Trimel Pharmaceuticals Corporation
TSX : TRL

Trimel Pharmaceuticals Corporation

April 16, 2012 07:30 ET

Trimel Pharmaceuticals Corporation Provides CompleoTRT™ Phase III Recruitment Update

TORONTO, ONTARIO--(Marketwire - April 16, 2012) - Trimel Pharmaceuticals Corporation (TSX:TRL) (the "Company" or "Trimel") announced today that the Company's ongoing CompleoTRT™ Phase III study has reached a key milestone in patient recruitment, with over 200 of the required study cohort of 280 patients now participating in the study.

The Company has benefited from recently expanding the number of active clinical sites from 30 to 37 in order to accelerate patient inflow and build study momentum towards an expected completion in the fourth quarter of 2012. The Phase III study represents the final stage of product development prior submission of a New Drug Application ("NDA") to the United States Food and Drug Administration ("FDA") for marketing approval.

"Our CompleoTRT™ Phase III study continues to proceed according to our expectations," said Bruce D. Brydon, Chairman and Chief Executive Officer of Trimel. "Achieving yet another milestone in 2012 on the path towards the filing of a CompleoTRT™ NDA is part of Trimel's commitment to providing hypogonadal men with a first-in-class 'no touch' patient centric treatment option."

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, 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 grew 24% in 2011 versus 2010 to now exceed $1.6 billion in annual sales volume.

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 currently in Phase III clinical testing in the United States. CompleoTRT™ is under investigation 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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