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Trimel Reports Physician Market Research Results for CompleoTRT(TM)


Published on 2012-10-22 04:46:47 - Market Wire
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October 22, 2012 07:30 ET

Trimel Reports Physician Market Research Results for CompleoTRT™

Key research findings:

-- 87% of physicians surveyed indicated that they would likely prescribe CompleoTRT™

-- 77% of physicians surveyed felt that patients would not have issues using an intranasal testosterone product

-- Physicians surveyed with previous experience with the product indicated they would prescribe CompleoTRT™ to 36% of all of their Low T Patients and 45% of their newly diagnosed Low T patients

-- Overall, the 113 Physicians surveyed anticipated that CompleoTRT™ would be used in 18% of their Low T patients and 23% of their newly diagnosed Low T patients

-- The benefits of CompleoTRT™ most mentioned were safety (no or little risk of transference), ease of use and convenience

TORONTO, ONTARIO--(Marketwire - Oct. 22, 2012) - Trimel Pharmaceuticals Corporation (TSX:TRL) ("the "Company" or "Trimel") today announced positive results from a recently completed independent market research study on the reception by physicians of CompleoTRT™, Trimel's innovative 'no-touch' treatment for male hypogonadism, or more commonly referred to as "Low T". According to IMS Health, 2011 sales of marketed treatments for Low T were approximately $1.6 billion, and have been projected to reach $5 billion by 2017, according to a leading syndicated market research company.

The quantitative study conducted in the United States surveyed 113 physicians covering urologists, endocrinologists and primary care physicians that are well versed in treating Low T with currently marketed testosterone replacement therapies.

After reviewing a profile of CompleoTRT™, all physicians surveyed who had prior experience with CompleoTRT™ as part of the recently completed clinical development program indicated that they would likely prescribe CompleoTRT™ to their Low T patients. These physicians anticipated that they would use CompleoTRT™ to treat 36% of their Low T patients and 45% of all of their newly diagnosed Low T patients. Looking at the 113 respondents as a whole, 87% of the physicians surveyed indicated that they would initiate CompleoTRT™ therapy. Overall, the 113 Physicians surveyed anticipated that CompleoTRT™ would be used in 18% of their Low T patients and 23% of their newly diagnosed Low T patients.

When asked for their opinion on the acceptability of an intranasal treatment, 77 percent of the physicians responded that patients would not have an issue with using an intranasal product. The CompleoTRT™ benefits most mentioned by the respondents related to safety and the reduced risk of secondary transference of testosterone to women and young children, as well the ease of use and convenience of CompleoTRT™ administration.

Bruce D. Brydon, Chairman and Chief Executive Officer, offered the following comments: "These results obtained from the CompleoTRT™ physician market research speaks to the innovation of CompleoTRT™. If CompleoTRT™ is approved [by the US Food and Drug Administration] and becomes commercially available, we believe the study results suggest a meaningful potential penetration in the testosterone replacement market. As CompleoTRT™ is such a novel product, if approved, we believe physician prescribing and patient preference could be driven by the direct experience of Low T patients using the product."

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.

On October 15th 2012, Trimel announced the completion of enrolment and randomization of 304 patients in the Phase III clinical trial evaluating CompleoTRT™ in patients with male hypogonadism. Efficacy results from the Phase III clinical trial are expected to be available in the current quarter of 2012.

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 having completed enrolment and randomization in a Phase III clinical trial in the United States in July 2012. 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:

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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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