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."