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Sanofi's MS-drug Alemtuzumab meets first primary goal

12.07.2011

French drug maker Sanofi SA announced mixed results of a late-stage trial of multiple sclerosis drug Lemtrada. The two-year study CARE-MS I is the first of two randomised, Phase 3 clinical trials comparing Sanofi's alemtuzumab to Rebif. The CARE-MS I study incorporated 581 patients with relapsing-remitting multiple sclerosis who had not had prior treatment for their illness and showed that Lemtrada helped patients more than Rebif, Merck KGaA's established multiple sclerosis therapy. The product cut relapse rates by 55 percent over two years compared with Rebif Sanofi said in a statement on Monday. But Lemtrada failed on the second goal; statistically, it is not better than Rebif in helping stave off disability for the duration of the test. Sanofi's shares not unexpectedly fell after the announcement. Another Phase 3 clinical trial, CARE-MS II, is currently underway, evaluating Lemtrada against Rebif in relapsing-remitting multiple sclerosis patients who have relapsed while on therapy. The medicine’s prospects were at the heart of the Genzyme takeover talks this year. Cambridge, Massachusetts-based Genzyme was projecting peak annual sales of as much as $3.5 billion, saying Lemtrada was likely to become its bestseller. Sanofi said in October that analysts’ estimates of about $700 million were a valuation “probably closer to the reality of the product.” Sanofi expects to file the drug for U.S. and European Union approval in multiple sclerosis in early 2012 and has been granted fast track designation by the U.S. FDA. Sanofi has time. Cash is not the problem. On Monday the French drugmaker revealed it was selling its Dermik dermatology business to Canada's Valeant Pharmaceuticals for $425 million.

Miscellaneous

23.11.2009

Reykjavik - Decode Genetics, a pioneering Icelandic biotechnology company, has filed for bankruptcy. The firm has been experiencing serious financial trouble since autumn last year when it informed investors of insufficient funds...

BioFunding

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Europe’s ambitious pilot biobanking project, the BBMRI (Biobanking and Bio­molecular Resources Research Infrastructure) has attracted massive investment from national biobanking initiatives. The project is to link up to 300...

Tech Review

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16.11.2009

Only a year after bioprocessing world market leader Millipore Corp. entered into a partnership with Dutch stainless steel bioreactor specialist Applikon Biotechnology BV, the companies have rolled out a major project – the...

Politics / Law

16.11.2009

Shipments of soybeans from the US are unlikely to return to normal anytime soon, even though in November the European Commission expanded the range of transgenic species that may enter the bloc. “It‘s highly unlikely that imports...

Politics / Law

16.11.2009

Brussels – European Commission President Jose Manuel Barroso is planning to appoint a chief scientific adviser to combine the process of political decision-making with scientific advice in fields like GMOs, synthetic biology, and...

Miscellaneous

16.11.2009

Brussels/New York – China’s annual research output exploded in the past decade, soaring from 20,000 publications in 1998 to 112,000 a decade later. It has now outpaced the EU and Japan, and is set to overtake the US within the...

Politics / Law

16.11.2009

Brussels/Strasbourg – The pharmaceutical industry has agreed to accept a review of direct-to-consumer information on prescription medicines prior to its publication on the Internet or in newspapers. According to Euractiv, EFPIA...

Politics / Law

15.11.2009

Brussels – In the run-up to the presentation of the European Commission’s new European Innovation Act next spring, the SME interest group at Business-Europe has begun lobbying for lower taxes, financial aid and a set of common IP...

BioFunding

15.11.2009

Brussels – The Innovative Medicines Initiative (IMI) has published its second call for funding. “By accelerating and optimising R&D processes, we are trying to remove bottlenecks in the drug development process,” explained Arthur...

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