UPDATE 3-Europe urged to halt psoriasis drug Raptiva sales
* Suspension of psoriasis drug Raptiva urged in Europe
* Three cases of serious brain infection confirmed
* U.S. regulators reviewing infections (Adds details on brain infections, closing shares)
WASHINGTON, Feb 19 (Reuters) - Sales of Merck KGaA's (MRCG.DE) psoriasis drug Raptiva should be suspended in light of serious brain infections confirmed in three patients, European authorities recommended on Thursday.
The European Medicines Agency (EMEA) said a committee had concluded "the benefits of Raptiva no longer outweigh its risks, because of safety concerns" following the instances of progressive multifocal leukoencephalopathy, or PML. Two patients with confirmed PML died.
The European Commission will consider the advice. It usually follows EMEA recommendations.
Merck KGaA, which markets Raptiva in Europe, said it would work with European authorities "to undertake all necessary measures to comply with the EMEA recommendations."
U.S. regulators are reviewing the three confirmed PML cases, as well as another possible case, the Food and Drug Administration said. That patient also died.
Genentech Inc DNA.N, which markets Raptiva in the United States, is developing a plan meant to minimize the drug's risks, company spokeswoman Tara Cooper said.
Merck shares fell 2 percent in German trading. Genentech shares closed nearly flat on the New York Stock Exchange.
Sanford Bernstein analyst Geoffrey Porges said it appeared "increasingly likely" Raptiva would be pulled from the U.S. market. The withdrawal in the United States and Europe "would have a very limited impact" on Genentech as the drug contributed less than 1 percent to the company's 2008 revenue, Porges said in a research note.
Merck KGaA said 2008 sales of Raptiva totaled 93 million euros ($118.1 million). Genentech said its Raptiva sales were about $108 million for 2008.
Raptiva was approved in the United States in October 2003 and in Europe in September 2004 for treating moderate to severe psoriasis, an autoimmune disease that causes scaly red patches on the skin. About 46,000 patients have been treated with Raptiva worldwide, Merck said.
The drug works by suppressing the body's immune system, which may leave patients vulnerable to infections.
In October 2008, Genentech added a strong "black box" warning after the first PML case was reported in a Raptiva patient. PML is a rare brain infection that often causes severe disability or death. It has no known treatment. Continued...
