Harbor Biosciences signs development agreements for HE2000, HE3235 and HE3286 with CIPI

Jan 18 2011

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.