Medicure Launches New Clinical Program
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WINNIPEG, MANITOBA, Jan 12 (MARKET WIRE) --
Medicure Inc. (TSX: MPH) is pleased to announce initiation of a clinical
program to investigate the efficacy and safety of Avastrem(TM) (pyridoxal
5'- phosphate) for the management of tardive dyskinesia. The Company will
provide details of the planned tardive dyskinesia study in humans in the
coming weeks.
Tardive dyskinesia (TD) is a socially stigmatizing and potentially
irreversible long-term disorder caused by treatment with antipsychotic
medications which are generally prescribed for conditions such as
schizophrenia and schizoaffective disorder. As a neurological disorder,
TD has been linked with poor quality of life and increased medical
morbidity and mortality. TD is characterized by repetitive, involuntary,
purposeless movements and may include grimacing, tongue protrusion, lip
smacking, puckering and pursing of lips, and rapid eye blinking. TD can
also lead to unintelligible speech, respiratory distress, postural
imbalance, and depression. Treatment of TD is challenging for the
clinician as dose reduction of the prescribed antipsychotic medication
may be accompanied by worsening of symptoms or psychotic relapse. Despite
extensive research, there are currently no FDA-approved drugs for TD
management.
"We have closely assessed several clinical opportunities for Avastrem's
application in the management of neurological disorders," commented
Albert D. Friesen, Medicure's President and CEO. "We decided to pursue
the TD opportunity due to the significant medical need, limited treatment
options, Avastrem's potential efficacy in this area and the feasibility
of a TD clinical program from a logistical and cost perspective."
Medicure's Avastrem contains the active metabolite of pyridoxine (vitamin
B6). Although not approved and subject to several limitations, pyridoxine
has demonstrated efficacy in the management of TD in a number of clinical
trials and case reports. Medicure believes that Avastrem could be
therapeutically superior to pyridoxine because it can be given at
significantly lower, more tolerable doses and does not display the
adverse side effects associated with pyridoxine. Extensive clinical and
preclinical studies conducted by Medicure have established Avastrem's
pharmacokinetics and its exceptional safety profile. Medicure holds
intellectual property relating to Avastrem including its formulation and
use in TD.
Dr. Friesen noted that, "While Medicure's primary focus remains the
continued growth of AGGRASTAT(R) sales through its US marketing
subsidiary, Medicure Pharma, the Company is exploring potential clinical
applications of its lead compounds in a prudent and cost-effective
manner."
About Medicure Inc.
Medicure Inc is a biopharmaceutical company focused on the research,
development and commercialization of novel small molecules to treat
cardiovascular and neurological disorders. The Company's primary business
activity is the marketing and distribution of AGGRASTAT(R) (tirofiban
hydrochloride) in the United States for acute coronary syndromes.
This press release contains forward-looking statements, as defined under
applicable securities legislation, that involve risks, which may cause
actual results to differ materially from the statements made, and
accordingly may be deemed to be forward-looking statements made pursuant
to the safe harbor provisions of the Private Securities Litigation Reform
Act of 1995. The forward-looking statements are made as of the date
hereof, and the Company disclaims any intention and has no obligation or
responsibility to update or revise any forward-looking statements,
whether as a result of new information, future events, or otherwise
except as required by law. Such forward-looking statements involve known
and unknown risks, uncertainties and other factors that may cause the
actual results, events or developments to be materially different from
any future results, events or developments expressed or implied by such
forward-looking statements. Such factors include, among others, the
Company's stage of development, lack of product revenues, additional
capital requirements, risks associated with the completion of clinical
trials and obtaining regulatory approval to market the Company's
products, the ability to protect its intellectual property, dependence on
collaborative partners and the ability to meet its debt obligations.
These factors should be considered carefully and readers are cautioned
not to place undue reliance on such forward-looking statements.
Additional risks and uncertainties relating to the Company and its
business can be found in the "Risk Factors" section of its Form 20F for
the year ended May 31, 2008.
Contacts:
Medicure Inc.
Albert D. Friesen, Ph.D.
President & CEO
1-888-435-2220
(204) 488-9823 (FAX)
Email: info@medicure.com
Website: www.medicure.com
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