Healthcare Industry News: Lundbeck
News Release - October 13, 2006
Merck & Co., Inc. and Lundbeck Announce Update in Submission Plans for U.S. Approval of GaboxadolWHITEHOUSE STATION, N.J. & COPENHAGEN, Denmark--(HSMN NewsFeed)--Merck & Co., Inc., Whitehouse Station, N. J., U.S.A. and H. Lundbeck A/S of Denmark today announced that submission of a New Drug Application (NDA) for gaboxadol with the U.S. Food and Drug Administration will no longer occur in the first quarter of 2007. The companies plan to submit the NDA in mid-2007.
The delay in the NDA submission for gaboxadol, a novel investigational drug in Phase III development for the treatment of insomnia, results from slower than anticipated enrollment in ongoing Phase III trials.
In 2004, the companies agreed to collaborate on the development and commercialization of gaboxadol in the United States.
About Merck & Co., Inc.
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, the Company currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Company medicines but help deliver them to the people who need them. The Company also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.
Merck & Co., Inc. Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements in Item 1 of Merck & Co., Inc.'s Form 10-K for the year ended Dec. 31, 2005, and in its periodic reports on Form 10-Q and Form 8-K, which the Company incorporates by reference.
H. Lundbeck A/S is an international pharmaceutical company engaged in the research and development, production, marketing and sale of drugs for the treatment of psychiatric and neurological disorders. In 2005, the company's revenue was DKK 9.1 billion (approximately EUR 1.2 billion or USD 1.5 billion). The number of employees is approximately 5,000 globally. For further information, please visit www.Lundbeck.com.
Lundbeck Forward-Looking Statement
The content of this release will have no influence on the Lundbeck Group's financial result for 2006.
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.