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Forest, Almirall Drug Wins Backing of FDA Panel Advisers

Forest Laboratories Inc. and Almirall SA’s experimental drug to help patients with a chronic lung disease breathe more easily should be approved, a panel of U.S. regulatory advisers said.

The panel voted 12-2 today to recommend approval of aclidinium bromide, a twice-daily medication that reduces complications stemming from chronic obstructive pulmonary disease. The condition, typically caused by smoking, affects 12 million Americans and is the third-leading cause of death nationwide, according to the National Institutes of Health.

In studies, the inhaled medication improved lung function and reduced symptoms such as breathlessness, heaviness in the chest, excessive mucus and cough for as much as 24 hours. Patients taking the highest dose may have increased heart risks, and additional studies are needed to confirm the drug’s long-term safety, panel members said.

“In this population, where half the patients are still smoking and have serious lung disease, it’s impressive to be able to show what the medication can do,” said Paul Greenberger, professor of allergy and immunology at Northwestern University Feinberg School of Medicine in Chicago.

Critical Question

The critical question remains the cardiovascular risk, said William Calhoun, vice chairman for research at the University of Texas Medical Branch in Galveston, Texas. Most panel members joined Calhoun in calling for a comprehensive registry or a one-to two-year study to ensure there aren’t rare, serious side effects stemming from the use of aclidinium bromide.

“I voted yes reluctantly,” said panel member Timothy Lesar, director of clinical pharmacy services at Albany Medical Center in New York. “There should be post-marketing studies to see if the signal is a true problem with the drug.”

Forest rose 1.2 percent to $32.21 in New York. Almirall, based in Barcelona, fell less than 1 percent to 5.98 euros at the close of trading in Madrid, before the vote was taken. Forest, based in New York, has the rights to the treatment in the U.S., while Almirall owns them in the rest of the world.

Aclidinium bromide blocks the contraction of smooth muscles in the airways, letting the lungs dilate and allowing patients with COPD breathe more easily. The condition typically worsens over time, making patients feel as if they are starved for air. The disease makes it hard to breathe during exercise and when patients have a respiratory infection. There is no cure.

Inhaled treatments for COPD include Spiriva from Boehringer Ingelheim GmbH and Pfizer Inc., used to reduce exacerbations of the disease, and steroids such as AstraZeneca Plc’s Symbicort and GlaxoSmithKline Plc’s Advair. London-based Glaxo is also working with Theravance Inc., based in San Francisco, to develop once-daily treatments, according to Theravance’s website.

The FDA typically follows the advice of its advisory panels, although it’s not required to do so. If the drug is approved, it may generate $150 million in sales for Forest in 2015, according to the average of two analysts’ estimates compiled by Bloomberg.

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