Category Archives: MS Treatment

The U.S. Food and Drug Administration accepted Sanofi (SAN)s application for approval of the multiple sclerosis drug Lemtrada, five months after rejecting an initial filing because of the way data was formatted. Sanofis Genzyme unit expects a decision by the agency in the second half of the year, the Paris-based company said in a statement today. The FDA refused to accept the first Lemtrada filing and asked that the company modify the presentation of data to allow regulators to better navigate the application, Sanofi said Aug. 27. Chief Executive Officer Chris Viehbacher is counting on new drugs to help boost earnings at Frances biggest drugmaker. Investors still underestimate the companys pipeline of experimental medicines, he said in an interview Jan. 25. Sanofi also has applied for marketing authorization for Lemtrada in the European Union, and the European Medicines Agency is expected to rule in the second quarter, according to the statement. Sanofi, which obtained Lemtrada in the $20.1 billion purchase of Genzyme in 2011, is developing the medicine in collaboration with Bayer AG. (BAYN) Sanofi rose 0.5 percent to close at 73.09 euros Jan. 25 in Paris trading. The stock has gained 2.4 percent this year. The FDA in September … Continue reading →

NEW YORK (AP) -- French drugmaker Sanofi said Monday that the Food and Drug Administration will review its experimental multiple sclerosis treatment Lemtrada. Genzyme, Sanofi's U.S. biotech business, said the FDA will conduct a standard 10-month review and will make a decision on the drug in late 2013. Sanofi wants to market Lemtrada as a treatment for relapsing multiple sclerosis. German drugmaker Bayer will have an option to help market the drug in the U.S. if it is approved. Genzyme filed for marketing approval of Lemtrada in June, but the FDA refused the application because it wanted Genzyme to make changes to its application. European Union regulators are also reviewing the drug. Sanofi also gave an update on early sales of Aubagio, an MS drug that was approved in September 2012 and launched in October. The company said more than 80 percent of U.S. multiple sclerosis specialists have written a prescription for the drug. About half of the patients who are taking Aubagio were most recently treated with Teva Pharmaceutical Industries Ltd.'s drug Copaxone or Biogen Idec Inc.'s Avonex. About 20 percent of patients hadn't been treated before. U.S shares of Sanofi fell 17 cents to $49.10 in morning trading. … Continue reading →

* Net profit falls on tax error * 2013 forecast weaker than expected * Q4 adjusted earnings $1.40/shr vs $1.46 view (Updates with CFO and analyst comments) By Toni Clarke BOSTON, Jan 28 (Reuters) - Biogen Idec Inc (NasdaqGS: BIIB - news) said fourth-quarter net profit fell slightly due to a tax accounting error, but the company's shares rose more than 3 percent Monday on higher-than-expected drug sales and optimism over a new multiple sclerosis treatment. The oral drug BG-12, to be sold under the brand name Tecfidera, is expected to become a leading treatment for multiple sclerosis after its planned second quarter introduction. Gene Mack, an analyst at Brean Capital LLC, estimates that by 2015, Tecfidera will account for $1.4 billion, or roughly 25 percent, of the company's multiple sclerosis drug sales. In the fourth quarter, global sales of Biogen's multiple sclerosis drug Tysabri rose 14 percent to $433 million a year ago, while sales of another MS treatment, Avonex, rose 7 percent to $753 million, the company said. Biogen markets Tysabri in conjunction with Elan Corp Plc. "We believe we are entering into an era of significant long-term growth driven by multiple potential new product launches," George Scangos, … Continue reading →

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Genzyme, a Sanofi Company (EURONEXT: SAN and NYSE: SNY), announced that the U.S. Food and Drug Administration (FDA) has accepted for review the companys supplemental Biologics License Application (sBLA) file seeking approval of LEMTRADA (alemtuzumab) for the treatment of relapsing multiple sclerosis (RMS). The company also reported key highlights from the U.S. launch of once-daily, oral AUBAGIO (teriflunomide). LEMTRADA sBLA Accepted by FDA The FDA has accepted for standard review the companys sBLA file seeking approval of LEMTRADA. Genzyme expects FDA action on the application in the second half of 2013. Genzyme has already submitted its marketing authorization application for LEMTRADA to the European Medicines Agency (EMA) and the review process is underway. The Committee for Medicinal Products for Human Use (CHMP) opinion for LEMTRADA is expected in Q2 2013. The LEMTRADA clinical development program includes CARE-MS I and CARE-MS II (Comparison of Alemtuzumab and RebifEfficacy in Multiple Sclerosis), randomized Phase III studies comparing LEMTRADA to a standard of care MS treatment, Rebif,in patients with relapsing-remitting MS who were nave to prior treatment or who had relapsed while on prior therapy, respectively. Genzyme announced publication of results of these studies in The Lancet in November 2012. AUBAGIO … Continue reading →

SINGAPORE, Jan. 28, 2013 /PRNewswire/ -- Psoriasis is a little-understood skin condition that carries a strong social stigma through its emotional impact on sufferers that can far outweigh the disease's physical impact. That is why proper support and guidance from healthcare providers is crucial in achieving optimal treatment adherence, one of the main challenges in psoriasis management. (Logo: http://www.newscom.com/cgi-bin/prnh/20110606/460992 ) LEO Pharma, the global leader in dermatology care, announced the launch of the PsorCARE program in Asia, starting with Singapore, on 26 January 2013. The first-of-its-kind initiative in the region, PsorCARE, which stands for "Psoriasis Coach All-Round Education", will kick off on 26 January, 2013. Developed by LEO Pharma Asia and PsorAsia, PsorCARE's goal is to enhance the counseling skills of healthcare practitioners for optimal patient-healthcare provider relationship leading to better treatment outcomes for those who suffer from the skin condition Psoriasis. "LEO Pharma is committed to bringing this program to Asia because we are aware of the challenges that patients with Psoriasis face in their everyday lives. We want patients with Psoriasis to know that trained support is available and that it is possible for them to live life as normally as possible. Our ultimate aim is to give … Continue reading →

