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
Logo - http://photos.prnewswire.com/prnh/20150612/222796LOGO
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.
About Allergan
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.
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 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.
References
- 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.
CONTACTS:
Allergan
Investors:
Lisa DeFrancesco
(862) 261-7152
Media:
Mark Marmur (U.S.)
(862) 261-7558
Janet Kettels (Int'l)
+447738506476
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/allergan-receives-chmp-positive-opinion-for-enzepi-pancrelipase-for-patients-with-exocrine-pancreatic-insufficiency-epi-300260078.html
SOURCE Allergan plc