Sanofi's MS-drug Alemtuzumab meets first primary goal


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.

Politics / Law, Miscellaneous, AustriaAustria


Graz – Austria is likely to lead the EU’s efforts to integrate existing national biobanks and associated data throughout Europe into a European biobanking infrastructure. The resource is aimed at reaching critical mass for the...

Politics / Law


In the fast-moving biotech sector, ethical frameworks always trail behind develop­ments. Advances in fields like cloning, embryonic stem cell research, and biofuel production have mostly outstripped efforts to preview their...

BioPeople, GermanyGermany


Tumour immunotherapy specialist BioPheresis GmbH (Heidelberg) has appointed Dr. Niels Emmerich as its new Chief Executive Officer. The immunologist co-founded immatics biotechnologies GmbH, and served as the company´s COO until...

BioFunding, UK


Little Chalfont/Fairfield - General Electrics has kicked off a “GE Healthymagination Fund” worth US$250m. The new equity fund is designed for global investment in high-tech enterprises developing innovative diagnostics,...

Clinical Trial, BeNeLux


Leuven – Belgian public company NV has been given approval for ChondroCelect as the first Advanced Therapy Medicinal Product from the European Commission. TiGenix will now commercialise the treatment with in vitro expanded...

Clinical Trial, BeNeLux


Brussels – UCB Pharma SA’s arthritis treatment Cimzia (certolizumab pegol), in combination with methotrexate (MTX), has received the green light from the European Commission. The PEGylated antibody, which targets tumor necrosis...

Germany, Politics / LawGermany


Berlin – Germany has launched Europe’s first civil high-throughput screening facility for high-risk infectious agents within the framework of ERA-NET PathoGenoMics. The novel bio-safety level 3 (BSL3) unit at the Max Planck...

Clinical Trial, SwitzerlandSwitzerland


Basel – Swiss drug manufacturer F. Hoffman-LaRoche has reported a full phase III data set suggesting that its HER2-targeting antibody drug trastuzumab (Herceptin) prolongs survival by more than 4 months in patients with gastric...

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