Trimel Pharmaceuticals Corporation
TSX : TRL

Trimel Pharmaceuticals Corporation

December 09, 2014 07:00 ET

Trimel Announces Closing of Exclusive Agreement for NATESTO™

U.S. Commercial Launch Planned for Q1 2015

TORONTO, ONTARIO--(Marketwired - Dec. 9, 2014) - Trimel Pharmaceuticals Corporation (TSX:TRL) today announced the closing of the previously communicated agreement between its subsidiary, Trimel BioPharma SRL, and an affiliate of Endo International plc (NASDAQ:ENDP)(TSX:ENL), of which Endo has been granted the exclusive rights to market NATESTO™ in the United States and Mexico. Trimel has received an upfront payment of US$25 million on closing of the transaction, together with a US$5 million prepaid inventory deposit.

NATESTO™ is the first and only FDA-approved testosterone nasal gel for replacement therapy in adult males diagnosed with hypogonadism, which further expands Endo's Branded Pharmaceutical Men's Health portfolio. Endo intends to launch the product in the U.S., through its Endo Pharmaceuticals subsidiary, in the first quarter of 2015.

"We are delighted to complete this agreement for NATESTO™ with Endo before the end of 2014," said Tom Rossi, President and CEO of Trimel. "We look forward to working with Endo to support the U.S. launch early next year."

About NATESTO™ (testosterone) Nasal Gel

Indications and Usage

NATESTO™ is an androgen indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone including:

  • Primary hypogonadism (congenital or acquired)
  • Hypogonadotropic hypogonadism (congenital or acquired)

Limitations of Use

Safety and efficacy of NATESTO™ in males less than 18 years old have not been established.

Dosage

NATESTO™ for intranasal use is available as a metered-dose pump. One pump actuation delivers 5.5 mg of testosterone. The recommended dose of NATESTO™ is 11 mg of testosterone (two pump actuations, one per nostril), applied intranasally three times daily for a total daily dose of 33 mg.

Contraindications

  • Men with carcinoma of the breast or known or suspected prostate cancer
  • Pregnant or breast-feeding women. Testosterone may cause fetal harm

Warnings and Precautions

  • Nasal adverse reactions: nasal signs and symptoms should be monitored. NATESTO™ is not recommended for use in patients with chronic nasal conditions or alterations in nasal anatomy
  • Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH
  • Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients using testosterone products. Evaluate patients with signs or symptoms consistent with DVT or PE
  • Women and children should not use NATESTO™
  • Exogenous administration of androgens may lead to azoospermia
  • Edema with or without congestive heart failure (CHF) may be a complication in patients with pre-existing cardiac, renal, or hepatic disease
  • Sleep apnea may occur in those with risk factors
  • Monitor serum testosterone, prostate-specific antigen (PSA), hemoglobin, hematocrit, liver function tests, and lipid concentrations periodically

Adverse Reactions

The most common adverse reactions (incidence ≥3%) to NATESTO™ observed in clinical trials were an increase in prostate specific antigen (PSA), headache, rhinorrhea, epistaxis, nasal discomfort, nasopharyngitis, bronchitis, upper respiratory tract infection, sinusitis and nasal scab.

About Trimel

Trimel is a specialty pharmaceutical company involved in the sale, distribution, and development of products with a focus in men's health, women's health, and respiratory medicine. NATESTO™, a product utilizing Trimel's licensed nasal gel technology, has been approved for sale in the United States by the FDA and is licensed to an affiliate of Endo International plc for commercialization. For more information, please visit www.trimelpharmaceuticals.com.

About Endo

Endo International plc is a global specialty healthcare company focused on improving patients' lives while creating shareholder value. Endo develops, manufactures, markets, and distributes quality branded pharmaceutical, generic pharmaceutical, over the counter medications and medical device products through its operating companies. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA. Learn more at www.endo.com.

Notice regarding forward-looking statements:

Information in this press release that is not current or historical factual information may constitute forward looking information within the meaning of securities laws. Implicit in this information are assumptions regarding our future operational results. These assumptions, although considered reasonable by the company at the time of preparation, may prove to be incorrect. Readers are cautioned that actual performance of the company is subject to a number of risks and uncertainties, including with respect to the performance of NATESTO™ and could differ materially from what is currently expected as set out above. For more exhaustive information on these risks and uncertainties you should refer to our annual information form dated March 5, 2014 which is available at www.sedar.com. Forward-looking information contained in this press release is based on our current estimates, expectations and projections, which we believe are reasonable as of the current date. You should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While we may elect to, we are under no obligation and do not undertake to update this information at any particular time, whether as a result of new information, future events or otherwise, except as required by applicable securities law.

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