-- Company’s Extensive Late-Stage Portfolio Could Address Unmet Patient Needs and Redefine Success in the Treatment of Multiple Sclerosis --
WESTON, Mass.--(BUSINESS WIRE)-- Biogen Idec (NASDAQ: BIIB) today announced that more than 45 company- and partner-sponsored platform and poster presentations will be presented during the 26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Gothenburg, Sweden, October 13 – 16, 2010. ECTRIMS is the world’s largest medical meeting dedicated to research and advances in multiple sclerosis (MS). Data being presented will include Biogen Idec’s currently marketed products, TYSABRI® (natalizumab) and AVONEX® (interferon beta-1a), as well as four late-stage programs: prolonged-release fampridine tablets, the oral compound BG-12 (dimethyl fumarate), PEGylated interferon beta-1a and daclizumab.
“We are fully committed to the MS community with our leading MS therapies, AVONEX and TYSABRI, both of which have been used in a broad range of patients worldwide. We are also working diligently towards moving prolonged-release fampridine tablets, a treatment with the potential to improve walking ability in MS patients, through the regulatory process in markets outside of the United States,” said John R. Richert, M.D., Vice President and Senior Fellow, Neurology Research and Development at Biogen Idec. “With three compounds in late-stage clinical studies Biogen Idec has one of the deepest late-stage pipelines in the industry. We are not resting on our laurels and will continue to work tirelessly until we find a cure for this disease.”
Data from one of the industry’s most extensive MS pipelines
Prolonged-release fampridine tablets
There will be six posters featuring prolonged-release fampridine tablets, which is being developed for its potential to improve walking in adult patients with MS. Biogen Idec has licensed the rights to develop and commercialize prolonged-release fampridine tablets outside the United States (U.S.) from Acorda Therapeutics, Inc. Acorda is developing and commercializing this compound in the U.S., where it is approved for use under the trade name AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg.
Highlights include the following posters:
- Walking speed improvements in a pooled analysis of prolonged-release fampridine in patients with multiple sclerosis – Poster P922
- Analysis of open-label extension studies of prolonged-release fampridine tablets in multiple sclerosis – Poster P518
BG-12 (dimethyl fumarate)
There will be four BG-12 posters and presentations. BG-12 showed positive safety and efficacy data in a Phase IIb study, which supported its further clinical investigation. Results from this study also stimulated further evaluation of BG-12’s potential for neuroprotection. Two Phase III clinical trials, DEFINE and CONFIRM, have completed enrollment and full data readouts are expected in 2011.
- Feasibility of magnetization transfer ratio imaging in multicentre trials of patients with multiple sclerosis – Poster P764
- BG-12 exhibits anti-inflammatory and prometabolic effects in brain astrocytes – Poster P879
- Oral BG-12 in combination with interferon beta-1a or glatiramer acetate: pharmacokinetics, safety and tolerability – Poster P478
- Neuroprotective effects of dimethyl fumarate and monomethyl fumarate on primary cultures of human spinal cord astrocytes after oxidative challenge – Poster P887
PEGylated interferon beta-1a
There are three PEGylated interferon beta-1a posters being presented. PEGylated interferon beta-1a is being evaluated for its ability to last longer in a patient's system, potentially leading to an MS treatment that would require fewer injections. Data presented at ECTRIMS supports the continued evaluation of the compound in the ongoing Phase III ADVANCE clinical study, which is currently enrolling patients.
- The ADVANCE Phase 3 study of PEGylated interferon beta-1a in relapsing multiple sclerosis: rationale and design – Poster P904
- Development of a high-throughput whole-blood expression profiling method to identify genes induced by IFN beta-1a or PEGylated IFN beta-1a in healthy control subjects – Poster P971
- Pharmacological changes related to the Th17 regulatory network induced by interferon beta-1a and PEGylated interferon beta-1a in healthy volunteers – Poster P968
Two daclizumab posters are being presented. Daclizumab is currently in late-stage clinical trials for the treatment of relapsing-remitting MS, the most common form of MS. Both posters being presented at ECTRIMS support the evaluation of daclizumab in the ongoing, Phase III DECIDE trial. Biogen Idec is developing daclizumab in collaboration with Abbott.
- Daclizumab treatment and CD56bright NK cell counts independently predict being lesion free on brain MRI scans: Results from the Phase II CHOICE trial – Poster P557
- CD56bright NK cell counts correlate with therapeutic response to daclizumab independently of other pharmacodynamic response markers – Poster P561
Biogen Idec is also sponsoring two symposia during the Congress. Both will feature presentations from world-renowned experts in MS:
- Wednesday, October 13, 2010 – 16:00 to 17:00 CET
- Redefining Success in MS: Making Informed Treatment Decision
- Thursday, October 14, 2010 – 18:00 to 19:00 CET
- Redefining Success in MS: Remission and Improvement – Today and Tomorrow
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 worldwide 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 Prolonged-Release Fampridine Tablets
Prolonged-release fampridine tablets has been developed to improve walking in adult patients with MS. Studies have shown that prolonged-release fampridine tablets can increase conduction velocity along damaged nerves, which may result in enhanced nerve function. This prolonged-release formulation is being developed and commercialized in the U.S. by Acorda Therapeutics, Inc. It is approved in the U.S. under the trade name AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg. Biogen Idec is planning to commercialize the product outside of the U.S. under a licensing agreement with Acorda.
BG-12 (BG00012, dimethyl fumarate) is an investigational oral therapy in Phase III clinical development for the treatment of relapsing-remitting MS, the most common form of MS, and in Phase II for rheumatoid arthritis. BG-12 received Fast Track designation in MS 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.
The Phase IIb study of BG-12, which was published in The Lancet, showed that BG-12 reduced the number of new gadolinium enhancing (Gd+) lesions by 69 percent in patients with relapsing-remitting MS 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.
Results from this study stimulated further evaluation of BG-12’s potential for neuroprotection. BG-12 is the first compound in trials for the treatment of MS that has been shown to activate the Nrf2 pathway.
About PEGylated Interferon Beta-1a
PEGylated interferon beta-1a is under investigation for the treatment of relapsing MS and is currently enrolling a Phase III clinical trial. PEGylated interferon beta-1a, administered via subcutaneous injection, is being evaluated for its ability to last longer in a patient's system, potentially leading to an MS treatment that would require fewer injections. Patients interested in learning more about the ADVANCE trial may speak with their physician or e-mail [email protected].
Daclizumab is a humanized monoclonal antibody that binds to the CD25 alpha subunit of the high affinity IL-2 receptor. CD25 is expressed at low levels on resting T-cells (immune cells) and at high levels on T-cells that can become activated in response to autoimmune conditions such as MS. Daclizumab is believed to work by selectively binding to and inhibiting this receptor on activated T-cells without causing T-cell depletion. Daclizumab is an investigational agent in clinical development for the treatment of MS in collaboration between Abbott and Biogen Idec. Daclizumab is currently being studied in two registrational clinical trials in patients with MS. Patients interested in learning more about the DECIDE trial may speak with their physician or e-mail [email protected].
This press release contains forward-looking statements about our products in development, which may be identified by words such as "believe," "expect," "may," "plan," "will" and similar expressions. Drug development and commercialization involve a high degree of risk. Factors which could cause actual results to differ materially from our current expectations include 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, or we may encounter other unexpected hurdles. For more detailed information on the risks and uncertainties associated with our drug development and other activities, see the Risk Factors section of our reports on Form 10-K and Form 10-Q and in other reports we filed with the Securities and Exchange Commission. Any 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.
Kate Weiss, +1 781-464-3260
Kia Khaleghpour, +1 781-464-2442
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