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Apr-16-2008Relaunched Drug Tysabri Avoids Prior Brain Problem(topic overview)
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Biogen Idec and Elan also announced today at the meeting that TYSABRI treatment significantly increases the proportion of patients with MS considered to be disease free, according to post-hoc analyses of the AFFIRM and SENTINEL clinical trials. The proportion of patients considered disease free in the studies was determined based upon both clinical and MRI criteria. [1] In the AFFIRM trial, patients were randomized to receive TYSABRI or placebo, while in the SENTINEL trial, randomized patients received TYSABRI plus interferon beta-1a or placebo plus interferon beta-1a. Over a two-year period, patients were evaluated utilizing clinical criteria, MRI criteria and combined criteria with both trials demonstrating TYSABRI treatment significantly increased the proportions of patients considered disease free.[1]
By individual criteria, TYSABRI benefit was also demonstrated using clinical (AFFIRM: 64.3% vs. 38.9%; SENTINEL: 47.4% vs. 28.0%) and MRI definitions of disease free (AFFIRM: 57.7% vs. 14.2%; SENTINEL: 65.5% vs. 27.6%). In both studies, results were similar in patients with highly-active and non-highly active MS. The abstract for this study, " Natalizumab Increases the Proportion of Patients Free of Clinical or MRI Disease Activity in Relapsing Multiple Sclerosis " (Poster #P02.156), is available online at the AAN ' s Web site.[1] The company also said that analyses show tysabri significantly increased the proportion of multiple sclerosis patients who are considered disease free for over two years.[2]
Specifically, Biogen Idec and Elan said the proportion of patients considered disease free over two years was'significantly higher in the Tysabri-treated group compared with the placebo group, regardless of how disease free was defined.' Biogen Idec shares were up 2% to $64.96 in afternoon action on the Nasdaq while shares of Elan, based in Ireland, added 6.3% to $22.05 on the New York Stock Exchange.[3] Biogen Idec BIIB and Elan ELN presented positive safety data and new patient rates for multiple sclerosis drug Tysabri, at the annual meeting of the American Academy of Neurology in Chicago Tuesday.[4] NEW YORK (Reuters) - Biogen Idec and its partner Elan Corp said on Tuesday no new cases of a potentially deadly brain infection have been seen among patients taking their Tysabri multiple sclerosis drug since it was re-introduced in July 2006.[5] April 15 (Bloomberg) -- Biogen Idec Inc., the world's largest maker of multiple sclerosis drugs, said its fastest- growing product, Tysabri, was linked to no new cases of the deadly brain infection tied to the drug three years ago.[6]
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.[1] " 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.[7] 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, Assistant Professor of Neurology, Multiple Sclerosis Center at University of California 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. Biogen Idec will have an MS simulator for attendees to use, allowing them to experience the symptoms many patients with MS suffer.[7]
CHICAGO--( BUSINESS WIRE )--Biogen Idec (NASDAQ: BIIB) today announced that 17 company-sponsored plenary sessions, platform presentations, and poster presentations will be presented during the 60 th Annual Meeting of the American Academy of Neurology. 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 (natalizumab) and AVONEX (Interferon beta-1a); and two additional agents in development; BG-12 (dimethyl fumarate) and daclizumab.[7]
" These data suggest that neurologists and patients are increasingly choosing TYSABRI for the treatment of their disease. The significant clinical benefits are established and TYSABRI continues to offer the potential for compelling efficacy and hope for those patients living with MS, " said Michael Panzara, MD, MPH, Vice President and Chief Medical Officer, Neurology Strategic Business Unit, Biogen Idec.[1] NEW YORK, Apr. 15, 2008 (Thomson Financial delivered by Newstex) -- Biogen Idec (NASDAQ:BIIB) and Elan Corp. Tuesday reported positive data related to Tysabri, saying that additional analysis of the 26,000 patients on commercial and clinical therapy worldwide since the re-launch of the drug in 2006 found no cases of progressive multifocal leukoencephalopathy.[3] Notably, the companies said there were no new cases of progressive multifocal leukoencephalopathy (PML), a rare and typically fatal brain virus that prompted the drug to be temporarily removed from the market in 2005. Biogen and Elan said they are making progress toward their public goal of reaching 100,000 patients on Tysabri by the end of 2010. Bear Stearns analyst Mark Schoenebaum said in a note to investors that the weekly worldwide patients are accelerating nicely and have tracked above his estimates.[4]
