Healthcare Industry News:  histone deacetylase 

Biopharmaceuticals Oncology Regulatory

 News Release - November 26, 2007

Marketing Application for Vorinostat Filed in Europe for the Treatment of Advanced, Refractory Cutaneous T-Cell Lymphoma

WHITEHOUSE STATION, N.J.--(HSMN NewsFeed)--Merck & Co., Inc., Whitehouse Station, NJ, USA, which operates in many countries as Merck Sharp & Dohme or MSD, announced today that the Company has filed a marketing authorisation application with the European Medicines Agency (EMEA) for vorinostat for the treatment of advanced, refractory cutaneous T-cell lymphoma (CTCL) in the European Union. In the United States, the tablet is sold under the trade name ZOLINZA® (vorinostat). If approved, the centralized filing of this application would allow MSD to market this product in all 27 Member States in the European Union as well as Iceland and Norway. Additional other international regulatory filings are underway.

"The filing of a marketing application for vorinostat in Europe reflects our ongoing commitment to bring novel anticancer agents to market worldwide," said Stephen Friend, M.D., Ph.D., executive vice president, Oncology, MRL. "Vorinostat is one of several investigational therapies that represent an important part of the growing MSD Oncology franchise, offering the potential to become an important therapeutic option for CTCL as well a variety of cancer tumor types."

The European submission follows the approval of ZOLINZA in October 2006 by the U.S. Food and Drug Administration for the treatment of cutaneous manifestations in patients with CTCL who have progressive, persistent or recurrent disease on or following two systemic therapies. CTCL, a type of non-Hodgkin's lymphoma, is a form of cancer in T-cells, a type of white blood cell. In CTCL, the malignant T-cells are drawn to the skin, where some are deposited.

Vorinostat, which also has been granted orphan drug designation by the EMEA for the treatment of CTCL, belongs to a new class of targeted anticancer agents called histone deacetylase (HDAC) inhibitors. Histone deacetylation is thought to be a mechanism for silencing some tumor suppressor genes and other genes responsible for cell cycle progression, cell proliferation, programmed cell death (apoptosis) and differentiation (transformation of young cells into specialized cells). In addition to CTCL, vorinostat also is being studied in a variety of hematological and solid tumors. For information about enrolling in these clinical trials, please visit www.msdcancertrials.com.

About MSD Oncology

MSD Oncology focuses on all aspects of cancer care – prevention, treatment, and supportive care. Through strong internal research capabilities, selective alliances and acquisitions, and enabling technologies such as the Molecular Profiling platform of Rosetta, MSD Oncology is looking to lead in the discovery, development and delivery of targeted anticancer therapies customized for patient subpopulations. MSD Oncology conducts research at sites in Boston, Massachusetts; Seattle, Washington; West Point, Pennsylvania; Japan and Italy.

About Merck & Co., Inc., Whitehouse Station, NJ, USA

Merck & Co., Inc. (Whitehouse Station, NJ, USA), which operates in many countries as Merck Sharp & Dohme or MSD, 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 its medicines but help deliver them to the people who need them. Merck & Co., Inc. (Whitehouse Station, NJ, USA) also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.

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 & Co., Inc., Whitehouse Station, NJ, USA (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 risk factors and cautionary statements in Item 1A of the Company'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.


Source: Merck

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