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Tobira Therapeutics : TBRA) Set to be Acquired by Allergan (AGN) as Cenicriviroc Approaches Phase III Development

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09/27/2016 | 07:41pm CEST

Tobira Therapeutics, Inc. (NASDAQ: TBRA) is a clinical-stage biopharmaceutical company focused on the development and commercialization of therapies for non-alcoholic steatohepatitis (NASH) and other liver diseases. The company’s lead product candidate, cenicriviroc (CVC), is a dual inhibitor of the CCR2 and CCR5 pathways currently being evaluated for the treatment of NASH in adults with liver fibrosis and primary sclerosing cholangitis (PSC). Tobira is currently on track to complete planning for phase III trials of CVC by the end of 2016, according to an update issued last month, after topline data from the company’s CENTAUR phase IIb study demonstrated a “clinically relevant and statistically significant improvement in fibrosis of at least one stage without worsening of NASH, after only one year of treatment.”

According to a 2015 article published in the World Journal of Hepatology (http://nnw.fm/qRe9d), NASH is typically a precursor to non-alcoholic fatty liver disease (NAFLD), which is considered the most common liver disease in the western world. As the prevalence of NAFLD continues to rise, NASH-related cirrhosis and hepatocellular carcinoma are expected to become major health care problems and the leading indication of liver transplantation. The report goes on to estimate that roughly 20 to 30 percent of the general population in the western world suffers from NAFLD, with the disease being particularly common in obese individuals. Despite the rising prevalence of NASH worldwide, there are currently no approved treatments for the disease.

By disrupting CCR2 and CCR5 signaling pathways in affected patients, CVC aims to decrease recruitment and migration of pro-inflammatory monocytes to existing liver conditions, effectively slowing or halting the progression of NASH and the potential development of cirrhosis.

“We are excited about the results of the CENTAUR trial, which we believe is the first study to prospectively meet an endpoint recommended for Phase 3 studies to support marketing authorization, namely ‘an improvement in fibrosis by at least one stage without worsening of NASH,’” Laurent Fisher, M.D., chief executive officer of Tobira, stated in a news release. “This is an important milestone as fibrosis is a key predictor of mortality and liver-related events. We are confident about our path forward, and we look forward to discussing the Phase 3 study with regulators and presenting the CENTAUR data at a medical meeting later this year.”

Last week, Tobira made headlines when it was announced that the company had entered into a definitive agreement with Allergan (NYSE: AGN), a leading global pharmaceutical firm, through which Allergan intends to acquire Tobira for an upfront payment of $28.35 per share. The agreement also includes up to $49.84 per share in contingent value rights that may be payable based on future development, regulatory and commercial milestones. Pending future developments, the deal could be worth nearly $1.7 billion. Tobira’s PPS hovered near $38.95 as of the afternoon of Monday, September 26, 2016.

The boards of both companies have already unanimously approved the acquisition, and holders of roughly 36 percent of the outstanding shares of Tobira common stock have entered agreements to tender their shares into the offer. Remaining shares are expected to be acquired as part of a second-step merger, which will be initiated as soon as practicable after close of the tender offer. The Allergan acquisition is subject to customary closing conditions, with the transaction expected to close by the end of this year. Executives from both companies expressed excitement regarding the acquisition, particularly as it relates to the ongoing clinical development of CVC.

“The combination of our team’s innovation in the NASH space and the infrastructure, development expertise and world-class ability of Allergan to market medicines will enable us to more rapidly develop and commercialize needed medications for patients suffering from NASH and other serious fibrotic diseases around the world,” concluded Fischer.

For more information, visit www.Tobiratx.com

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