The companies said no cases of progressive multifocal leukoencephalopathy, or PML, were seen by the end of March among about 26,000 patients taking the drug. Given the favorable safety findings, the companies said they were moving towards their goal of having 100,000 patients on the medicine by the end of 2010.[5] The company said that as of the end of March 2008, approximately 26,000 patients were on commercial and clinical therapy worldwide with no cases of progressive multifocal leukoencephalopathy, or PML, reported since re-launch in the U.S. and launch internationally in July 2006.[2]
Notably, since the drug's relaunch in July 2006, there have been no cases of a rare, often deadly, brain infection called progressive multifocal leukoencephalopathy, or PML, that caused the drug to be pulled from the market in early 2005.[8]
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.[7] 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 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.[7]
Factors which could cause actual results to differ materially from the companies ' current expectations include the risk that we may be unable to adequately address concerns or questions raised by the FDA or other regulatory authorities, that concerns may arise from additional data, that the incidence and/or risk of PML or other opportunistic infections in patients treated with TYSABRI may be higher than observed in clinical trials, that the companies may encounter other unexpected hurdles, or that new therapies for MS with better efficacy or safety profiles or more convenient methods of administration are introduced into the market.[1] Important risk factors include the risk that we may be unable to adequately address concerns or questions raised by FDA 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.[7]
TYSABRI is available in the U.S. through the TOUCH Prescribing Program. All U.S. prescribers, infusion sites, and patients receiving TYSABRI are required to enroll in TOUCH. Safety information is also collected through ongoing clinical trials and registries, including TYGRIS and the pregnancy registry, making this the largest long-term patient follow-up effort undertaken for any MS therapy. The abstract for this study, " Natalizumab Utilization and Safety in Patients with Relapsing Multiple Sclerosis: Updated Results from TOUCH and TYGRIS " (Presentation #S02.002), is available online at the AAN ' s Web site.[1] The companies also said Tysabri'significantly increases the proportion of patients with MS (multiple sclerosis) considered to be disease free,' according to post-hoc analyses of the AFFIRM and SENTINEL clinical trials.[3] Using clinical and MRI disease-free criteria combined, a stringent definition of disease free, 36.7% and 31.7% of patients in the TYSABRI groups were disease free compared with 7.2% and 10.9% given placebo in the AFFIRM and SENTINEL trials, respectively.[1]
We are also excited that patients with Crohn ' s Disease are now enrolling in the TOUCH program and beginning to receive TYSABRI treatment in the U.S., " said Gordon Francis, MD, Senior Vice President, Global Clinical Development, Elan.[1] Biogen Idec Inc. and Elan PLC reported that about 26,000 patients are using their Tysabri multiple-sclerosis treatment, as of the end of March.[8] For more detailed information on the risks and uncertainties associated with the companies ' drug development and other activities, see the periodic and current reports that Biogen Idec and Elan have filed with the Securities and Exchange Commission. Biogen Idec and its directors, executive officers and other members of its management and employees may be deemed to be participants in the solicitation of proxies from the stockholders of Biogen Idec in connection with the Company ' s 2008 annual meeting of stockholders.[1] Information concerning the interests of participants in the solicitation of proxies will be included in any proxy statement filed by Biogen Idec in connection with the Company ' s 2008 annual meeting of stockholders.[1]
Biogen Idec stockholders are advised to read carefully any proxy statement filed in connection with the Company ' s 2008 annual meeting of stockholders when it becomes available before making any voting or investment decision.[1]
The Company ' s proxy statement will also be available for free by writing to Biogen Idec Inc., 14 Cambridge Center, Cambridge, MA 02142.[1] The proxy statements and other reports, when available, can be obtained free of charge at the SEC ' s web site at www.sec.gov or from Biogen Idec at www.biogenidec.com.[1]
Adverse event reporting in the post-marketing setting is voluntary. It is possible that not all reactions have been reported, or that some reactions are not reported to Biogen Idec or Elan in a timely manner.[1] Genentech and Biogen Idec hoped to expand the drug into the intractable form of multiple sclerosis.[4] 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.[7] " Positive outcomes for patients continue to support TYSABRI ' s strength as a valuable treatment for multiple sclerosis patients in more than 30 countries around the world.[1]
