*above video: looking back at Morningstar's Julie Stralow saying "investors shouldn't worry about big pharma credit quality" can only make people cringe now.
Just after news of Sanofi, a manufacturer and distributor of multiple sclerosis (MS) drugs such as Lemtrada (Alemtuzumab), being made regarding it’s okay in Australia; Monday just brought more in the form of legalities.
The U.S. law firm Lieff Cabraser Heimann & Berstein, LLP, they have offices in San Francisco, New York, and Nashville, have filed a class action suit against France’s Sanofi over what they are stating are “misleading statements on the safety and efficacy of its multiple sclerosis drug Lemtrada.”
Sanofi, a global pharmaceutical group that deals in research and development, manufacturing and marketing of healthcare products, bought the biotech firm Genzyme a couple years ago and with that purchase, the drug Lemtrada came with it.
Part of the deal, shareholders had received what are call contingent value right (CVRs) that were linked to Lemtrada’s future success, is what the law firm is stating is the issue.
They filed “on behalf of all purchasers of the CVRs of Sanofi between March 6, 2012 and November 7, 2013, inclusive (the “Class Period”)” and have let it be known they can be a part of it as long as they contact the lead plaintiff by February 10, 2014.
Last month the FDA Advisory Committee on Peripheral and Central Nervous System Drugs had delivered a report stating they had concerns regarding the safety and efficacy of the drug.
Basically letting it be known Sanofi’s senior executives made false and/or misleading statements about the forecasts for the drug and were able to mislead investors about the clinical trial outcomes for it.
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In 2008, early tests at Cambridge University suggest the drug was good for treating and even possibly reversing MS and favorable results had been reported in 2011 from a phase 3 trial against Rebif and, although it had been approved in Europe last month, the U.S.’s FDA apparently has concerns about the competence of the clinical trials.
With the publishing of the FDA’s concerns, Lieff Cabraser Heimann & Berstein, filed their lawsuit stating: “Defendants also misled investors about the design of two pivotal Lemtrada trials by failing to disclose that the trials contained high levels of placebo effect and observer bias, which tainted the results and thereby lowered the likelihood of approval by the Food and Drug Administration.”
The FDA is expected to “rule” on whether to approve Lemtrada for marketing here in the States by December 27th but, at this point, it isn’t looking good for Sanofi.
For more info: for those who live in Lima, Ohio, the Northwestern Ohio MS Chapter can be reached at: 401 Tomahawk Drive, Maumee, OH at (419) 897-7263. They are located approximately an hour and a half from Lima, Ohio and 45 minutes from Findlay, Ohio. For directions please click here at Google Maps
Multiple Sclerosis Community Support:
- MS World ~ “We've come together from around the world to help each other cope with the challenges of living with Multiple Sclerosis.”
- Patients like Me ~ “Our Promise PatientsLikeMe is committed to putting patients first. We do this by providing a better, more effective way for you to share your real-world health experiences in order to help yourself, other patients like you and organizations that focus on your conditions.”
- Med Help, Multiple Sclerosis ~ “Today, MedHelp empowers over 12 million people each month to take control over their health and find answers to their medical questions. MedHelp, a privately-funded company, has over 16 years of accumulated information from doctors and other patients across hundreds of conditions. In addition, MedHelp has long-standing partnerships with the top medical institutions such as the Cleveland Clinic, National Jewish, Partners Health, and Mount Sinai. MedHelp's audience, archives, and partnerships make it a unique health destination on the Internet.”
Sources: http://www.ms-uk.org/lemtrada; http://finance.yahoo.com/news/lieff-cabraser-announces-class-action-140000168.html, Business Wire, San Francisco; http://en.sanofi.com/our_company/worldwide/worldwide.aspx