Prague, Czech Republic
Biogen Idec (NASDAQ: BIIB) today announced that nearly 25 posters and symposia sponsored by the company will be presented at the 23rd Congress of the European Committee for Treatment and Research of Multiple Sclerosis (ECTRIMS) in Prague, Czech Republic. These presentations and symposia will cover five agents that are marketed or currently in development by Biogen Idec and its partners for the treatment of multiple sclerosis (MS). The two approved therapies for MS are TYSABRI(R)(natalizumab) and AVONEX(R) (Interferon beta-1a); and agents in development are BG-12 (dimethyl fumarate), daclizumab and RITUXAN(R) (rituximab).
"The number of presentations and symposia by Biogen Idec at ECTRIMS are evidence of our dedication and leadership in discovering and developing treatments for multiple sclerosis patients," said Alfred Sandrock, MD, PhD, Senior Vice President, Neurology Research and Development, Biogen Idec. "Biogen Idec strives to provide a continuum of care for all MS patients at every stage of their disease. Building upon the foundation that we established with TYSABRI and AVONEX, our extensive clinical pipeline looks to the future. In addition, our compounds in earlier stages of development target such unmet needs as neurodegeneration and remyelination, with the goal to reverse the damage inflicted by MS."
The following are selected highlights of presentations at ECTRIMS:
TYSABRI
-- Use of natalizumab in patients with relapsing multiple sclerosis: updated safety results from TOUCH(TM) and TYGRIS(Poster #565 - Saturday, October 13, 2007, 3:30 p.m. CEST)
-- Natalizumab increases the proportion of patients with multiple sclerosis who are disease-free (Poster #567 - Saturday, October 13, 2007, 3:30 p.m. CEST)
-- The effect of plasma exchange in accelerating clearance of natalizumab in patients with multiple sclerosis: results of the PLEX study (Poster #576 - Saturday, October 13, 2007, 3:30 p.m. CEST)
AVONEX
-- Progression of disability at two years predicts disability at eight years: analysis from the Phase III clinical trial of intramuscular Interferon beta-1a (Poster #195 - Friday, October 12, 2007, 3:30 p.m. CEST)
-- Final results from the Global QUASIMS Study: a worldwide comparative study of the efficacy and tolerability of interferon-beta products for the treatment of relapsing multiple sclerosis (Poster #197 - Friday, October 12, 2007, 3:30 p.m. CEST)
BG-12
-- Two Phase III studies to determine the efficacy and safety of BG-12, a novel, oral fumaric acid derivative, in patients with relapsing multiple sclerosis (Poster #579 - Saturday, October 13, 2007, 3:30 p.m. CEST)
-- Activation of Nrf2 and modulation of disease progression in EAE models by BG-12 (dimethyl fumarate) suggests a novel mechanism of action combining anti-inflammatory and neuroprotective modalities (Poster #503 - Friday, October 12, 2007, 3:30 p.m. CEST)
"We are excited about BG-12's novel, dual mechanism of action," continued Dr. Sandrock. "With approval to run the Phase III studies in 17 countries, we are pleased to have a global program that offers both anti-inflammatory and neuroprotective properties to patients in need."
Daclizumab
Daclizumab is a humanized monoclonal antibody to the IL-2 receptor of T cells that is in Phase II development for MS.
-- Preliminary CHOICE results: a Phase II, randomised, double-blind, placebo-controlled multicentre study of subcutaneous daclizumab in patients with active, relapsing forms of multiple sclerosis on interferon beta (Platform Presentation #50 - Friday, October 12, 2007, 2:50 p.m. CEST)
RITUXAN
RITUXAN is a targeted B-cell therapy that is in development for MS.
-- Safety and efficacy of rituximab in adults with relapsing-remitting multiple sclerosis: esults of a Phase II placebo-controlled, multicentre trial through 48 weeks (Poster #554 - Saturday, October 13, 2007, 3:30 p.m. CEST)
Biogen Idec and Elan Corporation, plc will also be hosting two symposia during ECTRIMS: "Optimising MS therapy to fit patients' lives" will be held on Thursday, October 11, 2007 at 2:30 p.m. CEST and "Urgency to treat: can we modify the course of MS?" will be held on Friday, October 12, 2007 at 6:00 p.m. CEST. Both symposia will be held in the Main Hall of the Prague Congress Centre.
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.
About Our Products
TYSABRI
TYSABRI is a treatment approved for relapsing forms of MS in the United States and relapsing-remitting MS in the European Union. According to data that have been published in the New England Journal of Medicine, after two years, TYSABRI treatment led to a 68% relative reduction (p<0.001) in the annualized relapse rate compared to placebo and reduced the relative risk of disability progression by 42-54% (p<0.001).
TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Other serious adverse events that have occurred in TYSABRI-treated patients included hypersensitivity reactions (e.g., anaphylaxis) and infections. Serious opportunistic and other atypical infections have been observed in TYSABRI-treated patients, some of whom were receiving concurrent immunosuppressants. Herpes infections were slightly more common in patients treated with TYSABRI. In MS trials, the incidence and rate of other serious and common adverse events, including the overall incidence and rate of infections, were balanced between treatment groups. Common adverse events reported in TYSABRI-treated patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain, and rash.
In addition to the United States and European Union, TYSABRI is also approved in Switzerland, Canada, Australia, New Zealand and Israel. TYSABRI was discovered by Elan and is co-developed with Biogen Idec.
AVONEX
AVONEX is the most prescribed treatment for relapsing forms of MS worldwide, with more than 130,000 patients on therapy. It is used worldwide as a treatment for relapsing forms of MS to slow the progression of disability and reduce relapses. AVONEX is also approved for patients who have their first clinical MS attack and have a brain MRI scan consistent with MS. The most common side effects associated with AVONEX multiple sclerosis treatment are flu-like symptoms, including myalgia, fever, fatigue, headache, chills, nausea, vomiting, pain and asthenia.
AVONEX should be used with caution in patients with depression or other mood disorders and in patients with seizure disorders. AVONEX should not be used by pregnant women. Patients with cardiac disease should be closely monitored. Patients should also be monitored for signs of hepatic injury.
Daclizumab
Although daclizumab is currently marketed for other uses, it is not approved for use in patients with multiple sclerosis.
RITUXAN
Although RITUXAN is currently marketed for other uses, it is not approved for use in patients with multiple sclerosis.
For full prescribing information on TYSABRI and warnings that come with the product, please visit www.tysabri.com. For full prescribing information on AVONEX, please visit www.avonex.com. or full prescribing information on RITUXAN, please visit www.rituxan.com.
Safe Harbor/Forward-Looking Statements
This press release contains forward-looking statements about our expected product sales, product development and other matters. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from that which we expect. The commercial potential of products in pre-clinical and clinical development is subject to a number of risks and uncertainties, including the risk of unexpected delays or hurdles and the uncertainty of obtaining regulatory approval. Drug development and commercialization involves a high degree of risk. Additional factors that could cause our actual results to differ include our continued dependence on our two principal products, AVONEX and RITUXAN, the uncertainty of success in commercializing other products including TYSABRI, the occurrence of adverse safety events with our products, the failure to execute our growth strategy successfully or to compete effectively in our markets, our dependence on collaborations over which we may not always have full control, possible adverse impact of government regulation and changes in the availability of reimbursement for our products, problems with our manufacturing processes and our reliance on third parties, fluctuations in our operating results, our ability to protect our intellectual property rights and the cost of doing so, the risks of doing business internationally and the other risks and uncertainties that are described in Item 1A "Risk Factors" in our most recent Form 10-Q filing with the SEC. These forward-looking statements speak only as of the date of this press release, and we do not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise.
Source: Business Wire (Business Wire India)