SEOUL, Republic of Korea, June 15, 2021 /PRNewswire/ — Mezzion Pharma Co., Ltd. (140410.KQ), and Mezzion Pharmaceuticals, Inc. (individually or collectively, “Mezzion”), a leader in the field of rare single ventricle congenital heart disease (“SVHD”) and SVHD patients with Fontan circulation, is pleased to announce that Bill Breitenbach has joined Mezzion as the Chief Commercial Officer (CCO) effective June 1st, 2021. As CCO, Bill will be responsible for the management and oversight of all global commercial operations, including the planning, recruiting, and development of the leadership team, and for overseeing the pre-launch preparations and launch of UDENAFIL in selected major markets for the treatment of SVHD patients who have undergone Fontan surgical palliation.
Mr. Breitenbach comes to Mezzion following a distinguished and lengthy career at Novo Nordisk and elsewhere during which he coordinated and oversaw five product launches in the USA and was associated with seven others. Amongst his achievements and under his management, Levemir® and Levemir® Flex Touch device® sales were driven to $1.9 billion in annual sales. Bill and his team overdelivered on the Tresiba® launch goals by 116% reaching $324M in year 1. As General Manager of the BioPharm Business unit, responsible for the sales and marketing efforts for the $1.2B hemophilia and growth hormone portfolio, he similarly repositioned the organization to overachieve new goals by 107%. He subsequently led market access efforts for the Prime Therapeutics account across the entire product portfolio (diabetes, growth hormone, obesity, and hemophilia), while collaborating with Regional Market Access, Sales, Operations, Medical Affairs, and Finance teams to gain and protect product access while driving pull-through. Market access is a critical determinant of pricing and formulary positioning that has to be negotiated with payors in the USA.
Before joining Novo Nordisk in 2006, Bill was the Director of Marketing for NPS Pharmaceuticals, where he built out the marketing department while supporting the commercialization of their osteoporosis business.
Bill started his pharmaceutical career with Rhone Poulenc Rorer Pharmaceuticals, which subsequently merged with Hoechst-Marion-Roussel and became Aventis Pharmaceuticals. He held several roles in Sales, Sales Leadership, Operations and Marketing across multiple disease states.
Mr. Breitenbach stated, “Subject to the necessary regulatory approvals, I am very much looking forward to driving the commercial success of udenafil while helping to improve the lives of SVHD patients that have undergone Fontan surgical palliation.”
Dean Park, CEO and President, Mezzion, commented, “We are excited to have Bill on board, and we look forward to leveraging his broad experiences, expertise and past successes, as we build our own team in advance of anticipated regulatory approvals and product launch. Bill’s leadership and experience across multiple disease states, including rare diseases, will be invaluable to Mezzion’s efforts as it prepares to bring its novel pharmacotherapeutic option to this global rare pediatric disease population.”
About the Fontan Procedure and Subsequent Expectations
The Fontan procedure is a surgical intervention that allows for the survival of children born with congenital heart disease characterized by only a single functional pumping chamber. This procedure consists of re-configuring the circulation to allow the single ventricle to pump blood to the body while connecting the great veins directly to the arteries that bring blood to the lungs. In this “Fontan circulation” the blood returning from the body bypasses the heart and travels to the lungs without the assistance of a dedicated right ventricle pumping chamber. The goal of the Fontan procedure is to separate the systemic and pulmonary circulations and to improve oxygen levels by redirecting venous blood directly to the lungs.
While the Fontan procedure creates a stable circulation, the risk of hospitalization and cardiac death rises significantly in the second and third decades after Fontan completion, a risk that is associated with a decline in exercise capacity. The Fontan circulation is also associated with non-cardiac complications such as protein-losing enteropathy, plastic bronchitis, and liver failure, all of which can be attributed to a chronic elevation in central venous pressure and a chronically reduced cardiac output. For all of these reasons, a 35 year-old patient who has gone through Fontan palliation has the approximate life expectancy of a 75 year old with normal cardiac physiology.
According to the Society of Thoracic Surgeons, approximately 1,100 Fontan procedures are conducted annually in the USA and, based on published long term survival statistics, Mezzion believes that approximately 35, 000 Fontan palliated patients are currently alive in the USA , with similar ratios relative to the total population in other key markets. Subject to regulatory approvals, patients initially targeted for treatment should be about 24,000 overall.
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).
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.
SOURCE Mezzion Pharma Co. Ltd.