Trimel Pharmaceuticals Corporation Announces First Quarter 2012 Financial Results and Provides Product Development Update
(firmenpresse) - TORONTO, ONTARIO -- (Marketwire) -- 05/08/12 -- Trimel Pharmaceuticals Corporation (TSX: TRL) ("Trimel or "the Company") today reported its financial results for the three month period ended March 31, 2012. The Company also provided investors today with an update on the status of its product development programs.
Management of the Company will host a conference call to discuss these results on Wednesday, May 9, 2012, at 8:30 a.m. Eastern Time. Presenting from Trimel will be Bruce Brydon, Chairman of the Board and Chief Executive Officer, Tom Rossi, President and Chief Operating Officer and Kenneth Howling, Chief Financial Officer.
To access the call live, please dial 416-340-2218 (Toronto), 1-866-226-1793 (Canada and U.S.), and 00-800-9559-6849 (International). Listeners are encouraged to dial in 10 minutes before the call begins to avoid delays.
A replay of the conference call will be available until 7:00 p.m. Eastern Time on Wednesday, May 16, 2012 by dialing 905-694-9451 (Toronto), 1-800-408-3053 (Canada and U.S.) or 00-800-3366-3052 (International), using access code: 7046128#.
Financial Results for the Three Months Ended March 31, 2012
For the three month period ended March 31, 2012, Trimel incurred Research and Development expenses ("R&D") of US$4.2 million as compared to US$1.9 million for the comparable 2011 period. The increase in R&D spending for the 2012 period relates primarily to the costs associated with the advancement of the CompleoTRT™ Phase III clinical trial.
Trimel incurred General and Administrative expenses of US$2.2 million for the three month period ended March 31, 2012 as compared to US$1.9 million for the comparable 2011 period. The increase in spending for the 2012 period as compared to spending levels for the same 2011 period was primarily attributable to the impact of headcount additions and an increase in related compensation expenses that occurred after March 31, 2011.
For the three month period ended March 31, 2012, the Company incurred a net loss of US$0.08 per share, as compared to US$0.09 per share for the comparable 2011 period.
As at March 31, 2012, the Company had total assets of US$17.6 million as compared to US$22.2 million at December 31, 2011 and total liabilities of US$5.6 million at March 31, 2012 as compared to US$4.3 million at December 31, 2011.
The information set out above is in summary form. Readers are encouraged to review the Company's annual information form, financial statements (and accompanying notes), together with management's discussion and analysis available on SEDAR at .
Annual General Meeting
Shareholders of record as of May 22, 2012 are invited to participate in the Company's annual general meeting on June 28, 2012. Proxy materials and meeting venue details will be provided shortly.
Product Development Update
CompleoTRT™ (Testosterone - Hypogonadism ("Low T"))
Phase III Update
CompleoTRT™, Trimel's most advanced product development program, entered Phase III clinical trials in September 2011. Patient recruitment continues as the Company moves toward an expected completion of study enrolment by the end of June. The Company has started compiling the documentation required for a new drug application ("NDA") for marketing authorization with the United States Food and Drug Administration ("FDA"), and expects to submit the NDA at the end of 2012 or in the first quarter of 2013.
Allergic Rhinitis / Drug-Drug Interaction Study
The Company announced in April 2012 the completion of the treatment phase of a special population study that will be included in the CompleoTRT™ NDA. The Allergic Rhinitis / Drug-Drug interaction ("AR/DD") study involves the assessment of CompleoTRT™'s relative bioavailability, safety and tolerability when administered to patients suffering from seasonal allergic rhinitis. Completed AR/DD study results are expected by the end of the second quarter of 2012, with the final report to be included in the CompleoTRT™ NDA.
Testosterone Market Dynamics - First Quarter 2012
According to IMS Health, nearly 1.6 million testosterone prescriptions were written in the first quarter of 2012, reflecting growth of 32.5% versus the same period in 2011. This represents an acceleration of prescription growth rates as physicians and patient awareness of this medical condition increases.
