Kinex Pharmaceuticals, a global oncology specialty pharmaceutical company, and Hanmi Pharmaceutical, a global leading pharma company with development of new biologics, NCEs and innovative new drugs, have announced the execution of an agreement for Kinex Pharmaceuticals to lead the development of the Orascovery programme in India.
The addition of this territory is part of the strategic plan to support Kinex and Hanmi’s joint effort to execute a global regulatory strategy. This also strengthens the existing agreement forged with Hanmi in December of 2011. With this agreement, Hanmi has granted to Kinex Pharmaceuticals the rights to develop and commercialise all products derived from the Orascovery programme for all indications globally apart from Korea and Japan.
Kinex Pharmaceuticals will assume all development responsibility in the licensed territories. ZenRx has joined the effort to develop Oraxol and Oratecan in the New Zealand and Australia territories, and PharmaEssentia of Taiwan has joined the effort to develop Oraxol and Oratecan in Taiwan and Singapore.
Dr. Gwan Sun Lee, chief executive officer of Hanmi Pharmaceutical stated: “Kinex is a faithful partner who has been successfully progressing development of the Orascovery programme. We are pleased to continue to work closely with Kinex and as we work together to bring more treatment options to patients”
Flint Besecker, chief operating officer and Board Member of Kinex Pharmaceuticals, commented: “Hanmi has been an excellent partner. The assignment of the Indian Territory fills a remaining gap in our execution of the overall business strategy to develop these products globally. The companies’ well-coordinated networks of key opinion leaders and development sites have been instrumental in advancing our programs and helped facilitate productive discussions with different regulatory authorities. Kinex is also delighted to note that the preclinical development of the oral version of Docetaxel is also advancing nicely with support from the Innovation and Technology Commission (ITC) of the Government of the Hong Kong Special Administrative Region and the support of the Department of Applied Biology and Chemical Technology of the Hong Kong Polytechnic University.”
The Orascovery programme 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 clinical phase products include an oral formulation of paclitaxel and an oral formulation of irinotecan, both of them in in multiple clinical studies globally.
Any opinions, findings, conclusions or recommendations expressed in this material do not reflect the views of the Government of the Hong Kong Special Administrative Region, the Innovation and Technology Commission or the Small Entrepreneur Research Assistance Programme Project Assessment Panel.