Merck and Lundbeck End Development of Insomnia Drug
WHITEHOUSE STATION, N.J. & COPENHAGEN, Denmark -- Merck & Co., Inc., and H. Lundbeck A/S announced today the discontinuation of their joint development program for gaboxadol, an investigational new medicine for the treatment of insomnia currently in Phase III development. Data from recently completed clinical studies suggest that the overall clinical profile for gaboxadol in insomnia does not support further development.
As a result of this new information, Merck and Lundbeck will not file a new drug application for gaboxadol for the treatment of insomnia with the U.S. Food and Drug Administration (FDA), or other regulatory agencies worldwide, and are terminating ongoing clinical studies.
"The termination of our joint insomnia development program with Lundbeck is clearly disappointing," said Dr. Peter S. Kim, president of Merck Research Laboratories. "Lundbeck has been a valued partner for the past three years, and our collaboration has benefited from the strong relationship between the companies. Although Merck will not be continuing with the clinical development program for gaboxadol for the treatment of insomnia, we remain committed to our neuroscience and sleep disorders research program, one of nine priority disease areas for research and product development. As part of that commitment, we also welcome the opportunity to engage in other joint development efforts with Lundbeck in the future."
"When developing new and innovative medicines there are always risks of failure, particularly for broad-based therapeutics which often carry a higher threshold for demonstrating value to physicians, and ultimately to patients," said senior vice president Anders Gersel Pedersen, head of development at Lundbeck. "It is clearly disappointing, but we will continue to develop new and innovative medicines to treat unmet medical needs and to seek strong and productive partnerships like the one we have experienced with Merck to maximize these efforts."
About Merck & Co., Inc.
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck 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 Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.
About Lundbeck
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 2006, the company's revenue was DKK 9.2 billion (approximately EUR 1.2 billion or USD 1.6 billion). The number of employees is approximately 5,300 globally. For further information, please visit www.lundbeck.com
Merck 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. Merck 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 Merck's business, particularly those mentioned in the risk factors in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2006, and in its periodic reports on Form 10-Q and Form 8-K, which the Company incorporates by reference.
H. Lundbeck A/S Forward-Looking Statement
The content of this release will have no influence on the Lundbeck Group's financial guidance for 2007. The company expects a profit from operations of more than DKK 2.5 billion and an EBIT margin of 25 pct. for 2007.
Contact: Merck & Co., Inc. Media: Amy Rose, 908-423-6537 Pam Eisele, 267-305-7896 Investors: Graeme Bell, 908-423-5185 or H. Lundbeck A/S Steen Juul Jensen, Vice President +45 36 43 30 06 Caroline Broge, Media Relations Officer +45 36 43 26 38 Mads Bjerregaard Pedersen, Investor Relations Officer +45 36 43 41 04 or H. Lundbeck A/S, North America Jacob Tolstrup, Investor Relations Manager 201-350-0187