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.

Clinical Trial, GermanyGermany


Apogenix GmbH (Heidelberg) has initiated a Phase II proof-of-concept study with its lead compound AGP101 + radiotherapy (vs radiotherapy alone) in 83 patients with Glioblastoma Multiforme (GBM). The clinical trial, which is...

Clinical Trial, UK


Funxional Therapeutics Ltd (Cambridge, UK) has completed the Phase I programme of its anti-inflammatory compound FX125L, which belongs to the therapeutic class of Broad-Spectrum Chemokine Inhibitors (BSCIs). In its second safety...

Clinical Trial


The EMA has finished its review of the benefits and risks of taking Biogen Idec and Elan’s multiple sclerosis drug natali­zumab (Tysabri) after 23 (14 EU, thereof 1 death) cases of potentially deadly brain infections with the JC...

Politics / Law


London – The European Medicines Agency (formerly EMEA, now EMA) reported in January that it is adapting its organisational structure to its increasing workload and interactions with patient and consumer organisations. Human pre-...

Politics / Law


GM rice looks set to arrive on plates in China within the next few years following a decision by the Chinese Agriculture Ministry’s bio­safety panel. Made up of 78 high-ranking experts, the panel has for the first time ever...



Dr. Peter Heinrich has joined medical device company Magforce Nanotechnologies AG (Berlin) as Chief Executive Officer after former CEO Dr. Uwe Maschek chose to step down at the end of 2009. Heinrich co-founded MediGene AG, and...

BioPeople, UKUK


Optos plc (London) has announced two changes in its management team. Dr. Peter Fellner has taken the helm at the retinal imaging company after Dr. John Padfield retired from his position as Chairman of the Board at the end of...



Reykjavik – Icelandic gene-hunter deCode Genetics has emerged from bankruptcy and will continue its genetics research and gene-based diagnostics as a private company, but it will abandon its efforts to develop drugs from its...

Politics / Law, Denmark


When the 2009 United Nations Climate Change Conference ended in December with the “Copenhagen Accord”, the final press release claims that the declaration “was supported by a majority of countries, including amongst them the...

BioPeople, Germany


Frankfurt – Raupach & Wollert-Elmendorff is expanding into the life sciences sector. In January, the respected German advisors for business law announced they had hired Peter Homberg as an Equity Partner. Homberg is a renowned...

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