-- Expands Allergan’s Innovative GI Pipeline with
ABI-M201 and ABI-M301, Preclinical Compounds Targeting Ulcerative
Colitis and Crohn’s Disease, as well as Future Compounds for
Irritable Bowel Syndrome --
Allergan plc (NYSE:AGN) and Assembly Biosciences, Inc.
(NASDAQ:ASMB) today announced that Allergan has entered into a
research, development, collaboration and license agreement for the
worldwide rights to Assembly’s microbiome gastrointestinal (GI)
development programs. The agreement provides Allergan with
worldwide rights to preclinical compounds ABI-M201 and ABI-M301,
targeting ulcerative colitis (UC) and Crohn’s disease (CD), as well
as two additional compounds to be identified by Assembly for
Irritable Bowel Syndromes (IBS); with Diarrhea (IBS-D), with
Constipation (IBS-C) or Mixed (IBS-M).
Under the terms of the agreement, Allergan will make an upfront
payment to Assembly of $50 million for the exclusive, worldwide
rights to develop and commercialize the UC, CD and IBS compounds.
Additionally, Assembly will be entitled to receive success-based
development and commercial milestone payments. Assembly is also
eligible to receive tiered royalties based on net sales. Allergan
and Assembly will generally share development costs through
proof-of-concept (POC) studies, and Allergan will assume all
post-POC development costs.
The Assembly microbiome program consists of a fully integrated
platform that includes a robust strain identification and selection
process, methods for strain isolation and growth under current Good
Manufacturing Practices and a patent-pending delivery system,
GEMICEL®, which allows for targeted oral delivery of live biologic
and conventional therapies to the lower gastrointestinal tract.
“The Microbiome -- the microbial populations that colonize the
human body -- is rapidly gaining prominence in numerous fields of
research relevant to Allergan’s key areas of focus, including GI
disorders,” said David Nicholson, Chief R&D Officer,
Allergan. “Assembly is well positioned to identify and select
unique therapeutic candidates and deliver them to the optimal site
in the GI tract through a novel oral delivery system.”
This collaboration reinforces Allergan’s commitment to building
a robust portfolio through Open Science. As with most of our
agreements, we enter into partnerships which, through creative
structures, leverage the expertise of our partners to potentially
deliver innovative treatments for improved patient care.
“Our fully-integrated microbiome platform reflects Assembly’s
commitment as one of the leaders in the exciting new field of
microbiome therapeutics, which has the potential to address a range
of diseases in entirely new ways,” said Derek Small, Chief
Executive Officer of Assembly. “We are delighted to enter into this
collaboration with Allergan, an innovator in GI, as we work
together to realize the potential of microbiome therapies and
provide treatments to patients with serious GI disorders.”
“Inflammatory diseases of the GI tract, including Crohn’s
disease and ulcerative colitis, are debilitating conditions that
remain poorly treated for many patients,” said Martin J. Blaser,
MD, Director of the New York University Human Microbiome
Program. “Therapies leveraging the microbiome may be able to
address these disorders in fundamentally new ways. I am encouraged
that microbiome innovators such as Assembly and Allergan are
working to convert their promising new approaches into clinically
useful products to help these patients.”
The transaction is expected to close in the first quarter of
2017, subject to customary closing conditions, including the
expiration or early termination of the waiting period under the
Hart-Scott-Rodino Antitrust Improvements Act of 1976.
About Crohn’s Disease and Ulcerative
Colitis1,2
Crohn’s disease and ulcerative colitis are chronic inflammatory
conditions of the gastrointestinal tract. Crohn’s disease most
commonly affects the end of the small bowel (the ileum) and the
colon (also called the large intestine), but it may affect any part
of the gastrointestinal (GI) tract, from the mouth to the anus.
Ulcerative colitis is limited to the colon. It is estimated that
1.6 million Americans and 2.2 million Europeans suffer from Crohn's
disease or ulcerative colitis. The majority of patients are
diagnosed in young adulthood and these incidence rates continue to
rise, which will continue to place a significant burden on global
healthcare systems.
