WINNIPEG, MB / ACCESSWIRE / April 23, 2024 / 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, announced today that through its subsidiary, Medicure International Inc., the U.S.

温尼伯，MB/ACCESSWIRE/2024年4月23日/Medicure Inc.（“Medicure”或“公司”）（TSXV:MPH）（OTC粉红色：MCUJF），一家专注于为美国市场的患者和处方者开发和商业化药品和保健产品的公司，今天宣布通过其子公司Medicure International Inc.，美国。

Food and Drug Administration (FDA) has granted Fast Track designation for MC-1, an investigational product for the prevention or treatment of seizures associated with pyridox(am)ine 5'-phosphate oxidase (PNPO) deficiency. Fast Track designation is intended to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need..

美国食品和药物管理局（FDA）已授予MC-1快速通道名称，MC-1是一种用于预防或治疗与吡ido（am）ine 5'-磷酸氧化酶（PNPO）缺乏症相关的癫痫发作的研究产品。快速通道指定旨在促进治疗严重疾病并满足未满足医疗需求的药物的开发和加速审查。。

The designation was requested based on the potential for MC-1 to address an unmet medical need for PNPO deficiency, a serious and life-threatening condition. Medicure is in the launch phase of its Phase 3 clinical trial to treat approximately 10 PNPO deficient patients at sites in the U.S. and Australia with daily doses of MC-1..

根据MC-1解决PNPO缺乏症（一种严重且危及生命的疾病）的医疗需求未得到满足的潜力，要求进行指定。Medicure正处于其3期临床试验的启动阶段，该试验旨在用每日剂量的MC-1治疗美国和澳大利亚的大约10名PNPO缺陷患者。。

PNPO deficiency is a rare neurometabolic disorder, often leading to neonatal onset seizures that are resistant to other antiseizure medications, resulting in severe neurological dysfunction and ultimately death if untreated.

PNPO缺乏症是一种罕见的神经代谢疾病，通常会导致新生儿发作，对其他抗癫痫药物产生耐药性，导致严重的神经功能障碍，如果不治疗，最终会导致死亡。

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

FDA已授予MC-1罕见儿科疾病和孤儿药的名称，用于治疗与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。。

If a new drug application ('NDA') for MC-1 for patients with PNPO deficiency is approved, Medicure is eligible to receive a priority review voucher from the FDA, which can be redeemed or sold, and provides significant value.

如果批准了针对PNPO缺乏症患者的MC-1新药申请（“NDA”），Medicure有资格获得FDA的优先审查凭证，该凭证可以赎回或出售，并具有重要价值。

About Medicure Inc.

关于Medicure Inc。

Medicure is a pharmaceutical 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.

Medicure是一家制药公司，专注于为美国市场的患者和处方者开发和商业化药品和保健产品。该公司目前的重点是在美国营销和分销阿加司他®（盐酸替罗非班）注射液和ZYPITAMAG®（匹伐他汀）片剂，并通过该公司的美国销售。

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还经营Marley Drug，Inc.（“Marley Drug”），这是一家位于北卡罗来纳州的药店，提供扩展供应药物计划，服务于华盛顿特区和波多黎各的所有50个州。Marley Drug®致力于改善患者及其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。