Tobira Therapeutics, Dong-A ST sign license agreements for Evogliptin and Cenicriviroc

Tobira has acquired exclusive rights to develop and market evogliptin in combination with cenicriviroc (CVC) and as a single agent in the United States, Canada, Europe and Australia for all therapeutic indications.

Dong-A has received an exclusive license to develop and market CVC, as both a single agent and in combination with evogliptin in the Republic of Korea for all therapeutic indications. Both companies plan to initiate development programs for the combination of the two agents for the treatment of patients with non-alcoholic steatohepatitis (NASH) and also plan to collaborate on a global Phase 3 program for CVC single agent for NASH.

Under the terms of the agreement, Dong-A received an upfront cash payment of $1.5 million and is eligible to receive up to an additional $25 million in payments linked to the achievement of Phase 3 completion and approval milestones for the first indication and up to an additional $10 million for additional indications. Dong-A may receive up to an additional $35 million for commercial milestones.

Tobira received an upfront cash payment of $0.5 million and is eligible to receive up to an additional $2.5 million in payments linked to the achievement of similar milestones per indication in the Republic of Korea. In addition, each party will receive tiered royalty payments based on net sales. Each company is responsible for its own development costs incurred within its respective territory.

"This relationship with Dong-A is an important step toward our goal of developing much needed combination therapies for the millions of patients suffering from NASH and to become the preferred partner for companies seeking to develop NASH therapies," said Laurent Fischer, M.D., chief executive officer of Tobira.

"While incretin therapies are already standard of care for diabetes, they also have the potential to impact the metabolic issues that play a role in NASH disease progression. Evogliptin is a potent DPP-4 inhibitor administered as a small 5mg once-daily tablet and has demonstrated compelling preclinical and clinical activity for the treatment of type 2 diabetes. It complements the anti-inflammatory and anti-fibrotic effects of cenicriviroc and has the potential to be combined in a fixed dose combination tablet."

Evogliptin (Suganon) was launched in the Republic of Korea in March of this year for blood glucose control in patients with type 2 diabetes mellitus. There is a substantial amount of data suggesting that the incretin/GLP-1 pathways targeted by evogliptin are implicated in the progression of non-alcoholic fatty liver disease (NAFLD) and NASH. The combination of agents is intended to simultaneously address the metabolic pathogenesis of NASH and the inflammation and fibrosis that cause liver damage and often lead to cirrhosis, liver cancer or liver failure. The ultimate goal is to achieve greater improvement of liver-related outcomes.

"We are pleased to be working with Tobira to further the development of evogliptin in combination with CVC," said Soo-Hyoung Kang, president & CEO of Dong-A ST Co., Ltd.

"Their focus and experience in liver disease will allow us to explore the potential of our drugs to help patients suffering from non-alcoholic steatohepatitis. NASH is an epidemic that affects millions of people globally, including many people in South Korea, and we are excited to be combining two potentially best-in-class products to develop a much needed therapy for these patients. "

Tobira plans to conduct preclinical toxicology and pharmacokinetics studies with evogliptin required prior to initiating a Phase 1 study of the CVC-evogliptin combination in late 2016.