Hanmi Pharmaceuticals to Assign the Rights to Five New Territories to Kinex as
Part of the Orascovery Program Strategic Plan
BUFFALO, N.Y., Oct. 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
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."
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
SOURCE Kinex Pharmaceuticals
Contact: Patrick Gallagher, Kinex Pharmaceuticals, firstname.lastname@example.org,
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