Trimel Pharmaceuticals Corporation

Trimel Pharmaceuticals Corporation

September 13, 2011 08:00 ET

Trimel Pharmaceuticals Corporation Announces Commencement of CompleoTRT U.S. Phase III Study

TORONTO, ONTARIO--(Marketwire - Sept. 13, 2011) - Trimel Pharmaceuticals Corporation (TSX:TRL) (the "Company" or "Trimel") announced today that it has submitted its final study protocol to the Food and Drug Administration (FDA) and has received ethics board approval thereby clearing the way for the Company to initiate the pivotal Phase III study for Trimel's lead product CompleoTRT. The Company intends to now move forward with patient recruitment at over 30 sites in the United States and expects patient dosing to commence in the coming weeks. The Phase III study will represent the final stage of product development prior to Trimel submitting a New Drug Application (NDA) to the FDA for marketing approval in the United States.

"The start of the CompleoTRT Phase III pivotal study is a major milestone for our Company" said Bruce D. Brydon, Chairman and Chief Executive Officer of Trimel. "There are few if any start-up companies that have progressed from inception to commencing a Phase III study in less than three years."

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 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 an 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, CompleoTRT, 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.

Contact Information