- Testosterone Phase II(b) Clinical Trial Nearing Completion
- Acquisition of Second Technology Platform
- Private Placement Recently Closed
TORONTO,Feb. 10 /PRNewswire/ - Trimel BioPharma Holdings Inc. is today providing an update on a number of operational items that have contributed significantly to advancing the Company and achieving its initial objectives. Trimel
Testosterone Phase II(b) Clinical Trial Nearing Completion
Trimel BioPharma Holdings Inc. is developing a product to treat male hypogonadism (or "Low T"). Hypogonadism is a biochemical syndrome characterized by a deficiency in serum testosterone that can be either acquired or inherited and seriously affects the quality of life for those afflicted with the syndrome. Trimel's developmental product for hypogonadism is delivered utilizing a Bio-Adhesive Gel Nasal Deposit System. This unique delivery systems avoids transference issues that are associated with the current topical gel therapies and provides portability which is a significantly more convenient dosing regime versus most other products currently available in the marketplace.
Trimel's hypogonadism product, Compleo - which in Latin means "to bring man up to strength", is being developed initially for the North American and European markets. Sales of currently available treatments for hypogonadism in North America approximate $1 billion, where the estimated treatment ratio is only 10% of those afflicted, and the European market is approximately half the size the North American market.
Earlier this quarter, the ongoing Phase II(b) clinical trial for Compleo closed its input screening and it is expected that all subjects will complete dosing by the end of the quarter. No serious Adverse Events have been reported and early data indicates that the product is efficacious and meets the Food and Drug Administration's (FDA) clinical endpoints.
Trimel has exclusive rights to employ the Bio-Adhesive Gel Nasal Deposit System in four specific treatment areas including testosterone for males (above), in the Female Sexual Dysfunction therapeutic class where statistics reveal that 43% of women between the age of 18 and 59 suffer from various symptoms, for Parkinsonism and for an anxiety agent for the treatment of acute panic breakthrough disorder.
Second Technology Platform Acquired
In December of 2009, Trimel successfully acquired through the complete asset purchase of enabling technologies from Direct Haler A/S, a privately held Danish company. These technologies received the European Drug Delivery Devices Product Differentiation Innovation of the Year Award from Frost Sullivan for 2009. These technologies are focused on the delivery of pharmaceutical compounds through pulmonary inhalation and nasal dispersion systems that utilize unique patented dosing technologies. These technologies are applicable to numerous pharmaceutical compounds covering a wide variety of therapeutic classes.
These technologies provide patients with improved uptake of medication over current therapies. Key features of these technologies are: a) the Product dose is visible within the device and therefore patients can be assured that their required dose has been delivered; b) the dosage device is disposable and therefore there is no risk of re-infection; and c) the dose is deposited at the site of action which avoids many of the side effects associated with certain classes of drugs.
As part of the acquisition, Trimel has acquired three product candidates that are in clinical development. These product candidates are being developed to provide patients suffering from allergy or asthma with a unique treatment modality to dramatically improve their quality of life. Trimel is also exploring other product candidates in the areas of pain management and supportive cancer therapy.
Completion of Private Placement
Trimel recently completed an initial round of private equity financing. This financing was achieved through a limited offering that was only made available to Friends and Family and a very limited number of select exempt investors. The Company, through this offering, successfully raised over $4.5 million in new capital. Investors, including the Company's founder, have contributed approximately $18 million to the Company since inception, and this capital has enabled the Company to make the significant advancements as outlined above.
Trimel BioPharma Holdings Inc. is a privately held company focused on improving the utility of known pharmaceutical compounds by employing 21st century dosing technologies that are specifically designed to avoid first pass metabolism. These Localized Dosing Technologies (LDT) allow Trimel to precisely target the distribution of medication thereby circumventing the gastrointestinal tract and liver to improve patient outcomes and reduce side effects.
Trimel currently has three proprietary LDT platforms and is actively pursuing the development and application of these technologies with several high value high volume pharmaceutical compounds.
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Caution Regarding Forward-Looking Information and "Safe Harbor" Statement
All statements, other than statements of historical facts, made in this press release are forward-looking statements and may be forward-looking information in accordance with applicable securities laws (collectively, "forward-looking statements"). These forward-looking statements relate to, among other things, the Company's objectives, goals, strategies, beliefs, intentions, plans, estimates, and outlook, including, without limitation, statements concerning the following:
- the state of the Company's product pipeline; - the prospective benefits of product candidates in clinical development; - the number of subjects and timing of completion of dosing in respect of the ongoing Phase II(b) clinical trials for Compleo.
Forward-looking statements are identified by words such as "believe", "anticipate", "estimate", "expect", "intend", "plan", "expect", "project", "may" and "will" and other similar expressions. Although not all forward-looking statements contain these identifying words, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. Although the Company has indicated certain of these statements set out herein, all of the statements in this press release that contain forward-looking statements are qualified by these cautionary statements.
Although the Company believes that the expectations reflected in any forward-looking statements made in this press release are reasonable, actual results may differ materially from those expressed, or implied, in such statements. Such forward-looking statements are based on a number of assumptions which may prove to be incorrect, including, but not limited to assumptions regarding: the regulatory and legislative environment; general commercial risks; the ability of the Corporation to establish and maintain a market for the Company's products; market and consumer acceptance; operations; profitability; the Company's reliance on third parties; attraction and retention of key employees and consultants; competition; intellectual property; product development; availability of raw materials; inventory valuation, obsolescence and spoilage; health and safety risks; information; acquisition of companies, assets or technologies; availability of credit; investment, borrowing and interest rates; and liability insurance.
Important risks and factors that could cause actual results to differ materially from expectations include: (a) that the Company is a start-up business with no demonstrated history of profitable operations and accordingly (i) there is uncertainty regarding the ability of the Company to ever achieve, sustain or increase profitability, and (ii) there is no assurance the Company will be able to fund its operations with existing capital, or that it will be able to raise additional capital to fund operations; (b) the Company's dependence on, and ability to attract and retain, key personnel; (c) that the Company is under the control of a single controlling shareholder; (d) the cost of any future acquisitions and the ability to integrate any acquired businesses; (e) contractual disagreements and negotiations with third parties; (f) difficulties obtaining necessary approvals for development of products from the U.S. Food and Drug Administration, the Canadian Therapeutic Products Directorate or other regulatory authorities; (g) the results of continuing and future safety and efficacy studies by industry and government agencies; (h) uncertainties associated with the development, acquisition and launch of new products; (i) acceptance and demand for new pharmaceutical products; (j) the impact of competitive products and pricing; (k) the availability of raw materials and finished products; (l) the unpredictability of protection afforded by any patents or other intellectual and proprietary property; (m) any claims for infringement of the intellectual property rights of others; (n) potential product liability; (o) reliance on key strategic alliances; (p) the general regulatory environment; (q) tax rate assumptions; (r) the outcome of legal proceedings; and (s) fluctuating operating results. The Company cautions that the foregoing list of important factors that may affect future results is not exhaustive. The Company does not undertake to update or revise any forward-looking statements, except as may be required by law.
This press release shall not constitute an offer to sell, or a solicitation of an offer to buy, any securities, and no offering of securities is currently being made or is intended.
SOURCE Trimel BioPharma Holdings Inc.
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