Biogen Idec (BIIB) recently announced positive top-line data on its phase III multiple sclerosis candidate, peginterferon beta-1a. Results from the ADVANCE study showed that peginterferon beta-1a met the primary endpoint as well as secondary endpoints. Detailed Results Two doses (once in two weeks and once in four weeks) of peginterferon beta-1a were compared to placebo in the study that was conducted to evaluate the safety and efficacy of the candidate in patients suffering from relapsing-remitting multiple sclerosis (RRMS). Both dosing regimens met the primary endpoint of annualized relapse rate (ARR) at one year. While ARR reduction was 35.6% in the two-week regimen, the four-week regimen saw a 27.5% reduction in ARR. Secondary endpoints included reduction of the risk of 12-week confirmed disability progression as measured by the Expanded Disability Status Scale (38% for both dosing arms), reduction in the proportion of patients who relapsed (39% the two-week dosing arm and 26% in the four-week dosing arm) and reduction in the number of new or newly enlarging T2-hyperintense lesions on brain MRI scans (67% in the two-week dosing arm and 28% in the four-week dosing arm). Biogen said that safety and tolerability profiles were favorable in both arms. Biogen intends to … Continue reading →

400,000 Americans have multiple sclerosis. Effects range from vision and speech impairment to balance issues and permanent disabilities. As our Katie Gibas reports, Upstate New York has some of the highest MS rates in the country. To view our videos, you need to enable JavaScript. Learn how. install Adobe Flash 9 or above. Install now. Then come back here and refresh the page. Brenda Irving has been living with multiple sclerosis since she was 23. Susan Peck was diagnosed 11 years ago. For both women, it was a scary and sudden onset. "I was on vacation with my husband and my mom and dad, and we were just enjoying the vacation and I woke up blind," said Brenda Irving, who has multiple sclerosis. Susan Peck, who also has multiple sclerosis added, "I woke up one morning and my entire right side was numb, my arm was numb and tingly." 400,000 Americans have MS. Effects range from vision and speech impairment to balance issues and permanent disabilities. "It feels like a leg or a foot might not work. It changes each day. I say put your best forward, no matter what stage of MS you have, and each hour, that might … Continue reading →

Please turn on JavaScript. Media requires JavaScript to play. Fire and Rescue Service (NIFRS) whistleblower Linda Ford told the Health Committee she continued "to be treated like a criminal", on 23 January 2013. Ms Ford won 20,000 in compensation after she took a case against the NIFRS. Three investigations were carried out into the NIFRS following whistle-blowing allegations which centred on fraud, unapproved bonuses and failings to deal with staff grievances. Ms Ford told committee members her treatment had been "appalling", and doubted whether anyone "would come forward now having seen what I have been through". She explained that she had returned to work following suspension but had not been allowed to return to her previous role, and had been told she was not allowed to speak to other members of the finance department. Ulster Unionist Roy Beggs thanked Ms Ford for her actions. "There has been a litany of bad practice that had to be exposed," he added. Replying to a question from Conall McDevitt from the SDLP, Ms Ford was also critical of the Permanent Secretary of the Department of Health, to whom she had made the disclosure. Earlier in the session, the committee was briefed by members … Continue reading →

By RTT News, January 24, 2013, 07:57:00 AM EDT (RTTNews.com) - Biogen Idec Inc. ( BIIB ) on Thursday released the primary efficacy analysis and safety data from its Phase 3 pivotal clinical trial, ADVANCE. The company said results support peginterferon beta-1a as a potential treatment dosed every two weeks or every four weeks for relapsing-remitting multiple sclerosis or RRMS. Peginterferon beta-1a is a new molecular entity in which interferon beta-1a is pegylated to extend its half-life and prolong its exposure in the body, enabling study of a less frequent dosing schedule. The primary endpoint of ADVANCE, annualized relapse rate or ARR at one year, was met for both the two-week and four-week dose regimens. Results showed that peginterferon beta-1a also met the secondary endpoints of risk of 12-week confirmed disability progression, proportion of patients who relapsed and magnetic resonance imaging or MRI assessments for both dose regimens. The company noted that Adverse events or AEs, serious adverse events or SAEs and discontinuations due to AEs were similar across both dose groups. Overall with both dose regimens studied, the risk-benefit profile of peginterferon beta-1a appears to be favorable. The ADVANCE study included more than 1,500 patients with RRMS and was … Continue reading →

(Reuters) - Biogen Idec Inc said on Thursday that a late-stage clinical trial of an experimental multiple sclerosis treatment showed it to be safe and effective in cutting the annual rate of relapse in patients with the autoimmune disease. The injectable treatment, peginterferon beta-1a, also known as Peg-Avonex, is designed to reduce the dosing schedule typical of standard interferon drugs such as Biogen's own Avonex, as it is designed to last longer in the body. Biogen said the results "support peginterferon beta-1a as a potential treatment dosed every two weeks or every four weeks for relapsing-remitting multiple sclerosis." The company said fewer patients relapsed on an every two-week dosing schedule than those on an every four-week schedule in the trial. The study included more than 1,500 patients with relapsing-remitting multiple sclerosis. Both schedules of use worked at about the same rate to reduce the progression of disability with MS, an autoimmune disease that affects the brain and spinal cord, the company said. Still, analysts are mainly focused on another multiple sclerosis drug in development by Biogen, BG-12, a pill that some expect could become the leading treatment for the disease. David Ferreiro, an analyst at Oppenheimer, said in a research … Continue reading →