The company Remains Committed to Bringing Moxduo® to Market.
QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today that Dr. John Holaday has stepped down as Managing Director and Chief Executive Officer. The Company’s Board of Directors has appointed Dr. Edward Rudnic to Chief Executive Officer with immediate effect.
Dr. Rudnic has been QRxPharma’s Chief Operating Officer since early 2012.
“This change in leadership was set by mutual agreement to address the challenges facing the Company,” said Peter Farrell, Chairman of the Board, QRxPharma. “We thank John for his seven years of service, dedication and pursuit of bringing to market safer therapies, like Moxduo, for the management of pain.”
Dr. Rudnic brings more than 30 years of senior management and product commercialisation experience to QRxPharma through his career as an executive in the life sciences industry. Dr. Rudnic founded Advancis Pharmaceuticals (later renamed MiddleBrook Pharmaceuticals) and has previously held senior level positions with Shire Pharmaceuticals, Pharmavene, Schering Plough and E.R. Squibb. Dr. Rudnic has a B.S. in Pharmacy, M.S. in Pharmaceutics, and a Ph.D. in Pharmaceutical Sciences from the University of Rhode Island.
“I will be focused on successfully managing this transition and establishing a commercialisation strategy to hopefully bring Moxduo to market. To this end, we are postponing submission of the Moxduo Marketing Authorisation Application in Europe and evaluating the regulatory paths with our strategic collaborators in other jurisdictions,” said Dr. Rudnic. “I expect to meet with shareholders in Australia later this month to outline initial thoughts on these objectives.”
QRxPharma will provide additional information to shareholders on the Moxduo development program following official notification form the United States Food and Drug Administration (FDA) on or before the 25 May 2014 the Prescription Drug User Fee Act (PDUFA) date and the subsequent post-PDUFA date Agency meeting which is typically held within 60 days. The Board is in the process of finalising the terms of Dr. Rudnic’s employment, which will be disclosed to the market once agreed.