Forest Laboratories and Nycomed Receive Complete Response Letter for Roflumilast
May 17 2010 - 6:45PM
Business Wire
Forest Laboratories, Inc. (NYSE: FRX) and Nycomed today
announced that the U.S. Food and Drug Administration (FDA) issued a
complete response letter regarding the New Drug Application (NDA)
for roflumilast. 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. 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.
About COPD
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.
About Nycomed
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.
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.
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.
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