Navigation Links
Nycomed Announces FDA Filing for Daxas(R) in COPD
Date:7/20/2009

ZURICH, July 20 /PRNewswire/ -- Nycomed today announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Daxas(R) as a once-daily oral treatment for patients with symptomatic COPD. The NDA submission is based on encouraging results from four Phase III trials of Daxas(R) (roflumilast) in the treatment of symptomatic COPD. Two pivotal 12-month studies showed positive effects on exacerbation rates and pulmonary function (FEV(1)). Two supporting six-month studies also confirmed the efficacy of Daxas when used with standard bronchodilator treatments. Full data from all four studies are to be published during 2009.

In May 2009, Nycomed also completed the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMEA) for Daxas as a once-daily oral treatment for patients with symptomatic COPD. The filing is currently under regulatory review.

Hakan Bjorklund, Chief Executive Officer of Nycomed, said: "With its novel mode of action, Daxas represents an important new approach to the management of COPD -- a disease which is predicted to become the third leading cause of death worldwide by 2030. The FDA filing, which follows the submission of Daxas to the EMEA in May, is another important step for Daxas in the key US market. Discussions with potential US commercialisation partners are now well advanced."

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. According to World Health Organization (WHO) estimates, 80 million people have moderate to severe COPD worldwide. More than three 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.

(See http://www.who.int/respiratory/copd/burden/en/index.html )

About Daxas

Nycomed's Daxas 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. Daxas is expected to act on the underlying mechanism of COPD and related inflammatory diseases. It could significantly improve the way these conditions are managed, reducing exacerbations requiring medical intervention, including hospitalisation. If approved, Daxas, a once-a-day tablet, will be the first drug in its class. It will also be the first new approach to the management of COPD in a generation. Current treatment for COPD patients includes the use of inhaled bronchodilators and inhaled corticosteroids.

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 euro 3.4 billion in

2008 and an adjusted EBITDA of euro 1.2 billion.

For more information visit www.nycomed.com


'/>"/>
SOURCE Nycomed
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Wyeth and Nycomed Announce Court Denial of Preliminary Injunction
2. NPS Pharmaceuticals and Nycomed Announce Licensing Agreement for GATTEX(TM) in Territories Outside North America
3. Bradley Pharmaceuticals Announces Filing of Definitive Proxy Statement for Special Meeting of Stockholders to Approve Merger With Nycomed
4. Frost & Sullivan Commends Nycomed for Excellence in Product Differentiation Innovation
5. HHS Announces $75 Million in Supplemental Funding to States for Pandemic Flu Preparedness
6. CRC Health Group Announces Acquisition of Bayside Marin Recovery Center, San Rafael
7. UHW Announces: Antelope Valley Hospital Caregivers and Board Vote to Ratify First Union Contract With SEIU UHW-West
8. HEI, Inc. Announces Sale of RFID Division Assets
9. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Zyloprim(R)
10. Mettler-Toledo International Inc. Announces Webcast of Presentation at Thomas Weisel Partners 2007 Healthcare Conference
11. Z Trim Announces Revocation of Gregory Halpern Severence Agreement
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/26/2016)... ... May 26, 2016 , ... On Memorial Day, Hope For ... their lives in military battle for the country. The nonprofit Hope For Heroes ... more programs that empower independence for disabled military veterans, as well as police, firemen, ...
(Date:5/26/2016)... ... 2016 , ... Cardiac arrhythmia is a common complication following ... survival, reports a team of UPMC researchers in the largest study of its ... Thoracic and Cardiovascular Surgery, provide critical information that will hopefully lead to better ...
(Date:5/26/2016)... ... May 26, 2016 , ... MadgeTech will be showcasing its line ... in Warner, New Hampshire at the MadgeTech headquarters. With products sold in more than ... by government agencies, including NASA. , In 2012, NASA strategically set up 17 ...
(Date:5/26/2016)... ... May 26, 2016 , ... Dr. James ... Fighting Blindness, Long Island Chapter on June 4, 2016, 1:30-3:30 pm at the ... founder of Retina Group of New York , is a Board Certified ...
(Date:5/26/2016)... (PRWEB) , ... May 26, 2016 , ... In an effort to provide hair restoration ... to both Snapchat users and those who do not use the app. Dr. Mohebi, the ... new page, Dr. Mohebi Live . , Dr. Mohebi says, “The positive response ...
Breaking Medicine News(10 mins):
(Date:5/27/2016)... , May 27, 2016 Amarantus BioScience ... on developing products for Regenerative Medicine, Neurology and Orphan Diseases, today ... be presenting at two upcoming investor conferences: SeeThru ... Third Avenue, New York City , NY ... Marcum MicroCap Conference   Where: Grand Hyatt ...
(Date:5/26/2016)... May 26, 2016 According to a ... Management Market - U.S. Industry Analysis, Size, Share, Growth, Trends, ... in the U.S. was valued at US$ 5.89 Bn in ... 3.4% from 2015 to 2023 to reach US$ 7.99 Bn ... current and emerging needle free drug delivery devices and the ...
(Date:5/26/2016)... -- TARE (Transarterial Radio-embolization) Using Yttrium-90 ... Overall Decreased Use of Hospital Resource ... healthcare company, has today announced the publication of ... ISPOR (International Society for Pharmacoeconomics and Outcomes Research), ... yttrium-90 glass microspheres is associated with cost savings ...
Breaking Medicine Technology: