FDA Office Of Orphan Products Development Designates Udenafil As An Orphan Drug For Use In Patients With A Single Functional Ventricle That Have Undergone Fontan Surgical Palliation

SEOUL, Korea, Sept. 8, 2015 /PRNewswire/ -- On September 1^st, 2015, the FDA Office of Orphan Products Development (OOPD) issued a letter designating udenafil as an orphan drug for use in patients with a single functional ventricle that have undergone Fontan surgical palliation.

Protocols for the pivotal Phase III trials in such patients are currently under special protocol review by FDA. Once that review process has been finalized, Mezzion Pharma will immediately proceed with a definitive multinational phase III efficacy and safety trial in conjunction with the Pediatric Heart Network (PHN), which is funded by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH).

Mezzion Pharma Chairman and CEO Mr. Dong Hyun Park stated, "We are delighted to receive this orphan drug designation for udenafil under which OOPD will actively assist our company in the development of this important new indication. That assistance will greatly benefit adolescent Fontan patients in the USA, who currently have few therapeutic options. The orphan drug designation will also potentially provide Mezzion Pharma with a seven year marketing exclusivity covering the use of udenafil in Fontan patients, a significant tax credit and a waiver of FDA regulatory filing fees for this indication."   

Mezzion Pharma Co. Ltd.

Mezzion Pharma is a publicly-listed biotech company in Korea focusing on the development of new drugs.

Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risk and uncertainties that may individually or mutually impact the matters herein described, including but not limited to FDA review and approval, product development and acceptance, manufacturing, competition, and/or other factors, which are outside the control of the Company.

Contact:
Mr. Won Geun KIM
Director
Tel: +82 2 560 8008
Email: [email protected]

SOURCE Mezzion Pharma Co. Ltd.

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