Trimel Pharmaceuticals Announces Natesto Abstract Presentation At The 2015 Endocrine Society Annual Meeting

TORONTO--(BUSINESS WIRE)--Trimel Pharmaceuticals Corporation (TSX:TRL) today announced that an abstract highlighting the Phase III study results and therapeutic potential of NATESTO™, a product utilizing Trimel's licensed nasal gel technology, was featured at the Endocrine Society 97th Annual Meeting in San Diego, California on Saturday, March 7, 2015.

The abstract, entitled A Novel Testosterone Nasal Gel Formulation Normalizes Androgen Levels in Hypogonadal Men, was presented by Alan D. Rogol, MD, Ph.D. Professor, Emeritus at the University of Virginia.

“NATESTO™ is a convenient and easy-to-use form of testosterone to treat adult male hypogonadism. The nasal applicator allows self-administration in a matter of seconds, while avoiding hand contact and incidental secondary exposure of testosterone to others,” said Dr. Rogol. “This first presentation of the pivotal clinical trial results – used to obtain FDA approval of NATESTO™ – is a significant step in communicating the benefits of this product to the specialist healthcare community.”

About the Phase III Study

NATESTO™ was evaluated in a one year, multicenter, randomized, open-label Phase III study, including potential dose titration. The study enrolled 306 hypogonadal men, with a mean age of 54 years (range 28-80 years). Patients were provided NATESTO™ and administered per instruction, with 228 patients and 78 patients treated with 22 mg and 33 mg of testosterone daily, respectively. At Day 90, 200/273 subjects (73%; 95% CI 68-79) in the intent-to-treat (ITT) population and 180/237 subjects (76%; 95% CI 71-81) in the per-protocol (PP) population were in the normal range. In the group treated only with 33 mg, ninety percent (90%) had average concentration (Cavg) within the normal range (300 to 1050 ng/dL) on Day 90; the percentage of patients with Cavg below the normal range (less than 300 ng/dL) on Day 90 was 10% and no subject had a Cavg value exceeding 1050 ng/dL. Statistically significant improvements from baseline were observed in erectile function and mood. The incidence of adverse events was low. The mean prostate-specific antigen (PSA) increase was low, consistent with low increases in dihydrotestosterone (DHT) and DHT/T levels. All of these findings are suggestive of an excellent safety profile. Therapy was well-tolerated and well-accepted. The study was entirely funded by Trimel BioPharma SRL.

About NATESTO™ (Testosterone) Nasal Gel

NATESTO™ (testosterone) nasal gel was approved for use in the United States by the Food and Drug Administration in May 2014. NATESTO™ is the first and only approved testosterone nasal gel in the United States for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. The commercial rights to NATESTO™ in the United States and Mexico have been licensed by Trimel to an affiliate of Endo International plc (NASDAQ:ENDP) (TSX:ENL).

For further information on NATESTO™ in the United States (including the product label and prescribing information), please see the FDA website at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm, or visit: www.NATESTO.com.

In January 2015, Trimel filed a New Drug Submission with Health Canada for NATESTO™, the first testosterone nasal gel filed in Canada for approval.

About Trimel

Trimel is a specialty pharmaceutical company involved in the sale, distribution and development of products with a focus in men's and women's health.

Trimel markets ESTRACE® in Canada, a product indicated for the symptomatic relief of menopausal symptoms. NATESTO™, a product utilizing Trimel's licensed nasal gel technology, is the first testosterone nasal gel filed in Canada for approval, and is the first and only approved testosterone nasal gel in the United States for replacement therapy in adult males diagnosed with hypogonadism. The commercial rights to NATESTO™ in the United States and Mexico have been licensed by Trimel to an affiliate of Endo International plc.

For more information, please visit www.trimelpharmaceuticals.com.

Contacts

Trimel Pharmaceuticals
Tiana DiMichele, 416-679-0822
tdimichele@trimelpharmaceuticals.com

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