WINNIPEG, MB / ACCESSWIRE / November 23, 2023 / Medicure Inc. ('Medicure' or the 'Company') (TSXV:MPH)(OTC PINK:MCUJF), a company focused on the development and commercialization of pharmaceuticals and healthcare products for patients and prescribers in the United States market, today announced that the FDA provides complete approval to enroll patients in its pivotal Phase 3 clinical trial to evaluate the use of its investigational product MC-1 for treatment of a rare pediatric disease called pyridox(am)ine 5′-phosphate oxidase (PNPO) deficiency.

温尼伯，MB/ACCESSWIRE/2023年11月23日/Medicure Inc.（'Medicure'或'公司'）（TSXV:MPH）（OTC PINK:MCUJF），一家专注于制药和医疗保健产品开发和商业化的公司为美国市场上的患者和处方者提供服务，今天宣布，FDA完全批准将患者纳入其关键的3期临床试验，以评估其研究产品MC-1用于治疗一种罕见的儿科疾病，称为吡哆醇（am）ine 5′-磷酸氧化酶（PNPO）缺乏症。

The study involves approximately 10 patients at sites in the United States and Australia, and the Company is seeking marketing approval initially in those countries..

该研究涉及美国和澳大利亚约10名患者，该公司最初正在这些国家寻求营销批准。。

The U.S. Food and Drug Administration ('FDA') has granted both Orphan Drug Designation and Rare Pediatric Disease Designation to MC-1 for the treatment of seizures associated with PNPO deficiency. Additionally, the European Medicines Agency ('EMA') has granted Orphan Drug Designation to MC-1 for the treatment of PNPO deficiency..

美国食品药品监督管理局（FDA）已向MC-1授予孤儿药名称和罕见儿科疾病名称，以治疗与PNPO缺乏症相关的癫痫发作。此外，欧洲药品管理局（EMA）已授予MC-1孤儿药名称，用于治疗PNPO缺乏症。。

Under the Food and Drug Administration Safety and Innovation Act (FDASIA) passed into federal law in 2012, the FDA grants a Rare Pediatric Disease Designation for serious and life-threatening diseases in which the serious or life-threatening manifestations primarily affect individuals from birth to 18 years of age, with a prevalence of less than 200,000 people in the United States.

根据2012年通过联邦法律的食品和药物管理局安全与创新法案（FDASA），FDA为严重和危及生命的疾病授予罕见的儿科疾病名称，其中严重或危及生命的表现主要影响出生至18岁，在美国患病率不到20万人。

If a new drug application ('NDA') for MC-1 for patients with PNPO deficiency is approved, the Company may be eligible to receive a priority review voucher ('PRV') from the FDA, which can be redeemed to obtain priority review for any subsequent marketing application..

如果针对PNPO缺乏症患者的MC-1新药申请（'NDA'）获得批准，该公司可能有资格从FDA获得优先审核凭证（'PRV'），可以赎回以获得优先权任何后续营销申请的审查。。

'MC-1 has the potential to become the first FDA-approved therapy for patients with PNPO deficiency. We sincerely thank all of the clinicians, patients and their families for participating in this study.' said Dr. Albert D. Friesen, CEO of Medicure and Chair of its Board of Directors.

'MC-1有可能成为FDA批准的PNPO缺乏症患者的首个疗法。我们衷心感谢所有临床医生，患者及其家属参加本研究。”Medicure首席执行官兼董事会主席Albert D.Friesen博士说。

About Medicure Inc.

关于Medicure Inc。

Medicure is a pharmaceutical company focused on the development and commercialization of therapies for the U.S. cardiovascular 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.

Medicure是一家专注于美国心血管市场治疗的开发和商业化的制药公司。本公司目前的重点是在美国销售和销售AGGRASTAT®（盐酸替罗非班）注射液和ZYPITAMAG®（匹伐他汀）片剂，并通过公司的美国销售。

subsidiary, Medicure Pharma Inc. Medicure also operates Marley Drug, Inc. ('Marley Drug'), a pharmacy located in North Carolina that offers an Extended Supply drug program serving all 50 states, Washington D.C. and Puerto Rico. Marley Drug® is committed to improving the health status of its patients and the communities they serve while reducing overall health care costs for employers and other health care consumers.

