DUBLIN and KENILWORTH, N.J., July
7, 2015 /PRNewswire/ -- Allergan plc (NYSE: AGN) and
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that they have entered
into an agreement under which Allergan will acquire the exclusive
worldwide rights to Merck's investigational small molecule oral
calcitonin gene-related peptide (CGRP) receptor antagonists, which
are being developed for the treatment and prevention of migraine,
subject to expiration or termination of the waiting period under
the Hart-Scott-Rodino Antitrust Improvements Act of 1976
(HSR).
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Under the terms of the agreement, Allergan will acquire these
rights for an upfront payment of $250
million, $125 million of which
is payable upon HSR clearance and $125
million of which is payable in April of 2016. Merck will
additionally be entitled to receive potential development and
commercial milestone payments and tiered double-digit royalties
based on commercialization of the programs. Allergan will be fully
responsible for development of the CGRP programs, as well as
manufacturing and commercialization upon approval and launch of the
products. Allergan said its 2015 earnings-per-share forecast
provided on May 11, 2015 is unchanged
as a result of the acquisition. Allergan remains committed to
de-levering to below 3.5x debt to Adjusted EBITDA by the end of the
first quarter of 2016.
The agreement gives Allergan rights to two CGRP receptor
antagonists:
- MK-1602, an oral small molecule antagonist for the acute
treatment of migraines. A phase 2 study of MK-1602 has been
completed and end of phase 2 discussions with FDA are planned prior
to initiating phase 3. A phase 3 study is expected to begin in
2016.
- MK-8031, an oral small molecule antagonist for the prevention
of migraines. A phase 2 study of MK-8031 is expected to begin
in 2016.
In July 2011, Merck announced that
it had discontinued clinical development of an earlier
investigational oral CGRP antagonist, Telcagepant (MK-0974), after
some patients showed evidence of liver toxicity. The MK-1602 &
MK-8031 molecules belong to a different chemical series than
Telcagepant, and in clinical trials to date have not shown evidence
of liver toxicity. The potential of the CGRP antagonist mechanism
has received validation from episodic and chronic migraine studies
of injectable candidates in development.
"The agreement to acquire exclusive worldwide rights to Merck's
CGRP migraine development program builds on our existing strength
in neurosciences and helps position Allergan as a potential leader
in the acute treatment of migraine and prevention of migraine for
millions of patients," said David
Nicholson, Executive Vice President, Global Brands Research
and Development at Allergan. "With two novel oral therapies
in development for treating and preventing migraines, we have the
opportunity to provide therapies that could alleviate an intensely
debilitating and immobilizing condition for patients worldwide. We
look forward to supporting the continued development of these
programs and to potentially bringing these new therapies to
market."
"We are pleased that this agreement will enable Allergan to
advance these promising molecules for the potential benefit of
migraine sufferers, and that Merck will be able to continue to
further focus our research and development resources on our
priority therapeutic areas," said Iain D.
Dukes, Senior Vice President of Business Development &
Licensing, Merck Research Laboratories.
Migraine is a common disorder of the brain that affects
approximately 36 million Americans.[i] Migraines are
characterized by attacks of intense, usually one-sided, throbbing
head pain that can last from four to 72 hours. The pain associated
with migraine is frequently accompanied by other symptoms,
including nausea, vomiting, dizziness and increased sensitivity to
light and sound.[ii]
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.
For more information, visit Allergan's website at
www.allergan.com.
About Merck
Today's Merck is a global healthcare leader working to help the
world be well. Merck is known as MSD outside of the United States and Canada. Through our prescription medicines,
vaccines, biologic therapies and animal health products, we work
with customers and operate in more than 140 countries to deliver
innovative health solutions. We also demonstrate our commitment to
increasing access to healthcare through far-reaching policies,
programs and partnerships. For more information, visit
www.merck.com and connect with us on Twitter, Facebook and
YouTube.
Allergan 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; risks associated with
acquisitions, mergers and joint ventures; 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 Quarterly
Report on Form 10-Q for the quarter ended March 31, 2015. Except as expressly required by
law, Allergan disclaims any intent or obligation to update these
forward-looking statements.
Merck Forward-Looking Statement
This news release includes "forward-looking statements" within
the meaning of the safe harbor provisions of the United States
Private Securities Litigation Reform Act of 1995. These statements
are based upon the current beliefs and expectations of Merck's
management and are subject to significant risks and uncertainties.
If underlying assumptions prove inaccurate or risks or
uncertainties materialize, actual results may differ materially
from those set forth in the forward-looking statements.
Risks and uncertainties include, but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of pharmaceutical industry regulation and healthcare
legislation in the United States
and internationally; global trends toward healthcare cost
containment; technological advances, new products and patents
attained by competitors; challenges inherent in new product
development, including obtaining regulatory approval; Merck's
ability to accurately predict future market conditions;
manufacturing difficulties or delays; financial instability of
international economies and sovereign risk; dependence on the
effectiveness of Merck's patents and other protections for
innovative products; and the exposure to litigation, including
patent litigation, and/or regulatory actions.
Merck undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in Merck's 2014 Annual
Report on Form 10-K and the company's other filings with the
Securities and Exchange Commission (SEC) available at the SEC's
Internet site (www.sec.gov).
[i] Migraine Research Foundation.
http://migraineresearchfoundation.org/fact-sheet.html
[ii] Migraine Research Foundation.
http://migraineresearchfoundation.org/about-migraine.html
CONTACTS:
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Allergan:
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Investors:
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Lisa
DeFrancesco
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(862)
261-7152
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Media:
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David
Belian
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(862)
261-8141
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Mark
Marmur
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(862)
261-7558
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Merck:
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Investors:
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Justin
Holko
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(908)
740-1879
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Media:
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Lainie
Keller
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(908)
236-5036
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SOURCE Allergan plc