SOURCE: Adamis Pharmaceuticals Corporation

December 07, 2010 09:30 ET

Adamis Pharmaceuticals Announces Phase 3 Meets Primary Endpoint

SAN DIEGO, CA--(Marketwire - December 7, 2010) - Adamis Pharmaceuticals Corporation (OTCBB: ADMP) announced the successful completion of a Phase 3 contraceptive trial of the company's contraceptive gel product candidate named Savvy® (C31G). The study met its primary endpoint and was conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), in the Contraceptive Clinical Trials Network at 14 sites in the United States. The results of the NICHD study are published in Obstetrics and Gynecology, v.116, pages 1265-1273, in December, 2010.

The Phase 3 trial was a randomized, double-masked, controlled comparator study to assess whether a gel containing the spermicide, C31G, was non-inferior to Conceptrol®, a commercially available product containing nonoxynol-9 (N-9). The clinical investigators found that C31G was not inferior in contraceptive efficacy to the comparator drug Conceptrol®. Thus, the study met its primary objective. Moreover, the gel was well-tolerated and had a high degree of acceptability in women who completed the study. No drug-related serious adverse events were observed with C31G. Drug-related side effects of C31G were generally mild and did not lead to discontinuation.

Currently, all spermicides commercially available in the U.S. contain the active ingredient N-9 in a carrier such as a gel, film, cream, foam, suppository, or tablet. N-9 has been reported in some studies to cause irritant and allergic reactions in some users. Although the Conceptrol® product was effective and well-tolerated in the NICHD comparative trial, there were a significantly lower number of drug-related events with the C31G gel and fewer women discontinued the study due to drug-related side effects. In an interview with Reuters Health, lead researcher Dr. Anne E. Burke of The John's Hopkins School of Medicine stated, "There are concerns with nonoxynol-9, such as vaginal side effects and genital irritation for some users. It seems that C31G might offer improvements in those regards." C31G does not contain nonoxynol-9 and, if commercialized, may offer a welcome alternative for women who seek a non-hormonal method of contraception. 

C31G previously was the subject of two Phase 3 clinical trials conducted in Africa, supported by Family Health International and the United States Agency for International Development, to determine whether C31G was safe and effective for reducing women's risk of acquiring HIV infection. The external independent Data Monitoring Committee reviewing those trials concluded in 2005 and 2006 that, while there were no safety concerns based on the results of the studies to date, continuing the trials would not allow the effect of C31G on HIV acquisition to be determined because of a lower than expected rate of HIV seroconversion in the trials. The committee determined that continuation of the trials was not warranted due to a lack of statistical significance between C31G gel and the vehicle control in the interim data. Accordingly, the trials were discontinued.

Adamis estimates that the market for a product with the characteristics of C31G to be in the $500 million range. Dr. Dennis J. Carlo, President and CEO, stated, that "Since the product does not fit in the core business of the company, Adamis is currently evaluating various out-licensing opportunities. We are currently in discussions with multiple organizations that have a focus or business unit in the area of contraception."

About Adamis Pharmaceuticals

Adamis Pharmaceuticals has three wholly-owned subsidiaries: Cellegy Holdings, Inc.; Adamis Corporation; and Biosyn, Inc. Adamis Corporation has two wholly-owned subsidiaries, Adamis Laboratories and Adamis Viral Therapies. Adamis Labs has niche prescription products in the allergy and respiratory therapeutic area and intends to launch additional products in this area. Adamis Viral Therapies is focused on the development of patented, proprietary technologies for the potential treatment of human prostate cancer.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. These statements relate to future events or our future results of operations or future financial performance, including, but not limited to the following statements: the company's ability to successfully develop and market C31G assuming it is approved for marketing by the FDA and other regulatory authorities; regulatory issues or delays with the FDA; and the intellectual property protection that may be afforded by any patents or patent applications relating to C31G. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, which may cause Adamis' actual results to be materially different from these forward-looking statements. These risks and uncertainties include, but are not limited to: whether C31G will be approved for marketing by the FDA and other regulatory authorities; whether the company will be able to obtain required funding to pursue activities relating to C31G; whether C31G is a commercially viable product and can be commercialized, manufactured, and marketed in a cost-effective manner; the extent of consumer demand for any such product; and whether any third party will be interested in entering into agreements relating to development and marketing of C31G. It is uncertain whether C31G will ever be commercialized or whether the company will ever realize revenues therefrom. Certain of these risks, uncertainties, and other factors, as well as other risks and uncertainties relating to the company's business are described in greater detail in Adamis' filings from time to time with the SEC, all of which are available free of charge on the SEC's web site at Adamis expressly disclaims any intent to update any forward-looking statements.

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