Nycomed's novel COPD therapy roflumilast receives FDA approval
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Nycomed's novel COPD therapy roflumilast receives FDA approval
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* FDA granted approval for DalirespTM (roflumilast; marketed as Daxas® in the
EU, Canada and other ex-US countries) in the United States as a treatment to
reduce the risk of COPD exacerbations in patients with severe COPD.
Nycomed's US partner Forest Laboratories, Inc. (NYSE: FRX) announced today that
DalirespTM (roflumilast) was approved by the US Food and Drug Administration
(FDA) as a treatment to reduce the risk of chronic obstructive pulmonary disease
(COPD) exacerbations in patients with severe COPD associated with chronic
bronchitis and a history of exacerbations.
COPD is an under-diagnosed, progressive, irreversible lung disease. 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.
Daliresp is the first and only selective phosphodiesterase-4 (PDE4) inhibitor
approved and is an oral tablet taken once daily. While the specific mechanism by
which Daliresp exerts its therapeutic action in COPD patients is not well
defined, it is thought to be related to the effects of increased intracellular
cyclic AMP in lung cells. Forest expects Daliresp to be available to wholesalers
in the second calendar quarter of 2011.
Commenting on today's announcement, Guido Oelkers, Executive Vice President,
Commercial Operations at Nycomed, said: "Nycomed is very pleased with the US
approval of Daliresp by the FDA. With Forest we have an ideal partner, who is
absolutely committed to make this innovative treatment available in the United
States for the many patients suffering from severe COPD. The approval of
Daliresp offers clinicians and patients a much needed new treatment option
alongside existing inhaled therapies."
"The introduction of Daliresp as an additional treatment option to reduce the
risk of COPD exacerbations is an important development for patients with severe
COPD associated with chronic bronchitis and a history of exacerbations," said
Professor Stephen Rennard, M.D., University of Nebraska Medical Center and
clinical trial investigator. "Reducing the risk of COPD exacerbations is an
important goal of COPD treatment."
About roflumilast
Roflumilast is an orally administered selective phosphodiesterase 4 (PDE4)
enzyme inhibitor, which has been shown to inhibit COPD related inflammation with
a novel mode of action(1). Roflumilast, a once-a-day tablet, is the first drug
in a new class of treatment for severe COPD and the first oral anti-inflammatory
treatment specifically developed for COPD patients.
Four large randomized placebo controlled trials have shown that roflumilast
significantly reduces exacerbations and improves lung function when added to
first-line maintenance therapy.
Roflumilast is generally well tolerated. In clinical COPD trials involving
12,000 patients, the most commonly reported adverse reactions were diarrhoea
(5.9%), weight decreased (3.4%), nausea (2.9%), abdominal pain (1.9%) and
headache (1.7%). The majority of these adverse reactions were mild or moderate.
These adverse reactions mainly occurred within the first weeks of therapy and
mostly resolved on continued treatment.
Other pharmacological treatment for COPD patients includes the use of inhaled
bronchodilators and inhaled corticosteroids.
Roflumilast has been approved in the European Union and Canada in 2010 and it is
marketed under the brand name Daxas®. In February 2011 it received marketing
authorisation from the Brazilian National Health Surveillance Agency (ANVISA).
Daxas® has been launched in several countries already, as for example Germany,
Denmark, Sweden, UK, Canada and Spain. It is scheduled to be launched in other
markets in 2011.
In the US, roflumilast will be available in the second calendar quarter of 2011
and marketed exclusively by Forest Laboratories as DalirespTM. In August 2009
Forest Laboratories and Nycomed entered into a definitive collaboration and
distribution agreement pursuant to which Forest acquired an exclusive license
for Daliresp in the United States.
US Indication: DalirespTM is indicated as a treatment to reduce the risk of COPD
exacerbations in patients with severe COPD associated with chronic bronchitis
and a history of exacerbations. Limitations of use: DalirespTM is not a
bronchodilator and is not indicated for the relief of acute bronchospasm.
For further information on the US specific indication, safety and data
highlights, please visit the Forest website: www.FRX.com
About COPD
COPD remains a significant area of unmet medical need. It is a progressive and
irreversible lung disease resulting in difficulty in breathing. The disease is
characterised by severe episodes of worsening, called exacerbations or lung
attacks. According to World Health Organization (WHO) estimates, 80 million
people have moderate to severe COPD worldwide. More than 3 million people died
of COPD in 2005, which corresponds to 5% of all deaths globally. The WHO
predicts that total deaths from COPD could increase by more than 30% in the next
10 years unless urgent action is taken to reduce the underlying risk factors,
especially smoking. (http://www.who.int/respiratory/copd/burden/en/index.html)
Approximately 12 million people in the US are currently diagnosed with COPD and
an additional 12 million are likely to have the disease and not know.
Approximately half of COPD patients treated by a physician with controller
medications have severe COPD. Of the patients diagnosed with severe COPD, almost
three quarters, or 2.8 million, have chronic bronchitis.
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.
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
For further information
Nycomed
Media:
General phone: +41 44 555 15 10
Beatrix Benz, phone: +41 44 555 15 08
Tobias Cottmann, phone: +41 44 555 15 01
Investors:
Christian B. Seidelin, phone: +41 44 555 11 04
Forest Laboratories
Media & Investors:
Frank J. Murdolo, phone: +1 212 224 67 14
(1) Hatzelmann A, Morcillo EJ, Lungarella G, et al. The preclinical pharmacology
of roflumilast - a selective, oral phosphodiesterase 4 inhibitor in development
for chronic obstructive pulmonary disease, Pulmonary Pharmacology & Therapeutics
(2010), doi: 10.1016/j.pupt.2010.03.011
--- End of Message ---
Nycomed
Thurgauerstrasse 130 Glattpark-Opfikon Switzerland
Press Release Roflumilast FDA EN:
http://hugin.info/144179/R/1493295/429094.pdf
Press Release Roflumilast FDA DE:
http://hugin.info/144179/R/1493295/429095.pdf
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Datum: 01.03.2011 - 10:01 Uhr
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