Biogen Idec Announces Multiple Sclerosis Franchise and Pipeline Presentations at the 60th Annual Meeting of the American Academy of Neurology.CHICAGO -- Biogen Idec (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : BIIB BIIB Basic Imagery Interpretation Brief ) today announced that 17 company-sponsored plenary sessions, platform presentations, and poster presentations will be presented during the 60th Annual Meeting of the American Academy of Neurology The American Academy of Neurology (AAN) is a professional society for neurologists and neuroscientists. As a medical specialty society it was established in 1949 by A.B. Baker of the University of Minnesota to advance the art and science of neurology, and thereby promote the best . These presentations will cover four compounds that are marketed or currently in development by Biogen Idec and its partners for the treatment of multiple sclerosis (MS). This includes two approved therapies for MS; TYSABRI([R]) (natalizumab) and AVONEX([R]) (Interferon beta-1a); and two additional agents in development; BG-12 (dimethyl fumarate fumarate /fu·ma·rate/ (fu´mah-rat) a salt of fumaric acid. fumarate a salt of fumaric acid. ) and daclizumab. "The presentations and posters at AAN AAN American Association of Neurology show Biogen Idec's broad commitment to those living with MS," said Michael Panzara, MD, MPH, Vice President and Chief Medical Officer, Neurology Strategic Business Unit, Biogen Idec. "No company is doing more for patients with MS than Biogen Idec. We have been a leader in developing and commercializing therapies, with two products on the market to help treat MS, and four additional development programs that target other potential pathways of the disease. Through additional development and research, our hope is that we will be able to both treat the symptoms of MS and eventually reverse the damaging effects that are a result of the disease." The following are selected highlights of presentations during the meeting: TYSABRI Platform Presentations * Natalizumab Utilization and Safety in Patients with Relapsing Multiple Sclerosis: Updated Results from TOUCH[TM] and TYGRIS (Presentation #S02.002 - Tuesday, April 15, 2:15 p.m. CDT CDT abbr. Central Daylight Time CDT Central Daylight Time CDT n abbr (US) (= Central Daylight Time) → hora de verano del centro; (BRIT ) * The Safety of TYSABRI Re-Dosing and Treatment (STRATA) Study (Presentation #S02.003 - Tuesday, April 15, 2:30 p.m. CDT) * Statistical Analysis of Clinical Endpoints in Studies of Disease-Modifying Therapies for Multiple Sclerosis Although there is no known definitive cure, several therapies for multiple sclerosis have proven to be helpful. Multiple sclerosis (abbreviated MS) is a chronic, inflammatory, demyelinating disease that affects the central nervous system (CNS). (Presentation #S02.001 - Tuesday, April 15, 2:00 p.m. CDT) * Plasma Exchange Accelerates the Decline of Serum Natalizumab Concentration in Patients with Multiple Sclerosis: Results of the Natalizumab PLEX PLEX Programming Language for Exchanges PLEX Plans and Exercises PLEX Planet Extreme (Russian gaming site) PLEX Procedure Language Extension Study (Presentation #S22.005 - Wednesday, April 16, 3:00 p.m. CDT) * Plasma Exchange Augments Leukocyte leukocyte (l  `kəsīt'): see blood. leukocyte or white blood cell or white corpuscle Transmigration trans·mi·gra·tion n. Movement from one site to another, which may entail the crossing of some usually limiting membrane or barrier, as in diapedesis. transmigration 1. diapedesis. 2. across an In Vitro Blood-Brain Barrier in Natalizumab-Treated Patients with Multiple Sclerosis (Presentation #S27.005 - Wednesday, April 16, 3:00 p.m. CDT) Poster Presentations * Natalizumab Increases the Proportion of Patients Free of Clinical or MRI 1. (application) MRI - Magnetic Resonance Imaging. 2. MRI - Measurement Requirements and Interface. Disease Activity in Relapsing Multiple Sclerosis (Poster #P02.156 - Tuesday, April 15, 11:30 a.m. - 2:30 p.m. CDT) * Natalizumab Reduces Multiple Sclerosis Severity: Analysis of Patients from the AFFIRM and SENTINEL Studies Using the Multiple Sclerosis Severity Scale (Poster #P04.169 - Wednesday, April 16, 7:00 - 10:00 a.m. CDT) * Pain in Patients with Multiple Sclerosis: Effects of Natalizumab (Poster #P04.181 - Wednesday, April 16, 7:00 - 10:00 a.m. CDT) * Impact of Natalizumab on Multiple Sclerosis Patient-Reported Experiences: A Cross Sectional Survey (Poster #P05.065 - Wednesday, April 16, 4:00 - 7:00 p.m. CDT) AVONEX * Progression of Disability over 2 Years Predicts Disability at 8 Years in Relapsing Multiple Sclerosis: Analysis from the Phase 3 Clinical Trial phase 3 clinical trial Phase 3 study. See Phase study. of Intramuscular intramuscular /in·tra·mus·cu·lar/ (-mus´ku-ler) within the muscular substance. in·tra·mus·cu·lar adj. Abbr. IM Within a muscle. Interferon Beta-1a (Poster #P04.156 - Wednesday, April 16, 7:00 - 10:00 a.m. CDT) * Multiple Sclerosis Patients Taking Interferon Beta-1a Have Full Biological Activity in Both Stable and Breakthrough Disease (Poster #P07.150 - Thursday, April 17, 11:30 a.m. - 2:30 p.m. CDT) * Safety and Tolerability of the First Single-Use, Fully Integrated Autoinjector for IM Interferon Beta-1a (Poster #P02.144 - Tuesday, April 15, 11:30 a.m. - 2:30 p.m. CDT) * Incidence of Binding and Neutralizing Antibodies in Sera and Cerebrospinal Fluid of Patients with Relapsing-Remitting Multiple Sclerosis Treated with Interferon Beta (Poster #P05.084 - Wednesday, April 16, 4:00 - 7:00 p.m. CDT) * Efficacy of Interferon Beta-1a in Patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP CIDP Chronic Inflammatory Demyelinating Polyneuropathy CIDP Central Instrument Data Processor CIDP Canary Island Date Palm (Phoenix canariensis) ) (Poster #P07.101 - Thursday, April 17, 11:30 a.m. - 2:30 p.m. CDT) BG-12 BG-12 (dimethyl fumarate) is an oral, small molecule immuno-modulator in Phase III development for relapsing forms of MS. * The Efficacy of BG00012 in Patients with Relapsing-Remitting Multiple Sclerosis: Subgroup Analyses from the Phase 2b Study (Poster #P02.134 - Tuesday, April 15, 11:30 a.m. - 2:30 p.m. CDT) * Activation of Nrf2 and Modulation of Disease by BG00012 (Dimethyl Fumarate) Suggest a Dual Cytoprotective and Anti-Inflammatory Mechanism of Action (Poster #P01.085 - Tuesday, April 15, 7:00 - 10:00 a.m. CDT) Daclizumab Daclizumab is a humanized monoclonal antibody specific for the IL-2 receptor of T cells that is in Phase II development for MS. * A Phase 2 Randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , Double-Blinded, Placebo-Controlled, Multicenter Study of Subcutaneous Daclizumab, a Humanized Anti-CD-25 Monoclonal Antibody, in Patients with Active, Relapsing Forms of Multiple Sclerosis - Week 44 Results (Plenary session #PL01.003 - Wednesday, April 16, 9:00 a.m. CDT) Corporate Therapeutic Update On April 15, Biogen Idec will be hosting a symposium for meeting attendees entitled "We're Taking the Future of MS Personally - Corporate Therapeutic Update from Biogen Idec: MS, Biogen Idec, and the Future of Personalized Medicine." The symposium will provide an update on Biogen Idec's multiple sclerosis and neurology products and drug development pipeline, as well as a presentation on the future of personalized medicine in MS by Philip L. De Jager, MD, PhD, Assistant Professor of Neurology at Harvard Medical School Harvard Medical School (HMS) is one of the graduate schools of Harvard University. It is a prestigious American medical school located in the Longwood Medical Area of the Mission Hill neighborhood of Boston, Massachusetts. . A panel discussion focused on the role of personalized medicine in the future, as well as the need to treat decisively with medications available now, will also be part of the symposium and will include Dr. De Jager, Dr. Panzara, moderator Bruce A. Cree, MD, PhD, MCR MCR My Chemical Romance (band) MCR Minimum Capital Requirement MCR Minimum Cell Rate MCR Middle Common Room (UK universities) MCR Multivariate Curve Resolution , Assistant Professor of Neurology, Multiple Sclerosis Center at University of California The University of California has a combined student body of more than 191,000 students, over 1,340,000 living alumni, and a combined systemwide and campus endowment of just over $7.3 billion (8th largest in the United States). San Francisco; Dusan Stefoski, MD, Director, Rush Multiple Sclerosis Center; Associate Professor of Neurology, Rush University Medical College; Ralf Gold, MD, Professor and Chair, Department of Neurology, St. Josef Hospital, Ruhr University (Germany); and Steven L. Galetta, MD, Van Meter Professor of Neurology, University of Pennsylvania School of Medicine The University of Pennsylvania's School of Medicine, presently located in the University City section of Philadelphia, Pennsylvania, was the United States's first school of medicine, founded at the College of Philadelphia, as the University was then called. . MS Simulator Biogen Idec will have an MS simulator for attendees to use, allowing them to experience the symptoms many patients with MS suffer. The simulator will be available on the exhibit hall floor during the meeting. About Biogen Idec Biogen Idec creates new standards of care Standards of care are medical or psychological treatment guidelines, and can be general or specific. They specify appropriate treatment protocols based on scientific evidence, and collaboration between medical