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Published on 12/13/2005 in the Prospect News Biotech Daily.

EPIX to cut workforce 50% after FDA fails to approve Vasovist

New York, Dec. 13 - EPIX Pharmaceuticals, Inc. said it will reduce its employees by 50% to 48 from the current 93 in response to the Food and Drug Administration's request for more studies before it grants approval to the company's blood-pool contrast agent Vasovist.

EPIX said the lay-offs will affect both research and development and general and administrative workers and will be made in January.

The staff cuts will result in a one-time charge of $1.2 million but are expected to reduce the company's cash burn for 2006 by 30% or $7 million. Anticipated cash burn for 2005 is $25 million.

As part of the actions, EPIX will focus on Vasovist, EP-2104R and its highest priority research.

"We regret the loss of these talented and hard-working individuals who have contributed so much over the years to EPIX," said interim chief executive officer Michael Astrue in a news release.

"We also regret the suspension of many of our innovative early-stage research programs that might contribute in the diagnosis of severely ill patients, but we need to take these steps in order to bring our lead programs forward as quickly as we can."

On Nov. 23, EPIX announced it received a second approvable letter from the FDA that asked for more studies, work that the company said would require a substantial period of time to complete.

At the time, EPIX warned it would have to "substantially" scale back its research and employment.

No safety or manufacturing issues were raised in the FDA letter but it indicated that at least one additional clinical trial and a re-read of images obtained in completed phase 3 trials will be necessary before the agency can approve Vasovist.

EPIX also said it extended Astrue's term as interim CEO by two months to six months.

EPIX is based in Cambridge, Mass., and develops pharmaceuticals for use in the diagnosis, treatment and monitoring of disease.


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