Nycomed and Forest Laboratories, Inc. (NYSE: FRX) today announced that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the New Drug Application (NDA) for roflumilast (Daxas®). Roflumilast was reviewed as a potential treatment to reduce COPD exacerbations associated with chronic bronchitis in patients at risk for exacerbations.
In the complete response letter the FDA requested certain additional information and analyses. No additional patient trials have been requested for the continued review of the NDA. Nycomed and Forest are committed to working with the FDA to address the outstanding matters and the companies anticipate a response to the FDA during the third calendar quarter of 2010.
On April 23, 2010, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) published a positive opinion, recommending the approval of Daxas® in the European Union.
COPD is an under-diagnosed, progressive lung disease that is the fourth leading cause of death in the U.S, with mortality due to COPD continuing to increase over the past 30 years. Approximately 12 million people in the U.S. are currently diagnosed with COPD and an additional 14 million are likely to have the disease and not know. Of the patients diagnosed with COPD, over 80% or 9.8 million have COPD associated with chronic bronchitis.
Symptoms of COPD include breathlessness, chronic cough and excessive production of phlegm. A significant worsening of symptoms called an exacerbation can last several weeks and often requires substantial medical intervention, including hospitalization. Exacerbations can result in worsening health status, lung function decline, and increased risk of death.
About Roflumilast (Daxas®)
Roflumilast is a phosphodiesterase 4 (PDE4) enzyme inhibitor that targets the underlying inflammation associated with COPD. If approved, roflumilast, a once-a-day oral tablet, will be the first in a new class of treatment for COPD. Roflumilast is not a steroid.
Forest Laboratories (NYSE: FRX) is a U.S.-based pharmaceutical company with a long track record of building partnerships and developing and marketing products that make a positive difference in people's lives. In addition to its well-established franchises in therapeutic areas of the central nervous and cardiovascular systems, Forest's current pipeline includes product candidates in all stages of development and across a wide range of therapeutic areas. The Company is headquartered in New York, NY. To learn more about Forest Laboratories, visit www.FRX.com.
Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories’ Annual Report on Form 10-K, Quarterly Report on Form 10-Q, and any subsequent SEC filings.
Nycomed is a privately owned global pharmaceutical company with a differentiated portfolio focused on branded medicines in gastroenterology, respiratory and inflammatory diseases, pain, osteoporosis and tissue management. An extensive range of OTC products completes the portfolio.
Its R&D is structured around partnerships and in-licensing is a cornerstone of the company's growth strategy.
Nycomed employs 12,000 associates worldwide, and its products are available in more than 100 countries. It has strong platforms in Europe and in fast-growing markets such as Russia/CIS and Latin America. While the US and Japan are commercialised through best-in-class partners, Nycomed plans to further strengthen its own position in key Asian markets.
Headquartered in Zurich, Switzerland, the company generated total sales of €3.2 billion in 2009 and an adjusted EBITDA of €1.1 billion.