Harbor BioSciences Signs Pharmaceutical Development Agreements With China State Institute of Pharmaceutical Industry (CIPI)
18 Janvier 2011 - 2:30PM
Harbor BioSciences, Inc. (OTCBB:HRBR), a leader in the development
of a proprietary class of adrenal steroid hormones as novel
pharmaceuticals, announced it has licensed the research and
development and commercialization rights for three of its products,
exclusively in the People's Republic of China and Hong Kong, to
China State Institute of Pharmaceutical Industry (CIPI). Harbor
BioSciences retains the rights to these products in the U.S. and
the rest of the world, and CIPI will make available to the company
all pre-clinical and clinical data it generates.
"The agreements with CIPI, the first of their kind for both
parties, provide the opportunity to move all of our products
forward through development simultaneously without any financial
support from Harbor BioSciences," explained James Frincke, Ph.D.,
President and Chief Executive Officer. "Furthermore, the
agreements provide the opportunity for Harbor BioSciences to
capture value for our research and development efforts completed to
date, while retaining U.S. and other world-markets rights."
CIPI is a major supplier of both generic drugs and traditional
Chinese medicines in China and Hong Kong. The three license
agreements cover Harbor BioSciences compounds HE2000, HE3235
(Apoptone®) and HE3286 (Triolex®) for any clinical use in the
People's Republic of China and Hong Kong.
CIPI plans to develop the Harbor BioSciences compounds for major
indications including diabetes, cancer, inflammation and infectious
diseases. A March 25, 2010 article in the "New England Journal
of Medicine" disclosed that Type 2 diabetes has become a major
health problem in China and may be epidemic. The article
indicates there are now 92.4 million people in China with diabetes
and 148.2 million who have pre-diabetes.
"We are very excited to be working with Harbor
BioSciences," commented Yu Xiong, Sr. Vice President of
CIPI. "The compounds that we licensed from Harbor BioSciences,
with their demonstrated safety profile and activity, are compatible
with new health initiatives of our government. With our
resources and extensive experience developing pharmaceuticals, CIPI
has initiated dedicated project teams in order to develop each
compound simultaneously and to commercialize them as quickly as
possible."
Harbor BioSciences believes these are the first drug development
agreements between a western pioneer drug company and a
government-owned Chinese drug developer for pharmaceutical
development to be conducted in the People's Republic of
China. CIPI, a low cost drug manufacturer, has agreed to
supply the licensed products to Harbor BioSciences for use in
clinical studies and sales outside of China and Hong
Kong. Harbor BioSciences can also elect to distribute these
compounds in countries that accept the State Food and Drug
Administration's (SFDA) drug approval process.
With its unique and proprietary technology platform, Harbor
BioSciences has been developing a new series of small molecule
compounds that are metabolites or synthetic analogs of endogenous
hormones derived by the adrenal glands from the body's most
abundant circulating adrenal steroid. These steroid hormones,
designed to restore the biological activity of cellular signaling
pathways disrupted by disease and aging, have been demonstrated in
humans to possess several properties of potential therapeutic
benefit including modulation of abnormal metabolism, inflammation
and cell proliferation.
Through its medicinal chemistry program, Harbor BioSciences has
produced potent drug candidates with improved pharmaceutical
properties. By first defining the chemical identities of a
potential native hormone and then applying the tools of medicinal
chemistry, the company has created or identified molecules that are
not only orally bioavailable but also potentially more potent and
useful as pharmaceuticals and nutraceuticals.
Clinical drug development candidates licensed to CIPI include
Triolex (HE3286), which has completed Phase IIa clinical trials in
patients with Type 2 diabetes and is in early stage development for
ulcerative colitis and rheumatoid arthritis; Apoptone (HE3235),
which has demonstrated activity in Phase I/IIa trials of prostate
cancer; and HE2000, which has shown to limit opportunistic
infections, including tuberculosis, in humans infected with the
HIV-1 virus, to reduce parasite levels in patients with
uncomplicated malaria and to attenuate non-productive lung
inflammation in animal models.
Harbor BioSciences will receive milestone payments for Triolex,
Apoptone and HE2000, excluding infectious diseases, at the
completion of Phase II and III clinical studies and upon approval
by the SFDA. Harbor BioSciences will also receive royalties
based on net profits for the life of each agreement. The term
of each agreement runs until the latter of (1) the expiration of
the last licensed patent or any Harbor, CIPI or joint improvement
patent and (2) the first documented third party sale of a competing
generic product in the licensed territory. In addition, Harbor
BioSciences is CIPI's sole agent with commercial development and
sales rights to all of CIPI's improvements that are sold outside
the licensed territory. Sales of licensed drugs that are
covered by CIPI's improvements outside the territory bear a royalty
to Harbor BioSciences.
About CIPI
CIPI was recently formed by a merger of the Shanghai Institute
of Pharmaceutical Industry (SIPI) and other institutes and
companies. SIPI's R&D focus has been in the areas
of cancer, infectious diseases, cardiovascular, autoimmune
disorders, endocrinology and CNS. CIPI is a subsidiary of the
China National Pharmaceutical Group Corporation (Sinopharm),
China's largest pharmaceutical and health industrial group under
the state-owned Assets Supervision and Administration Commission of
the State Council. Sinopharm's core businesses include
R&D, manufacturing, distribution and retail sales. Its
products are manufactured in more than 10 pharmaceutical and
biological production facilities. Sinopharm has more than 20
joint ventures with global pharmaceutical companies and through
trade and cooperative relations, has a presence in more than 100
countries and regions. Sinopharm reported in June 2010
six-month revenues of approximately $4.75 billion U.S. and net
profits of approximately $137 million U.S.
For additional information on Sinopharm and CIPI please go to
www.harborbiosciences.com.
SAFE HARBOR STATEMENT
Any statement included in this press release that are not a
description of historical facts are forward-looking statements that
involve risks, uncertainties, assumptions and other factors which,
if they do not materialize or prove correct, could cause Harbor
BioSciences' actual results to differ materially from historical
results or those expressed or implied by such forward-looking
statements. Such statements are subject to certain risks and
uncertainties inherent in the Company's business, including, but
not limited to: the Company's ability and/or CIPI's ability to
complete preclinical and clinical trials successfully and within
specified timelines, if at all; whether the conditions for the
Company to receive milestone payments from CIPI will occur; whether
net profits will be realized resulting in the Company's receipt of
royalty payments; the Company's capital needs; the Company's
ability to obtain additional funding; our ability to obtain
regulatory approval for Apoptone, Triolex, or any other
investigational drug candidate; and other risks detailed from time
to time in the Company's filings with the Securities and Exchange
Commission. Existing and prospective investors are cautioned
not to place undue reliance on these forward-looking statements,
which speak only as of the date of this press release. Except
as required by law, Harbor BioSciences undertakes no obligation to
update or revise the information contained in this press release as
a result of new information, future events or circumstances arising
after the date of this press release.
CONTACT: Robert Weber
Chief Financial Officer
Harbor BioSciences, Inc.
(858) 587-9333
rweber@harborbiosciences.com
Harbor Diversified (PK) (USOTC:HRBR)
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