Trimel Announces Positive CompleoTRT(TM) Phase III Trial Results

Thu Dec 6, 2012 7:00am EST

* Reuters is not responsible for the content in this press release.

Trimel Pharmaceuticals Corporation (TSX:TRL) ("the Company" or "Trimel")
today announced that its Phase III pivotal clinical trial for
CompleoTRT(TM) has met its primary efficacy endpoints. Based on these
clinical results, Trimel will move forward to prepare for a meeting with
the FDA and continue the process of completing its New Drug Application
("NDA") for filing with the United States Food and Drug Administration

    The CompleoTRT(TM) Phase III clinical trial results demonstrated that
after 90 days of product dosing, average serum testosterone levels for
patients involved in the study were within FDA efficacy guidance for a
testosterone replacement therapy.  The Company's and external expert
analysis of the Phase III clinical trial efficacy data is based on
results from 306 patients who participated in the study. Safety data
observed to this point is consistent with other testosterone therapies
and no drug-related serious adverse events have been observed or
reported. As originally agreed with the FDA, Trimel is collecting
additional nasal safety data on patients who will have been administered
CompleoTRT(TM) for up to 360 days as part of the NDA submission. Trimel
expects to complete this in Q1 2013 and subsequently file the NDA with
the FDA in an expeditious fashion.

    CompleoTRT(TM)'s unique intranasal no-touch delivery system is designed
to provide patients with the therapeutic effect of supplementing
testosterone levels with a small amount of drug as a bioadhesive
intranasal gel.

    According to IMS Health, nearly 5.8 million testosterone prescriptions
were written in the first ten months of 2012, reflecting growth of 34%
over the same period in 2011. This represents an acceleration of
prescription growth rates as awareness of this medical condition by
physicians and patients has increased.

    Bruce D. Brydon, Chairman and CEO of Trimel, offered the following
comment: "We believe that the results which we have announced today fully
demonstrate that CompleoTRT(TM) can deliver testosterone effectively
without the risk of transference and the use of time consuming and
inelegant gel applications to various sites on the male body.
Furthermore, study data to date demonstrates that the intranasal route of
administration, and the pharmacokinetic profile which results, is safe,
effective and fully differentiated from currently marketed testosterone
products. Your company has accomplished much in its four year history,
and I wish to thank our shareholders in helping us achieve this key
milestone. We look forward to continuing to execute on our business plan
in 2013."

    About CompleoTRT(TM)

    CompleoTRT(TM) is designed to represent a significant advancement in the
treatment of male hypogonadism, or low testosterone - commonly known as
"Low T". CompleoTRT(TM)'s unique delivery technology is designed to
provide patients with the therapeutic effect of supplementing
testosterone levels while doing so with a small amount of drug in the
form of a bioadhesive intranasal gel.

    CompleoTRT(TM)'s intranasal no-touch delivery system is designed to avoid
the risk of accidental transfer (secondary transference) of testosterone
to spouses or other family members, thus offering unique patient benefits
and improved safety as compared to other currently marketed products
indicated to treat "Low T". Since Trimel took over development in May
2009, CompleoTRT(TM) has been optimized to meet FDA regulatory
requirements, including the development of a no-touch applicator device
that is designed to ensure that CompleoTRT(TM) is dosed accurately and

    About Hypogonadism ("Low T")

    Subject to FDA approval, Trimel's lead product candidate, CompleoTRT(TM),
would be indicated for the treatment of male hypogonadism or low
testosterone - commonly known as "Low T." Hypogonadism is a biochemical
syndrome characterized by a deficiency in serum testosterone levels that
can be either acquired or inherited, and seriously affects the quality of
life for those affected with the syndrome. Low testosterone is estimated
to affect 13 million men in the United States, of which an estimated 90%
go untreated. According to IMS Health, sales of marketed treatments for
low testosterone in North America grew 24% in 2011 versus 2010 to now
exceed $1.6 billion in annual sales volume.

