SuperGen, Inc. Announces Withdrawal Of Orathecin(TM) Marketing Authorization Application
DUBLIN, Calif., Jan. 20 /PRNewswire-FirstCall/ -- SuperGen, Inc. (Nasdaq: SUPG - News) today announced that it has withdrawn its Marketing Authorization Application (MAA) for Orathecin(TM) (rubitecan) Capsules from the European Medicines Agency (EMEA). Orathecin is the Company's investigational drug being developed for the treatment of pancreatic cancer in patients who have failed at least one prior chemotherapy regimen. SuperGen's decision is based on extensive discussions with the EMEA.
The Company currently has a Phase II clinical trial ongoing in the United States studying Orathecin and gemcitabine as a first-line combination therapy for advanced pancreatic cancer patients who have not undergone chemotherapy. SuperGen intends to make a decision on future development or the alternative disposition of Orathecin based on a review of the interim results of this trial, expected to occur during the first half of 2006.
Orathecin(TM) (rubitecan) Capsules, an orally active camptothecin, is a topoisomerase I inhibitor that is being developed for the treatment of pancreatic cancer.
Orathecin has Orphan Drug status in both the U.S. and EU. The Orathecin European filing, or Marketing Authorization Application, 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 patients. Orathecin has also been evaluated in numerous other cancers and blood disorders. SuperGen originally submitted its MAA for Orathecin to the EMEA on July 1, 2004.
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. SuperGen's product portfolio includes Nipent® (pentostatin for injection); Mitomycin (generic brand of Mutamycin®); and SurfaceSafe® cleaner. For more information about SuperGen, please visit http://www.supergen.com.
This news release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions, and include statements regarding the expected timeline for review of the interim results of the Orathecin clinical trial. These forward-looking statements are not guarantees of SuperGen's future performance and involve a number of risks and uncertainties that may cause actual results to differ materially from the results discussed in these statements Factors that might cause results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, whether the drug will be timely approved, if at all in any country where a filing has been made; whether the drug, if approved will be successfully commercialized; and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission, including their most recently filed Forms 10-Q or 10-K. SuperGen undertakes no duty to update any of these forward-looking statements to conform them to actual results.
Timothy L. Enns Sharon Weinstein SuperGen, Inc. Noonan Russo Tel: (925) 560-0100 x111 Tel: (212) 845-4271 E-mail: firstname.lastname@example.org E-mail: email@example.com
Source: SuperGen, Inc.