and/or psychological professionals involved in the treatment of a given 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 Marketed Products and Development Pipeline About 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 The New England Journal of Medicine (New Engl J Med or NEJM) is an English-language peer-reviewed medical journal published by the Massachusetts Medical Society. It is one of the most popular and widely-read peer-reviewed general medical journals in the world. , after two years, TYSABRI treatment led to a 68% relative reduction (p<0.001) in the annualized annualized Of or relating to a variable that has been mathematically converted to a yearly rate. Inflation and interest rates are generally annualized since it is on this basis that these two variables are ordinarily stated and compared. relapse rate compared to placebo and reduced the relative risk of disability progression by 42-54% (p<0.001). TYSABRI was recently approved to induce and maintain clinical response and remission in adult patients with moderately to severely active Crohn's disease (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. TYSABRI increases the risk of progressive multifocal leukoencephalopathy Progressive Multifocal Leukoencephalopathy Definition Progressive multifocal leukoencephalopathy (PML) is a rapidly progressive neuromuscular disease caused by opportunistic infection of brain cells (oligodendrocytes and astrocytes) by the JC virus (PML PML - Parallel ML. ["Synchronous Operations as First-Class Values", J.H. Reppy <jhr@research.att.com>, Proc SIGPLAN 88 Conf Prog Lang Design and Impl, June 1988, pp. 250-259]. ), 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 anaphylaxis (ăn'əfəlăk`sĭs), hypersensitive state that may develop after introduction of a foreign protein or other antigen into the body tissues. ) and infections. Serious opportunistic and other atypical infections have been observed in TYSABRI-treated patients, some of whom were receiving concurrent immunosuppressants immunosuppressants, n.pl the agents that lower or reduce immune response; useful in organ transplant surgery to prevent organ rejection. Corticosteroid hormones given in large amounts; cytotoxic drugs, including antimetabolites and alkylating agents; . Herpes infections were slightly more common in patients treated with TYSABRI. In MS and CD clinical trials, the incidence and rate of other serious adverse events, including serious infections, were similar in patients receiving TYSABRI and those receiving placebo. Common adverse events reported in TYSABRI-treated MS patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain, and rash. Other common adverse events reported in TYSABRI-treated CD patients include respiratory tract infections and nausea. Clinically significant liver injury has been reported in patients treated with TYSABRI in the post-marketing setting. TYSABRI is approved in more than 30 countries including the United States and many countries throughout the European Union, as well as Switzerland, Canada, Australia, New Zealand and Israel. 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 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. 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 is currently in Phase III clinical development. About Daclizumab Daclizumab is currently in Phase II clinical development. Biogen Idec is developing daclizumab for MS in collaboration with PDL See page description language. 1. PDL - Page Description Language. 2. PDL - Program Design Language. 3. PDL - Push Down List. 4. PDL - Dave Lebling, one of the co-authors of Zork. BioPharma, Inc. Safe Harbor This press release contains forward-looking statements about our marketed products and our products in development. Drug development and commercialization involves a high degree of risk, and all of our products are subject to a number of risks and uncertainties. Important risk factors include the risk that we may be unable to adequately address concerns or questions raised by FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. or other regulatory authorities, the occurrence of adverse safety events with our products, that concerns may arise from additional data, that we may not be able to get the drugs in development approved and that the incidence and/or risk of any safety issues with respect to our products may be higher than observed in clinical trials. The company may also encounter other unexpected hurdles. Additional risks and uncertainties that are described in Item 1.A. Risk Factors in our reports on Form 10-K and Form 10-Q and in other periodic and current 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. |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion