American Marconi Wireless News - Medicure Announces Completion of Enrollment in Its MEND-PNPO Phase 3 Clinical Trial

The MEND-PNPO study has successfully enrolled 10 patients, meeting the Company's enrollment objective. Patients enrolled in the study continue to progress through their respective treatment and follow-up periods, with several patients having already completed key study milestones.

PNPO deficiency is an ultra-rare inherited neurometabolic disorder caused by mutations in the PNPO gene, resulting in an inability to produce adequate levels of pyridoxal 5'-phosphate (P5P), the active form of vitamin B6. The condition commonly presents in newborns and infants with severe, difficult-to-control seizures and can lead to significant developmental impairment, neurological dysfunction, and death if untreated. Please note, MC-1 is not FDA-approved. The safety and effectiveness of MC-1 has not been established.

The U.S. Food and Drug Administration ("FDA") has granted both Rare Pediatric Disease Designation and Orphan Drug Designation to MC-1 for the treatment of seizures associated with PNPO deficiency. In addition, the European Medicines Agency ("EMA") has granted Orphan Drug Designation to MC-1 for the treatment of PNPO deficiency. Medicure has also received Fast Track Designation for MC-1 in PNPO deficiency, which is intended to facilitate the development and review of a future New Drug Application ("NDA") by the FDA.

Upon approval of an NDA for MC-1 in PNPO deficiency, Medicure is eligible to receive a Priority Review Voucher from the FDA, which may be redeemed or sold.

The Company presented the design and baseline data from the MEND-PNPO study at the European Epilepsy Congress (EEC) in Athens, Greece, earlier this year. The presentation was delivered by lead investigator Phillip Pearl, MD, Director of Epilepsy and Clinical Neurophysiology at Boston Children's Hospital and William G. Lennox Chair and Professor of Neurology at Harvard Medical School. It outlined the study design, primary and secondary endpoints, and MC-1 dosing regimen, along with baseline pyridoxal 5'-phosphate (P5P) levels in enrolled patients. The same data will be presented later this year at the Child Neurology Society (CNS) Annual Meeting in Montreal, Canada, and the American Epilepsy Society (AES) Annual Meeting in Denver, Colorado.

"The completion of enrollment in the MEND-PNPO study marks a major milestone for Medicure and for the PNPO deficiency community," said Albert D. Friesen, President, Chief Executive Officer of Medicure and Chair of its Board of Directors. "We are grateful to the patients, families, investigators, and study coordinators whose commitment made this achievement possible. Our focus now turns to completing patient follow-up and advancing MC-1 toward a potential NDA submission as we work to bring the first approved therapy for PNPO deficiency to patients in need."

About Medicure Inc.
Medicure is a company focused on the development and commercialization of pharmaceuticals and healthcare products for patients and prescribers in the United States market. The present focus of the Company is the marketing and distribution of AGGRASTAT^® (tirofiban hydrochloride) injection and ZYPITAMAG^® (pitavastatin) tablets in the United States, where they are sold through the Company's U.S. subsidiary, Medicure Pharma Inc. Medicure also operates Marley Drug Inc. ("Marley Drug"), a pharmacy subsidiary servicing all 50 states, Washington D.C. and Puerto Rico. Marley Drug^® is committed to improving access to medications for all Americans together with exceptional customer service and free home delivery. Medicure also operates Gateway Medical Pharmacy ("Gateway"), located in Portland, Oregon in a medical office building near major transportation lines and multiple healthcare clinics and centers. In addition to regular customers, the pharmacy services multiple long-term care facilities and provides non-sterile compounding services. Medicure also operates West Olympia Pharmacy ("West Olympia"), located in Olympia, Washington in a medical office complex near multiple clinics. For more information visit www.marleydrug.com. For more information about Medicure please visit www.medicure.com. For additional information about AGGRASTAT^®, please visit www.aggrastat.com or refer to the full Prescribing Information. For additional information about ZYPITAMAG^®, please visit www.zypitamag.com or refer to the full Prescribing Information.

To be added to Medicure's e-mail list, please visit:
http://medicure.mediaroom.com/alerts

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward Looking Information: Statements contained in this press release that are not statements of historical fact, including, without limitation, statements containing the words "believes", "may", "plans", "will", "estimates", "continues", "anticipates", "intends", "expects" and similar expressions, may constitute "forward-looking information" within the meaning of applicable Canadian and U.S. federal securities laws (such forward-looking information and forward-looking statements are hereinafter collectively referred to as "forward-looking statements"). Forward-looking statements, include estimates, analysis and opinions of management of the Company made in light of its experience and its perception of trends, current conditions and expected developments, as well as other factors which the Company believes to be relevant and reasonable in the circumstances. Inherent in forward-looking statements are known and unknown risks, uncertainties and other factors beyond the Company's ability to predict or control 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, and as such, readers are cautioned not to place undue reliance on forward-looking statements. Such risk factors include, among others, the Company's future product revenues, expected results, including future revenue from P5P, the filing of an NDA submission, the likelihood of approval of an NDA, the likelihood of receiving a priority review voucher from the United State Food and Drug Administration, expected future growth in revenues, stage of development, additional capital requirements, risks associated with the completion and timing of clinical trials and obtaining regulatory approval to market the 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 statements are based on a number of assumptions which may prove to be incorrect, including, but not limited to, assumptions about: general business and economic conditions; the impact of changes in Canadian-US dollar and other foreign exchange rates on the Company's revenues, costs and results; the 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 is not exhaustive. The Company undertakes no 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 current Form 20F.

AGGRASTAT^® (tirofiban hydrochloride) injection, ZYPITAMAG^® (pitavastatin) tablets, and Marley Drug^® are registered trademarks.

For more information, please contact:
Dr. Albert D. Friesen
Chief Executive Officer
Tel. 888-435-2220
Fax 204-488-9823
E-mail: [email protected]
www.medicure.com

SOURCE: Medicure, Inc.

View the original press release on ACCESS Newswire

A.Malone--AMWN