SEOUL, South Korea, April 25, 2023 /PRNewswire/ — Mezzion Pharma (“Mezzion”), a rare disease focused pharmaceutical company, announced that it has secured nearly $40M USD to fund FUEL-2, their confirmatory phase 3 clinical trial, along with future commercialization and regulatory submissions in other countries including Europe.
Mezzion is looking to bring to market JURVIGO® (udenafil), a highly selective, unique and potent phosphodiesterase type 5 inhibitor (“PDE-5 inhibitor”), for specific use in the estimated global 70K single ventricle congenital heart disease (“SV-CHD”) patients with ages of twelve and above who have undergone Fontan surgical palliation.
The average life expectancy for a Fontan patient is 35-45 and apart from JURVIGO®, there are currently no other pharmacotherapies undertaking clinical development directed to the Fontan patient population. The primary aim of JURVIGO® treatment in Fontan subject is to (1) improve their exercise capacity, (2) improve their ability to perform everyday physical activities with less effort, and (3) potentially improve their life expectancy and quality of life. Another potential benefit associated with JURVIGO® treatment may be the slowing of the progression of Fontan-associated liver disease in the Fontan subjects.
Founder and CEO, Mr. Dong-Hyun Park, shared, “We have secured the funds necessary for stable and aggressive progress of FUEL-2 and for submitting to regulatory authorities in other countries including Europe. We submitted the FUEL-2 protocol to the FDA and partnered with a leading global CRO for what will be the largest clinical trial ever conducted in Fontan patients. In addition, we are expanding on global partnerships with hospital systems, advocacy groups, provider networks, and industry leaders dedicated to improving outcomes for those with SV-CHD. Our hope is that by continuing to invest in and support the Fontan patients, others will be inspired to do the same.”
The investment is a paid-in capital increase from BRV Capital Management (“BRV Capital”), a global growth investment platform of BlueRun Ventures, a Silicon Valley-based institutional investment firm known for its early lead investment in PayPal and Waze, the core technology behind Google Maps. Within their healthcare segment, BRV Capital invests in promising biotech companies that can dominate the global market based on differentiated products. BRV has made successful investments/exit into ST Pharm and Arvelle Therapeutics.
Mr. Yoon Kwan, CIO of BRV Capital, stated, “BRV Capital participated in the Cardiology Conference by Children’s Hospital of Philadelphia (CHOP) in Puerto Rico at the end of February of this year and met many doctors and heart disease related professionals in person as part of its diligence effort. And also, we’ve been thoroughly reviewing Mezzion’s FUEL-1 data and the U.S. FDA’s response letters and comments carefully for a long time. As a result, the possibility of new drug approval based on the FUEL-2 Protocol was evaluated very high, so the head office decided to invest in Mezzion.”
Mr. Kwan continued with, “The future market value was estimated considering attainable drug price after commercialization. BRV, as an institutional investor that focuses not on short-term profits, but on differentiated technology-based investments that can substantially grow, we would like to provide support from the new drug approval of udenafil to the success of global commercialization with strong partnership. We also subscribe to Mezzion’s corporate philosophy of helping all the patients around the World who are suffering from congenital diseases to open-up a new life.”
About BRV Capital Management:
BRV Capital is a tech-focused growth equity arm of BlueRun Ventures, with a highly localized presence in Asia. BRV Capital helps to create unique long-term growth by backing category winners in their respective industries and maximizing their potential through leveraging over 20 years of deep industry insight and global expertise in applying technological innovations.
Founded in 1998, BlueRun Ventures has identified and led several iconic technology investments as the first institutional investor, including PayPal (PYPL), Waze (GOOG), Coupa (COUP), Kabbage (AMEX), Topsy (AAPL), and Chomp (AAPL). BRV Capital in parallel focuses on technology-powered growth opportunities in Asia, and its current select investments include Ecopro Materials (leading EV battery component technology provider in Korea), LINE MAN Wongnai (top O2O platform in Thailand), and Green Labs (leading agricultural technology company pioneering digitalization of the entire agriculture value chain). BRV Capital closed its third Asia-focused fund, BRV Lotus Fund III, in 2021 and will continue to focus on cross-border value creation leveraging BRV’s deep and long investment insight into mobility.
About Mezzion Pharma Co., Ltd. Mezzion Pharma Co., Ltd. is headquartered in Korea. Mezzion 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 the potential benefits of udenafil; Mezzion Pharma’s expectations regarding the anticipated timing of any future clinical trials; Mezzion Pharma’s expectations on regulatory submissions for marketing approval of udenafil for the treatment of patients that have undergone the Fontan operation, to improve exercise capacity in the United States, including the timing of these submissions; and Mezzion Pharma’s expectations regarding 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: the expectation that Mezzion Pharma will need additional funds to finance its operations; Mezzion Pharma’s or any of its collaborative partners’ ability to initiate and/or complete clinical trials; the unpredictability of the regulatory process; the possibility that Mezzion Pharma’s or any of its clinical trials will not be successful; Mezzion Pharma’s dependence on the success of udenafil; Mezzion Pharma’s reliance on third parties for the manufacture of Mezzion Pharma’s udenafil and udenafil tablets; possible regulatory developments in the United States and foreign countries; and 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.
Media Contact:
Dr. James Yeager, Deerfield, Illinois, USA, Tel: +1-847-2122679
Email: james.yeager@mezzion.com
Mr. S.I. Noh, Seoul, Korea, Tel: +82 2 560 8000
Email: 09428lgtokyo@mezzion.co.kr
SOURCE Mezzion Pharma Co. Ltd.
