– Company’s Franchise Continues to Redefine Success in the Treatment of MS –
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Biogen Idec (NASDAQ: BIIB) today announced more than 70 platform and poster presentations from the company’s multiple sclerosis (MS) franchise being presented during the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Düsseldorf, Germany. Held from September 9 -12, 2009, ECTRIMS is the world’s largest medical meeting dedicated to MS. Data being presented will include the company’s currently marketed products, TYSABRI® (natalizumab) and AVONEX® (Interferon beta-1a), as well as three Phase III programs; BG-12 (dimethyl fumarate), PEGylated interferon beta-1a and Fampridine-SR.
“Biogen Idec is a recognized leader in the field of MS research and treatment. AVONEX pioneered the interferon class of treatments and TYSABRI has offered patients a new level of efficacy not seen with any other approved MS therapy. The success seen to date by the tens of thousands of patients who have taken these therapies, along with the hope of our late-stage pipeline, is a testament to how we are setting new expectations in the treatment of MS as we work towards the ultimate goal of finding a cure for this disease,” said Alfred Sandrock, MD, PhD, senior vice president, Neurology Research and Development, Biogen Idec.
The following represents select data highlights from the company’s portfolio of marketed products and late-stage pipeline programs. All data are embargoed until the date and time of the presentation.
TYSABRI
There are 47 TYSABRI posters and presentations during the Congress, including the following posters which show the potential of TYSABRI to redefine successful MS treatment by offering improvement across functional, imaging and patient-reported measures:
- Natalizumab improves disability on the Multiple Sclerosis Functional Composite in a randomised, double-blind, placebo-controlled study of patients with relapsing multiple sclerosis (poster P434);
- Evolution of voxel-wise magnetization transfer ratio in natalizumab and interferon beta-1a IM treated patients with multiple sclerosis. A case-control study (poster P721); and
- What do multiple sclerosis patients experience? Effect of natalizumab on disease-specific quality of life over time (poster P872).
AVONEX
There are 13 AVONEX posters and presentations during the Congress, including:
- CHAMPIONS: 10-year follow-up after a clinically isolated syndrome in patients at high risk for developing multiple sclerosis (poster P446), which supports the benefits of starting early treatment with AVONEX;
- Reducing the risk of informative censoring in long-term study designs: evidence from ASSURANCE (poster P535), which supports the benefits of long-term treatment with AVONEX; and
- An evaluation of adverse skin reactions in patients with multiple sclerosis (poster P787), which focuses on fewer injection site reactions seen in patients taking AVONEX.
Biogen Idec’s Phase III Pipeline
Thirteen posters focusing on Biogen Idec’s extensive MS pipeline will be presented during ECTRIMS. Biogen Idec’s phase III MS portfolio consists of BG-12, a novel oral compound that recently completed accrual in the CONFIRM Phase III clinical trial; PEGylated interferon beta-1a, which may reduce the frequency of treatment injections and provide patients with an effective and more convenient dosing option; and Fampridine-SR, an oral sustained-release compound being developed to improve walking ability in people with MS. Highlights on these compounds include:
- Dimethyl fumarate (BG00012) inhibits astrocyte and microglial activation (poster P457), which provides evidence that the compound may have a dual mechanism of action thought to demonstrate anti-inflammatory and neuroprotective properties;
- Pharmacokinetic, pharmacodynamic, and safety profiles of PEGylated interferon beta-1a in healthy volunteers: results from two phase 1 clinical studies (poster P436), which are the data that supported the advancement of the compound into the ongoing Phase III ADVANCE trial; and
- Interim analysis of an open-label extension study of sustained release fampridine in patients with multiple sclerosis (presentation 43) , which are data from a long-term extension study of the first phase III Fampridine-SR trial sponsored by Acorda Therapeutics, known as MS-F203.
Biogen Idec will also host two symposia during ECTRIMS. Both will feature presentations from world-renowned experts in MS, with a focus on how Biogen Idec’s portfolio is allowing MS patients to expect more from their MS treatments:
- Thursday, September 10, 2009 - 7:15 p.m. to 8:15 p.m. CET - “Redefining Success in MS: Advancing a New Treatment Paradigm"
- Friday, September 11, 2009 - 12:45 p.m. to 1:45 p.m. CET - “Redefining Success in MS: Challenging Treatment Expectations"
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 TYSABRI
TYSABRI is approved in more than 40 countries. In the U.S., it is approved for relapsing forms of MS and in the European Union for relapsing-remitting MS. According to data from the Phase III AFFIRM trial published in the New England Journal of Medicine, 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 disability progression by 42-54 percent (p<0.001).
