SuperGen, Inc.

SuperGen Submits Application for EMEA Approval of Orathecin

DUBLIN, California, July 1 (ots/PRNewswire) --


      - 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.

@@start.t1@@      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.com

        For 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.com
@@end@@

      Web site: http://www.supergen.com


ots Originaltext: SuperGen, Inc.
Im Internet recherchierbar: http://www.newsaktuell.ch

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



Das könnte Sie auch interessieren: