Trimel Pharmaceuticals Corporation
TSX : TRL

Trimel Pharmaceuticals Corporation

February 14, 2012 07:30 ET

Trimel Pharmaceuticals' Female Sexual Dysfunction Program Achieves Key Milestones

- Results of TBS-2 Phase II Vibrotactile Stimulation study yield positive outcomes for all Anorgasmia parameters

- Company to initiate multinational TBS-2 Phase II Ambulatory clinical program

- Dialogue with the United States Food and Drug Administration together with qualitative patient research has produced refined selection criteria and efficacy metrics for TBS-2 Phase II Ambulatory study

-TEFINA™ filed with United States Patent and Trademark Office as TBS-2 trade name

TORONTO, ONTARIO--(Marketwire - Feb. 14, 2012) - Trimel Pharmaceuticals Corporation (TSX:TRL) ("the "Company" or "Trimel") today announced the achievement of key milestones furthering the development of its no-touch bioadhesive intranasal gel product Tefina (TBS-2) for the treatment of Female Anorgasmia:

Tefina™ Phase II Vibrotactile Stimulation Study (VTS) Results

The Company announced today that the results from the Vibrotactile Stimulation (VTS) study demonstrated that Tefina had successfully met all study endpoints.

The VTS study measured the occurrence of, time to reach, and the quality of the orgasm, as compared to placebo. On the key metric of achieving orgasm, the results indicate that the separation between placebo and active drug demonstrates a significantly positive finding for Tefina. The VTS study further investigated improvements in the key measures of sensuality, sexual arousal and genital sensation. For all the metrics listed, Tefina again demonstrated a meaningful separation from placebo.

Tefina™ Phase II Multinational Ambulatory (AMB) Study.

Given the successful outcome from the VTS study, the Company expects to move expeditiously to implement its second Phase II study of Anorgasmia. This upcoming clinical study will be one of the largest to ever explore a "use as required" treatment for women experiencing any form of Anorgasmia.

Tefina™ Regulatory Update

Based on a cooperative dialogue with the US Food and Drug Administration (FDA), the Company has executed an extensive qualitative research program with women experiencing Anorgasmia. The findings of this research has provided supportive evidence that has been integrated into the patient selection and endpoint measurement criteria that will be implemented in the Phase II AMB Study.

TBS-2 Tradename - Tefina™

The application to the United States Patent and Trademark Office for the trademark "Tefina" underscores the Company's belief in trade marking a product once it has demonstrated safety and efficacy through a Phase II trial.

Bruce D. Brydon, Chairman and Chief Executive Officer of Trimel, offers the following comments "The positive conclusion of the Phase II VTS study along with its predecessor programs denotes ground breaking support for our decision to pursue a "use as required" product for women experiencing Anorgasmia. These pioneering insights in female sexual health, where to date no "use as required" product has been approved, gives even greater importance to our corroborative effort with the FDA to improve diagnostic criteria and assistive measurements for implementation in our Phase II AMB study. Implementing these principles is expected to provide a more efficient continuum along the pathway to product approval.

About Tefina™ (TBS-2)

Trimel's product candidate Tefina is a no-touch bioadhesive intranasal low-dose gel formulation of testosterone. Tefina is being developed to offer women experiencing Anorgasmia, a "use as required" treatment option improving their quality of life. Tefina is expected to present an attractive safety profile, with virtually no androgen-related side effects such as acne, facial and body hair growth or deepening of the voice. Moreover, there is no expected risk of skin-to-skin transfer of testosterone to third parties with the nasal applicator currently under development.

About Female Anorgasmia

Female Anorgasmia is an indication recognized by the Food and Drug Administration, or FDA, as a form of Female Sexual Dysfunction characterised by a woman's inability to achieve or persistent difficulty in achieving orgasm. This condition affects 1 in 5 pre and post menopausal women worldwide. Currently there are no approved treatments for Anorgasmia and therefore represents an unmet need for women suffering distress from this condition.

About Trimel

Trimel Pharmaceuticals Corporation (TSX:TRL). Developing Medications for Female Sexual Health and conditions related to Aging, and Well Being. Trimel is developing multiple blockbuster product opportunities, including CompleoTRT, a no-touch bioadhesive intranasal Testosterone gel for the treatment of male hypogonadism, a condition commonly referred to as "Low T". For more information, please visit www.trimelpharmaceuticals.com.

Notice regarding forward-looking statements:

Information in this press release that is not current or historical factual information may constitute forward-looking information within the meaning of securities laws. Implicit in this information, are assumptions regarding our future operational results. These assumptions, although considered reasonable by the Company at the time of preparation, may prove to be incorrect. Readers are cautioned that actual performance of the Company is subject to a number of risks and uncertainties, and could differ materially from what is currently expected as set out above. For more exhaustive information on these risks and uncertainties you should refer to our final prospectus which is available at www.sedar.com. Forward-looking information contained in this press release is based on our current estimates, expectations and projections, which we believe are reasonable as of the current date. You should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While we may elect to, we are under no obligation and do not undertake to update this information at any particular time, whether as a result of new information, future events or otherwise, except as required by applicable securities law.

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