Allergan Announces Third Acquisition for September

Allergan will expand their non-alcoholic steatohepatitis pipeline with the acquisition of Tobira therapeutics.

Allergan has announced its third acquisition for the month of September, the biopharmaceutical company Tobira Therapeutics.

Previous acquisitions this month include RetroSense Therapeutics and Vitae Pharmaceuticals. Allergan’s latest acquisition will make them a leader in research and development for non-alcoholic steatohepatitis (NASH), as well as expand their research and development (R&D) pipeline for other liver diseases, according to a company press release.

“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. “With the increasing rates of diabetes, obesity and other metabolic conditions in the US and in developed nations globally, NASH is set to become one of the next epidemic-level chronic diseases we face as a society. It is important that we invest in new treatments today so that healthcare systems, providers and patients have treatment options to face this challenge in the coming years."

Non-alcoholic steatohepatitis is a severe type of non-alcoholic fatty liver disease that develops when the accumulation of fat in the liver causes inflammation and cell damage. This inflammation can lead to fibrosis that progresses into cirrhosis, portal hypertension, liver cancer, and liver failure, according to a press release from Allergan.

Cenicriviroc and Evogliptin are 2 differentiated complementary developmental programs to treat elements of non-alcoholic steatohepatitis, which will be added to Allergan’s global Gastroenterology R&D pipeline.

“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,” said Brent Saunders. “We will continue to look for differentiated development-stage assets that can bolster this position and enhance our commitment to innovation in this disease.”

Cenicriviroc is an oral immunomodulator that blocks chemokine receptors CCR2 and CCR5 that are involved with inflammation and fibrosis associated with non-alcoholic steatohepatitis. A phase 2b study of the drug showed improvement in fibrosis of at least 1 stage without worsening of the disease after a year, according to Allergan.

“We are delighted that cenicriviroc will be rapidly advancing into Phase 3 studies under the stewardship of Allergan, an industry leader with world class capabilities in advancing novel treatment options to patients across the globe, and I look forward to the future success of this partnership,” said Dennis Podlesak, chairman of the Board of Tobira.

The new acquisition also adds Evogliptin to their pipeline. The drug is an oral Dipeptidyl peptidase-4 inhibitor currently in a phase 1 trial to determine the safety, tolerability, and pharmacokinetics of the drug when administered without cenicriviroc (CVC).

In patients with non-alcoholic steatohepatitis, increased Dipeptidyl peptidase-4 serum levels and hepatic Dipeptidyl peptidase-4 expression is associated with disease severity, Allergan reports.

“Both the CVC and Evogliptin programs provide highly differentiated compounds that can make a significant impact in the treatment of NASH, where today there are no approved therapies available for patients. Importantly, NASH treatment may well require a multi-therapeutic approach to address the multiple factors of the disease. CVC has been shown in clinical trials to provide significant improvement in liver fibrosis, the hallmark of NASH. Liver fibrosis is associated with key long-term outcomes, including overall mortality, liver transplantation and liver-related events. Evogliptin, in preclinical models, has been shown to decrease hepatic glucose production, improve hepatic triglyceride content and steatosis, and reduce histologic markers of inflammation of the liver,” said David Nicholson, chief research & development officer, Allergan. “Together, these programs provide a highly complementary potential therapeutic approach to address the inflammatory, metabolic and fibrotic elements of NASH that the medical community will need to treat this condition.”

The Board of Directors for both companies have unanimously approved the acquisition that has a total potential consideration of up to $1.695 billion, Allergan said.

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