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SuperGen Submits Second Module of Orathecin's^(TM) 'Rolling' New Drug Application as an Oral Treatment for Pancreatic Cancer

February 7, 2003
Dublin, California

SuperGen Inc. announced today that it has submitted to the Food and Drug Administration (FDA) the second of three data modules of the New Drug Application (NDA) for its anticancer compound Orathecin^(TM), an oral chemotherapy compound for the treatment of pancreatic cancer patients who are refractory (resistant) to available therapies. The submission is taking place on a 'rolling' basis with the first module, which contained the chemistry, manufacturing and controls (CMC) section, having been submitted on December 30, 2002.

The second module of the NDA contains the pre-clinical information on Orathecin and consists of 18 volumes and over 4,000 pages of data and analysis.

"We have analyzed and submitted the pre-clinical information quickly and without any unexpected complications," said Dr. Audrey Jakubowski, Ph.D., vice president of regulatory affairs at SuperGen. "We are now turning our attention to the largest module, which represents the massive amounts of data generated from the human studies of Orathecin. In total, more than 2,700 people participated in clinical studies over the past four years."

"Today's submission is a testament to the quality and professionalism of our expert regulatory team," said Dr. Joseph Rubinfeld, chairman and chief executive officer of SuperGen. "The work involved in successfully completing and submitting a New Drug Application is laborious and complex. However, the team is focused on the goal of quickly and efficiently concluding this process."

In November 2002, the company was granted a 'fast-track' designation for Orathecin. Fast-track designation means that the FDA will facilitate and expedite the development and review of the application for the approval of a new drug, if it is intended for the treatment of a serious or life-threatening condition and demonstrates the potential to address an unmet medical need.

The NDA submission will contain data on over 2,700 patients treated under Orathecin study protocols and will be based on portions of the company's Phase III clinical program, the largest randomized pancreatic cancer program ever initiated worldwide. The submission will also be supported by data from a Phase II clinical study of Orathecin in refractory pancreatic cancer. The Phase II data were presented at the 2000 Annual Meeting of the American Society of Clinical Oncology (ASCO) and were reviewed by an independent, third party, expert radiology review panel.

Pancreatic cancer is associated with high patient mortality causing more than 75,000 deaths annually worldwide. It is the fourth-leading cause of death by cancer in the United States with an average one-year survival rate of less than 5 percent.

Based in Dublin, California, SuperGen is a pharmaceutical company dedicated to the development and commercialization of products intended to treat life-threatening diseases, particularly cancer. The company's website can be reached at 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 are subject to the safe harbors created thereby. Such forward-looking statements include statements regarding our expectations about Orathecin?. The success of such a product could differ materially from those projected in the forward-looking statements as a result of known and unknown risk factors and uncertainties. Such factors may include, but are not limited to: risks and uncertainties related to how quickly data can be analyzed to submit an NDA with the FDA, the results of the studies, how lengthy the FDA review process will take, if the application will be accepted, filed, and approved or if Orathecin will ever reach the market. Reference is made to the discussion of risk factors detailed in the Company's filings with the Securities and Exchange Commission, including the report on Form 10-K for the year ending 2001 and the report on Form 10-Q for the quarter ending September 30, 2002.

Contacts:
Tim Enns, Vice President, Investor Relations & Business Development,
SuperGen Inc., 800-353-1075, ext. 111

Press Release
SOURCE: SuperGen Inc.

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	Pancreas Cancer News and Archives
		For educational purposes only; not to be relied upon. Please read Pancreatica Disclaimer
	SuperGen Submits Second Module of Orathecin's^(TM) 'Rolling' New Drug Application as an Oral Treatment for Pancreatic Cancer February 7, 2003 Dublin, California SuperGen Inc. announced today that it has submitted to the Food and Drug Administration (FDA) the second of three data modules of the New Drug Application (NDA) for its anticancer compound Orathecin^(TM), an oral chemotherapy compound for the treatment of pancreatic cancer patients who are refractory (resistant) to available therapies. The submission is taking place on a 'rolling' basis with the first module, which contained the chemistry, manufacturing and controls (CMC) section, having been submitted on December 30, 2002. The second module of the NDA contains the pre-clinical information on Orathecin and consists of 18 volumes and over 4,000 pages of data and analysis. "We have analyzed and submitted the pre-clinical information quickly and without any unexpected complications," said Dr. Audrey Jakubowski, Ph.D., vice president of regulatory affairs at SuperGen. "We are now turning our attention to the largest module, which represents the massive amounts of data generated from the human studies of Orathecin. In total, more than 2,700 people participated in clinical studies over the past four years." "Today's submission is a testament to the quality and professionalism of our expert regulatory team," said Dr. Joseph Rubinfeld, chairman and chief executive officer of SuperGen. "The work involved in successfully completing and submitting a New Drug Application is laborious and complex. However, the team is focused on the goal of quickly and efficiently concluding this process." In November 2002, the company was granted a 'fast-track' designation for Orathecin. Fast-track designation means that the FDA will facilitate and expedite the development and review of the application for the approval of a new drug, if it is intended for the treatment of a serious or life-threatening condition and demonstrates the potential to address an unmet medical need. The NDA submission will contain data on over 2,700 patients treated under Orathecin study protocols and will be based on portions of the company's Phase III clinical program, the largest randomized pancreatic cancer program ever initiated worldwide. The submission will also be supported by data from a Phase II clinical study of Orathecin in refractory pancreatic cancer. The Phase II data were presented at the 2000 Annual Meeting of the American Society of Clinical Oncology (ASCO) and were reviewed by an independent, third party, expert radiology review panel. Pancreatic cancer is associated with high patient mortality causing more than 75,000 deaths annually worldwide. It is the fourth-leading cause of death by cancer in the United States with an average one-year survival rate of less than 5 percent. Based in Dublin, California, SuperGen is a pharmaceutical company dedicated to the development and commercialization of products intended to treat life-threatening diseases, particularly cancer. The company's website can be reached at 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 are subject to the safe harbors created thereby. Such forward-looking statements include statements regarding our expectations about Orathecin?. The success of such a product could differ materially from those projected in the forward-looking statements as a result of known and unknown risk factors and uncertainties. Such factors may include, but are not limited to: risks and uncertainties related to how quickly data can be analyzed to submit an NDA with the FDA, the results of the studies, how lengthy the FDA review process will take, if the application will be accepted, filed, and approved or if Orathecin will ever reach the market. Reference is made to the discussion of risk factors detailed in the Company's filings with the Securities and Exchange Commission, including the report on Form 10-K for the year ending 2001 and the report on Form 10-Q for the quarter ending September 30, 2002. Contacts: Tim Enns, Vice President, Investor Relations & Business Development, SuperGen Inc., 800-353-1075, ext. 111 Press Release SOURCE: SuperGen Inc.

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