cladribine

*** Pharmaceuticals Germany's Merck said it failed to win approval for its oral multiple-sclerosis drug cladribine from the U.S., pending further information, but analysts largely consider a rejection the most likely scenario.

Business Watch 2011

The FDA said there is substantial evidence for the efficacy of cladribine.

Merck Drug Fails to Convince FDA Sarah Sloat 2011

Merck's decision to stop market applications for its MS medicine cladribine and pull the product from Russia and Australia—which comes after the U.S. Food and Drug Administration required more testing to allay safety concerns—means Novartis has the only oral multiple-sclerosis treatment in the market at the moment.

Novartis Seen Gaining as Merck Scraps MS Drug Goran Mijuk 2011

Merck is currently conducting clinical trials—Clarity Extension and Oracle MS—with cladribine tablets, with top-line results expected at the end of 2011.

Merck Drug Fails to Convince FDA Sarah Sloat 2011

Rival Merck KGaA suffered a blow last month when European drug regulators said the company's oral M.S. drug, cladribine, shouldn't be approved for sale in the European Union.

Novartis Unveils M.S. Drug Pricing Jeanne Whalen 2010

When Gilenya was approved in the U.S. last year, analysts and industry experts expected the pill to be a game-changer, together with Merck's cladribine, and take a substantial portion of the market in MS drugs which had a size of about $12.6 billion in 2010, according to research firm Espicom.

Novartis Seen Gaining as Merck Scraps MS Drug Goran Mijuk 2011

The forecast that included potential cladribine sales projected an increase in total revenues of between 13% and 18%.

Merck's Net Profit Jumps Natascha Divac 2011

The conglomerate confirmed its 2011 forecast, which excludes the potential approval of multiple-sclerosis drug cladribine by U.S. authorities.

Merck's Net Profit Jumps Natascha Divac 2011

The German company had released two different revenue forecasts in February, one including and one excluding potential sales for cladribine.

Merck's Net Profit Jumps Natascha Divac 2011

The German company expected an increase in total revenues of between 13% and 18% in the case of an approval of cladribine in the U.S. Without cladribine, Merck expects a rise of only 10% to 15%.

Merck Drug Fails to Convince FDA Sarah Sloat 2011