Antares Pharma and Population Council Announce Preliminary Positive Phase 2 Trial Results
First Transdermal Contraceptive ATD™ Gel Contains Nestorone®
EWING, N.J. & NEW YORK--(BUSINESS WIRE)--May 15, 2009 - Antares Pharma, Inc. (NYSE Amex: AIS) and the Population Council announced preliminary positive results from the Phase 2 trial for a novel contraceptive gel containing the progestin Nestorone and the bio-identical estrogen estradiol (NES/E2) utilizing the Antares ATD (advanced transdermal delivery) gel system.
The trial is a dose finding, open-label, cross-over study to evaluate the effect of NES/E2 transdermal gel delivery on ovulation suppression in normal ovulating women. Eighteen women have participated in the trial, which is taking place in three sites: Los Angeles, California; Santo Domingo, Dominican Republic; and Santiago, Chile, and is scheduled to conclude active treatment in October 2009.
The preliminary data shows that all doses suppress ovulation. In addition, no serious adverse events have been recorded, and there have been no instances of skin irritation to date in the study.
Each woman in the study receives three separate doses of the gel for 21 days, separated by a washout month in which no products are administered. The primary objective of the study is 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 include determining the plasma profile of estradiol needed to reach estrogen replacement levels and to maintain regular bleeding patterns. General safety and tolerability of the NES/E2 gel, including any local skin irritation, is also being assessed.
This study follows on the successful completion of a Phase 1 study, which found an effective combined dose that consistently delivered Nestorone. In the Phase 1 study, serum levels, following multiple administrations, matched the target range expected to provide effective contraception. Blood levels for estradiol were also, on average, within the range for maintenance of a normal estrogenic environment and likely resulting in regular bleeding patterns.
Commenting on the progress of the current study, Regine Sitruk-Ware, executive director for research and development in the Reproductive Health Program of the Population Council, said, “We are encouraged by the preliminary results for this study. This is the first time these formulations have been used with ovulating women, and thus far they are meeting our expectations for both safety and efficacy.”
Antares senior vice president and managing director of the pharmaceutical group Dario Carrara Ph.D., said, "We are very pleased with the progress of the study and that the interim results validate the product concept. A transdermal gel offers an excellent opportunity to provide safe and effective contraception through an innovative drug delivery system in a large and growing global 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 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. 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 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. Together the parties expect to partner Nesterone with a worldwide or regional organization in order to commercialize it.
Nestorone is a fourth-generation synthetic progestin contraceptive derived from progesterone 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 percent 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 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 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 III trial. Antares has three validated drug delivery systems: the ATDTM Advanced Transdermal Gel Delivery system, injection technology platforms including both VibexTM disposable pressure assisted auto injectors and Vision® reusable needle-free injectors; and Easy TecTM oral disintegrating tablets (ODT). Two of the systems have generated FDA approved products. Antares Pharma leverages its multiple drug delivery systems to add value to existing drugs and to create new 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.
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: that the Company may experience 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.
About the Population Council
The Population Council is an international, nonprofit, 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.
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Posted: May 2009