Natesto™ is the first nasal testosterone replacement therapy approved by
FDA

TORONTO, May 28, 2014 /CNW/ – 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

Image with caption: “Natesto Testosterone Nasal Gel (CNW Group/Trimel Pharmaceuticals Corporation)”. Image available at: http://photos.newswire.ca/images/download/20140528_C7379_PHOTO_EN_40870.jpg