Trimel Pharmaceuticals Corporation

Trimel Pharmaceuticals Corporation

December 16, 2011 07:30 ET

Trimel to Present Anorgasmia (FSD) Phase II Clinical Trial Results

TORONTO, ONTARIO--(Marketwire - Dec. 16, 2011) - Trimel Pharmaceuticals Corporation (TSX:TRL) ("the "Company" or "Trimel") today announced that it will present the results of its Phase II clinical study which measured parameters related to female orgasm at an upcoming Trimel R&D Event on February 14th, 2012 in Toronto.

Trimel's recently completed Phase II study measured the effect of its product TBS-2 in women experiencing Anorgasmia, a form of Female Sexual Dysfunction (FSD). The clinical study measured the occurrence of orgasm, time to orgasm, the quality of orgasm, and placebo response rates. Having already received favourable interim results, the Company expects the Phase II final study report to be completed by the end of December. Trimel will then complete its review of the data in preparation for the R&D Event in February.

In addition to the Phase II study described above, the Company has successfully completed both a Phase I and Phase I/II study where it dosed TBS-2 at therapeutic levels for the first time in patients. These clinical studies together demonstrated that the administered TBS-2 dose did not create any negative effects and the dose was cleared within a 24 hour period returning Testosterone blood levels back to normal range. The Phase I/II study further demonstrated positive physiological effects related to orgasm with a physical response seen within 30 minutes of dosing.

The R&D Event will also include a full corporate update, including a progress report on the ongoing CompleoTRT Phase III program for the treatment of Male Hypogonadism.

"We are excited by the opportunity to share these clinical results with all stakeholders at the upcoming R&D Event in February" said Bruce D. Brydon, Chairman and Chief Executive Officer of Trimel. "CompleoTRT is progressing towards the goal of entering a billion dollar therapeutic category that is rapidly expanding, alongside TBS-2 addressing an unmet medical need in 1 in 5 women with no approved treatment options"

Details regarding the event, which will be webcast, will be provided early in the new year.

About TBS-2

Trimel's product candidate TBS-2 is a bioadhesive intranasal low-dose gel formulation of testosterone. TBS-2 is being developed to offer women with Anorgasmia, an on-demand treatment option improving their quality of life. TBS-2 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 CompleoTRT

CompleoTRT is designed to represent a significant advancement in the treatment of male hypogonadism, or low testosterone - commonly known as "Low T". CompleoTRT's unique delivery technology is designed to provide patients with the therapeutic effect of supplementing testosterone levels while doing so with a small amount of drug in the form of a bio-adhesive intranasal gel.

CompleoTRT's intranasal no-touch delivery system is designed to avoid the risk of accidental transfer (secondary transference) of testosterone to spouses or other family members, thus offering unique patient benefits and improved safety as compared to other currently marketed products indicated to treat "Low T". Moreover, CompleoTRT is designed to avoid the negative effects from first-pass metabolism on the product, liver, or both.

Since Trimel took over development in May 2009, CompleoTRT has been optimized to meet FDA regulatory requirements, including the development of a no-touch applicator device that is designed to ensure that CompleoTRT is dosed accurately and discretely. Trimel's research program to date has demonstrated that CompleoTRT is safe and effective, with over 3500 drug exposures studied thus far in the United States.

About Hypogonadism ("Low T")

Subject to FDA approval, Trimel's lead product candidate, Compleo TRT, would be indicated for the treatment of male hypogonadism or low testosterone - commonly known as "Low T". Hypogonadism is a biochemical syndrome characterized by a deficiency in serum testosterone levels that can be either acquired or inherited, and seriously affects the quality of life for those affected with the syndrome. Low testosterone is estimated to affect 13 million men in the United States, of which an estimated 90% go untreated. According to IMS Health, sales of marketed treatments for low testosterone in North America exceeded $1 billion annually in 2010

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 product opportunities, including CompleoTRT, a bio-adhesive intranasal Testosterone gel for the treatment of male hypogonadism, a condition commonly referred to as "Low T". For more information, please visit

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 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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