Dong-A ST gains Korean rights to potential NASH candidate

Seoul, Korea

Seoul-based Dong-A ST has signed a new licensing deal with Tobira Therapeutics ($TBRA) that will see it gain access to research and sell the California company's fatty liver disease treatment with its new diabetes drug in its native Korea.

Dong-A launched its DPP-4 Type 2 diabetes drug Suganon (evogliptin) in the Republic of Korea just last month, and this week it signed an $80 million deal with San Francisco, CA-based Tobira to trial its drug in combination with the U.S. biotech's experimental nonalcoholic steatohepatitis (NASH) treatment cenicriviroc (CVC).

NASH is a liver-scarring disease that affects millions of people but has no approved therapies, and its commercial prospects have spurred a frenzy of activity in R&D around the industry--with some analysts estimating the market could be worth $40 billion at its peak in the next decade.

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Specifically, the companies have signed two licensing deals that will see Tobira acquire exclusive rights to develop and market the diabetes treatment evogliptin in combination with CVC, while also seeing the company develop the drug in North America, Europe and Australia as a single agent in all of its indications.

Meanwhile, Dong-A gains exclusive license to develop and market CVC, as both a single agent and in combination with evogliptin, in South Korea for all licenses. 

Both companies said in a statement that they plan to start a new program for a combo treatment in patients with NASH and also plan to work together on a global Phase III program for CVC as a single agent for NASH.

Combining one targeted NASH drug with a diabetes med is a new way of approaching the disease, with the drugmakers saying in a statement: "We are excited to be combining two potentially best-in-class products to develop a much needed therapy for these patients."

Under the terms of the deal, 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 III 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.

DPP-4 inhibitors such as Suganon have become the standard of care for diabetes, but they also have the potential to impact the metabolic issues that play a role in NASH disease progression, according to Laurent Fischer, CEO of Tobira. The drug is not approved in the U.S.

CVC is currently in midstage trials as a once-daily immunomodulator pill that blocks two chemokine receptors, CCR2 and CCR5, which are believed to cause liver scarring.

Fischer added that Suganon "complements the anti-inflammatory and anti-fibrotic effects of cenicriviroc and has the potential to be combined in a fixed dose combination tablet."

Tobira said it plans to conduct preclinical toxicology and pharmacokinetics studies with evogliptin, which are required prior to initiating a Phase I study of the CVC-evogliptin combination in late 2016.

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