Antares Pharma, Inc. (AMEX:AIS) and the Population Council (an international, non-profit research organization) announced positive results from the Phase I trial for a novel contraceptive gel containing the progestin, Nestorone and the bio-identical estrogen, estradiol utilizing the Antares ATD™ (Advanced Transdermal Delivery) gel system.
The trial was a prospective, open-label, dose-ranging pharmacokinetic study to determine absorption of Nestorone and estradiol using the ATD gel system. Twelve postmenopausal women were selected for the trial in order to avoid interference with the menstrual cycle of premenopausal women.
There were two separate treatment periods in the study. In the first period there was a single administration of two different doses of Nestorone concurrently with estradiol, and in the second treatment period the most effective combined dose of Nestorone and estradiol was tested as a once-daily dosing for ten consecutive days. The primary objectives of the study included the determination of the pharmacokinetic profile of Nestorone, and the required Nestorone dose to achieve the appropriate therapeutic levels for effective contraception (ovulation suppression). Secondary objectives included determining the profile of estradiol needed to reach estrogen replacement levels, maintaining regular bleeding patterns as well as evaluating local skin irritation and tolerability of the Nestorone/estradiol ATD gel.
Data showed that an effective combined dose was identified that consistently delivered Nestorone. Serum levels following multiple administrations matched the target range expected to provide effective contraception. Serum levels for estradiol were also, on average, within the range for maintenance of regular bleeding patterns.
Importantly, the gel was well tolerated, with no serious adverse events recorded. Most subjects did not experience skin irritation at the site of application.
Commenting on the study outcomes, Dario N. R. Carrara, Ph.D., Senior Vice President and Managing Director for the Pharmaceutical Group, said, "We are pleased to present the preliminary data for Nestorone/estradiol ATD gel. The promising results obtained now from our joint Phase I study validate once again the capability of our ATD system to successfully deliver transdermally active substances in a broad variety of therapeutic fields. We are delighted with the results, as we believe a transdermal gel for contraception represents an excellent business opportunity in a large and growing market segment.”
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 transdermal gel offers an interesting contraceptive option, in that both the formulation and the active compounds are designed to reduce the adverse events profile observed with current contraceptive methods, potentially increasing compliance rates. Worldwide contraception product sales in 2005 were $3.6 billion, with projections of approximately $4.5 billion by 2010, as reported by Thomson Pharma®.
Under the terms of the joint development agreement, Antares is responsible for research and development activities as they relate to ATD formulation and manufacturing using 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. The parties together expect to identify a worldwide or regional commercial development partner.
Nestorone is a fourth-generation synthetic progestin contraceptive that has no androgenic hormonal effects and a good safety profile. It is not active when administered orally and is therefore especially appropriate for topical application as well as for use when breastfeeding.
About ATD™ Gel Technology
ATD™ Gel Technology is a hydroalcoholic transdermal gel containing less than 50% ethanol and a patented mixture of penetration enhancers. The matrix including Nestorone and bio-identical estradiol is designed to simultaneously deliver both drugs across the skin in a controlled and sustained fashion over a 24-hours period, and result in therapeutic plasma levels. The gel is crystal clear and cosmetically appealing, and dries readily after application to the abdomen, thighs, arms or shoulders without leaving residues. Due to the low ethanol content, the gel is minimally irritating, as demonstrated by a similar FDA-approved formulation using ATD™ Gel Technology, ELESTRIN™ (low-dose estradiol for treating menopausal hot flashes).
About Antares Pharma
Antares Pharma is a specialized pharma product development company committed to improving pharmaceuticals through its patented drug delivery systems. Antares has three validated drug delivery platforms: the ATDTM Advanced Transdermal Delivery system, subcutaneous injection technology platforms including both VibexTM disposable mini-needle injection device and ValeoTM/Vision® reusable needle-free injection devices; and Easy TecTM oral fast-melt technology. Two of the platforms have generated FDA approved products. Antares Pharma leverages its multiple drug delivery platforms to add value to existing drugs and to create new pharmaceutical products and injectable devices. The Company’s products are engineered to improve safety and efficacy profiles by minimizing dosing and reducing side effects while enabling improved patient compliance. 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.
About the Population Council
The Population Council is an international, non-profit, nongovernmental research organization that seeks to improve the well-being and reproductive health of current and future generations around the world and to help achieve a humane, equitable, and sustainable balance between people and resources. The Council conducts biomedical, social science, and public health research and helps build research capacities in developing countries. Established in 1952, the Council is governed by an international board of trustees. Its New York headquarters supports a global network of regional and country offices.
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, that involve significant risks and uncertainties, including those discussed in this release and others that can be found in the “Risk Factors” section of Antares’ Annual Report on Form 10-K for the year ended December 31, 2006 and in Antares’ periodic reports on Form 10-Q and other filings made with the Securities and Exchange Commission. Antares is providing this information as of the date of this release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
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