for hemophilia B.
Collaboration Agreement
The company has collaboration agreement with Genentech, Inc.
Competition
AVONEX AND TYSABRI: AVONEX and TYSABRI both compete primarily with three other products: REBIF, which is co-promoted by Merck Serono and Pfizer in the U.S. and sold by Merck Serono in Europe. BETASERON, sold by Berlex (an affiliate of Bayer Schering Pharma AG) in the U.S. and sold under the name BETAFERON by Bayer Schering Pharma AG in the EU. COPAXONE, sold by Teva Neuroscience, Inc., or Teva, in the U.S. and co-promoted by Teva and Sanofi-Aventis in Europe.
RITUXAN AND ZEVALIN — B-CELL NHLs: ZEVALIN competes with BEXXAR (tositumomab, iodine I-131 tositumomab), a radiolabeled molecule developed by Corixa Corporation which is being developed and commercialized by GlaxoSmithKline. Other potential competitors include Campath (Berlex, Inc.), which is indicated for B-cell chronic lymphocytic leukemia; Velcade (Millennium Pharmaceuticals, Inc.) which is indicated for multiple myeloma; and Humax CD20 (GenMab) which is in late-stage development for refractory CLL and NHL.
RITUXAN IN RA: RITUXAN would compete with different types of therapies in the RA market, including: anti-TNF therapies, such as REMICADE (infliximab), a drug sold worldwide by Centocor, Inc., a subsidiary of Johnson & Johnson, HUMIRA (adalimumab), a drug sold by Abbott Laboratories, and ENBREL (etanercept), a drug sold by Amgen, Inc. and Wyeth Pharmaceuticals, Inc.; and ORENCIA (abatacept), a drug developed by Bristol-Myers Squibb Company.
History
Biogen Idec, Inc. was founded in 1985.
