Trimel Pharmaceuticals Corporation

TSX : TRL


Trimel Pharmaceuticals Corporation

December 06, 2012 07:00 ET

Trimel Announces Positive CompleoTRT™ Phase III Trial Results

CompleoTRT™ Achieves Phase III Efficacy Endpoints

TORONTO, ONTARIO--(Marketwire - Dec. 6, 2012) - Trimel Pharmaceuticals Corporation (TSX:TRL) ("the Company" or "Trimel") today announced that its Phase III pivotal clinical trial for CompleoTRT™ has met its primary efficacy endpoints. Based on these clinical results, Trimel will move forward to prepare for a meeting with the FDA and continue the process of completing its New Drug Application ("NDA") for filing with the United States Food and Drug Administration ("FDA").

The CompleoTRT™ Phase III clinical trial results demonstrated that after 90 days of product dosing, average serum testosterone levels for patients involved in the study were within FDA efficacy guidance for a testosterone replacement therapy. The Company's and external expert analysis of the Phase III clinical trial efficacy data is based on results from 306 patients who participated in the study. Safety data observed to this point is consistent with other testosterone therapies and no drug-related serious adverse events have been observed or reported. As originally agreed with the FDA, Trimel is collecting additional nasal safety data on patients who will have been administered CompleoTRT™ for up to 360 days as part of the NDA submission. Trimel expects to complete this in Q1 2013 and subsequently file the NDA with the FDA in an expeditious fashion.

CompleoTRT™'s unique intranasal no-touch delivery system is designed to provide patients with the therapeutic effect of supplementing testosterone levels with a small amount of drug as a bioadhesive intranasal gel.

According to IMS Health, nearly 5.8 million testosterone prescriptions were written in the first ten months of 2012, reflecting growth of 34% over the same period in 2011. This represents an acceleration of prescription growth rates as awareness of this medical condition by physicians and patients has increased.

Bruce D. Brydon, Chairman and CEO of Trimel, offered the following comment: "We believe that the results which we have announced today fully demonstrate that CompleoTRT™ can deliver testosterone effectively without the risk of transference and the use of time consuming and inelegant gel applications to various sites on the male body. Furthermore, study data to date demonstrates that the intranasal route of administration, and the pharmacokinetic profile which results, is safe, effective and fully differentiated from currently marketed testosterone products. Your company has accomplished much in its four year history, and I wish to thank our shareholders in helping us achieve this key milestone. We look forward to continuing to execute on our business plan in 2013."

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 bioadhesive 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". 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.

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 bioadhesive intranasal testosterone gel that has completed Phase III clinical efficacy 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.

For further information regarding Trimel Pharmaceuticals Corporation, please contact either Bruce Brydon, Chairman of the Board and Chief Executive Officer at (416) 679-0711 or Kenneth Howling, Chief Financial Officer at (416) 679-0536 or via email at ir@trimelpharmaceuticals.com.

Notice regarding forward-looking statements:

This 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 release uses words such as "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 release is based in part, on 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 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. Actual results, performance or achievement could differ materially from that expressed in, or implied by; any forward-looking information in this 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 including applicable securities laws. 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 release.

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