UPDATE 1-Merck KGaA says sees EU statement on MS pill in Q3
* Head of drug unit says is confident about EU approval
* Says Merck still in talks with FDA over cladribine pill
(Adds details, background)
FRANKFURT, April 9 (Reuters) - Germany's Merck KGaA (MRCG.DE) still sees its application for European approval of multiple sclerosis pill cladribine on track, while regulatory clearance in the United States remains uncertain.
The head of Merck's drug unit Elmar Schnee said on Friday at the group's annual shareholder meeting that advisors to EU regulators would probably issue an assessment of the drug in the third quarter, adding he was confident about an approval.
Merck filed for European approval in July 2009. [ID:nLN726496]
It has previously said that in an ideal scenario, cladribine could win European approval in the fourth quarter.
Merck has slipped behind Swiss rival Novartis (NOVN.VX) in the race to get the first oral multiple sclerosis treatment to market after the U.S. Food and Drug Administration (FDA) held up its application to bring cladribine to market. [ID:nLDE60I05W]
Novartis has since submitted its pill, FTY720 or Gilenia, for approval in the United States and Europe while investors have been kept wondering what Merck has to do to get its U.S. application back on track.
The German company also said on Friday it was still in talks with the FDA to refile cladribine application as soon as possible.
Novartis on Feb. 22 won U.S. priority review status for its oral treatment for multiple sclerosis.[ID:nLDE61L07B]
Reporting by Frank Siebelt; Writing by Ludwig Burger)
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