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Kinex Pharmaceuticals Will Take the Lead in the Orascovery Program Development in China
Date:7/9/2013

BUFFALO, N.Y., July 9, 2013 /PRNewswire/ -- Kinex Pharmaceuticals and Hanmi Pharmaceutical Co., Ltd. are pleased to announce the execution of an agreement for Kinex Pharmaceuticals to lead Orascovery program development in China. This further strengthens the existing agreement forged in December of 2011. Under the terms of the 2011 agreement, Kinex Pharmaceuticals acquired the rights to develop and commercialize all products derived from the Orascovery program for all indications in the United States, European Union, Eastern Europe, Russia, South America, Australia, New Zealand, Taiwan, and Hong Kong.

The Orascovery program is based on important platform technology initially developed by Hanmi Pharmaceutical, including compound HM30181A, which is a highly potent and selective P-glycoprotein (PGP) pump inhibitor. Suppression of the PGP pump in the gastrointestinal tract allows certain clinically important compounds, (such as paclitaxel and irinotecan, among others) which would normally be effluxed back into the gastrointestinal tract and excreted, to enter the bloodstream and be bioavailable through oral administration.  Importantly, HM30181A is a very effective PGP inhibitor that is not systemically absorbed. The current lead products include an oral formulation of paclitaxel, which is in Phase II clinical trials in Korea, and an oral formulation of irinotecan, which has just completed Phase I clinical trials in Korea.

Kinex Pharmaceuticals will assume all development responsibility in the licensed territories. Kinex and Hanmi will also work together to ensure that the product development in various geographic regions will complement each other in overall strategic global product development.

Dr. Gwan Sun Lee, Chief Executive Officer of Hanmi Pharmaceutical stated: "Kinex has been a great collaborative partner. Our joint development efforts with Kinex continue to advance the products and research program, derived from the Orascovery program, which will lead to opportunities to further expand our end markets. We are delighted to further expand our alliance with Kinex, our partner in the Orascovery program since December 2011. We have full confidence in Kinex and this additional collaborative effort is our vote of confidence with Kinex and its management team."

Dr. Jeewoong Son, Senior Vice-President and Head of Innovation R&D at Hanmi, added: "We are impressed by the Kinex management team and the collaborative effort on both KX01 and the Orascovery program, which have been very successful. Our joint effort in developing a strategic global drug development plan through partnerships has been rewarding. Adding China territory to Kinex territory will further support this global development strategy. The taxanes have demonstrated a strong synergistic effect with KX01, an orally bioavailable dual src kinase/pretubulin inhibitor which Kinex and Hanmi are also collaborating. This attribute may allow the development of an excellent combination therapy to help patients in the future. Hanmi is fully committed in our partnership with Kinex."

Dr. David Hangauer, Chief Scientific Officer of Kinex and a member of the Joint Steering Committee for the Kinex/Hanmi Collaboration, said: "We are pleased with the opportunity to further expand our collaboration with Hanmi. As part of our ongoing partnership, Hanmi has advanced the KX01 program to an IND application with the Korean FDA in late 2012 and began the associated clinical studies in Korea starting in December 2012. Their support has been very helpful to Kinex as we prepared our IND for Oraxol, an oral form of paclitaxel, which has been submitted to the US FDA. The level of support provided by Hanmi has been critical to advancing a number of our collaborative programs and I am delighted to see that our partnership is expanding even further. We have initiated a research effort in Hong Kong/China and this expansion will complement our research efforts in a very positive way."

"We continue to be impressed by Hanmi's strong commitment to research and development and their business growth strategy. Our global drug development strategy through partnerships is advancing nicely. We have recently also established a partnership to develop Oraxol (oral paclitaxel) and Oratecan (oral form of irinotecan) with Dr. Cheung-Tak Hung of Zenith Technology Corporation, a very successful Clinical Contract Research Organization, for the New Zealand and Australia territory as part of our global development effort. The addition of China will further foster our global drug development strategy. We look forward to continue our very successful collaboration with Hanmi in developing our expanding pipeline of oral anti-cancer drugs," said Dr. Rudolf Kwan, Chief Medical Officer of Kinex Pharmaceuticals.

About KINEX:

Founded in 2004, Kinex is led by a strong, experienced Management Team and Board of Directors with a track record of achieving value-creating milestones and cumulative experience of over 250 years in both the pharmaceutical and biotechnology industries. This includes the filing of more than 11 NDAs and 20 INDs with the Food and Drug Administration and the development of more than 10 marketed products, including a number of blockbusters. Kinex has utilized the proprietary platform technologies Mimetica™, Opal™, and Orascovery™ to discover new compounds and to build a pipeline of drug candidates with unique mechanisms that address unmet medical needs with large market potential. With offices in both Buffalo, NY and Hong Kong, Kinex has numerous existing partnerships in Asia and New Zealand, as well as investors throughout the United States and Asia.

For Kinex Inquiries Please contact:

Mr. Patrick Gallagher
Kinex Pharmaceuticals
701 Ellicott Street
Buffalo, NY 14203
pgallagher@kinexpharma.com


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