Allergan Partners with TARGET PharmaSolutions to Advance NASH Research

• Five-Year Study to Enroll 15,000 Adults and Children with NAFLD or NASH
• NASH Fastest Growing Cause of Liver Cancer and Liver Transplant in the U.S.

DUBLIN, April 20, 2017 /PRNewswire/ — Allergan, a leading global biopharmaceutical company, announced today that it will collaborate with TARGET PharmaSolutions, a clinical data company focused on real world evidence, on its TARGET-NASH study. TARGET-NASH is a five-year longitudinal observational study that looks at patients with nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH). TARGET-NASH was launched in advance of related drug approvals in order to help facilitate a greater understanding of the impact of NASH and future treatment options. Allergan has a strong commitment to developing treatments for NASH and is pleased to sign on with TARGET-NASH.

“Allergan is focused on identifying, developing and bringing forward innovative treatments for patients with significant unmet medical needs, such as non-alcoholic steatohepatitis (NASH),” said David Nicholson, Chief Research & Development Officer, Allergan. “NASH is an emerging healthcare crisis affecting both adults and children. This unique collaboration will help to further our collective understanding of the disease, effective modes of treatment and outcomes across the spectrum of patient groups.”

TARGET-NASH is a unique program as it involves academia, industry, regulatory agencies and the NASH/NAFLD community. TARGET-NASH’s first patient enrollment occurred August 1, 2016, and over the course of the five-year study the program looks to enroll 15,000 adults and children with NAFLD or NASH. The study design is disease focused, not drug specific, allowing for continuous acquisition of natural history and outcomes data as new drugs enter the market and clinical treatment paradigms evolve.

TARGET PharmaSolutions’ TARGET study model is based on the success of HCV-TARGET, a case study in Hepatitis C. Formed in 2011 by Drs. Michael Fried, MD (University of North Carolina) and David Nelson, MD (University of Florida), HCV-TARGET has enrolled over 10,000 patients and has generated data that has been used by physicians, payers, and regulatory agencies around the world.

“TARGET-NASH is critical for the scientific and regulatory community as we prepare for new agents for the treatment of NASH,” said Arun Sanyal, MD, Co-Chair, TARGET-NASH Steering Committee. “In the immediate term, it will give us a critical understanding of NASH diagnosis and management in the real world across multiple populations. In the longer term, it is the perfect platform to have a deep understanding of the safety and effectiveness of these new agents across populations not included or underrepresented in Phase 3 clinical trials.”

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.i NASH occurs when the accumulation of liver fat is accompanied by inflammation and cellular damage.ii The inflammation can lead to fibrosis (scarring) of the liver and eventually lead to complications such as cirrhosis, portal hypertension, liver cancer, and eventual liver failure.ii

NAFLD and NASH affect approximately 30% and 5%, respectively, of the US population and NAFLD affects more than 20% of the population worldwide.iii NASH is the fastest growing cause of liver cancer and liver transplant in the U.S.iv Liver cancer among women grew by 3.8% (95% CI=3.4 to 4.1) per year over the past five years, replacing thyroid cancer as the most rapidly increasing cancer incidence among women.v 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 category leadership in several gastrointestinal disorders (GI) and shown continued commitment to innovate and advance science and treatments for unmet medical needs. NASH is an adjacency to 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 Phase 1 ready farnesoid X receptor (FXR) agonist expected to be complementary to CVC and Evogliptin. 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
This press release contains forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements, including statements about prevalence and unmet need. Each forward‐looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include those related to preclinical and clinical development, manufacturing and formulation development; the risk that future clinical studies need to be discontinued for any reason, including safety, tolerability, enrollment, manufacturing or economic reasons; the risk that findings from our completed nonclinical and clinical studies may not be replicated in later studies; efficacy, safety and tolerability; decisions by regulatory authorities; those risks related to competition and future business decisions made by us and our competitors or potential competitors; developments in the intellectual property landscape; and the risks listed under the heading “Risk Factors” and elsewhere in Ironwood’s Annual Report on Form 10-K for the year ended December 31, 2016, Allergan’s Annual Report on Form 10-K for the year ended December 31, 2016 and in the subsequent SEC filings of each company. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and Ironwood and Allergan undertake no 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.
^v The National Institute of Health. ttps://www.nih.gov/news-event…

SOURCE: Allergan