TYSABRI is redefining success in the treatment of MS. In post-hoc analyses of the Phase III AFFIRM trial and as published in The Lancet Neurology, 37 percent of TYSBARI-treated patients remained free of their MS activity, compared to seven percent of placebo-treated patients. In addition, data has been presented showing that treatment with TYSABRI significantly increased the probability of sustained improvement in disability in patients with a baseline expanded disability status scale (EDSS) score ≥ 2.0 by 69 percent relative to placebo.
TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain. Other serious adverse events that have occurred in TYSABRI-treated patients include hypersensitivity reactions (e.g., anaphylaxis) and infections, including opportunistic and other atypical infections. Clinically significant liver injury has been reported in patients treated with TYSABRI in the post-marketing setting. Common adverse events reported in TYSABRI-treated MS patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain and rash.
TYSABRI is co-marketed by Biogen Idec Inc. and Elan Pharmaceuticals, Inc. For more information about TYSABRI, please visit www.tysabri.com, www.biogenidec.com or www.elan.com, or call 1-800-456-2255.
About AVONEX
AVONEX is the most prescribed treatment for relapsing forms of MS worldwide, with approximately 135,000 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. Routine periodic blood chemistry and hematology tests are recommended during treatment with AVONEX. Rare cases of anaphylaxis have been reported. Please see complete prescribing information available at www.AVONEX.com.
About BG-12
BG-12 (BG00012, dimethyl fumarate) is an investigational oral therapy in Phase III clinical development for the treatment of relapsing-remitting multiple sclerosis, the most common form of MS. In 2008 BG-12 received Fast Track designation from the U.S. Food and Drug Administration (FDA), which may expedite U.S. regulatory review. Biogen Idec retains full worldwide commercial rights to BG-12.
A Phase IIb study published in The Lancet showed that BG-12 reduced the number of new gadolinium enhancing (Gd+) lesions by 69 percent in patients with RRMS when compared to treatment with placebo (p<0.0001). The presence of Gd+ lesions is thought to indicate continuing inflammatory activity within the central nervous system. BG-12 is the first compound in trials for the treatment of MS that has been shown to activate the Nrf2 pathway. Experimentally, the Nrf2 pathway has demonstrated neuroprotective and anti-inflammatory properties. Activation of this pathway in MS patients may potentially prevent further cell damage and tissue loss. Phase III clinical trials for BG-12 are underway to investigate the compound’s potential as a treatment for RRMS – DEFINE is fully enrolled and CONFRIM is fully accrued. Both trials are underway at approximately 200 centers worldwide.
About PEGylated Interferon beta-1a
PEGylated interferon beta-1a is an investigational therapy currently in Phase III clinical development for the treatment of relapsing multiple sclerosis (RMS). PEGylated interferon beta-1a received Fast Track designation from the U.S Food and Drug Administration (FDA), which may expedite U.S. regulatory review.
Biogen Idec expects to enroll more than 1,200 patients in the global Phase III trial, called ADVANCE, which is a randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of PEGylated interferon beta-1a in patients with RMS. ADVANCE will determine the efficacy of PEGylated interferon beta-1a in reducing relapse rates in patients at one year. The study will also examine if, over time, treatment with PEGylated interferon beta-1a can slow disease progression and lead to a decrease in the number of T2 hyperintense brain lesions commonly seen in MS patients.
About Fampridine-SR
Fampridine-SR is a sustained-release tablet formulation of the investigational drug fampridine (4-aminopyridine or 4-AP). In laboratory studies, fampridine has been found to improve impulse conduction in nerve fibers in which the insulating layer, called myelin, has been damaged. Fampridine-SR is being developed and commercialized in the United States (US) by Acorda Therapeutics and commercialized in markets outside of the US by Biogen Idec.
Biogen Idec expects to file for approval by the European Medicines Agency (EMEA) in early 2010. A New Drug Application (NDA) for Fampridine-SR has been filed and assigned priority review by the U.S. Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) date of October 22, 2009. The PDUFA date is the target date for the FDA to complete its review of Fampridine-SR.
Biogen Idec Safe Harbor
This press release contains forward-looking statements about the anticipated development and timing of programs in our clinical pipeline. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those that we expect, including the risk that we may not fully enroll our planned clinical trials, unexpected concerns may arise from additional data or analysis, regulatory authorities may require additional information, further studies, or may fail to approve the drug, competitive pressures, our dependence on collaborations over which we may not always have full control, our ability to attract and retain qualified personnel, our ability to protect our intellectual property rights and the cost of doing so, product liability claims, and the other risks and uncertainties that are described in Item 1.A. Risk Factors in our annual report on Form 10-K and in other reports we file 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.
