SAN DIEGO, Feb. 1, 2016 /PRNewswire/ -- HUYA Bioscience International (HUYA) President, CEO, Executive Chairman & Founder Dr. Mireille Gillings announced that Eisai Co., Ltd. has acquired from HUYA an exclusive license agreement for HBI-8000 in Japan, South Korea, Thailand, Malaysia, Indonesia,Philippines, Vietnam and Singapore. HBI-8000 is the first approved oral class I-selective histone deacetylase (HDAC) inhibitor, which is now in various stage of development globally for Non-Hodgkin's Lymphoma (NHL) in Japan and solid tumors including Immuno-Oncology in the United States. The product was recently granted orphan drug designation by Japan's Ministry of Health, Labour and Welfare based on the estimated size of the Japanese PTCL patient population, existing data as well as the clinical development plan forJapan.
HUYA will complete the development of HBI-8000 for NHL in Japan for commercialization by Eisai who will hold exclusive rights to develop future indications such as solid tumors in the licensed territory. Eisai will pay HUYA an upfront and milestones up to $280M plus royalties on net sales. HUYA will manufacture and supply the product to Eisai for commercialization and other future development.
"This collaboration aligns with Eisai's drive to contribute to patients in our focused field of oncology. Eisai and HUYA will cooperate to develop and commercialize this HDAC inhibitor which we hope to deliver to the market as a treatment that will fulfill the diverse needs of, and bring about benefits for, patients with cancer and their families" said Mr. Terushige Iike, Chief Product Creation Officer of Eisai Product Creation Systems.
"We are delighted to enter into this partnership with Eisai. Our excitement about HBI-8000 increases almost daily, particularly as we are also demonstrating important immunological properties for this oral product with exemplary safety. Patients with both liquid and solid tumors will benefit as our precision medicine team develops 8000 to its full potential" said Dr. Mireille Gillings, President, CEO & Executive Chairman of HUYA. "The license reinforces our vision of leveraging clinical data generated within Asia using the Tripartite Cooperation Treaty to expand into other countries such as Japan and Korea. Eisai's global strength in oncology will help ensure the drug's path to regulatory approval."
HBI-8000 is a member of the benzamide class of histone deacetylase (HDAC) inhibitors designed to block the catalytic pocket of Class I HDACs. HBI-8000 is an orally bioavailable, low-nanomolar inhibitor of cancer-associated HDAC enzymes with favorable pharmacology and safety profiles. HBI-8000 inhibits cancer-associated Class I HDAC1, HDAC2, HDAC3, as well as Class IIb HDAC10 at nanomolar concentrations and stimulates accumulation of acetylated histones H3 and H4 in tumor cells. Studies with human-derived tumor cell lines have demonstrated that HBI-8000 inhibits the growth of many tumor cell lines via multiple mechanisms of action, including epigenetic regulation of tumor cell growth and apoptosis, immunomodulatory effects regulating antitumor activity, as well as repression of genes associated with drug resistance. To date, HBI-8000 has been dosed in various types of hematological and solid tumors in several clinical trials, including a Phase 1 trial completed in the United States.
About HUYA Bioscience International
HUYA Bioscience International is the leader in enabling and accelerating the global development of novel biopharmaceutical product opportunities originating in China. Extensive collaborations are established with Chinese biopharmaceutical, academic and commercial organizations to speed development and value creation in worldwide markets for China-sourced product candidates. With the largest Chinese compound portfolio covering all therapeutic areas, HUYA has emerged as the partner-of-choice for maximizing the value of biopharmaceutical innovation in China. HUYA has offices in the U.S., Japan, South Korea and eight strategic locations across China. With the largest team of scientists working with Chinese innovators, HUYA identifies and advances promising drug candidates globally. HUYA received the Asia-Pacific Stevie® Award in the Health Products and Services & Pharmaceuticals category and Dr. Mireille Gillings received the Gold Stevie Award in the Woman of the Year 2015 American Business Award category. For more information, please visit www.huyabio.com
About Eisai Co., Ltd.
Eisai Co., Ltd. is a Japan-based global research-based pharmaceutical company, and aims to be a "human health care (hhc)" company that gives first thought to patients and their families, and to increasing the benefits health care provides. Eisai Co., Ltd. has a global network of research facilities, manufacturing sites, and marketing subsidiaries, and more than 10,000 employees worldwide are engaged in development and provision of innovative new drugs in areas of unmet medical needs. For further information on Eisai Co., Ltd., please visit www.eisai.com.
Bob Goodenow, Ph.D.
Chief Business Officer
HUYA Bioscience International