TORONTO, ONTARIO -- (Marketwire) -- 03/18/13 -- Trimel Pharmaceuticals Corporation (TSX: TRL) (the "Company" or "Trimel") today announced positive secondary efficacy endpoint and safety results from the CompleoTRT pivotal Phase III clinical study. These results complement the previously announced Phase III pivotal clinical trial results indicating that CompleoTRT met its primary efficacy endpoints.
The pivotal study protocol included evaluations of the impact of treatment with CompleoTRT on body composition (total body mass, lean body mass, fat mass, percent body fat), bone mineral density, mood and erectile function. Following 90 days of CompleoTRT treatment, a statistically significant improvement over baseline was observed in all domains related to erectile function and mood. As well, CompleoTRT treatment demonstrated favourable trends with respect to its effect on bone mineral density and improvements in body composition parameters.
The safety study results demonstrated that after 360 days of treatment, the CompleoTRT safety profile was consistent with currently marketed topical testosterone replacement therapies. There were no drug related serious adverse events observed at any safety time point during the study, and there was a decrease in mild and moderate drug related adverse events over time. Measures of nasal tolerability demonstrated that CompleoTRT was well tolerated in the nasal mucosa, with no adverse event trends.
The collection of the safety data from the Phase III study represents the completion of the clinical development for CompleoTRT, and following a constructive discussion with the Food and Drug Administration ("FDA"), Trimel is moving forward as planned and expects to file the New Drug Application with the FDA in the second quarter of 2013.
Trimel's most advanced product candidate, CompleoTRT, is a bioadhesive intranasal gel formulation of testosterone. CompleoTRT is designed with a view to providing hypogonadal patients with superior safety and enhanced convenience over currently available treatment options.
Subject to FDA approval, CompleoTRT is designed to be applied to the interior lateral wall of the nasal cavity, where internal studies have demonstrated that the gel is fully absorbed into the nasal mucosa within 15-30 minutes. There is virtually no smell or taste associated with the gel. It is expected that, as a result of the "no touch" targeted delivery to the nasal mucosa, CompleoTRT should avoid skin-to-skin transference to spouses or other family members, a health risk that led the FDA to issue a "black-box" warning in May 2009 for secondary transference for all topical testosterone gel preparations.
Trimel Pharmaceuticals Corporation (TSX: TRL) - Trimel is a specialty pharmaceutical company actively developing medications for male hypogonadism, female sexual dysfunction and various respiratory disorders. CompleoTRT, a product utilizing Trimel's licensed bioadhesive intranasal gel technology, has successfully completed its pivotal Phase III study for the treatment of male hypogonadism, a condition commonly referred to as "Low T", and Trimel is preparing to file its New Drug Application with the FDA in the second quarter of 2013. For more information, please visit www.trimelpharmaceuticals.com.
Notice regarding forward-looking statements:
This press release contains forward-looking information. This forward-looking information is not based on historical facts but rather on the expectations of the Company's management regarding the future growth of the Company and its respective results of operations, performance and business prospects and opportunities. Forward-looking information may include financial and other projections, as well as statements regarding future plans, objectives or economic performance, or the assumptions underlying any of the foregoing. This press release uses words such as "believe", "expect", "would", "will", "expects", "anticipates", "intends", "estimates", or similar expressions to identify forward-looking information. Such forward-looking information reflects the current beliefs of the Company's management based on information currently available to them.
Forward-looking information included in this press release is based, in part, on factors and assumptions that may change, thus causing actual future results or anticipated events to differ materially from those expressed or implied in any forward-looking information. Such factors and assumptions include that: the Company will achieve, sustain or increase profitability, and will be able to fund its operations with existing capital, and/or it will be able to raise additional capital to fund operations; the Company will be able to attract and retain key personnel; the Company will be able to acquire any necessary technology or businesses and effectively integrate such acquisitions; the Company will be successful in developing and clinically testing products under development; the Company will be successful in obtaining all necessary approvals for commercialization of its products from the U.S. Food and Drug Administration, the Canadian Therapeutic Products Directorate or other regulatory authorities; the results of continuing and future safety and efficacy studies by industry and government agencies relating to the Company's products will be favourable; the Company's products will not be adversely impacted by competitive products and pricing; raw materials and finished products necessary for the Company's products will be available; the Company will be able to maintain and enforce the protection afforded by any patents or other intellectual property rights; the Company's products will be successfully licensed to third parties to market and distribute such products on favourable terms; the Company's key strategic alliances, out licensing and partnering arrangements, now and in the future, will remain in place and in force; the general regulatory environment will not change in a manner adverse to the business of the Company; the tax treatment of the Company and its subsidiaries will remain constant and the Company will not become subject to any material legal proceedings. The Company cautions that the foregoing list of assumptions is not exhaustive.
Forward-looking information involves known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the Company to differ materially from any future results, performance or achievements expressed or implied by the forward-looking information. Risks related to forward-looking statements includes those risks described in the Company's Annual Information Form dated March 9, 2012 under the heading "Risk Factors" and updated by the Company's short form prospectus dated July 11, 2012 under the headings "Forward-Looking Statements" and "Risk Factors". Actual results, performance or achievement could differ materially from that expressed in, or implied by, any forward-looking information in this press release, and, accordingly, investors should not place undue reliance on any such forward-looking information. Further, any forward-looking information speaks only as of the date on which such statement is made and the Company undertakes no obligation to update any forward-looking information to reflect the occurrence of unanticipated events, except as required by law. New factors emerge from time to time and the importance of current factors may change from time to time and it is not possible for management of the Company to predict all of such factors, changes in such factors and to assess in advance the impact of each such factor on the business of the Company or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking information contained in this press release.
Trimel Pharmaceuticals Corporation
Kenneth G. Howling
Chief Financial Officer
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