Dublin, Ireland-based global pharmaceutical company Allergan plc (NYSE: AGN) agreed to acquire San Francisco-based Tobira Therapeutics Inc. (NASDAQ: TBRA), a biopharmaceutical company developing therapies for non-alcoholic liver diseases, for $28.35 per share in cash, and up to $49.84 per share in contingent milestone payments, in a deal valued at up to $1.695 billion. The boards of directors of both companies have unanimously approved the deal.

Allergan also said it acquired biopharmaceutical company Akarna Therapeutics Ltd. from Forbion Capital Partners, New Science Ventures and Third Point Ventures, for $50 million.

“The acquisition of Tobira is a strategic R&D investment within a white space area of our global gastroenterology franchise and an opportunity to advance the development of novel treatments for NASH,” said Brent Saunders, CEO and president of Allergan.

“The acquisition of Akarna adds to our strategic approach to investing in innovation to advance the treatment of NASH for millions of patients who currently do not have therapeutic options to treat the disease,” he said.

Akarna’s lead program is a potential best-in-class FXR agonist for the treatment of non-alcoholic steatohepatitis (NASH). Akarna’s lead product candidate is currently in pre-clinical, IND-enabling toxicology and safety pharmacology studies. Akarna is a UK-registered company with offices in Cambridge, UK and San Diego, Calif.

“We are excited to be working with Allergan, a company that shares our vision to develop the best possible treatments for NASH,” said Akarna founder and chief executive Raju Mohan, PhD.

NASH is a severe type of non-alcoholic fatty liver disease (NAFLD), which is characterized by the accumulation of fat in the liver with no other apparent causes. NASH occurs when the accumulation of liver fat is accompanied by inflammation and cellular damage. The inflammation can lead to fibrosis (scarring) of the liver and eventually progress to cirrhosis, portal hypertension, liver cancer and eventual liver failure.

“I am extremely excited to see Tobira and Allergan come together,” said Tobira’s chief executive Laurent Fischer, MD.

“With this acquisition, Allergan will now have one of the strongest portfolios of development stage programs for the treatment of NASH, with Cenicriviroc as the cornerstone. We will continue to look for differentiated development-stage assets that can bolster this position and enhance our commitment to innovation in this disease,” added Saunders. “With the increasing rates of diabetes, obesity and other metabolic conditions in the U.S. and in developed nations globally, NASH is set to become one of the next epidemic-level chronic diseases we face as a society.”

Cenicriviroc (CVC) is a first-in-class, once-daily, oral Phase 3 ready potent immunomodulator that blocks two chemokine receptors, CCR2 and CCR5, which are involved in the inflammatory and fibrogenic pathways in NASH that cause liver damage and often lead to cirrhosis, liver cancer or liver failure. In the Phase 2b CENTAUR study, CVC demonstrated a clinically and statistically significant improvement in fibrosis of at least one stage without worsening of NASH, one of two key secondary endpoints, after one year of treatment.

The acquisition of Tobira also adds Evogliptin, an oral DPP-4 (Dipeptidyl peptidase-4) inhibitor for the potential treatment of NASH. Evogliptin is being studied in a Phase 1 trial assessing the safety, tolerability and steady-state pharmacokinetic parameters of the compound when administered with and without CVC. In NASH, increased DPP-4 serum levels and hepatic DPP-4 expression is correlated with disease severity.

The Tobira deal is subject to customary closing conditions, including U.S. antitrust clearance and the tender of a majority of the outstanding shares of Tobira common stock. Holders of approximately 36 percent of Tobira’s stock have agreed to tender their shares. The closing is expected by the end of 2016.

Covington & Burling LLP is serving as Allergan’s lead legal counsel. Centerview Partners and Citi are serving as financial advisors to Tobira and Skadden, Arps, Slate, Meagher & Flom LLP and Gunderson Dettmer Stough Villeneuve Franklin & Hachigian, LLP are serving as Tobira’s legal counsel.

Moelis & Co. LLC acted as financial advisor to Akarna, and Wilson Sonsini Goodrich & Rosati LLP acted as its legal counsel.



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