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Four Studies Published in The Lancet Show roflumilast (Daxas(R)), a New Oral Approach to COPD, Improves Lung Function and Reduces Exacerbations
Date:8/27/2009

potential, decreasing exacerbations and improving lung function. The uniformity of the results is really encouraging and gives us great hope that our faith in roflumilast has been confirmed. We are now undergoing the regulatory review process with the European and US authorities."

"Based on the results from the pivotal studies published this week, it appears that roflumilast provides added activity on top of other commonly used treatments for COPD," said Lawrence S. Olanoff, President and Chief Operating Officer of Forest Laboratories. "Roflumilast represents the first in a new class of agents to treat COPD and, if approved, would be the first oral anti-inflammatory maintenance treatment for the disease."

About Roflumilast (Daxas(R))

Roflumilast( )is an orally administered phosphodiesterase 4 (PDE4) enzyme inhibitor targeting cells and mediators in the body believed to be important in the COPD disease process. Roflumilast is expected to act on the underlying mechanism of COPD and related inflammatory diseases. If approved, roflumilast, a once-a-day oral tablet, will be the first in an entirely new class of treatment for COPD. It will also be the first oral anti-inflammatory treatment for COPD patients. Current treatment for COPD patients includes the use of inhaled bronchodilators and inhaled corticosteroids.

About COPD

COPD is an under-diagnosed progressive lung disease that may lead to death. Worldwide, COPD kills four people every minute and the World Health Organization (WHO) predicts that it will be the third leading cause of death by 2030. WHO estimates that 80 million people have moderate to severe COPD.

Symptoms of COPD include breathlessness, chronic cough and excessive production of phlegm. A significant worsening of symptoms called an exacerbation or lung attack can last several weeks. Breathing becomes severely compromised and patients may need to be admitted to
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