Antares Pharma, Inc. (AMEX:AIS) and the Population Council (an international, non-profit research organization) announced the initiation of a Phase II trial for a novel contraceptive advanced transdermal delivery (ATD™) gel containing the progestin Nestorone® and a form of estrogen, called estradiol, that is chemically identical to the estrogen made by a woman’s body. Population Council scientists discovered years ago that when Nestorone is orally ingested, the body rapidly inactivates it. The drug remains active, however, when applied to the skin. The new contraceptive candidate uses Antares ATD™ gel system, which is a clear and cosmetically acceptable drug delivery gel. After application, the drug is slowly absorbed across the skin into the systemic circulation.
The previous Phase I study identified an effective dose of the two hormones that consistently resulted in blood levels that would be expected to provide effective contraception and to maintain a woman’s normal estrogen levels and bleeding patterns. Additionally, the gel was well tolerated, with no serious adverse events recorded. The current Phase II trial will determine the lowest safe and effective dose to suppress ovulation. The trial, which involves both US and international study sites, will evaluate three active strengths of the combination gel in eighteen healthy, ovulating women. At different times during the course of the study, each woman will receive different dosages, with appropriate washout periods between doses.
Past studies showed that women using Nestorone experienced fewer side effects, such as acne, weight gain, and altered cholesterol levels, that are often experienced by women who use other common progestins. There are several indications from previous research that using Nestorone in combination with a natural estrogen (such as estradiol) in a transdermal formulation may result in a contraceptive method with fewer side effects than experienced with currently available methods.
Paul K. Wotton, Ph.D., president and CEO of Antares, said, "We are very pleased to initiate this Phase II study with the Population Council for the Nestorone/ estradiol ATD gel. The promising results obtained from our joint Phase I study validated the initial concept of a transdermal gel combining Nestorone with estradiol for contraception. We believe that this potentially represents an important opportunity to provide women with a convenient and easily administered alternative for contraception that is wholly within a woman’s control. Contraception continues to be a large and growing market worldwide. Together with the Population Council, and due to a confirmed medical need for this type of product, we will be seeking a commercialization partner for this product at the appropriate time.”
Regine Sitruk-Ware, MD, executive director of research and development at the Population Council, said, “We have already achieved very encouraging results with a Nestorone gel showing ovulation suppression in a high percentage of subjects. We believe this new formulation combining Nestorone and estradiol is likely to achieve a very high inhibition of ovulation and has the potential to become a safe and effective contraceptive that would be easy to use and convenient for women.”
The National Survey of Family Growth has revealed that 31 percent of women discontinue use of reversible contraceptives within six months of starting for method-related reasons, and 44 percent discontinue within 12 months. The Nestorone/estradiol contraceptive ATD gel may offer a needed and potentially attractive contraceptive option. The formulation, the active compounds, and the drug delivery system are all designed to reduce the serious side effects sometimes seen with current contraceptive methods, potentially increasing women’s ability and desire to continue using the method. 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 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, and management. The parties expect to identify a worldwide or regional commercial development partner together.
Nestorone is a novel synthetic progestin that has been shown to be highly effective at stopping ovulation at a low dose. It has no androgenic hormonal effects and has a good safety profile. It is not active when taken orally and is therefore especially appropriate for topical application as well as for use when breastfeeding. Previous studies with Nestorone delivered via implants in women who were breastfeeding did not show any health impact on the infants.
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-hour period, and to result in therapeutic blood levels. The gel is clear and cosmetically appealing. It dries readily after application to the abdomen, thighs, arms or shoulders without leaving residues. Since the gel has 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 (www.antarespharma.com)
Antares Pharma is a product development company committed to improving pharmaceuticals through its patented drug delivery systems. Antares has multiple development partnerships with leading pharmaceutical companies. The Company’s products are designed to improve safety and efficacy profiles by minimizing dosing and reducing side effects while enabling improved patient compliance. 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 has three validated drug delivery systems: the ATDTM Advanced Transdermal Gel Delivery system; subcutaneous injection technology platforms, including VibexTM disposable pressure-assisted auto injectors, ValeoTM/Vision® reusable needle-free injectors, and disposable multi-use pen injectors; and Easy TecTM oral disintegrating tablets (ODT). Two of the systems have generated FDA-approved products. 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 (www.popcouncil.org)
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. www.popcouncil.org
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