PLYMOUTH MEETING, Pa., Oct. 16 /PRNewswire/ -- InfaCare Pharmaceutical Corporation, a privately held, pediatric-focused specialty pharmaceutical company, announced today the appointment of Ronald Dundore, Ph.D. as Vice President, Regulatory and Quality Affairs. Dr. Dundore joins InfaCare from AstraZeneca, where he was Director, U.S. Regulatory Affairs. Dr. Dundore received his Ph.D. in Pharmacology from Pennsylvania State University and has over 20 years of experience in the pharmaceutical industry as a regulatory professional and as a research and development scientist. He served in a variety of regulatory roles at Rhone-Poulenc Rorer and Zeneca Pharmaceuticals. Prior to these assignments, Ron served as a toxicologist for the FDA and was responsible for the review of a number of NDAs and INDs. He will take responsibility for setting and implementing regulatory strategy for InfaCare and will become a member of the company’s management team.
“We are pleased to welcome Ron to the InfaCare team, particularly at an important point where the firm can capitalize on the breadth of his regulatory expertise,” said John Post, CEO of InfaCare. “His experience with managing regulatory portfolios, coupled with the perspective gained from having been a member of the FDA’s reviewing organization, brings a unique blend of insight that will serve InfaCare well as interactions with the agency begin to accelerate.”
“InfaCare is at an exciting stage in the development of its lead drug, Stanate(R), for treating hyperbilirubinemia in neonates. Stanate(R) has significant potential clinical benefit in the treatment of a serious condition. InfaCare will soon be planning critical interactions with our regulatory counterparts and I look forward to working collaboratively towards an NDA for this important new drug,” said Dr. Dundore.
About InfaCare Pharmaceutical Corporation:
InfaCare Pharmaceutical Corporation is an emerging specialty pharmaceutical company focused on the development and commercialization of products for neonates and other children. InfaCare recently completed its first institutional financing, co-led by Atlas Venture and Pequot Ventures. The Company is led by John Post, President and CEO, and was founded by Dr. Robert Vukovich, the founder and former CEO of Roberts Pharmaceutical Corporation. InfaCare is headquartered in Plymouth Meeting, Pennsylvania.
About Stanate(R)
Stanate(R) (stannsoporfin) is an investigational drug in late-stage development for the treatment of severe neonatal hyperbilirubinemia. In the first few days of life, newborns often lack the ability to effectively eliminate bilirubin. While neonatal hyperbilirubinemia is normally a transient phenomenon, in more severe forms it can result in irreversible brain damage, a condition known as kernicterus. Administered by a single intramuscular injection, Stanate(R) has been used in over 800 neonates and found to rapidly reduce bilirubin and eliminate jaundice. The use of Stanate(R) may mitigate or eliminate the need for other medical intervention related to hyperbilirubinemia, and thereby has the potential to speed hospital discharge, reduce treatment costs, and improve parent and physician peace of mind.
For more information please visit our website (http://www.infacarepharm.com/) or contact Ron Goldfuss, Chief Financial Officer, InfaCare Pharmaceutical at 610-260-1485, rgoldfuss@infacare.com.
InfaCare Pharmaceutical Corporation
CONTACT: Ron Goldfuss, Chief Financial Officer, InfaCare Pharmaceutical,+1-610-260-1485, rgoldfuss@infacare.com
Web site: http://www.infacarepharm.com/
