Biotech Values

[DewDiligence]

Merck KGaA terminates worldwide program for Cladribine in MS:

http://www.reuters.com/article/2011/06/22/merckkgaa-cladribine-idUSLDE75L05O20110622

German drugmaker Merck KGaA (MRCG.DE) has given up seeking approval for its multiple sclerosis pill cladribine after U.S. drug regulators said more costly testing may be needed to allay side effect concerns. In Australia and Russia, where cladribine is already approved and available under the trade name Movectro, Merck said it plans to withdraw the product from the market.

Cladribine has been an unmitigated disaster. It was rejected by the EU in Sep 2010 (#msg-54812455). In the US, the writing was on the wall when the FDA issued a CRL in Mar 2011 after failing to evaluate the NDA during the allotted time despite its having a priority review designation (#msg-57103405).

One fewer competitor for Teva, MNTA, NVS, and BIIB to worry about.