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MEDICURE PROVIDES UPDATE ON TEND-TD PHASE II
CLINICAL TRIAL
Expands Enrollment with Addition of Trial Site
in India
WINNIPEG, Manitoba - (January 23, 2012) Medicure
Inc. ("Medicure" or the
"Company") (TSXV: MPH, OTC: MCUJ.PK) is
pleased to provide an update and announce the
addition of a site in India for its ongoing Phase
II Clinical Trial, TardoxalTM for the Treatment of
Tardive Dyskinesia (TEND-TD). The company has
received approval from the Drug Controller General
of India and anticipates enrollment in India to
begin in February 2012. The trial is approved in
the United States, by the Food and Drug
Administration (FDA), and in Canada, by Health
Canada, where sites are actively recruiting
patients.
The addition of the new trial site (Schizophrenia
Research Foundation, Chennai, India) is expected to
increase the rate of enrollment. Current enrollment
is at 29 patients, with 40 total patients needed
for a planned interim analysis. Results from the
interim analysis are expected in summer 2012. For a
complete list of study sites, please refer to the
TEND-TD page on the Medicure website.
"TD remains a significant concern when treating
patients with schizophrenia, even with the newer
antipsychotics. I am pleased that our facility is
participating in this exciting research, and look
forward to the interim results," commented Dr. Gary
Remington, Director of the Medication Assessment
Clinic, Schizophrenia Program, Centre for Addiction
and Mental Health; Professor and Schizophrenia
Head, Division of Brain and Therapeutics,
Department of Psychiatry, University of Toronto;
and, principal investigator of the Phase II
study.
The Company is also pleased to report that it has
received FDA Fast Track designation for the
clinical investigation of Tardoxal for the
treatment of moderate to severe TD. Fast Track
designation is designed to facilitate the
development and expedite the review of new drugs
that are intended to treat serious or
life-threatening conditions and that demonstrate
the potential to address unmet medical needs."
About TEND-TD
This 12-week, randomized, double-blind,
placebo-controlled, parallel group comparative
study will evaluate the safety and efficacy of
Tardoxal in the treatment of TD, a common side
effect of antipsychotic medications which are used
to treat schizophrenia and schizoaffective
disorders. Approximately 4 million people in the
United States receive antipsychotic drugs of which
approximately 5 to 20% have TD. The primary
objective of the Phase II study is to assess the
beneficial effect of Tardoxal on the reduction of
expressed symptoms of TD compared to placebo.
TEND-TD is conducted by Medicure's subsidiary,
Medicure International, Inc. Further study
information is available at:
About 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.
The condition 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. Management 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 the management or treatment
of TD.
About Tardoxal™
Tardoxal is a naturally occurring, small molecule
drug that may have the potential to provide a safe
and effective approach to treating patients with
TD. Medicure owns intellectual property relating to
Tardoxal including its formulation and use in TD.
Tardoxal is an experimental drug and has not been
approved for commercial use by regulatory bodies
such as the FDA or Health Canada.
About Medicure Inc.
Medicure is a specialty pharmaceutical company
focused on the development and commercialization of
novel small molecule therapeutics. The primary
focus of the Company and its subsidiaries is the
marketing and distribution of AGGRASTAT® (tirofiban
HCl) for acute coronary syndromes in the United
States, where it is sold through the Company's US
subsidiary, Medicure Pharma, Inc. For more
information on Medicure please visit .
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factors include, among others, the Company's future
product revenues, stage of development, additional
capital requirements, risks associated with the
completion and timing of clinical trials and
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Company's products, the ability to protect its
intellectual property, dependence upon
collaborative partners, changes in government
regulation or regulatory approval processes, and
rapid technological change in the industry. Such
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timing of the receipt of regulatory and
governmental approvals for the Company's research
and development projects; the availability of
financing for the Company's commercial operations
and/or research and development projects, or the
availability of financing on reasonable terms;
results of current and future clinical trials; the
uncertainties associated with the acceptance and
demand for new products and market competition. The
foregoing list of important factors and assumptions
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obligation to update publicly or otherwise revise
any forward-looking statements or the foregoing
list of factors, other than as may be required by
applicable legislation. Additional discussion
regarding the risks and uncertainties relating to
the Company and its business can be found in the
Company's other filings with the applicable
Canadian securities regulatory authorities or the
US Securities and Exchange Commission, and in the
"Risk Factors" section of its Form 20F for the year
ended May 31, 2010.
For more information, please contact:
Dawson Reimer
President & COO
Tel. 888-435-2220
Fax 204-488-9823
E-mail: info@medicure.com
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