Allergan Expands Leading Research & Development NASH Program with Novartis Clinical Collaboration

• Collaboration Focused on Phase 2b Clinical Trial to Evaluate Use of Allergan’s Cenicriviroc (CVC) and Novartis Lead FXR Agonist to Treat NASH
• NASH Fastest Growing Cause of Liver Cancer and Liver Transplant in the U.S.

DUBLIN, April 18, 2017 /PRNewswire/ — Allergan, a leading global biopharmaceutical company, announced today that it has entered into a clinical trial agreement with Novartis to conduct a Phase 2b study, using Allergan’s cenicriviroc (CVC) and Novartis’ lead FXR agonist for the treatment of non-alcoholic steatohepatitis (NASH). The Phase 2b study will assess the safety, efficacy and tolerability of this multi-therapy treatment approach for NASH. The financial details of this transaction are not disclosed.

“Our clinical collaboration with Novartis brings together our collective scientific and development expertise in NASH to focus on multi-therapy treatment, which is expected to be the most likely approach based on the multi-factorial aspects of this disease,” said David Nicholson, Chief Research & Development Officer, Allergan. “Collaboration with companies like Novartis will help us improve our understanding of the disease and deliver effective, high-value medicines for NASH patients. This is also another terrific example of Allergan’s Open Science Research & Development model in action.”

NASH is the progressive form of non-alcoholic fatty liver disease (NAFLD), which is characterized by the accumulation of fat in the liver with no other apparent causes.i NASH occurs when the accumulation of liver fat is accompanied by inflammation and cellular damage.ii The inflammation can result in fibrosis (scarring) of the liver and eventually lead to complications such as cirrhosis, portal hypertension, liver cancer and liver failure.ii There are currently no approved treatments for NASH.

CVC is a once-daily, oral, Phase 3 ready potent immunomodulator that blocks two chemokine receptors, CCR2 and CCR5, which are involved in inflammatory and fibrogenic pathways. In the Phase 2b CENTAUR study, CVC demonstrated a clinically meaningful improvement in fibrosis of at least one stage without worsening of NASH after one year of treatment, which is one of only two approvable Phase 3 endpoints. With its unique Mechanism of Action (MOA) and its favorable safety profile, CVC represents an ideal candidate to become the backbone of NASH multi-therapy treatment. CVC has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in patients with NASH and liver fibrosis.

Novartis is developing Farnesoid X receptor (FXR) agonists for the treatment of chronic liver diseases, including NASH. The most advanced investigational compound is a potent, non-bile acid FXR agonist, which recently received Fast Track designation from the FDA and is in a Phase 2 clinical trial. As part of this agreement, Novartis and Allergan will conduct a Phase 2b clinical trial to assess the safety, efficacy and tolerability of a multi-therapy treatment for NASH.

About Non-Alcoholic Steatohepatitis (NASH)
NASH is the progressive form of non-alcoholic fatty liver disease (NAFLD), which is characterized by the accumulation of fat in the liver with no other apparent causes.ii NASH occurs when the accumulation of liver fat is accompanied by inflammation and cellular damage.ii The inflammation can result in fibrosis (scarring) of the liver and eventually lead to complications such as cirrhosis, portal hypertension, liver cancer, and liver failure.ii

NAFLD and NASH affect approximately 30 percent and 5 percent, respectively, of the U.S. population and NAFLD affects more than 20 percent of the population worldwide.iii NASH is the fastest growing cause of liver cancer and liver transplant in the U.S.iv The increasing prevalence of NASH is related to the growing obesity epidemic and the disease is often diagnosed in patients who have diabetes, high cholesterol or high triglycerides.iii There is currently no approved treatment for NASH.

About Allergan NASH Programs
Allergan has demonstrated leadership in the gastrointestinal (GI) category and shown a continued commitment to innovate and advance science and treatments for unmet medical needs. Currently, NASH is an extension of Allergan’s broad GI portfolio and represents one of the greatest unmet medical needs.

In 2016, Allergan acquired cenicriviroc (CVC), evogliptin and AGN-242266 (formerly AKN-083), three programs targeting different mechanisms for the treatment of this multi-factorial disease. CVC is a once-daily, oral Phase 3 ready, potent immunomodulator that blocks two chemokine receptors, CCR2 and CCR5, which are involved in inflammatory and fibrogenic pathways. AGN-242266 is a potentially best-in-class, Phase 1 ready farnesoid X receptor (FXR) agonist expected to be highly complementary to CVC and Evogliptin. Allergan expects to advance AGN-242266 into a Phase I clinical trial in the first half of 2017. Allergan is committed to advancing its overall portfolio of NASH programs, to focus on bringing forward effective treatments for this critical disease area.

About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals, devices and biologic products for patients around the world.

Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women’s health, urology and anti-infective therapeutic categories.

Allergan is an industry leader in Open Science, the Company’s R&D model, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. This approach has led to Allergan building one of the broadest development pipelines in the pharmaceutical industry with 70+ mid-to-late stage pipeline programs in development.

Our Company’s success is powered by our more than 16,000 global colleagues’ commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right.

With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.

For more information, visit Allergan’s website at www.Allergan.com.

Forward-Looking Statement
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan’s current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Allergan’s current expectations depending upon a number of factors affecting Allergan’s business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan’s products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan’s periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan’s Annual Report on Form 10-K for the year ended December 31, 2016. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

ⁱ The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Fatty Liver Disease (Nonalcoholic Steatohepatitis). ttps://www.niddk.nih.gov/heal…
ⁱⁱ Nonalcoholic fatty liver disease: A systematic review. ME, Rinella. Journal of the American Medical Association, 2015, Vol. 313, pp. 2263-2273.
ⁱⁱⁱ Sattar N, et al. Non-alcoholic fatty liver disease. Available from: ttp://www.bmj.com/content/349….
^iv Anderson, C.D. Curr Surg Rep (2015) 3: 24. doi:10.1007/s40137-015-0101-6.

SOURCE: Allergan