TORONTO, ONTARIO--(Marketwire - Oct. 15, 2012) - Trimel Pharmaceuticals Corporation (TSX:TRL) ("the "Company" or "Trimel") today announced progress on three of its product candidates:
CompleoTRT™ Phase III Efficacy Completed
The Company announced today that all patients have completed dosing of CompleoTRT™ for the efficacy portion of the Phase III clinical trial evaluating its lead product in patients with male hypogonadism or more commonly referred to as "Low T". The unique delivery of Compleo TRT™ is designed to provide hypogonadal men with the therapeutic effect of restoring testosterone levels while doing so with a micro volume amount of drug in the form of a bioadhesive intranasal gel. Efficacy results from the Phase III clinical trial are expected to be completed during the current quarter of 2012.
As previously announced on May 29, 2012, the preliminary review of early data from the Phase III trial demonstrated that patients treated with CompleoTRT™ achieved an average serum testosterone level that exceeds the threshold required by the FDA to confirm the efficacy of a testosterone replacement product.
The pivotal Phase III clinical trial is a randomized study in which patients are administered CompleoTRT™ and evaluated for efficacy after 90 days of treatment using the pharmacokinetic endpoint established for Low T therapies. The Phase III study in its entirety represents the final stage of product development prior to the submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for marketing approval in the United States.
Tefina™ - Phase II Ambulatory Trial Update
The Company has recently received clearance from the Therapeutic Goods Administration (TGA), Australia's regulatory body, and has initiated patient enrolment in Australia for the Tefina™ Phase II Ambulatory study exploring a "use-as-required" treatment for women experiencing Female Orgasmic Disorder ("FOD"), or more commonly referred to as anorgasmia. The portion of the study being conducted in the United States was initiated in May 2012 and is in the recruitment and dosing phase of the protocol.
FOD is defined as the persistent or recurrent delay in, or absence of, orgasm following a normal sexual excitement phase which can result in marked personal distress or interpersonal difficulties. FOD affects 1 in 5 women worldwide. Currently there are no approved FOD treatments therefore this condition represents a significant unmet need for women suffering distress from this condition.
The Company intends to enroll 240 patients in this Phase II study, with clinical sites in the United States, Canada and Australia.
The Tefina™ Ambulatory clinical study is a double-blinded, placebo-controlled, trial and will involve pre-menopausal women experiencing FOD. Patients in the study will receive Tefina™ or placebo at home instead of in a hospital setting. The primary efficacy endpoint of the Ambulatory trial will be the increase in the occurrence of orgasm over the treatment period compared against baseline levels. The Company expects to complete this study by mid-2013.
Trimel has entered into a letter of intent with a European-based development partner to co-develop single dose and fixed dose combinations of a portfolio of a number of established compounds for the treatment of a variety of respiratory disorders utilizing the Company's award-winning unit dose dry powder inhalation technology TriVair™. As part of this transaction, Trimel will gain rights to all know-how and intellectual property developed for territories outside of Europe, Russia and the Ukraine.
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. Trimel's research program to date has demonstrated that CompleoTRT™ is safe and effective, having recorded over 10,000 drug exposures in the studies conducted 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.
Trimel's product candidate Tefina™ is a bioadhesive 'no touch' intranasal low-dose gel formulation of testosterone. Tefina™ is being developed to offer women with female orgasmic disorder, a "use as required" treatment option. Tefina™ is expected to present an attractive safety profile, with virtually no androgen-related side effects such as acne, facial and body hair growth or deepening of the voice. Moreover, there is no expected risk of skin-to-skin transfer of testosterone to third parties with the multi-dose dispenser.
About Female Orgasmic Disorder ("Anorgasmia")
Female Orgasmic Disorder (FOD) is defined as the persistent or recurrent delay in, or absence of, orgasm following normal sexual excitement phase that causes marked personal distress or interpersonal difficulties. The etiology of FOD is often characterized by whether the dysfunction has been lifelong (primary) or acquired (secondary). This condition is estimated to affect one in five pre and post menopausal women worldwide. Currently there are no approved treatments for FOD and therefore represents an unmet need for women suffering distress from this condition.
In November 2009, Trimel acquired assets of Keldmann Healthcare A/S, which the Company rebranded as TriVair™. TriVair™ was the 2009 European Drug Delivery Devices Product Differentiation Innovation of the Year award-winning single unit dose dry powder inhalation drug delivery technology platform with applications for both nasal and pulmonary dosing. TriVair™ is designed to provide patients and their caregivers with immediate visual feedback to ensure that the dose has been accurately administered. Its technology avoids the issues associated with inhalation and actuation timing.
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 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.
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 firstname.lastname@example.org.
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 continue to 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.