Trimel Pharmaceuticals Corporation Announces FDA Acceptance of its Investigational New Drug Application for a Female Sexual Dysfunction Development Program
TORONTO, Aug. 2, 2011
TORONTO, Aug. 2, 2011 /CNW/ - Trimel Pharmaceuticals Corporation (TSX:TRL) today received acceptance from the Food and Drug Administration ("FDA") for its Investigational New Drug Application ("IND"), including the Company's initial U.S. study, for its bio-adhesive intranasal gel product development program, TBS-2. The Company's TBS-2 product is being developed to treat the subset indication of the female sexual dysfunction condition known as "Anorgasmia". Anorgasmia is the inability to achieve orgasm or an increased level of difficulty in achieving orgasm. Trimel Pharmaceuticals Corporation submitted the IND to the FDA in June of 2011.
Trimel is currently conducting a Phase II Vibrotactile Stimulation Study ("VTS") in conjunction with TBS-2. This study is designed to examine the ability of TBS-2 to induce orgasm in women who are diagnosed with primary or secondary Anorgasmia. Preliminary review of the VTS study data shows that positive results have been achieved to date. A previous Phase I / Phase II clinical study related to this product development program demonstrated an ability to deliver the medication (testosterone) without any negative side effects and the ability for the medication to clear the dose within the anticipated dosing range while demonstrating statistically significant downstream physiological effect.
Chairman of the Board and Chief Executive Officer Bruce Brydon commented, "The acceptance of Trimel's IND by the FDA for this particular study in female sexual dysfunction marks an important milestone for Trimel as well as the process of development of a product that can treat this unmet need in North America".
For further information regarding Trimel Pharmaceuticals Corporation, please contact either Bruce Brydon, 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.
Trimel Pharmaceuticals Corporation (TSX: TRL) is a leader in developing quality of life pharmaceuticals, targeting conditions related to Aging, Well Being and Female Sexual Health. Trimel is developing multiple product opportunities, including Compleo TRT, an intranasal bio-adhesive Testosterone gel for the treatment of male hypogonadism, a condition commonly referred to as "Low T". For more information, please visit www.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 Trimel Pharmaceuticals Corporation's ("TPC") management regarding the future growth of TPC, its 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 reflect the current beliefs of TPC'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: TPC 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; TPC will be able to attract and retain key personnel; TPC will be able to acquire any necessary technology or businesses and effectively integrate such acquisitions; TPC will be successful in developing and clinically testing products under development; TPC 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 TPC's products will be favourable; TPC's products will not be adversely impacted by competitive products and pricing; raw materials and finished products necessary for TPC's products will continue to be available; TPC will be able to maintain and enforce the protection afforded by any patents or other intellectual property rights; TPC's products will be successfully licensed to third parties to market and distribute such products on favourable terms; TPC'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 TPC; the tax treatment of TPC and its subsidiaries will remain constant and Trimel will not become subject to any material legal proceedings. TPC 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 TPC 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 TPC 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 TPC 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 TPC 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.
Kenneth G. Howling
Chief Financial Officer
416 679 0536
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