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Hanmi Pharmaceuticals to Assign the Rights to Five New Territories to Kinex as Part of the Orascovery Program Strategic Plan
Date:10/22/2013

BUFFALO, N.Y., Oct. 22, 2013 /PRNewswire/ -- Kinex Pharmaceuticals and Hanmi Pharmaceutical Co., Ltd. are pleased to announce the execution of an agreement for Kinex Pharmaceuticals to lead the development of the Orascovery program in Malaysia, Thailand, Vietnam, the Philippines, and Indonesia. The addition of these five new countries is part of the strategic plan to support Kinex and Hanmi's joint effort to execute a regulatory strategy in Asia. This also strengthens the existing agreement forged with Hanmi in December of 2011. Under the two previous collaborative agreements, Hanmi has granted Kinex Pharmaceuticals the rights to develop and commercialize all products derived from the Orascovery program for all indications in the United States, European Union, China, Eastern Europe, Russia, South America, Australia, New Zealand, Taiwan, Hong Kong, Singapore and Macau.

Kinex Pharmaceuticals will assume all development responsibility in the licensed territories. Kinex and Hanmi will collaborate to ensure that the clinical programs in the various geographic regions will complement each other and drive the overall global Orascovery product development and commercialization strategy. ZenRx has recently joined the effort to develop Oraxol and Oratecan in the New Zealand and Australia territories.

Dr. Gwan Sun Lee, Chief Executive Officer of Hanmi Pharmaceutical stated: "Kinex has been an excellent collaborative partner and Hanmi is delighted to further expand its relationship with Kinex.  In less than two years we have initiated a number of pre-clinical and clinical programs together.  Hanmi believes that by assigning these territories to Kinex under our agreement, we will further enhance the execution of our joint regulatory strategies for our products in Asia. Our combined activities have and will continue to leverage the streamlined development process that we have jointly established and will put a growing pipeline of Orascovery compounds in doctor's hands around the world."

Dr. David Hangauer, Chief Scientific Officer of Kinex and the Chairman of the Joint Steering Committee for the Kinex/Hanmi Collaboration, said: "The Hanmi team has been instrumental in the advancement of our dynamic programs.  Their large and experienced team dedicated to the Orascovery program has created and is executing an expedited development strategy with Kinex. Their support has been extremely helpful as was demonstrated recently by the US FDA's allowance of our IND for Oraxol, an oral form of paclitaxel.   The new territories assigned to Kinex will share many synergies with the research efforts that we have recently established in Hong Kong.  Both Kinex and Hanmi expect positive results from our growing collaboration."

Dr. Jeewoong Son, Senior Vice-President and Head of Innovation R&D at Hanmi, added: "Kinex and Hanmi have developed a novel global regulatory strategy and the assignment of the rights to these countries to Kinex is an important part of our overall plan.  We are very impressed by the Kinex management team.  Their collaborative effort on both the KX01 and the Orascovery programs has generated momentum and created success. Our joint effort in developing a strategic global drug development plan through partnerships has clearly been rewarding.  Hanmi is fully committed in our partnership with Kinex."

"2013 has been a remarkably active year for Kinex and Hanmi," added Dr. Rudolf Kwan, Chief Medical Officer of Kinex.  "We have initiated a number of preclinical studies and clinical trials globally.  The companies' well-coordinated and complimentary networks of KOLs and development sites have been instrumental in advancing our programs and have helped facilitate productive discussions with different regulatory authorities.   The addition of these Southeast Asian markets is part of our regulatory strategy developed jointly by Kinex and Hanmi.  This will augment our development efforts and dovetails nicely with our broader Asian blueprint."

Dr. Johnson Lau, CEO and Chairman of Kinex concluded, "Hanmi has been an excellent partner. The assignment of these markets under the existing agreement is part our overall business strategy to develop our products globally through partnerships. Through our commitment to this endeavor, both Kinex and Hanmi hope to advance our clinical programs rapidly so that more patients globally can benefit from our novel drugs."

About Orascovery

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.


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