子公司Medicure Pharma Inc.Medicure还运营Marley Drug，Inc.（'Marley Drug'），这是一家位于北卡罗来纳州的药房，为华盛顿特区和波多黎各的所有50个州提供扩展供应药物计划。Marley-Drug®致力于改善患者及其所服务社区的健康状况，同时降低雇主和其他医疗保健消费者的整体医疗保健成本。

For more information visit www.marleydrug.com. To learn more about The Extended Supply Generic Drug Program call 800.286.6781 or email info@marleydrug.com.For more information on Medicure please visit www.medicure.com. For additional information about AGGRASTAT®, please visit www.aggrastathdb.com or refer to the full Prescribing Information.

欲了解更多信息，请访问www.marleydrug.com。了解有关扩展供应仿制药计划的更多信息，请致电800.286.6781或发送电子邮件info@marleydrug.com.For有关Medicure的更多信息，请访问www.Medicure.com。有关AGGRASTAT®的更多信息，请访问www.aggrastathdb.com或参考完整的处方信息。

For additional information about ZYPITAMAG®, please visit www.zypitamag.com or refer to the full Prescribing Information..

有关ZYPITAMAG®的更多信息，请访问www.ZYPITAMAG.com或参考完整的处方信息。。

To receive investor and business updates from Medicure, please fill out this form click here to be added to Medicure's e-mail list.

要收到Medicure的投资者和业务更新，请填写此表格-点击此处将其添加到Medicure的电子邮件列表中。

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.

TSX Venture Exchange及其监管服务提供商（如TSX Venture Exchange的政策中所定义）均不对本版本的充分性或准确性承担责任。

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.

前瞻性信息：本新闻稿中包含的不是历史事实陈述的陈述，包括但不限于包含“相信”，“可能”，“计划”，“将会”，“估计”，“继续”，“预期”，“意图”，“期望”和类似表达，可能在适用的加拿大和美国的含义内构成“前瞻性信息”。

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.

联邦证券法（此类前瞻性信息和前瞻性声明在下文中统称为“前瞻性声明”）。前瞻性陈述包括根据公司的经验及其对趋势，现状和预期发展的看法以及公司认为相关合理的其他因素对公司管理层的估计，分析和意见。情况。

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.

前瞻性陈述中固有的已知和未知风险，不确定性和超出公司预测或控制能力的其他因素可能导致实际结果，事件或开发与任何未来结果，事件或开发表达或暗示的重大差异由这些前瞻性陈述，因此，提醒读者不要过分依赖前瞻性陈述。

Such risk factors include, among others, the Company's future product revenues, expected results, including future revenue from P5P, 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 i.

这些风险因素包括公司未来的产品收入，预期结果，包括P5P的未来收入，从美国食品和药物管理局获得优先审核凭证的可能性，预期的未来收入增长，发展阶段，额外资本要求，与临床试验的完成和时间安排以及获得监管部门批准销售公司产品相关的风险，保护其产品的能力。

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

AGGRASTAT®（盐酸替罗非班）注射液，ZYPITAMAG®（匹伐他汀）片剂和Marley Drug®是注册商标。

For more information, please contact:

欲了解更多信息，请联系：

Dr. Albert D. Friesen

Albert D.Friesen博士

Chief Executive Officer

首席执行官

Tel. 888-435-2220

电话888-435-2220

Fax 204-488-9823

传真204-488-9823

E-mail: info@medicure.com

电子邮件：info@medicure.com

www.medicure.com

www.medicure.com

SOURCE: Medicure, Inc.

来源：Medicure，Inc。

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https://www.accesswire.com/809592/medicure-announces-fda-provides-complete-approval-to-enroll-patients-in-its-pivotal-phase-3-trial-for-treatment-of-rare-pediatric-disease

https://www.accesswire.com/809592/medicure-announces-fda-provides-complete-approval-to-enroll-patients-in-its-pivotal-phase-3-trial-for-treatment-of-rare-pediatric-disease