January 14, 2009 / 7:01 PM / 9 years ago

UPDATE 1-Wyeth Alzeheimer drug moving ahead in Europe

NEW YORK, Jan 14 (Reuters) - Wyeth WYE.N said on Wednesday about a dozen European regulators have analyzed data from mid-stage trials of its bapineuzumab drug for Alzheimer's disease and are satisfied that it is appropriate to move ahead with larger late-stage studies.

Shares of Wyeth fell sharply on October 22 when the U.S. drugmaker said European regulators had asked that enrollment be delayed in two large late-stage trials of the drug so they could review results from smaller mid-stage trials to assess the drug's potential benefits and safety. The regulators also wanted to review designs of the larger planned studies.

"A dozen or more regulatory bodies have taken a look at the Phase 2 data and concluded that advancement is the correct course," Geno Germano, president of Wyeth's U.S. and pharmaceuticals business units, said on Wednesday at a J.P. Morgan healthcare conference in San Francisco.

Given positive signals from the European regulators, Germano said Wyeth expects to accelerate enrollment of patients in the phase 3 overseas studies.

Wyeth, which is developing the Alzheimer's drug with Irish drugmaker Elan Corp ELN.NELN.I, said in October that it hoped to begin the large phase 3 European trials in earnest in June after enrolling a fairly large number of patients.

But the company aroused concern with a warning that a further delay could occur if a "protracted set of discussions" was required with the European regulators reviewing the phase 2 studies.

Researchers last summer said a phase 2 trial of bapineuzumab showed it helped some patients with a certain genetic profile, but raised the risk of a potentially serious side effect in the brain.

Despite the mixed results, Wyeth and Elan vowed to pursue larger and more costly phase 3 trials in hopes the medicine would become the first one proven to treat the underlying cause of Alzheimer's disease.

Bapineuzumab is considered one of the most important products in Wyeth's and Elan's pipelines of experimental drugs.

Shares of Wyeth fell 22 cents to $37.87 on the New York Stock Exchange at mid-afternoon. Elan, which said on Tuesday it had hired Citigroup to review its strategic alternatives, slid 3.44 percent to $7.59, also on the NYSE. (Reporting by Ransdell Pierson; editing by Richard Chang)

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