DUBLIN, Calif., Oct. 9, 2012 (GLOBE NEWSWIRE) -- Astex Pharmaceuticals, Inc. (Nasdaq:ASTX), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics, announced that a $5 million dollar milestone was earned from Eisai Inc., for the first commercial sale of DACOGEN® in the European Union.
Dr. James S.J. Manuso, Astex chairman and chief executive officer, commented, "DACOGEN will continue to help patients around the world in the years ahead, and royalties on its sales will contribute to the funding of our prioritized development programs."
Janssen-Cilag International NV and its affiliates hold marketing and development rights for DACOGEN in all markets except the United States, Canada and Mexico, where rights are maintained by their strategic partner, Eisai Inc. and its affiliates. These marketing rights flow from a worldwide license from Astex Pharmaceuticals to Eisai Inc. Astex receives royalties from Eisai Inc. on the global sales of DACOGEN for any indication starting at 20% and escalating to a maximum of 30%. In accordance with Astex's license agreement with Eisai, Astex may receive up to $12.5 million in future payments if additional milestones are achieved for DACOGEN globally.
About DACOGEN (decitabine)
DACOGEN is a DNA hypomethylating agent currently approved for the treatment of myelodysplastic syndromes (MDS) in more than 35 countries worldwide including key markets such as the United States, Brazil, China, India, Korea, Russia and Turkey.
On September 28, 2012 Janssen-Cilag International NV announced that the European Commission (EC) had granted marketing authorization for DACOGEN (decitabine) for the treatment of adult patients (age 65 years and above) with newly diagnosed de novo or secondary acute myeloid leukemia (AML), according to the World Health Organization (WHO) classification, who are not candidates for standard induction chemotherapy.[i] The Orphan Drug designation for AML was also maintained by the Committee of Orphan Medicinal Products (COMP).
About Astex Pharmaceuticals
Astex Pharmaceuticals is dedicated to the discovery and development of novel small molecule therapeutics with a focus on oncology. The Company is developing a proprietary pipeline of novel therapies and is creating de-risked products for partnership with leading pharmaceutical companies. Astex Pharmaceuticals co-developed DACOGEN® (decitabine) for Injection and receives significant royalties on global sales from Eisai in North America and from Janssen-Cilag in the rest of the world.
For more information about Astex Pharmaceuticals, Inc., please visit http://www.astx.com.
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Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Astex Pharmaceuticals and its marketing partners. Risks and uncertainties include, but are not limited to, general industry conditions and competition; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; and increased scrutiny of the health care industry by government agencies. A further list and description of these risks, uncertainties and other factors can be found in the Astex Pharmaceuticals Annual Report on Form 10-K for the fiscal year ended December 31, 2011. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.astx.com or on request from Astex Pharmaceuticals. Astex Pharmaceuticals is not required to update any forward-looking statements as a result of new information or future events or developments.
[i] DACOGEN® SPC, approved 20.09.2012. The approved SPC is due to be published on the EC Community Register of medicinal products: http://ec.europa.eu/health/documents/community-register/html/newproc.htm#h.