vTv Therapeutics Inc. (Nasdaq:VTVT) today announced that vTv Therapeutics LLC has entered into a licensing agreement with Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (“Huadong Pharmaceutical”), a wholly-owned subsidiary of Huadong Medicine Co., Ltd. (SZSE: 000963.SZ), for rights to develop and commercialize vTv Therapeutics’ GLP-1r agonist program in China and other Pacific Rim countries.
Under the agreement, vTv has granted Huadong Pharmaceutical an exclusive license to develop, manufacture and commercialize vTv Therapeutics’ GLP-1r agonist program in China, Hong Kong, Macau, Taiwan, Thailand, Vietnam, Indonesia, Malaysia, Philippines, Singapore, Myanmar, Cambodia, Laos, Brunei, South Korea and Australia. Under the terms of the agreement, vTv Therapeutics will run a Phase 2 Multi-Regional Clinical Trial (MRCT) including sites in the US and other regions in the Pacific Rim.
The licensing agreement includes rights to TTP273, an oral small molecule GLP-1R agonist, which met its primary endpoint and demonstrated a statistically significant reduction in HbA1c in a Phase 2 trial of type 2 diabetes. The compound was well-tolerated, with negligible incidences of nausea and vomiting across all arms of the study. Trends towards weight loss were also observed.
vTv will receive an $8 million upfront payment in connection with the signing of the agreement subject to satisfaction of customary conditions and is eligible for up to an additional $75 million in milestone payments related to development, regulatory and commercial milestones. In addition, vTv will be eligible to receive royalty payments on sales of commercialized products in the territories.
“Worldwide, the number of people with type 2 diabetes has quadrupled over the last 35 years, and there are approximately 160 million people with diabetes in the Western Pacific region,” said Steve Holcombe, president and CEO of vTv Therapeutics. “We are extremely pleased to partner with Huadong, one of the largest and most successful pharmaceutical companies in China. Our partnership has the potential to expand the treatment options for patients with type 2 diabetes in the licensed Asian countries where there is a proven need for an oral small molecule therapy that demonstrates benefits similar to the injectable diabetes GLP-1 peptides without the commonly associated side effects.”
Bangliang LI, Chairman of Huadong Pharmaceutical, said, “Diabetes medications constitute the core product line of Huadong Pharmaceutical, and also the key area for Huadong’s R&D and innovative drug strategy in the future. The signing of the vTv license agreement is an important milestone for Huadong Pharmaceutical, as it accelerates its transformation from a generic drug company to an innovative drug company, elevates the profile of its international strategy, and furthers its mission of providing more and better products to the greatest number of patients. I wish this cooperation a complete success.”
TTP273 is an oral small molecule that works by activating the GLP-1 receptor. Activation of the GLP-1 receptor leads to the enhancement of insulin secretion and suppression of glucagon production and decreased food intake. There are currently several marketed injectable GLP-1 peptide therapies. These agents have demonstrated notable glucose lowering in addition to weight loss; however, their widespread use may be hindered by the route of administration (injection) and by the high incidence of gastrointestinal side effects (nausea and vomiting).
About Type 2 Diabetes
Type 2 diabetes is a result of the body’s inability to use insulin properly to control sugar in the bloodstream. Type 2 diabetes represents up to 95% of diabetes patients, imposing a growing burden on healthcare systems globally. Diabetes remains the 7th leading cause of death in the United States, costing the healthcare system $245 billion annually. According to the American Diabetes Association, there are 29.1 million Americans, or 9.3% of the population, living with diabetes.
About vTv Therapeutics
vTv Therapeutics Inc. is a clinical-stage biopharmaceutical company engaged in the discovery and development of orally administered small molecule drug candidates to fill significant unmet medical needs. vTv has a pipeline of clinical drug candidates led by programs for the treatment of Alzheimer’s disease and diabetes as well as treatment of inflammatory disorders and the prevention of muscle weakness.
About Huadong Pharmaceutical Company
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd, is a wholly owned subsidiary of Huadong Medicine Co., Ltd. The company was incorporated in December 1992 and is a comprehensive pharmaceutical company that integrates traditional Chinese medicine, western medicine, bio-tech products API and dosage forms. The company has formed a series of drugs in the field of diabetes treatment and is in a leading position of domestic manufacturers in China. One of the company’s main products Acarbose has more than $ 220 million in sales in 2016. The company currently has more than 20 varieties in the field of diabetes in the development process, in which liraglutide of GLP-1 received the first clinical approval in China in August 2016.
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Source: vTv Therapeutics Inc.