Trimel Pharmaceuticals Corporation
TSX : TRL

Trimel Pharmaceuticals Corporation

January 26, 2015 07:30 ET

Trimel Announces Filing of NATESTO™ With Health Canada

TORONTO, ONTARIO--(Marketwired - Jan. 26, 2015) - Trimel Pharmaceuticals Corporation (TSX:TRL) today announced that it has filed a New Drug Submission with Health Canada for NATESTO™ (testosterone) nasal gel for replacement therapy in men for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism).

"The filing of NATESTO™ with Health Canada represents another significant milestone for Trimel and the many patients this therapy aims to address," said Tom Rossi, President and CEO of Trimel. "We believe that NATESTO™ meets an important unmet medical need for men suffering from 'Low T' and, if approved, we look forward to bringing this treatment to market in Canada."

NATESTO™ is the first testosterone nasal gel filed in Canada for approval, and is the first and only approved testosterone nasal gel in the United States for replacement therapy in adult males diagnosed with hypogonadism. The commercial rights to NATESTO™ in the United States and Mexico have been licensed by Trimel to an affiliate of Endo International plc (NASDAQ:ENDP)(TSX:ENL). Endo intends to launch the product in the U.S., through its Endo Pharmaceuticals subsidiary, in this first quarter of 2015.

About NATESTO™ (Testosterone) Nasal Gel

NATESTO™ (testosterone) nasal gel was approved for use in the United States by the Food and Drug Administration in May 2014. NATESTO™ is the first and only approved testosterone nasal gel in the United States for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. For further information on NATESTO™ in the United States (including the product label and prescribing information), please see the Food and Drug Administration website at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm.

NATESTO™ (testosterone) nasal gel has not yet been approved by Health Canada for use in Canada.

About Trimel

Trimel is a specialty pharmaceutical company involved in the development, regulatory approval, sale and distribution of products with a focus in men's health, women's health and respiratory medicine. NATESTO™, a product utilizing Trimel's licensed nasal gel technology, has been approved for sale in the United States by the FDA and is licensed to an affiliate of Endo International plc for commercialization in the United States and Mexico. 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, including with respect to the approval of NATESTO™ by Health Canada 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 annual information form dated March 5, 2014 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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