Contact:
Mr. YT Song
Tel: +82 2 560 8011
Email: ytsong@mezzion.co.kr
Mezzion Pharma announces Top Line Data from FUEL will be presented at the American Heart Association (AHA), Late Breaking Scientific Sessions, in Philadelphia, PA, November 17, 2019
- There will be an off-site symposium event after the presentation of the Top Line Data on November 17th at The Union League
- Mezzion will host a FUEL Reception on November 17th at The Union League
- FUEL is the largest pediatric congenital heart disease drug trial ever conducted
- Udenafil has been granted Orphan Drug designation for treatment of SVHD post Fontan
SEOUL, Korea, Nov. 4, 2019 /PRNewswire/ -- Mezzion Pharma Co. Ltd. (140410: KOSDAQ) today announces that on Sunday, November 17, 2019, at 10:45 am EST, Dr. David Goldberg, Children’s Hospital of Philadelphia (“CHOP”), will present the results of Mezzion’s landmark FUEL Phase 3 Clinical Trial. The FUEL Trial was designed to evaluate the safety and efficacy of udenafil for the treatment of certain adolescents with congenital single ventricle heart disease (SVHD) who have undergone Fontan palliation. Dr. Goldberg’s presentation is scheduled at 10:45 am EST at the American Heart Association (“AHA”), Scientific Sessions, Late-Breaking Science, in Philadelphia, Pa.
The FUEL Trial is a study in 400 male and female adolescents with a single functional ventricle who had previously undergone Fontan surgical palliation. Study participants were drawn from a total of 30 Pediatric Heart Network http://www.pediatricheartnetwork.org/ (PHN) and auxiliary sites throughout the U.S., Canada, and Korea. The PHN is funded by the National Heart, Lung, and Blood Institute, part of the National Institutes of Health.
· Mezzion will exhibit at the AHA, Scientific Sessions, November 16-18, 2019
Mezzion will exhibit at Booth# 3218 at the AHA, Scientific Sessions, Philadelphia, PA.
· Presentation of FUEL Trial Results by Dr. David Goldberg, Sunday, November 17, 2019
10:45 am on Sunday, November 17th, at the American Heart Association Scientific Session, Late-Breaking Science, Sessions # LBS.05, located at Main Event 1, Pennsylvania Convention Center, Philadelphia. See AHA Scientific Sessions 2019, at Final Program at https://professional.heart.org/idc/groups/ahamah-public/@wcm/@sop/@scon/documents/downloadable/ucm_505033.pdf, November 16-18, Philadelphia, PA.
· FUEL Trial Reception hosted by Mezzion
On Sunday, November 17th, from 5:00 pm to 6:30 pm EST, Mezzion will host a reception at The Union League, 140 South Broad St., Philadelphia, PA 19102.
· The Satellite Symposium on “Fontan Physiology and Results of the FUEL Trial” will be presented at The Union League
Following the reception, the Satellite symposium is scheduled from 6:30 pm to 8:30 pm EST at The Union League.
See the complete description of the Symposium Speakers, agenda and objectives at Save the Date at https://goodworkshealth.com/save_the_date/.
· The Union League Dress Code and Cell Phone Usage
DRESS CODE FOR MEN: Jacket and tie are strongly preferred. Jacket and collared shirt
are required at all times; no jeans, hats, or sneakers permitted.
FOR WOMEN: Business suits, tailored pant or skirt ensembles and dresses.
See unionleague.org/dress-code.php for more information
Cell Phone Usage at The Union League is restricted to permitted areas only
In view of the results from the FUEL Trial and the safety data collected about udenafil, Mezzion Pharma intends to submit a New Drug Application to the U.S. Food and Drug Administration to seek approval for the use of udenafil to treat adolescents with SVHD who have undergone Fontan palliation.
In addition to this FUEL trial, Mezzion continues forward in its clinical efforts with the OLE Study, conducted under the auspices of the PHN, that is a long term safety extension study to supplement the FUEL Phase III clinical trial to provide safety information regarding the long-term use of udenafil in adolescents with single ventricle congenital heart disease, and the FALD study, also conducted under the auspices of the PHN, which is measuring the ability of udenafil to impact the effects of Fontan Associated Liver Disease.
Mezzion has been under a scientific publication embargo which has restricted Mezzion from providing specific data results due to contractual obligation until this presentation at the AHA, Scientific Sessions, Late-Breaking Science, in Philadelphia, Pa.
Mezzion Pharma Co. Ltd.
Mezzion Pharma is headquartered in South Korea. Mezzion Pharma and its wholly owned subsidiary, Mezzion Pharmaceuticals, Inc., have administrative offices in Deerfield, Illinois and Boca Raton, Florida. Mezzion Pharma is an innovation-driven pharmaceutical company that is focused on discovering, developing and commercializing novel therapeutics in the field of rare pediatric diseases. Mezzion Pharma is a publicly-listed pharmaceutical company in Korea on the Korean stock exchange under (140410: KOSDAQ).
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding Mezzion Pharma's expectations regarding: (a) the potential benefits of udenafil; anticipated timing of any future clinical trials; (b) regulatory submissions for marketing approval of udenafil for the treatment of Fontan patients to improve exercise capacity in the United States, including the timing of these submissions and approval; and (c) the potential commercial launch of udenafil, including the timing of a potential approval of udenafil. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: (d) need for additional funds to finance its operations; (e) Mezzion Pharma's or any of its collaborative partners' ability to initiate and/or complete clinical trials; (f) the unpredictability of the regulatory process; (g) the possibility that Mezzion Pharma or any of its clinical trials will not be successful; (g) Mezzion Pharma's dependence on the success of udenafil; (h) Mezzion Pharma's reliance on third parties for the manufacture of udenafil and udenafil tablets; (i) the possible regulatory developments in the United States and foreign countries; and (j) Mezzion Pharma's ability to attract and retain senior management personnel.
These and other risks and uncertainties are described more fully in Mezzion Pharma's most recent filings with the 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 Mezzion Pharma. All forward-looking statements contained in this press release speak only as of the date on which they were made. Mezzion undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
