Forest, Almirall’s Drug Raises Safety Question, FDA Says

Forest Laboratories Inc. and Almirall SA’s experimental drug to treat breathing complications tied to a common lung disease may be linked to more instances of cardiovascular deaths at higher doses, U.S. regulators said.

The twice-daily drug known chemically as aclidinium bromide helped patients with chronic obstructive pulmonary disease, or COPD, breathe easier, Food and Drug Administration staff said today in a report. Advisers to the agency are set to meet Feb. 23 to weigh whether safety questions about the medicine have been adequately assessed.

COPD, tied to smoking as a cause, is an umbrella term for conditions that make it difficult to breath, according to the National Institutes of Health. If approved, the drug may have $150 million in sales for New York-based Forest in 2015, according to the average of two analysts’ estimates compiled by Bloomberg.

“It is striking that all the cardiovascular deaths are reported for the higher aclidinium dose,” the FDA said in its report on the drug. “It is difficult to dismiss the apparent imbalance in cardiovascular death between the treatment groups, while at the same time, impossible to conclude that the data represent a true safety signal,” the agency said.

Frank Murdolo, a spokesman for Forest, said in an e-mail that the number of cardiovascular deaths in the group taking the drug “does not rise to the level of a clear safety signal.”

COPD Drugs

“The documents look relatively benign,” John Boris, an analyst with Citigroup in New York, said today in a note to clients. Boris said he expects the FDA to require more safety studies once the drug goes on the market.

Treatment for chronic obstructive pulmonary disease includes inhaled drugs to open the airways such as Boehringer Ingelheim GmbH’s Spiriva and inhaled steroids such as AstraZeneca Plc’s Symbicort and GlaxoSmithKline Plc’s Advair.

Shares of Forest fell less than 1 percent to $32 at the close in New York. Shares of Almirall, based in Barcelona, fell 1.6 percent to 6.11 euros.

Forest has the rights to aclidinium in the U.S. while Almirall owns them in the rest of the world.

London-based Glaxo also is working with Theravance Inc., based in San Francisco, to develop once-daily treatments, according to Theravance’s website.

Chronic obstructive pulmonary disease caused 126,000 deaths in the U.S. in 2005, according to the U.S. Centers for Disease Control and Prevention in Atlanta.

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