Antares Pharma and Population Council Announce
Positive Phase 2 Trial Results
First transdermal contraceptive ATD™ gel contains Nestorone®
EWING, NJ, and NEW YORK, NY (11 January 2010) — Antares Pharma, Inc. (NYSE Amex: AIS) and the Population Council today announced successful results from a dose-finding Phase 2 trial for a novel contraceptive gel containing the progestin Nestorone and estradiol (NES/E2) utilizing the Antares ATD (advanced transdermal delivery) gel system. Based on this successful data, the two parties continue to expect to partner with a worldwide or regional pharmaceutical company in order to commercialize this novel contraceptive gel.
This first-of-its-kind contraceptive gel may offer an attractive option for women. The combination of Nestorone, a highly potent and versatile synthetic progestin, and the natural estrogen estradiol was chosen due to the potential for superior safety profiles when compared to other commonly used hormones in contraceptives. The ATD system is currently utilized in Elestrin®, a marketed product for hormone replacement therapy (HRT) in postmenopausal women. The gel is easy to apply, crystal clear, fast drying, and cosmetically appealing.
The trial was a dose-finding, open-label, cross-over study to evaluate the effect of NES/E2 transdermal gel on ovulation suppression in normal women of fertile age. Eighteen women participated in the trial, which took place in three sites: Los Angeles, California; Santo Domingo, Dominican Republic; and Santiago, Chile. Each woman completing the study received each of the three separate doses of the gel for 21 days, separated by a washout month in which no products were administered when the women recovered normal ovulation. The primary objective of the study was to find the lowest acceptable dose of the NES/E2 gel to achieve appropriate therapeutic levels for effective contraception (ovulation suppression), as measured by progesterone levels and ultrasound evaluation of follicular development. Secondary objectives included determining the plasma profile of estradiol and the evaluation of bleeding patterns. General safety and tolerability of the NES/E2 gel, including any local skin irritation, was also assessed.
Active treatment concluded in October 2009. Safety and efficacy objectives were met, and no serious adverse events or instances of skin irritation were recorded.
Régine Sitruk-Ware, executive director for research and development in the Reproductive Health program of the Population Council, said, “We have demonstrated that the transdermal gel combining Nestorone and estradiol is able to suppress ovulation at all doses tested, and we determined the dose that gave the most stable levels of hormones to the subjects. Most women who participated in the study found the gel very easy to use and convenient. We believe this new formulation is likely to be a safe and effective contraceptive that offers a new option for women who may be unable to use alternative forms of contraception.”
"The advantage of using transdermal delivery has been seen with HRT products where recent studies have shown a reduced side-effects profile when compared to orally administered products. The ATD system offers a patient-friendly, fast-drying, and cosmetically appealing gel product that can be easily applied daily. This product may offer an excellent opportunity to provide the most safe and effective contraception through an innovative drug-delivery system in a large and growing global market segment,” said Dario N. Carrara, Ph.D., Antares senior vice president and managing director and the inventor of the ATD system.
The National Survey of Family Growth has revealed that 31 percent of women discontinue use of reversible contraceptives for method-related reasons within six months of starting use, and 44 percent do so within 12 months. The novel NES/E2 transdermal gel offers a potentially attractive contraceptive option, in that both the formulation and the active compounds are designed to reduce the adverse events profile observed with current contraceptive methods and therefore could result in higher continuation rates by users. According to Business Insights (2007) the contraceptive market is projected to reach $7.5 billion by 2011.
Under the terms of a joint development agreement, Antares is responsible for research and development activities as they relate to ATD formulation and manufacturing, using the Population Council’s patented and other proprietary information covering the compound. The Population Council is responsible for research on Nestorone and clinical trial design development and management.
About the Population Council
The Population Council confronts critical health and development issues—from stopping the spread of HIV to improving reproductive health and ensuring that young people lead full and productive lives. Through biomedical, social science, and public health research in 50 countries, we work with our partners to deliver solutions that lead to more effective policies, programs, and technologies that improve lives around the world. Established in 1952 and headquartered in New York, the Council is a nongovernmental, nonprofit organization governed by an international board of trustees.
About Antares Pharma
Antares Pharma focuses on self-injection delivery technologies and topical gel-based pharmaceutical products. The Company’s subcutaneous injection technology platforms include Vibex™ disposable pressure-assisted auto injectors, Valeo™/Vision® reusable needle-free injectors, and disposable multi-use pen injectors. In the injector area, Antares Pharma has a multi-product deal with Teva Pharmaceutical Industries, Ltd. that includes Tev-Tropin® human growth hormone and a partnership with Ferring Pharmaceuticals. In the gel-based area, the Company’s lead product candidate, Anturol®, an oxybutynin ATD™ gel for the treatment of OAB (overactive bladder), is currently under evaluation in a pivotal Phase 3 trial. Antares also has a partnership with BioSante that includes LibiGel® (transdermal testosterone gel) in Phase 3 clinical development for the treatment of female sexual dysfunction (FSD), and Elestrin (estradiol gel) indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, and currently marketed in the United States. Antares Pharma has corporate headquarters in Ewing, New Jersey, with subsidiaries performing research, development, manufacturing, and product commercialization activities in Minneapolis, Minnesota, and Basel, Switzerland.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements related to the Company’s future financial performance, and other statements which are other than statements of historical facts. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "intends," "plans," anticipates," "believes," "estimates," "predicts," "projects," "potential," "continue," and other similar terminology or the negative of these terms, but their absence does not mean that a particular statement is not forward-looking. Such forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated by the forward-looking statements. These risks and uncertainties include, among others, difficulties or delays in the initiation, progress, or completion of its clinical trials, including the Phase 3 trial of Anturol®, whether caused by competition, adverse events, investigative site initiation rates, patient enrollment rates, regulatory issues, or other factors; that clinical trials may not demonstrate that Anturol® is both safe and effective for the treatment of patients with overactive bladder syndrome; that the safety and/or efficacy results of the Phase 3 trial of Anturol® may not support an application for marketing approval in the United States or any other country; that an application for marketing approval may not be accepted for review or at all by the FDA or any other regulatory authority; and that the Company may lack the financial resources and access to capital to fund clinical trials. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year ended December 31, 2008, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.
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Contacts and Resources
The Population Council welcomes Landis MacKellar as co-editor of Population and Development Review.