DUBLIN, April 29, 2016 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a Positive Opinion for the Marketing Authorisation of ENZEPI® (pancrelipase) in the European Union. 1 ENZEPI® is a pancreatic enzyme replacement therapy (PERT) for patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis or other conditions (e.g. chronic pancreatitis, post pancreatectomy or pancreatic cancer).2 ENZEPI® is specifically formulated to meet 100 percent of the label-claimed lipase enzyme activity, in line with the CHMP guidelines.3,4
Patients with EPI cannot digest food normally because there is a deficiency in their exocrine pancreatic enzymes.5 ENZEPI® contains a defined amount of digestive enzymes including lipases, proteases and amylases which are required by the body to metabolise fats, proteins and sugars from food. Without these enzymes, patients with EPI are less able to absorb essential nutrients from food and can become malnourished. Effective management of EPI includes life-long pancreatic enzyme replacement therapy (PERT), lifestyle and dietary modifications and vitamin and nutrient supplements.
"Receiving the positive opinion for ENZEPI® is a key milestone to bringing this new therapy to EPI patients across the Europe Union," said David Nicholson, EVP and President of R&D, Allergan. "Working to bring ENZEPI® to European patients underscores our ongoing commitment to being a preferred partner to the gastro-intestinal (GI) specialty areas and we are now actively looking to bring additional treatments and therapies to GI and cystic fibrosis specialists."
In a clinical trial, ENZEPI® demonstrated comparable efficacy and tolerability to an existing PERT formulation.6 ENZEPI® will be available in four strengths2 to allow for individualised titration of dosage and a tailored treatment for each patient. ENZEPI® has been purified using an additional treatment step designed to inactivate viruses and thus increase the level of viral safety.7
"ENZEPI® has undergone extensive testing and offers accurate dosing which will give physicians confidence that they are prescribing the correct dose for their patients. It's very encouraging to see that ENZEPI® has received a positive opinion from the CHMP as this means that once it receives a Marketing Authorisation, patients and physicians will have another enzyme replacement therapy to choose from," said Professor Christopher Taylor, Consultant Paediatric Gastroenterologist at the University of Sheffield.
The Committee for Medicinal Products for Human Use (CHMP) is the scientific committee of the European Medicines Agency (EMA) and recommends medicines for Marketing Authorization across the 28 member states of the European Union. ENZEPI® is the first PERT to be reviewed through the Centralised Procedure. The final decision from the European Commission is expected within a few months. If approved, Allergan anticipate launching this new product across Europe by early 2017, following successful negotiations with the relevant national payer and reimbursement groups. ENZEPI® is already licensed in the U.S. and Canada as ZENPEP®.
Note to Editors:
About Exocrine Pancreatic Insufficiency 5,8
Exocrine pancreatic insufficiency (EPI) is a chronic condition characterised by poor absorption of fats, proteins, and carbohydrates. It is caused by inadequate delivery of pancreatic digestive enzymes to the intestine and can result in malabsorption and malnutrition. It is mostly associated with underlying conditions such as cystic fibrosis, chronic pancreatitis, pancreatic cancer and from the effects of gastrointestinal surgery.
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women's health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world's third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.
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.
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect the current perspective of Allergan on existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaim any intent or obligation to update these forward-looking statements. Actual results may differ materially from the current expectations of Allergan depending upon a number of factors affecting the business of the company. These factors include, among others, the risks associated with transactions and the transition of a marketed product between companies; the risk that ENZEPI does not reach its commercial potential in Europe; the impact of competitive products and pricing; market acceptance of and continued demand for ENZEPI and competitive products; the efficacy, safety and tolerability of ENZEPI; the difficulty of predicting the timing or outcome of regulatory approvals or actions, if any; 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, 2015 (certain of such periodic public filings having been filed under the "Actavis plc" name). Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.
- Committee for Medicinal Products for Human Use (CHMP) Meeting. European Medicines Agency, London, UK 25-28 April 2016. Positive opinion decision available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/04/news_detail_002518.jsp&mid=WC0b01ac058004d5c1
- ENZEPI® Summary of Product Characteristics, April 2016
- ENZEPI® stability data on file.
- CHMP. Guideline on the clinical development of medicinal products for the treatment of cystic fibrosis. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003507.pdf. Accessed April 2016
- U.S. Department of Health and Human Services. Food and Drug Administration. Federal Register: Part V I. April28, 2004. http://a257.g.akamaitech.net/7/257/2422/14mar200/0880/edocket.access.gpo.gov/2004/pdf/04-9652.pdf. Accessed April 2016.
- Taylor CJ et al. Comparison of two pancreatic enzyme products for exocrine insufficiency in patients with cystic fibrosis. J Cystic Fibrosis. 2016. In Press
- ENZEPI® viral inactivation data on file.
- Al-Kaade S. Exocrine pancreatic insufficiency. Medscape. http://emedicine.medscape.com/article/2121028overview. Accessed April 2016.
Mark Marmur (U.S.)
Janet Kettels (Int'l)
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