TOUCH is designed to determine the incidence of and risk factors for serious opportunistic infections (OIs), including PML, and to monitor patients for signs and symptoms of PML while promoting informed benefit-risk discussions prior to initiating TYSABRI treatment.[1] Tysabri, which has been shown highly effective in treating the progressive neurological disease, was temporarily suspended from the market in 2005 after several patients developed PML. But it was allowed back in 2006 -- with certain restrictions -- after U.S. regulators decided MS patients were willing to accept the risks in return for the potential benefits.[5]
Tysabri, which was temporarily suspended from the market in 2005 after several patients developed PML, was allowed back in 2006 with certain restrictions. The companies said the growth in global utilization plus increasing confidence in the favorable benefit-risk profile of Tysabri take them toward the goal of 100,000 patients on therapy by year-end 2010.[2] Growth in global utilization plus increasing confidence in the favorable benefit-risk profile of TYSABRI indicate the companies are making great progress toward the goal of 100,000 patients on therapy by year-end 2010. These data were presented today at the 60 th Annual Meeting of the American Academy of Neurology (AAN).[1] The new safety data were presented on Tuesday at the annual meeting of the American Academy of Neurology in Chicago.[5] The data on Tysabri usage and safety is being presented today at the American Academy of Neurology meeting in Chicago.[6]
CHICAGO--( BUSINESS WIRE )--Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) today announced new data on the global utilization, safety and overall patient exposure of TYSABRI (natalizumab).[1] " The ultimate goal of an MS treatment is to help patients remain symptom free for as long as possible. These data show natalizumab may do just that as about one-third of patients were shown to have no relapses, no disability progression and no new MRI markers. This is further evidence that treatment with natalizumab can result in truly dramatic outcomes for a large group of patients, " said the study ' s lead author, Steven Galetta, MD, Professor of Neurology, University of Pennsylvania School of Medicine.[1] MRI disease free was defined as no gadolinium-enhancing lesions seen on annual MRI scans and no new or enlarging T2-hyperintense lesions over two years.[1] Clinically, disease free was defined as no relapses and no progression of disability (as defined by 1.0-point increase in Expanded Disability Status Scale (EDSS) score from a baseline score of 1.0, or a 1.5-point increase from a baseline score of 0.0, sustained for 12 weeks) over two years.[1]
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). [7] Researchers will evaluate data including medical/MS history; prior TYSABRI use; prior use of immunomodulatory, antineoplastic, or immunosuppressive agents; and all serious adverse events, including PML and other serious OIs and malignancies.[1]
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.[7] Of those patients, over 9,900 have received at least one year of TYSABRI therapy and more than 3,600 patients have been on therapy for 18 months or longer.[1] Clinically significant liver injury has been reported in patients treated with TYSABRI in the post-marketing setting.[7]
For product labeling, press releases and additional information about the company, please visit www.biogenidec.com. Elan Corporation, plc is a neuroscience-based biotechnology company committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world. [1] The company noted that more than 36,700 patients have been treated with the drug, and more than 9,900 have taken it for at least one year.[4] The drug was being taken by 26,000 patients worldwide as of March 31, the Cambridge, Massachusetts-based company said today in a statement.[6]
At the end of the first quarter, the companies said there were 15,300 patients on the drug in the U.S., and more than 10,200 taking it outside of the U.S. -- overall a 25% rise since the last sequential quarter.[4] Before initiating treatment, all U.S. patients, prescribers and infusion sites must be enrolled in the TOUCH Prescribing Program ( T YSABRI O utreach: U nified C ommitment to H ealth).[1]
Drug development and commercialization involves a high degree of risk, and all of our products are subject to a number of risks and uncertainties. [7] 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[7]
Biogen Idec files annual, quarterly and special reports with the Securities and Exchange Commission (the " SEC " ). [1] Biogen Idec closed Tuesday's regular trading session at $64.93, up $1.21 or 1.90%.[2]
SOURCES
1. Biogen Idec and Elan Present New TYSABRI(R) Data at the 60th Annual Meeting of the American Academy of Neurology
2. RTTNews - Breaking News, financial breaking News, Positive EPS Surprises, Stock research .
3. Biogen Idec, Elan shares higher after reporting positive Tysabri data
4. Biogen, Elan See Rise in Tysabri Use | Biotech | BIIB ELN - TheStreet.com
5. Biogen says no new brain infections with Tysabri | Health | Reuters
6. Bloomberg.com: U.S.
7. Biogen Idec Announces Multiple Sclerosis Franchise and Pipeline Presentations at the 60th Annual Meeting of the American Academy of Neurology
8. Free Preview - WSJ.com
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