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. Forest and Nycomed 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.
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(R))
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.
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 EUR 3.2 billion in 2009 and an adjusted EBITDA of EUR 1.1 billion.
For more information visit www.nycomed.com.
About Forest Laboratories
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.