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.
About Assembly Biosciences
Assembly Biosciences, Inc. is a clinical-stage public
biotechnology company developing two innovative platform programs:
an HBV program advancing a new class of oral therapeutics for the
treatment of hepatitis B virus (HBV) infection and a microbiome
program developing novel oral biotherapeutics designed to address
diseases associated with the microbiome. Assembly’s HBV
program is advancing multiple drug candidates with the aim of
increasing cure rates in patients with chronic HBV. The company's
microbiome program consists of a fully integrated platform that
includes a robust strain identification and selection process,
methods for strain isolation and growth under current Good
Manufacturing Practices and a patent-pending delivery system,
GEMICEL®, which allows for targeted oral delivery of live biologic
and conventional therapies to the lower gastrointestinal tract.
Assembly is developing a robust pipeline of product candidates in
multiple disease indications. For more information, visit
assemblybio.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 future clinical
results based on prior clinical results; 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, 2015 and Quarterly Report on Form
10-Q for the quarter ended June 30, 2016 (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.
The information in this press release contains estimates and
other forward-looking statements regarding future events, including
statements about the clinical and therapeutic potential of
Assembly’s development programs, its ability to receive payments
from Allergan under the collaboration agreement and plans,
strategies, and intentions related to Assembly’s programs. Certain
forward looking statements may be identified by reference to a
future period or periods or by use of forward-looking terminology
such as "developing," "potential," "projected," "positioned,"
"eligible" or "may." Such forward-looking statements, which
Assembly intends to be covered by the safe harbor provisions
contained in Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended,
are just predictions and are subject to risks and uncertainties
that could cause the actual events or results to differ materially.
These risks and uncertainties include, among others: the
components, timing, cost and results of clinical trials and other
development activities involving Assembly’s product candidates
(including those licensed to Allergan); the unpredictability of the
preclinical and clinical development of Assembly’s product
candidates and of the duration and results of regulatory review of
those candidates by the FDA and foreign regulatory authorities;
Assembly’s anticipated capital expenditures, Assembly’s estimates
regarding its capital requirements, and its need for future
capital; and the possible impairment of, or inability to obtain,
intellectual property rights and the costs of obtaining such rights
from third parties. These and other potential risks and
uncertainties that could cause actual results to differ from the
results predicted are more fully detailed under the heading "Risk
Factors" in Assembly’s Annual Report on Form 10-K for the year
ended December 31, 2015, and Quarterly Report on Form 10-Q for the
quarter ending September 30, 2016 filed with the Securities and
Exchange Commission. It is not possible for Assembly management to
predict all risks nor can Assembly assess the impact of all factors
on its business or the extent to which any factor, or combination
of factors, may cause actual results to differ materially from
those contained in any forward-looking statements Assembly may
make. In light of these risks, uncertainties and assumptions, the
forward-looking events and circumstances discussed in this press
release may not occur and actual results could differ materially
and adversely from those anticipated. Except as required by law,
Assembly assumes no obligation to update publicly any
forward-looking statements, whether as a result of new information,
future events or otherwise.
1 Crohn’s & Colitis Foundation of America: What are
Crohn’s Disease and Ulcerative Colitis?:
http://www.ccfa.org/what-are-crohns-and-colitis/
2 Nature Reviews Gastroenterology & Hepatology
12, 720–727 (2015):
http://www.nature.com/nrgastro/journal/v12/n12/full/nrgastro.2015.150.html
ALLERGAN
INVESTORS:
Lisa DeFrancesco
(862) 261-7152
MEDIA:
Mark Marmur
(862) 261-7558
ASSEMBLY
INVESTORS:
Lauren Glaser
(415) 521-3828
MEDIA:
Barbara Lindheim
(212) 584-2276
barbara@assemblybio.com
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