Tobira and Korea's Dong-A ST sign $80M diabetes/NASH deal

San Francisco

South San Francisco, CA-based biotech Tobira Therapeutics ($TBRA) has signed a new licensing deal with Dong-A ST to help turn its recently approved DPP-4 diabetes drug into a new fatty liver combo treatment in a deal worth around $80 million.

Korean-based Dong-A ST and the U.S. biotech have signed two licensing deals that will see Tobira acquire exclusive rights to develop and market the diabetes treatment evogliptin in combination with its investigational NASH drug cenicriviroc (CVC), while also seeing the company develop the drug as a single agent in North America, Europe and Australia in all of its indications.

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

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Both companies said in a statement that they plan to start a new program for a combo treatment in patients with fatty liver disease (non-alcoholic steatohepatitis, or NASH) and also plan to work together on a global Phase III program for CVC as a single agent for NASH.

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.

Combining one targeted NASH drug with a diabetes med is a new way of approaching the disease, with the drugmakers saying in 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 ST 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 ST 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.

Evogliptin is currently approved in Korea (but not in the U.S.), where it is known as Suganon. The drug, a DPP-4 inhibitor, is licensed for type II diabetes patients to help lower their sugar levels and was launched just last month.

These types of incretin therapies 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.

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 required prior to initiating a Phase I study of the CVC-evogliptin combination in late 2016.

The potential of success in NASH has drawn a bevy of players into the field, led by Intercept Pharmaceuticals ($ICPT).

Gilead Sciences ($GILD) splashed into the space with a $470 million deal for a Phase II NASH treatment and more recently struck the potentially $1.2 billion deal with Nimbus and its early-stage NASH drug--with hepatitis C experts at Enanta Pharmaceuticals ($ENTA) and Genfit also entering the field as well. Analysts believe that individual treatments could take home an eye-watering $10 billion a year each, should they gain approval.

Tobira had been seeking an IPO but dropped its plans last year as companies began to struggle to get their IPOS off as headwinds abounded. It did however pull off a reverse merger with Regado Biosciences, raising $70 million for its R&D war chest--which will go towards its new pact.

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