Kinex and PharmaEssentia Expand Drug Development Partnership

BUFFALO, N.Y., Feb. 6, 2014 /PRNewswire/ -- Kinex Pharmaceuticals and PharmaEssentia Corporation (Taiwan) announced today the execution of a new licensing agreement granting PharmaEssentia exclusive development and commercial rights to Oraxol and Oratecan in Taiwan and Singapore.  Kinex will receive an upfront payment, milestones, and royalties.  PharmaEssentia has also committed to conducting clinical studies in Taiwan to contribute to the global registration programs for Oraxol and Oratecan. The companies currently have a licensing agreement in place in certain Asian territories for the dermatology preparations of Kinex's dual Src/Pretubulin Inhibitor, KX01. 

Oraxol and Oratecan are two of many compounds that could be developed by Kinex and its partners through the Orascovery program.  Orascovery is based on an important platform technology developed by Hanmi Pharmaceuticals using compound HM30181A, a potent and selective P-glycoprotein (PGP) pump inhibitor.   Suppression of the PGP pump allows certain clinically important compounds (such as paclitaxel, irinotecan, and others), which would normally be effluxed back into the gastrointestinal tract and excreted, to enter the bloodstream and become bioavailable through oral administration.  Importantly, HM30181A is a very potent PGP inhibitor that is not systemically absorbed.

Dr. Rudolf Kwan, Chief Medical Officer of Kinex said, "PharmaEssentia has both the leadership strength and development expertise to help accelerate the global registration programs for Oraxol and Oratecan.   They are a recognized leader in the biotechnology sector in Asia.   We are confident that our combined efforts will lead to even more rapid development successes for Oraxol, Oratecan and KX01."

"Based on existing treatment algorithms, we believe these compounds can bring unique benefits to the global healthcare system including, of course, Taiwan and Singapore," stated Dr. Ko-Chung Lin, CEO, PharmaEssentia.  Importantly, we believe these late stage products can be on the market in 2-3 years.  It is clear that patients and doctors need additional options when treating challenging diseases like cancer.  PharmaEssentia is excited to help create these new options as part of the Kinex, Hanmi and ZenRx team."

"We are pleased to be working with the accomplished PharmaEssentia team to accelerate the development of Oraxol and Oratecan," observed Dr. Wing-Kai Chan, Kinex's Head of Clinical Operations, Asia/Pacific.  "Working with their team in Taiwan and Singapore has many synergies with our clinical and preclinical work that is ongoing or planned in Korea, China, Hong Kong and New Zealand.  These regional collaborations are a key driver of our development strategy.  Further, we believe these efforts will allow us to add new compounds to our pipeline over time as our various platforms and products are proven out in a clinical setting."

Kinex recently announced that the first patient had been dosed in its Phase Ib Oraxol study in the US.  Further, Oraxol is in PII studies in Korea and will commence a PI in New Zealand in 2014. Oratecan has completed a PI trial in Korea with very encouraging results.  Clinical studies of Oraxol and Oratecan to date suggest that these potent, oral versions of paclitaxel and irinotecan will impact a broad spectrum of cancers. Kinex has global development and commercialization rights for Oraxol and Oratecan, excluding Korea, Japan and India that are owned by Hanmi, New Zealand and Australia which were licensed to Zenith Technology Corporation and Taiwan and Singapore which were licensed to PharmaEssentia.

Flint Besecker, CFO and Board Director of Kinex added, "Expanding our relationship with PharmaEssentia is highly consistent with our global development and regulatory strategy.  It allows us to further leverage our existing platform technologies and drug candidates with a group of experienced drug developers.  PharmaEssentia brings meaningful infrastructure and resources to Kinex's expanding global development programs.  We believe such partnerships will allow us to produce significant data and commercialize important products in the most time and cost efficient manner."

Dr. Ching-Leou Teng, Chairperson of PharmaEssentia and formerly with US FDA and ISIS Pharmaceuticals, concluded, "Kinex has been an excellent partner to PharmaEssentia and it has been very productive working with them on the KX01 dermatology program.   We are impressed with the growing pool of data for Oraxol and Oratecan and the Kinex team has established an innovative regulatory pathway to registration which we are very excited about.  Kinex's strategy could potentially allow initial commercialization of these excellent oncology products in Taiwan and Singapore in as short as 2-3 years."

About Kinex

Founded in 2002, Kinex is a global biotechnology company focused on the development and commercialization of next generation oral therapies for cancer and immunomodulatory diseases.

The company is dedicated to delivering innovative drugs that can have a life-changing impact on patients.  Through our consistent investment in R&D and scientific excellence we are developing two important drug programs that address unmet medical needs and focus on critical factors that can improve outcomes.   It is Kinex's goal to have our oral oncology treatment and maintenance platform as well as our breakthrough drugs involving the immune system help patients prevail over their disease.

Kinex and its partners currently have four global clinical trials ongoing at highly regarded medical institutions.  The Company expects one additional trial and two pre-clinical studies to commence by the end of 2013 and seven additional clinical trials to be initiated in 2014.  Our investigational compounds are being studied in a variety of solid tumors, including breast cancer, ovarian cancer, colon cancer, glioblastoma multiforme and gastric cancer. 

www.kinexpharma.com

About PharmaEssentia

PharmaEssentia Corporation is headquartered in Taipei, Taiwan. Founded in 2003, PharmaEssentia is a global biopharmaceutical company.  Its mission is to discover, develop, and deliver to the market a range of efficacious, safe and cost-effective therapeutic products for human disease through new drug research and development.  The company focuses its R&D efforts in dermatology, infectious diseases, and hematology.  PharmaEssentia is utilizing their proprietary PEGylation technology in a number of clinical and pre-clinical trials.  For further information please refer to

www.pharmaessentia.com

SOURCE Kinex Pharmaceuticals



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