Reuters: Regulatory News: UPDATE 1-U.S. FDA OKs Forest/Almirall drug for smoker's cough

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UPDATE 1-U.S. FDA OKs Forest/Almirall drug for smoker's cough Jul 23rd 2012, 19:21 Mon Jul 23, 2012 3:21pm EDT WASHINGTON, July 23 (Reuters) - Forest Laboratories Inc's inhaled treatment for smoker's cough, commonly called COPD and the fourth leading killer in America, has been approved by U.S. drug regulators, bolstering the company's plans to grow profits through new medicines. The U.S. Food and Drug Administration approved the twice-daily drug, to be sold as Tudorza Pressair, to treat symptoms of chronic obstructive pulmonary disease (COPD), a serious lung disease that makes breathing difficult and is often caused by cigarette smoking. Forest developed the drug with Spanish company Almirall SA and will market it in the United States. "The availability of long-term maintenance drugs for COPD provides additional treatment options for the millions of people who suffer with this debilitating disease," said Dr. Curtis Rosebraugh, director of the FDA's Office of Drug Evaluation II. About 14 million people in the United States and 64 million worldwide have COPD, which worsens with age and can persist even if smokers with the disease quit the habit. The FDA was originally supposed to decide on the drug by April 23, but delayed the decision to review data. Wall Street analysts have forecast that global sales of COPD treatments will exceed $5 billion in 2014. Aclidinium sales are expected to reach $164 million in 2015, according to analysts at Sanford Bernstein. The average forecast of analysts polled by Thomson Reuters is $248 million. The drug is one of several that Forest is counting on to increase profits now that its blockbuster antidepressant Lexapro faces generic competition. Last week, the company said profits declined 79 percent after Lexapro lost patent protection in March, with sales of the drug falling to $110 million from $585.7 million last year. Link this Share this Digg this Email Reprints

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