SYDNEY and BEDMINSTER, N.J., July 9, 2014 /PRNewswire/ -- QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today that Chairman, Dr. Peter Farrell and Director, Dr. Gary Pace have resigned from the QRxPharma board effective at 9:50am (AEST) 9 July 2014 prior to commencement of the General Meeting (GM) requisitioned by shareholders associated with Langley Walker. It is expected that Bruce Hancox and Dr. Richard Treagus will be appointed as directors pursuant to resolutions in the requisitioned notice of meeting, with those appointments taking effect from the close of the meeting.
The Company also announces that directors Peter Campbell and Michael Quinn have tendered their resignations from the QRxPharma board. In order to facilitate an orderly transition, their resignations will take effect at 5:00pm (AEST) 11 July 2014 or at such earlier time the newly elected directors can appoint one or more replacements.
"It has been an honour serving as QRxPharma chairman and I certainly share the frustration of shareholders with respect to the development of Moxduo and interactions with the FDA," said Dr. Farrell. "Speaking for the entire outgoing board, I am satisfied we are leaving the Company in a strong position to continue under the direction of the new board: (1) the Company has the financial resources to pursue an appropriate path forward in a timely manner and meet current obligations and entitlements; (2) all information and resources needed by the incoming board are intact and available; (3) the ongoing commitment of the current management team has been secured; and (4) the outgoing leadership are available to assist the incoming board to effect a smooth transition."
QRxPharma will proceed with the GM today at the offices of DibbsBarker, Lawyers, of Level 8, 123 Pitt Street, Sydney at 10:00am (AEST). Attached is the address to be delivered by Peter Campbell (Director and Chairman of the meeting).
QRxPharma Limited is an Australian based, commercial-stage specialty pharmaceutical company focused on the development and commercialisation of new pain management and abuse prevention products. The Company's product portfolio includes both late and early stage clinical drug candidates with the potential for reduced risks and improved patient outcomes. QRxPharma has entered into strategic agreements with Actavis Inc., Paladin Labs Inc., Aspen Group and Teva Pharmaceuticals for the commercialisation of immediate release Moxduo in the US, Canada, Australia (including New Zealand and Oceania), South Africa and Israel. The Company's clinical pipeline includes an intravenous (IV) and controlled release (CR) formulation of Moxduo. QRxPharma is also collaborating with Aesica Formulation Development Limited, for the worldwide promotion of QRxPharma's proprietary Stealth Beadlets(TM) abuse deterrence technology. For more information, visit www.qrxpharma.com.
Forward Looking Statements
This release contains forward-looking statements. Forward-looking statements are statements that are not historical facts; they include statements about our beliefs and expectations. Any statement in this release that states our intentions, beliefs, expectations or predictions (and the assumptions underlying them) is a forward-looking statement. These statements are based on plans, estimates and projections as they are currently available to the management of QRxPharma. Forward-looking statements therefore speak only as of the date they are made, and we undertake no obligation to update publicly any of them in light of new information or future events. By their very nature, forward-looking statements involve risks and uncertainties. A number of important factors could therefore cause actual results to differ materially from those contained in any forward-looking statement. Such factors include risks relating to the stage of products under development; uncertainties relating to clinical trials; dependence on third parties; future capital needs; and risks relating to the commercialisation of the Company's proposed products.
General Meeting Chairman's Address - Peter Campbell
9 July 2014
Thank you for your attendance at today's meeting. As you are aware, the Board called this general meeting of shareholders following receipt of a notice issued under section 249D of the Corporations Act 2001, from Walker Group.
Proxies lodged by larger shareholders have made it clear they want change to the current Board of Directors. As a consequence Dr. Peter Farrell, Chairman of the Board of QRxPharma, and Dr. Gary Pace, founder, have resigned effective from immediately before the start of this meeting. With these resignations, Resolutions 1 and 2 listed in the Notice of General Meeting are redundant and will not be considered at the meeting.
I, (Peter Campbell) and Michael Quinn have also tendered our resignations from the Board of QRxPharma. These resignations will take effect from 5.00 pm 11 July, 2014 - this Friday, so as to give the new directors time to appoint one or more replacements and facilitate an orderly transition.
Although he has resigned as a director, Dr Gary Pace has agreed to continue as a consultant in support of intellectual property issues and regulatory interactions for QRxPharma. The Board thanks Dr Pace for his commitment to effect a smooth transition and transfer of information to the incoming Board of Directors of QRxPharma.
The requisition has been unsettling for management and staff so in the interest of shareholders the Board has taken steps to retain them and their expertise pending the decisions of the new board. We are very appreciative of our employees' and consultants' goodwill under the circumstances.
Like all shareholders, your directors have been devastated by the recent turn of events. Throughout the clinical trials for Moxduo, the Company followed FDA guidance to meet the Combination Rule. The Company was encouraged by its interactions with the FDA leading up to June 2012 and was very disappointed at not receiving approval as a consequence of the revised interpretation in June 2012 by the FDA of the Combination Rule and its applicability to Moxduo. Despite the existing regulation that equivalence in efficacy and safety was required for approval, the FDA elected to ask for a clinical benefit for some particular patient population.
They then agreed that Study 022 and post hoc analyses could satisfy their requirements. That review took over 12 months during which time the FDA was under intense and controversial political pressure regarding opioid approvals. Unfortunately, at the April 2014 Advisory Committee meeting, the committee rejected Study 022's post hoc analyses, and preferred pre-specified outcomes and statistical metrics instead. Following this feedback, the FDA declined to approve Moxduo. Given this history, the focus now turns to feedback from the FDA in the meeting later tonight, and what that means for the future of Moxduo and QRxPharma.
I would like to take this opportunity to thank my fellow Board members, senior management and the entire QRxPharma staff and consultants in both Australia and the US for their commitment and efforts over the past seven years. The departing Board members wish the incoming Board and shareholders of QRxPharma every success.
SOURCE QRxPharma Limited