Tefina™ (Testosterone - Female Anorgasmia)
Tefina™- Phase II Vibrotactile Stimulation (VTS) Study results
On February 14th, 2012, the Company released clinical results from its recently reported Phase II study of Tefina™ in women experiencing anorgasmia. Anorgasmia 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. Tefina™ was studied in a hospital setting by employing the established VTS anorgasmia research model. Women experiencing primary or secondary anorgasmia were treated with a single dose of Tefina™ or a placebo, and then challenged with a VTS device designed to induce orgasm at different time points post dose. Patient reports, Vaginal Pulse Amplitude ("VPA") - a physiological measurement of blood flow in the vagina corresponding with engorgement of female genitalia, as well as clinically accepted patient questionnaires were used to measure the response.
Study analysis concluded that during the VTS treatment phase four women who were administered Tefina™ experienced orgasms, while an additional eight patients treated with Tefina™ were also determined to have experienced orgasms based on a post treatment assessment. Of the patients in the placebo arm, two patients reported experiencing orgasms during the VTS treatment however one patient seemed to have experienced an orgasm during the screening portion of the study and should have been excluded from proceeding into the treatment phase. Patients treated with Tefina™ also showed a statistically significant improvement in VPA versus placebo, and elevation of sexual arousal, as well as positive trends in terms of elevating sensuality and pleasurable genital sensation.
Tefina™ is expected to enter a multi-national Phase II trial in the second quarter of 2012. The current study design has an expected enrolment of 240 pre-menopausal women experiencing secondary anorgasmia and will be conducted as an ambulatory trial. As part of this double-blind placebo-controlled trial, patients will receive Tefina™ or a placebo at home instead of in a hospital setting. The primary efficacy end point of the ambulatory trial will be the increase in occurrence of orgasm over the treatment period compared against baseline levels. This upcoming clinical study will be one of the largest to ever explore a "use as required" treatment for women experiencing any form of anorgasmia.
Positive Pharmacokinetic Study Results
In March 2012, the Company announced positive results from the completion of a Pharmacokinetic ("PK") study investigating Tefina™. The Tefina™ PK study was designed to measure the levels of testosterone in the blood stream at prescribed time points post-administration, providing supportive evidence, as recommended by the FDA, related to the safety of the PK profile of Tefina™ from both single and multiple dose exposures in a cohort of healthy women.
Following the completion of the study where single and multiple dose administrations were given across three dosing levels, average levels of testosterone in the blood stream over a 24 hour period remained within the normal range. All women in the study also demonstrated a return to their starting testosterone blood levels (base-line) within 24 hours after the last administration of Tefina™.
The Company is fully engaged in discussions with strategic pharmaceutical companies relating to the commercialization of its lead products in North America and other international markets. The Company expects to conclude a transaction on a time value basis that proves most beneficial to shareholders.
Corporate Update
RBC Capital Markets Initiates Coverage
In April 2012, research analysts at RBC Capital Markets initiated coverage on Trimel's shares with an outperform speculative risk rating.
Mr. Tom Rossi appointed Chief Operating Officer
In March 2012, Mr. Rossi was appointed to the role of Chief Operating Officer in addition to his role as President. As Chief Operating Officer, Mr. Rossi is responsible for all of the daily operations of Trimel's business, reporting to the Chief Executive Officer.
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 bio-adhesive intranasal gel.
CompleoTRT™'s intranasal no-touch delivery system is designed to avoid the risk of accidental transfer (primary or 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 of the product in the second half of 2009, CompleoTRT™ has been optimized to meet FDA regulatory requirements, including the development of a product dispenser that is designed to ensure that CompleoTRT™ is dosed accurately and discretely. Trimel has now successfully manufactured over 60,000 multi-dose dispensers. Trimel's CompleoTRT™ clinical program, having previously demonstrated that CompleoTRT™ is safe and effective in a Phase II trial, has 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 the United States grew 24% in 2011 versus 2010 to now exceed $1.6 billion in annual sales volume.
About Tefina™
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 anorgasmia, 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 Anorgasmia
Female anorgasmia 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 anorgasmia is often characterized by whether the dysfunction has been lifelong (primary) or acquired (secondary). This condition affects 1 in 5 pre and post menopausal women worldwide. Currently there are no approved treatments for anorgasmia and therefore represents an unmet need for women suffering distress from this condition.
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 bio-adhesive 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 .
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 .
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.
Contacts:
Trimel Pharmaceuticals Corporation
Kenneth G. Howling
Chief Financial Officer
416 679 0536
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Datum: 08.05.2012 - 22:00 Uhr
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