    About Trimel

    Trimel Pharmaceuticals Corporation (TSX:TRL) - Developing medications for
Female Sexual Health and conditions related to Aging, and Well Being.
Trimel is developing multiple product opportunities, including
CompleoTRT(TM), a bioadhesive intranasal testosterone gel that has
completed Phase III clinical efficacy testing in the United States.
CompleoTRT(TM) is under investigation for the treatment of male
hypogonadism, a condition commonly referred to as "Low T". For more
information, please visit

    For further information regarding Trimel Pharmaceuticals Corporation,
please contact either Bruce Brydon, Chairman of the Board and Chief
Executive Officer at (416) 679-0711 or Kenneth Howling, Chief Financial
Officer at (416) 679-0536 or via email at

    Notice regarding forward-looking statements:

    This release contains forward-looking information. This forward-looking
information is not based on historical facts but rather on the
expectations of the Company's management regarding the future growth of
the Company and its respective results of operations, performance and
business prospects and opportunities. Forward-looking information may
include financial and other projections, as well as statements regarding
future plans, objectives or economic performance, or the assumptions
underlying any of the foregoing. This release uses words such as "will",
"expects", "anticipates", "intends", "estimates", or similar expressions
to identify forward-looking information. Such forward-looking information
reflects the current beliefs of the Company's management based on
information currently available to them.

    Forward-looking information included in this release is based in part, on
assumptions that may change, thus causing actual future results or
anticipated events to differ materially from those expressed or implied
in any forward-looking information. Such assumptions include that: the
Company will achieve, sustain or increase profitability, and will be able
to fund its operations with existing capital, and/or it will be able to
raise additional capital to fund operations; the Company will be able to
attract and retain key personnel; the Company will be able to acquire any
necessary technology or businesses and effectively integrate such
acquisitions; the Company will be successful in developing and clinically
testing products under development; the Company will be successful in
obtaining all necessary approvals for commercialization of its products
from the U.S. Food and Drug Administration, the Canadian Therapeutic
Products Directorate or other regulatory authorities; the results of
continuing and future safety and efficacy studies by industry and
government agencies relating to the Company's products will be
favourable; the Company's products will not be adversely impacted by
competitive products and pricing; raw materials and finished products
necessary for the Company's products will be available; the Company will
be able to maintain and enforce the protection afforded by any patents or
other intellectual property rights; the Company's products will be
successfully licensed to third parties to market and distribute such
products on favourable terms; the Company's key strategic alliances, out
licensing and partnering arrangements, now and in the future, will remain
in place and in force; the general regulatory environment will not change
in a manner adverse to the business of the Company; the tax treatment of
the Company and its subsidiaries will remain constant and the Company
will not become subject to any material legal proceedings. The Company
cautions that the foregoing list of assumptions is not exhaustive.

    Forward-looking information involves known and unknown risks,
uncertainties and other factors that may cause the actual results,
performance or achievements of the Company to differ materially from any
future results, performance or achievements expressed or implied by the
forward-looking information. Actual results, performance or achievement
could differ materially from that expressed in, or implied by; any
forward-looking information in this release, and, accordingly, investors
should not place undue reliance on any such forward-looking information.
Further, any forward-looking information speaks only as of the date on
which such statement is made and the Company undertakes no obligation to
update any forward-looking information to reflect the occurrence of
unanticipated events, except as required by law including applicable
securities laws. New factors emerge from time to time and the importance
of current factors may change from time to time and it is not possible
for management of the Company to predict all of such factors, changes in
such factors and to assess in advance the impact of each such factor on
the business of the Company or the extent to which any factor, or
combination of factors, may cause actual results to differ materially
from those contained in any forward-looking information contained in this

Trimel Pharmaceuticals Corporation
Kenneth G. Howling
Chief Financial Officer
416 679 0536

Trimel Pharmaceuticals Corporation
Bruce Brydon
Chairman of the Board and Chief Executive Officer
416 679 0711

Copyright 2012, Market Wire, All rights reserved.

Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.