Kinex Pharmaceuticals, LLC and Hanmi Pharmaceutical Co., Ltd. enter a license agreement under which Hanmi grants Kinex exclusive rights to their Orascovery technology (which includes a non-absorbed compound that facilitates the absorption of compounds that are usually not orally bioavailable or absorbed) and their current lead products including an oral formulation of paclitaxel, which is already in phase II clinical trials in Korea, and an oral formulation of irinotecan, which has just completed phase I clinical trials in Korea.

The Orascovery programme is one of the key platforms developed by Hanmi Pharmaceuticals. HM30181A is a P-glycoprotein pump inhibitor, (known for its effect in pumping drugs back to the gastrointestinal tract and thereby reducing drug absorption) which inhibits the pumping action of this protein and therefore, serves as an oral absorption enhancer. This compound is very potent and is largely not absorbed and therefore, exerts its effect mainly in the gastrointestinal tract.

In preclinical studies, it has been shown that the administration of this absorption enhancer together with paclitaxel enhances the oral bioavailability of paclitaxel from 1% to >40%. For irinotecan and topotecan, the oral bioavailabilities were shown to be enhanced from 8% and 11% to >40% and >50%, respectively. The composition of matter of HM30181A is covered by issued patents.

Dr Gwan Sun Lee, CEO of Hanmi Pharmaceuticals states: “This collaboration is an important strategic decision for Hanmi Pharmaceuticals as this will facilitate our company to further expand our product portfolio in the United States, European Union and other geographic areas. The choice of Kinex Pharmaceuticals, a good partner in the KX01 development, allows us to further strengthen our collaboration.”

Dr Jeewoong Son, chief medical officer and senior vice-president of Research and Development, states: “We were impressed by the experience of the management team of Kinex Pharmaceuticals. Our first collaboration on KX01 has been successful and our joint development team has functioned very well. We are excited to collaborate with the scientific team of Kinex Pharmaceutical and to explore the potential synergy between KX01 and the Orascovery programme. This strategic move will create a lot of value for both companies.”

“We are delighted to be selected by Hanmi Pharmaceuticals to work with them on the Orascovery programme. We are impressed by their strong commitment to research and development and their business growth strategy. This collaboration will also further strengthen our product pipeline and will provide the opportunity to explore the synergy between our lead compounds and an oral form of taxol, which may create substantial value for Kinex,” states President Emeritus of Kinex Pharmaceuticals, Dr Allen Barnett, who was credited for his effort in the discovery and development of Claritin when he was working at the Schering-Plough Research Institute.

“We are impressed by the Orascovery programme, in particular, the ability to enhance the oral bioavailability of paclitaxel and irinotecan to >40%. Together with their team, we are confident that our joint effort will explore the full potential of these important anti-cancer drugs given with the convenience of an oral route,” states chief medical officer of Kinex Pharmaceuticals, Dr Rudolf Kwan, who was previously vice-president of Clinical Research, Schering-Plough Research Institute.

Dr David Hangauer, chief scientific officer, states: “The opportunity to collaborate with this well established research and development team is particularly important because of the strong synergy that has been demonstrated between KX01 and the taxanes; this may allow the development of an excellent combination therapy to help patients in the future.”

Chuck Lannon, vice-chairman of the Board, states: “Hanmi is a great partner to Kinex Pharmaceuticals and we have enjoyed our working relationship tremendously. The fact that our partner is providing us more of a success-based agreement is a reflection of their confidence in the Kinex team and also their goodwill to help Kinex to develop into a successful pharmaceutical company.”

The acquisition of an oral formulation of paclitaxel is important to both Kinex and Hanmi Pharmaceuticals as the taxanes have been shown to exhibit a strong synergistic effect with KX01, an orally bioavailable dual src kinase/pretubulin inhibitor that Kinex Pharmaceuticals and Hanmi Pharmaceuticals have been collaborating to develop since April 2011.

Under the terms of the agreement, Kinex Pharmaceuticals will acquire the rights to the development and commercialization of all products derived from the Orascovery programme for all indications in the United States, European Union, Eastern Europe, Russia, South America, Australia, New Zealand, Taiwan and Hong Kong. Korea, Japan, Mainland China and India are not included in this agreement.

Kinex Pharmaceuticals will assume all development responsibility and associated costs in the licensed territories and will collaborate with Hanmi Pharmaceuticals during this process.

Kinex Pharmaceuticals will provide Hanmi Pharmaceuticals with an up-front payment and all other payments will be effective when the first product is approved by regulatory authorities or when Kinex Pharmaceuticals has achieved certain events that create shareholder value. There will also be royalty payments associated with product sales. A joint development team will be established to foster the collaboration.