Trimel Receives FDA Approval for Natesto(TM) Nasal Gel to Treat Men with Low Testosterone

TORONTO, May 28, 2014 /PRNewswire/ -- Trimel Pharmaceuticals Corporation (TSX: TRL) announced today that the United States Food and Drug Administration (FDA) has approved Natesto™ (testosterone), formerly CompleoTRT™, the first and only testosterone nasal gel for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Natesto™ is self-administered via a nasal applicator thereby minimizing the risk of secondary exposure to testosterone of women or children.

"In my practice I regularly encounter men demonstrating symptoms of hypogonadism and physicians will increasingly see this as the North American population ages," said Dr. Jeffrey Rosen, the medical director and founder of Clinical Research of South Florida (CRSA). "For these patients seeking to restore their testosterone levels, Natesto™ will offer an alternative delivery system that is safer and more convenient than the other options currently available on the market."

It is conservatively estimated that nearly 13 million American men may have low testosterone levels.  Current treatment guidelines focus on the restoration of the physiological testosterone level through the use of exogenous testosterone preparations, which include topical gels applied by the hands, subcutaneous pellets, transdermal patches, intramuscular injections, oral tablets, as well as a buccal patch.

"The FDA approval for Natesto™ is a major achievement for our company, as it validates our clinical research and development efforts, as well as reinforces our commitment to provide innovative treatment options for patients," said Tom Rossi, Trimel Pharmaceuticals Corporation President and CEO. "Men suffering from "Low T" will now have a different option to raise their testosterone levels.  This novel route of administration will enable men to take this therapy in mere seconds, without worrying about the risk associated with transferring the product to women or children.  We are now focused on getting Natesto™ to market as expeditiously as possible so that appropriate patients can have access to it."

About Male Hypogonadism

Male hypogonadism, or low testosterone, is a condition in which the testicles, hypothalamus or pituitary gland is affected by disease or damage that results in inhibiting hormone and testosterone secretion. Signs and symptoms associated with male hypogonadism include erectile dysfunction and decreased sexual desire, fatigue and loss of energy, depressed mood, osteoporosis and regression of secondary sexual characteristics.

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™
• Edema with or without congestive heart failure (CHF) may be a complication in patients with preexisting cardiac, renal, or hepatic disease
• Exogenous administration of androgens may lead to azoospermia
• 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 the Natesto™ Phase III Study

Natesto™ was evaluated in a multicenter, open-label, 90-day Phase III trial that enrolled 306 hypogonadal men at 39 clinical research centers in the United States. The mean age of patients was 54 years with a range of 28 to 80 years. Of the 306 patients, 271 (89%) were Caucasian, 18 (6%) were African-American, 16 (5%) were Asian, and 1 (less than 1%) had race recorded as "Other." Patients were instructed to administer Natesto™ intranasally. During the Natesto™ treatment period (Days 1 to 90), 78 patients were treated with 33 mg of testosterone daily.  Of these, a total of 73 men were included in the statistical evaluation of efficacy on Day 90 based on the intent-to-treat (ITT) population with last observation carried forward (LOCF).  Ninety percent (90%) of these patients had C_avg within the normal range (300 to 1050 ng/dL) on Day 90.  The percentage of patients with C_avg below the normal range (less than 300 ng/dL) on Day 90 was 10% and no subject had a C_avg value exceeding 1050 ng/dL.

About Trimel

Trimel is a specialty pharmaceutical company actively developing medications for male hypogonadism, female sexual dysfunction and various respiratory disorders. For more information, please visit www.trimelpharmaceuticals.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 the ability of the company to successfully commercialize 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.

SOURCE Trimel Pharmaceuticals Corporation