TherapeuticsMD, Inc. (NYSE MKT:TXMD), a women’s healthcare company ("TherapeuticsMD" or the "Company"), announced today that it received a Notice of Allowance from the U.S. Patent and Trademark Office pertaining to its U.S. Patent Application 13/684,002 - "Natural Combination Hormone Replacement Formulations and Therapies." This Patent Application covers the Company’s platform technology TX 12-001-HR, its oral bioidentical 17β-estradiol and progesterone combination drug candidate.
"Receiving this patent allowance is a critical step towards solidifying our IP protection for this important technology, and specifically in relation to our lead product candidate, TX 12-001-HR," said Robert Finizio, Chief Executive Officer and Co-founder of TherapeuticsMD. "Until now, it has been exceptionally difficult to combine these two bioidentical hormones and achieve consistent bioavailability. Based on clinical data presented earlier this year, we believe TX 12-001-HR has overcome these hurdles and that this novel combination of 17ß- estradiol and progesterone may achieve equivalent efficacy with better bioavailability as compared to current hormone therapies. We eagerly await the outcomes of the ongoing REPLENISH Trial."
About TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is a women’s healthcare company focused on developing and commercializing products targeted exclusively for women. We are developing advanced hormone therapy pharmaceutical products based on novel technologies that enable delivery of bioidentical hormones through a variety of dosage forms and administration routes. We also manufacture and distribute branded and generic prescription prenatal vitamins, as well as over-the-counter vitamins and cosmetics, under our vitaMedMD ® and BocaGreenMD ® brands. More information is available at the following websites: www.therapeuticsmd.com, www.ReplenishTrial.com, www.vitamedmd.com, www.vitamedmdrx.com, and www.bocagreenmd.com.Except for the historical information contained herein, the matters set forth in this press release, including statements regarding the Company’s expectations with respect to the timing and the ultimate results of the REPLENISH Trial, the Company’s belief that this patent allowance is a critical step towards solidifying the Company’s IP protection, specifically in relation to TX 12-001-HR, and the Company’s belief that TX 12-001-HR has overcome the hurdles of combining estradiol and progesterone while obtaining consistent bioavailability and that TX 12-001-HR may achieve equivalent efficacy with better bioavailability versus current hormone therapies are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including but not limited to: timely and successful completion of clinical studies and the results thereof; challenges and costs inherent in product marketing; the risks and uncertainties associated with economic and market conditions; risks and uncertainties associated with the Company’s business and finances in general; and other risks detailed in the Company’s filings with the U.S. Securities and Exchange Commission including its annual report on Form 10-K filed on March 12, 2013, reports on Form 10-Q and Form 8-K, and other such filings. These forward-looking statements are based on current information that may change. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and the Company undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.