10 July 2013 | News | By BioSpectrum Bureau
Kinex Pharmaceuticals will assume all development responsibility in the licensed territories
Singapore: Kinex Pharmaceuticals and Hanmi Pharmaceutical announced 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 US, 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 said, "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 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."