UPDATE: Merck KGaA May Appeal Negative Cladribine Opinion
September 24 2010 - 2:36AM
Dow Jones News
Merck KGaA (MRK.XE) may appeal a negative opinion on its
multiple sclerosis pill Cladribine made by an advisory panel of the
European Medicines Agency, Merck KGaA said Friday.
The EMA's Committee for Medicinal Products for Human Use, or
CHMP, said that the benefits don't outweigh the risks, the company
said in a statement.
Merck KGaA said it is committed to making the drug available in
Europe and is "evaluating all options to gain approval in the
European Union, including a potential appeal to request
re-examination of the submission by the CHMP."
Cladribine, which has the potential to become a blockbuster drug
with peak sales of more than EUR1 billion, has recently been
approved in Australia and Russia, but lost the race for approval in
the U.S. to Novartis AG's (NVS) rival product Gilenia, which
received FDA approval Wednesday.
Merck previously said it expects an FDA decision in the fourth
quarter.
Merck Serono initiated global submissions for Cladribine pills
in mid-2009 and to date has submitted regulatory applications for
Cladribine covering about 40 countries.
Like Novartis's Gilenia, cladribine aims to reduce relapses in
people with relapsing forms of MS. The two treatments raise the
possibility for the first time that oral treatments might become
available alongside the more cumbersome injections and infusions
currently used to treat MS.
-By Natascha Divac and April van Ert, Dow Jones Newswires; +49
69 29725 500; djnews.frankfurt@dowjones.com