November 26, 2010 / 7:30 AM / 9 years ago

FDA extends priority review of Merck KGaA's MS pill

* Follows rejection by EU drugs watchdog in Sept

* U.S. review extended by 3 months to Feb. 28, 2011

* Shares indicated 0.7 pct lower in pre-market trade

(Adds details, background)

FRANKFURT, Nov 26 (Reuters) - The U.S. drugs watchdog will take more time to decide over Merck KGaA’s (MRCG.DE) multiple sclerosis (MS) pill, the German company said on Friday, two months after drawing a rejection from European regulators.

The U.S. Food and Drug Administration (FDA) extended its review period for cladribine pills as a therapy for relapsing forms of (MS) by three months to Feb. 28, 2011, Merck said.

“The FDA extended the review period to provide additional time for a full review of additional information provided under the new drug application,” the company added.

The FDA had granted Priority Review status for cladribine tablets in July of 2010, reducing the standard 10-month review period to six months, which was set to end Nov. 28.

Most analysts are sceptical about cladribine’s prospects of clearing U.S. regulatory hurdles, leading them to exclude future U.S. cladribine sales from their earnings estimates. [ID:nLDE68S145]

European regulators on Sept. 24 dealt the German family-controlled group a body blow by advising against the cladribine pill in its potentially largest market. [ID:nLDE68N04J]

The EU’s drugs watchdog, whose view is invariably adopted by the European Commission for approval decisions, mainly took issue with cases of cancer that emerged in a drug trial.

Merck, so far only cleared to sell cladribine in Russia and Australia, is now pinning its hopes on the United States.

The family-controlled company, which traces its roots to a 17th century pharmacy, previously said it was still hopeful the drug could generate more than $1 billion in annual sales and that the FDA decision would not be influenced by European regulators’ opinion. [ID:nLDE68N04J]

Rival MS pill Gilenya, marketed by Novartis NOVN.VX, is already approved for sale in the U.S.

Reporting by Ludwig Burger

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