QRxPHARMA HALTS MOXDUO DEVELOPMENT
Sydney, Australia and Bedminster, New Jersey – QRxPharma Limited (ASX: QRX and OTCQX:
QRXPY) today announced that it is halting all further development work on the Moxduo portfolio of
products.
As announced on 26 May 2014, QRxPharma received a Complete Response Letter (CRL) from the
United States Food and Drug Administration (FDA) regarding its Moxduo New Drug Application
(NDA). Following the CRL, the Company had an End of Review (EOR) meeting with the agency on
US 9 July.
The management team has since conducted a detailed review of the MoxDuo technology with
particular emphasis on the EOR meeting with the FDA and made a recommendation to the Board to
halt all further development of the Moxduo IR, CR and IV programs. The Board of QRxPharma has
agreed with, and accepted this recommendation.
The Company believes that the Moxduo program will require a repeat Phase 2 clinical study, followed
by one or more pivotal Phase 3 clinical studies. The FDA has advised that agreement on a Special
Protocol Assessment (SPA) would be unlikely for these studies and given specific issues related to the
design of these clinical studies, such as a primary endpoint of 90% SpO2 and flexible dosing, both
which have been strongly encouraged by FDA, the likelihood of success is now in considerable doubt.
The Company estimates the time and cost for such a development program to be significant and is not
commercially justified given the limited residual patent life.
With immediate effect, the Company will be implementing a reduction in its overhead structure,
minimizing non-essential expenditure and retaining only a small core team tasked with exploring all
strategic alternatives for the Company and its assets.
The Company reported A$10.5 million in cash reserves at 30 June 2014, however as noted in the
recently filed Appendix 4C the Company has set aside in escrow A$3.62 million to cover potential
liabilities of its current employees, consultants and the former CEO arising from i) Notice
entitlements, ii) Termination payments and where applicable, iii) Retention payments. In addition, the
Company had been carrying as a liability excess annual leave entitlements. During July the Company
paid down A$0.43 million of this liability. Estimated free cash at 30 September 2014 will be
approximately A$3.0million
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For more information please contact:
Edward M Rudnic, Ph.D.
Chief Executive Officer
Tel: +1 301 538 7080
Email: ed.rudnic@qrxpharma.com
Chris J Campbell
Chief Financial Officer and Company Secretary
Tel: +61 2 8404 4131
Email: chris.campbell@qrxpharma.com2
Forward Looking Statements
This release contains forward-looking statements. Forward-looking statements are statements
