Antares Pharma Announces Issuance of New U.S. Patent Covering LibiGel®

EWING, N.J.--()--Antares Pharma, Inc. (NYSE Amex: AIS), a pharmaceutical company focused on self-injection pharmaceutical products and topical gel-based medicines, today announced that the U.S. Patent and Trademark Office (USPTO) issued U.S. Patent No. 8,067,399, titled “Methods and Apparatus for Transdermal or Transmucosal Application of Testosterone.” The patent covers a method for treating hypoactive sexual desire disorder (HSDD) or female sexual dysfunction (FSD) by alleviating clinical symptoms of hormonal disorders related to HSDD and FSD through the convenient administration of a specially designed transdermal or transmucosal formulation. The method may be used to treat menopausal females, including surgically menopausal and naturally menopausal females, as well as pre-menopausal females with low testosterone levels. The patent covers the formulation of LibiGel®, a product which is currently under development by its partner, BioSante Pharmaceuticals, Inc. The patent is expected to provide protection until December, 2028.

“As our partner, BioSante, continues to make substantial development progress for LibiGel®, we are pleased to announce the issuance of this important patent, providing additional intellectual property protection for the use of the product,” stated Paul K. Wotton, Ph.D., President and Chief Executive Officer. “If approved, we expect LibiGel® to become a significant revenue generating opportunity, and this patent provides additional intellectual property protection for the product for a substantially lengthened period of time.”

About Antares Pharma

Antares Pharma focuses on self-injection pharmaceutical products and topical gel-based medicines. The Company's subcutaneous and intramuscular injection technology platforms include VIBEX™ disposable pressure-assisted auto injectors, disposable multi-use pen injectors and Vision™ reusable needle-free injectors distributed as Tjet® and Zomajet® by Teva Pharmaceutical Industries, Ltd (Teva) and Ferring Pharmaceuticals (Ferring), respectively. In the injector area, Antares Pharma has a multi-product deal with Teva that includes Tev-Tropin® human growth hormone (hGH) and a partnership with Ferring that includes Zomacton® hGH. In the gel-based area, the Company's lead product candidate is Anturol® gel, an oxybutynin ATD™ gel that is currently under review by the FDA for the treatment of OAB (overactive bladder) which has been licensed to Watson Pharmaceuticals, Inc. for the U.S. and Canada. Antares’ partnership with BioSante 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 U.S. Antares Pharma has two facilities in the U.S. The Parenteral Products Division located in Minneapolis, Minnesota directs the manufacturing and marketing of the Company’s reusable needle-free injection devices and related disposables, and develops its disposable pressure-assisted auto injector and pen injector systems. The Company’s corporate offices and Pharma Division are located in Ewing, New Jersey, where pharmaceutical products are developed utilizing both the Company’s transdermal systems and drug/device combination products.

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. 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, changes in revenue growth, difficulties or delays in the initiation, progress, or completion of product development, clinical trials, difficulties or delays in the progress or completion of product development for any of the Company’s products or development of LibiGel by BioSante. 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, 2010, 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.

Contacts

Antares Pharma, Inc.
Robert F. Apple
Chief Financial Officer
609-359-3020
or
Investors:
Westwicke Partners, LLC
John Woolford, 443-213-0506
john.woolford@westwicke.com
or
Media:
Tiberend Strategic Advisors, Inc.
Jason Rando, 212-827-0020
jrando@tiberend.com

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Contacts

Antares Pharma, Inc.
Robert F. Apple
Chief Financial Officer
609-359-3020
or
Investors:
Westwicke Partners, LLC
John Woolford, 443-213-0506
john.woolford@westwicke.com
or
Media:
Tiberend Strategic Advisors, Inc.
Jason Rando, 212-827-0020
jrando@tiberend.com