Trimel BioPharma Holdings updates business developments

Feb 10 2010

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 is now well positioned with multiple Localized Dosing Technology (LTD) platforms, a robust and rapidly advancing product pipeline, a dedicated facility to meet its clinical development and manufacturing requirements and has ready access to capital to meet its financial needs as it executes its Business Plan.

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.