Antares Pharma (AMEX: AIS), Antares announced that the European Medicines Agency (“EMEA”) has provided positive guidance that the current placebo-controlled studies being carried out in the US should be sufficient for a decision regarding European registration of its testosterone Advanced Transdermal Delivery (ATD™) Gel, (known as LibiGel® in the US), which is currently in Phase III Clinical Trials.
Antares has received written notice from EMEA accepting the overall clinical development plan, design and endpoints of the pivotal North American Phase III trial for its testosterone ATD Gel. The agency concurs that a single phase III pivotal trial should provide confirmatory evidence if the clinical and statistical benefits shown in the study are compelling.
Antares had licensed its testosterone ATD gel formulation and product to BioSante Pharmaceuticals for the North American territories and elsewhere several years ago, but keeps the rights for Europe and other key markets. According to the existing contractual agreement, the Company has free access to the clinical and related data developed in the US to pursue the registration and development of the product in its markets.
The Company’s licensee announced the initiation of the Phase III program for LibiGel in December 2006, and recently received an FDA Special Protocol Assessment (SPA), which covers the pivotal Phase III trials of LibiGel for the treatment of Hypoactive Sexual Disorder Disease (“HSDD”). The two phase III efficacy trials have been reported to be double-blind, placebo-controlled trials each of which will enroll approximately 500 surgically menopausal women for six months of treatment. The primary endpoints in the LibiGel clinical trials are an increase in the number of satisfying sexual events and sexual desire and a secondary endpoint of a decrease in sexual distress. Further, the trials use validated instruments to measure the clinical endpoints. It has also been reported that the second LibiGel Phase III efficacy trial is expected to be initiated in early 2008. A related Phase III cardiovascular safety study of LibiGel.was initiated in January of 2008 which has been reported to be a randomized, double-blind, placebo-controlled, multi-center, cardiovascular events driven study of between 2,400 and 3,100 women exposed to LibiGel and placebo for 12 months and will continue to follow the women enrolled in the safety study for an additional four years after the NDA submission and possible approval of LibiGel.
“We are extremely pleased to announce that we have received a favorable response to our request for scientific advice from the EMEA regarding the registration of our testosterone ATD Gel in Europe,” said Dario N.R.Carrara, PhD., Senior Vice President and Managing Director of Antares’ Pharmaceutical Division.
“This is a significant advancement for the product development plan,” said Jack E. Stover, President and CEO of Antares Pharma, Inc. “Having a clear and defined registration path in Europe makes our testosterone ATD Gel for HSDD an attractive product for potential commercial partners that serve the patient population suffering from hypoactive sexual desire disorder and related female sexual dysfunction (FSD),” Stover concluded.
The Antares portfolio currently includes three women’s health/urology products in clinical trials and one FDA approved product. Anturol™ ATD™ gel is for the treatment of overactive bladder (OAB) is in Phase III, a nestorone/estradiol low-dose ATD™ gel contraceptive is in Phase I and the low-dose testosterone ATD™ gel for HSDD and Female Sexual Dysfunction (FSD) (mentioned above) is now in Phase III. The fourth product in this important therapeutic class is Elestrin™ which was approved by the FDA late last year and launched this past June.
Currently there is no FDA approved pharmaceutical product to treat HSDD or FSD, and if approved, this product may help address the unmet medical need. It should be noted further that Intrinsa®, a testosterone patch developed and marketed by Procter & Gamble was approved for FSD in Europe and has been launched to date in the United Kingdom, France and Germany. According to a study published in the Journal of the American Medical Association, 43 percent of American women (about 40 million) experience some degree of impaired sexual function and it is anticipated that the size of the European market is approximately the same as the US. The overall market potential for low-dose testosterone products for FSD has been estimated to range from between $2 billion to $5 billion.
Advanced Transdermal Delivery Systems (ATD™)
The ATD drug delivery platform is dedicated to the development of gels that offer a cosmetically superior option to patches, while delivering medication efficiently with less potential for skin irritation, minimizing gastrointestinal impact, as well as, the first-pass liver metabolism effect of many orally ingested drugs. Antares’ ATD gels are hydro-alcoholic and contain a combination of permeation enhancers to promote rapid drug absorption through the skin following application typically to the arms, shoulders, abdomen or thighs. The Company’s transdermal ATD gel system provides the options for delivering both systemically (penetrating into and through the subcutaneous tissues and then into the circulatory system) as well as locally (e.g. topically for skin and soft tissue injury, infection and local inflammation). Typically, the gel is administered daily, and is effective on a sustained release basis over approximately a 24-hour period of time.
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.
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.
The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. No forward-looking statement can be guaranteed and actual events and results may differ materially from those projected. Forward-looking statements, including statements regarding the timing of product sales, market estimates and market potential provide Antares' current expectation or forecasts of future events. Antares' results could differ materially from those reflected in these forward-looking statements due to decisions of regulatory authorities, Antares' ability to execute on its development plans and general financial, economic, regulatory and political conditions affecting the pharmaceutical industry generally.