Forest Labs sees delays for Savella and lung drug

Fri, 03/06/2009 - 9:17am
NEW YORK (AP) — Forest Laboratories Inc. on Friday announced delays for a fibromyalgia drug due to a change in its makeup, and for a lung disease drug candidate because of additional clinical testing. Forest said it expects to start shipping Savella to wholesalers and pharmacies by the middle of the year. The Food and Drug Administration approved Savella in January, but after receiving approval, Forest and its partner Cypress Biosciences Inc. made changes to the drug's formulation, which they described as "cosmetic" and "minor." The companies had planned to launch Savella this month. They now expect a response from the FDA by May. Savella, or milnacipran, was developed as an antidepressant by Laboratoires Pierre Fabre, but it was never approved in depression in the U.S. Cypress licensed the drug from Fabre and developed it with Forest for fibromyalgia, a nerve pain disorder. Separately, New York-based Forest and Barcelona-based Laboratorios Almirall SA say they will conduct more clinical tests of a chronic obstructive pulmonary disease drug, aclidinium bromide, before submitting it for FDA approval. The companies planned to ask for FDA approval in the fourth quarter of 2009 or first quarter in 2010, but say they are now not sure when they will file the new drug application. Forest and Almirall made the decision after meeting with the FDA to review studies that have already been completed. Aclidinium bromide is an inhaled drug intended to treat a common form of lung damage. It was developed by Almirall, and Forest bought the U.S. rights to the drug. Forest shares are trading at their lowest levels in more than 10 years, and Friday morning, they fell 20 cents to $19.05. Earlier the stock reached a low of $18.37.

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