SuperGen Submits Application for EMEA Approval of Orathecin
DUBLIN, California, July 1 (ots/PRNewswire)
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- EuroGen Subsidiary Seeks Centralized Review for Pancreatic Cancer Treatment
SuperGen, Inc. (Nasdaq: SUPG) announced today that a Marketing Authorization Application (MAA) seeking approval of Orathecin(TM) (rubitecan) Capsules has been submitted to the European Agency for the Evaluation of Medicinal Products (EMEA). Orathecin is the Company's investigational oral chemotherapy agent for the treatment of pancreatic cancer in patients who have failed at least one prior chemotherapy regimen.
The MAA for Orathecin has been submitted by SuperGen's European subsidiary, EuroGen Pharmaceuticals Ltd. and will be reviewed under the EMEA Centralized Procedure, where marketing authorization is applied for in all 25 EU Member States simultaneously. EMEA procedures provide that a decision on the Orathecin MAA will usually occur within 12 months of acceptance of the submission.
EuroGen, an oncology-focused pharmaceutical company, was established as a wholly-owned subsidiary of SuperGen in 2001. Based in Cheltenham, U.K, EuroGen has opened offices in Germany, France, Italy and Spain to support the company's commercialization and marketing programs throughout Europe.
"The Orathecin MAA submission marks a major milestone for SuperGen as we prepare to commercialize our therapeutic products in key global markets," stated James Manuso, Ph.D., President and Chief Executive Officer of SuperGen. "EuroGen will play a vital role in helping SuperGen meet its commitment to making Orathecin available to patients throughout Europe."
"EuroGen is positioned to become a significant new player in the European oncology market," said Larry Johnson, Chief Executive Officer of EuroGen. "SuperGen's thirteen-year heritage of pharmaceutical development and marketing will be leveraged, as we move forward on both present and future opportunities in Europe. EuroGen and SuperGen share a common vision and commitment to extending, improving, and ultimately saving the lives of cancer patients."
About Pancreatic Cancer
The incidence of pancreatic cancer in the EU is estimated to be approximately .7 per 10,000 persons. With the population of the EU currently at 450 million, the estimated advanced pancreatic market is 31,500 newly diagnosed patients per year. This incidence is almost identical to that of the United States.
About Orathecin
Orathecin(TM) (rubitecan) Capsules, an orally active camptothecin, is a topoisomerase I inhibitor, that was developed for the treatment of pancreatic cancer.
Orathecin has Orphan Drug status in both the US and EU. The Orathecin MAA contains data from a Phase III clinical program believed to be the largest program in pancreatic cancer ever initiated worldwide, with more than 1,000 pancreatic cancer patients who failed at least one prior chemotherapy regimen. Orathecin is also in clinical trials for numerous other cancers and blood disorders.
SuperGen's Orathecin New Drug Application (NDA) was submitted to the FDA on January 26, 2004. It was accepted for filing and assigned a User Fee goal date of November 26, 2004.
About SuperGen
Based in Dublin, California, SuperGen is a pharmaceutical company dedicated to the acquisition, rapid development and commercialization of therapies for solid tumors, hematological malignancies and blood disorders. The company's website can be reached at http://www.supergen.com.
This press release contains "forward-looking" statements within the meaning of section 21A of the Securities Act of 1933, as amended, and section 21E of the Securities Exchange Act of 1934, as amended, and is subject to the safe harbor created thereby. Such forward-looking statements include statements regarding expectations about Orathecin and its completed EMEA and FDA submissions. The success of Orathecin could differ materially from those projected in the forward-looking statements as a result of known and unknown risk factors and uncertainties associated with drug development. Such factors include, but are not limited to: risks and uncertainties related to the Orathecin MAA and NDA filings, how long the EMEA and FDA review processes will take, and if Orathecin will ever be approved by the EMEA or FDA and reach the market. References made to the discussion of the risk factors are detailed in the Company's filings with the Securities and Exchange Commission, including the report on Form 10-Q for the quarter ended March 31, 2004. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update or revise the information contained in any such forward-looking statements, whether as a result of new information, future events or otherwise.
For further information about EuroGen, please contact:
Larry Johnson Mark Lewis
EuroGen Pharmaceuticals, Ltd. Medical Knowledge Group
Tel: +44-1242-703-646 Tel: +44-207-413-3057
Fax: +44-1242-703-648 Fax: +44-207-413-3110
Email: ljohnson@eurogenpharma.com Email:mlewis@hillandknowlton.comFor further information about SuperGen and EuroGen, please contact:
Timothy L. Enns Sharon Weinstein
SuperGen, Inc. Euro RSCG Life NRP
Tel: +1-925-560-0100 x111 Tel: +1-212-845-4271
Fax: +1-925-551-6491 Fax: +1-212-845-4260
tenns@supergen.com sharon.weinstein@eurorscg.comWeb site: http://www.supergen.com
Contact:
Information about EuroGen: Larry Johnson of EuroGen Pharmaceuticals,
Ltd., +44-1242-703-646, fax, +44-1242-703-648, or
ljohnson@eurogenpharma.com; or Mark Lewis, Medical Knowledge Group,
+44-20-7413-3057, fax, +44-20-7413-3110, or
mlewis@hillandknowlton.com; or
information about SuperGen and EuroGen: Timothy L. Enns of SuperGen,
Inc.,
+1-925-560-0100, ext., 111, fax, +1-925-551-6491, or
tenns@supergen.com; or
Sharon Weinstein of Euro RSCG Life NRP, +1-212-845-4271, fax,
+1-212-845-4260,
or sharon.weinstein@eurorscg.com