Biotech Values

[DewDiligence]

Merck KGaA Starts Phase-3 Trial of Cladribine in CIS

http://www.reuters.com/article/marketsNews/idINLI33518120080918

›Sep 18, 2008

LONDON, Sept 18 (Reuters) - Germany's Merck KGaA (MRCG.DE) is launching a new late-stage Phase III clinical trial of its experimental multiple sclerosis pill cladribine, marking a step-up in investment for the product.

The latest study will evaluate the drug in patients at risk of developing multiple sclerosis (MS), after experiencing a first clinical event suggestive of MS, Merck said on Thursday.

Cladribine is already being tested in a fully enrolled Phase III pivotal trial for the treatment of relapsing forms of MS.

The new trial will look at the potential of the medicine in a wider group of patients at an earlier stage of disease.

Merck is racing other drugmakers, including Novartis to develop and launch the world's first MS drug that can be given by mouth, rather than injection.

Cladribine tablets have already been granted a fast track designation by the U.S. Food and Drug Administration.

Merck is an established leader in MS treatment through its existing Rebif medicine, which was acquired when the German drugmaker bought Swiss biotech firm Serono in 2006.‹