SYDNEY and BEDMINSTER, N.J., July 22, 2013 /PRNewswire/ -- QRxPharma Limited (ASX: QRX andOTCQX: QRXPY) announced today execution of a Collaboration Agreement with Aesica Formulation Development Limited, a subsidiary of Aesica Pharmaceuticals Limited, for the world-wide promotion of QRxPharma's proprietary Stealth Beadlets® abuse deterrence technology. Aesica supplies pharmaceutical contract development and manufacturing services globally and operates six manufacturing sites across the UK, Germany and Italy. Aesica offers controlled drug services across the supply chain for which abuse or diversion may occur and is actively building relationships for supplying controlled drug Active Pharmaceutical Ingredients (APIs) and finished dose products to market.
"We are delighted to announce our collaboration with Aesica," said Dr. John Holaday, Managing Director and Chief Executive Officer, QRxPharma. "Their extensive experience in formulation development and contract manufacturing, together with their established client base in the controlled drug market, create a wonderful opportunity for our companies to collaborate in the application of our proprietary abuse deterrence technology by third party pharma companies."
Under the non-exclusive Collaboration Agreement, Aesica will promote QRxPharma's Stealth Beadlets technology for inclusion in their clients' existing formulations of controlled drugs. Aesica will enter into fee-for-service contracts with such third parties for the development of the new Abuse Deterrent Formulations (ADF) of specific drugs of interest, whilst QRxPharma will negotiate license terms directly with each party.
QRxPharma's proprietary Stealth Beadlets abuse deterrence technology was developed for the MoxDuo CR (controlled release) formulation for the treatment of chronic pain. This program is ready for Phase 2 studies and has shown that Stealth Beadlets incorporated into the Company's delayed release technology provide a potential once to twice-a-day formulation. Work is underway to assure that this ADF technology comports with United States Food and Drug Administration (FDA) guidelines for providing abuse deterrence statements in product labeling.
"A head-to-head comparison between Stealth Beadlets and a market leading abuse deterrent technology showed that Stealth Beadlets were more than twice as effective in reducing the percentage of oxycodone that could be extracted from a crushed controlled release tablet," said Holaday.
Stealth Beadlets may be incorporated into almost any potentially abused drug (e.g. opioids, amphetamines, sedatives, etc.) that are sold in solid dosage forms (e.g. tablet, capsule, sachet); they provide significant resistance against the extraction of active ingredients if crushed, solubilized or heated. Stealth Beadlets have no effect on the active ingredient release profile and consist entirely of patient-safe, low cost, excipients that have GRAS (Generally Regarded As Safe) status with the FDA. Patent applications for the ADF technology are currently under review at the U.S. patent office, and, if granted, will provide for product exclusivity until 2029.
QRxPharma Limited is an Australian based, commercial-stage specialty pharmaceutical company focused on the development and commercialisation of new treatments for pain management. The Company's product portfolio includes both late and early stage clinical drug candidates with the potential for reduced risk, abbreviated development paths, and improved patient outcomes. The Company's lead product candidate, immediate release MOXDUO® for the treatment of acute pain, is presently under review at the US Food and Drug Administration. QRxPharma entered into strategic collaborations with Actavis Inc. in December 2011 and Paladin Labs Inc. in October 2012 for the commercialisation of immediate release MOXDUO in the US and Canadian acute pain markets respectively. Additionally, the Company's clinical pipeline includes an intravenous (IV) and continuous release (CR) formulation of MOXDUO. For more information, visit www.qrxpharma.com.
Aesica supplies contract development and contract manufacturing services for Formulated Products and Active Pharmaceutical Ingredients to a host of the world's leading pharmaceutical companies and emerging biotechnology organisations. The uniqueness of Aesica lies in its flexible and bespoke approach to service delivery, coupled with its ability to develop products from the initial clinical stage through to final commercial supply. It is this all-encompassing offering combined with its dedication to exceptional standards of service that truly sets Aesica apart from its counterparts.
- Aesica is one of the UK's fastest growing companies and over the last five years has more than trebled its turnover.
- The company currently employs approximately 1,300 people.
- In addition to its headquarters in Newcastle upon Tyne, UK, Aesica has development and manufacturing sites across Europe including Cramlington, Nottingham and Queenborough in the UK, as well as sites in Monheim and Zwickau in Germany and Pianezza in Italy. It also has sales representation in San Diego and Shanghai.
- The vision of Aesica is to become the number one supplier of APIs and formulated products to the pharmaceutical industry.
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.
SOURCE QRxPharma Limited