SAN DIEGO, Dec. 6, 2004 (PRIMEZONE) -- Maxim Pharmaceuticals (Nasdaq:MAXM) (SSE:MAXM) announced today that Richard Lowenthal, Senior Director of Regulatory Affairs and Drug Safety at Maxim, has resigned to pursue an opportunity to be one of the first employees of an early-stage biotechnology company. Sharon Tonetta, Ph.D., Vice President of Drug Development, and Mr. Lowenthal's supervisor at Maxim, will continue to head the company's regulatory affairs and drug safety. Additionally, John F. Bedard, a member of Maxim's board of directors, has agreed to act as interim lead of regulatory affairs. Mr. Bedard, a former Vice President, FDA Liaison and Global Strategy at Bristol-Myers Squibb, has over twenty-five years of experience directing drug development and registration programs in the pharmaceutical industry. Drug Safety will be lead by Emma Barrett, M.D., Maxim's Senior Director of Medical Affairs.
"While Rich will be missed, I have full confidence in Sharon Tonetta, John Bedard and Emma Barrett. Together they represent a significant amount of pharmaceutical development and regulatory experience, making a strong team as we continue to work towards submitting regulatory filings for Ceplene therapy in the treatment of acute myeloid leukemia patients in complete remission by mid 2005," stated Larry Stambaugh, Maxim's Chief Executive Officer.
Maxim Overview
Maxim Pharmaceuticals is a global biopharmaceutical company with a diverse pipeline of therapeutic candidates for life-threatening cancers and liver diseases. Maxim's research and development programs are designed to offer hope to patients by developing safe and effective therapeutic candidates that have the potential to extend survival while maintaining quality of life. Ceplene, Maxim's lead drug candidate, is an immune-modulator that reverses immune suppression and protects critical immune cells. Because Ceplene modifies basic immune functions, it has the potential to be used in a range of diseases. Additionally, Maxim is developing small-molecule apoptosis modulators for cancer, cardiovascular disease and degenerative diseases.
Ceplene and the apoptosis compounds are investigational drugs and have not been approved by the U.S. Food and Drug Administration or any international regulatory agency.
This news release contains certain forward-looking statements that involve risks and uncertainties. Such forward-looking statements include statements regarding the efficacy, safety and intended utilization of Ceplene, and the apoptosis modulators, and the conduct, results and timelines associated with the Company's operations and clinical trials. Such statements are only predictions and the Company's actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences include the risk that products that appeared promising in early research and clinical trials do not demonstrate safety or efficacy in larger-scale or later clinical trials, the risk that the Company will not obtain approval to market its products, the risks associated with dependence upon key personnel, the risks associated with dependence upon collaborative partners, and risks associated with the Company's negative cash flows from operations and resulting reliance on outside financing to meet its additional capital requirements. These factors and others are more fully discussed in the Company's periodic reports and other filings with the Securities and Exchange Commission. Note: The Maxim logo is a trademark of the Company.
Editor's Note: This release is also available on the Internet at http://www.maxim.com.
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