Merck announces withdrawal of MS drug from markets after FDA safety concerns


Darmstadt – Germany’s Merck KGaA will stop marketing of its multiple sclerosis (MS) pill cladribine (Movectro) in Australia and Russia where it has been already approved. The decision came several month after the US Food and Drug Administration said the company had to provide more data to demonstrate a positive benefit-risk ratio. Merck said yesterday that is was very unlikely to address the FDA requirements without carrying out additional costly clinical trials. Last autumn, the European Medicines Agency finally rejected authorisation of the symptomatic treatment of relapsing-remitting MS in Europe, the largest intended market of the drug, due to occurrence of cancer in some patients involved in a clinical trial. "The FDA feedback was consistent with the feedback previously received from the European Medicines Agency," the company said. Merck's cladribine, a chlorinated purine nucleoside analogon, which induces apoptosis after integration into the DNA, had initially been regarded as a formidable contender in the race with Novartis to bring the first oral treatment against MS to the market. Novartis received US authorisation for its sphingosine-1-phosphate receptor modulator fingolimod (Gilenya) last autumn, challenging the US$ 10 billion market share of MS injectables. The occurrence of cancer casts a bad light on cladribine, approved as a injectable treatment for hair cell leukemia.

Germany, FranceGermany


Martinsried/Paris - Sanofi has done some Christmas shopping in Munich and has licensed Scil Technology’s programme for the regenerative treatment of osteoarthritis and cartilage disorders. Under the agreement, Scil could reap up...



Monheim - It's nearly Christmas, and Bayer Crop Science gives out some presents. As the company announced, a $750 million settlement with U.S. rice farmers is now binding and can move forward. In summer the German firm had agreed...



Bonn – Germany’s federal government is prolonging one of its most successful measures to date for stimulating the establishment of high-tech companies – the High-Tech-Gründerfonds (HTGF). The HTGF was launched in 2005 with €272m...



Leverkusen – One short statement from the European Medicines Agency (EMA) means one giant step for German biotech company Biofrontera. The agency issued a favourable opinion on the firm’s marketing approval application for its...



While the European sovereign debt crisis keeps capital markets in a choke-hold, with potential negative effects on the financing situation in many industries – including biotech – there was encouraging news for drug-developing...



Heidelberg – There is still life in the European life science finance. EMBL Ventures has closed a €40m fund. The early stage investor and the venture capital arm of the European Molecular Biology Laboratory(EMBL) announced the...



Düsseldorf – BIO-Europe 2011 in Düsseldorf has again broken all previous records in terms of participants and company numbers. More than 3,000 representatives from 1,800 companies registered for Europe‘s largest partnering event....



Brussels/San Francisco – As the biggest biotech partnering event on the continent, BioEurope, draws to a close, the venture capital community sent ambivalent messages for life sciences. Dow Jones VentureSource, an analyst,...

Displaying results 11 to 20 out of 454

< Previous 11-20 Next >

© 2007-2015 BIOCOM


All Events


Product of the week


Current issue

All issues