Merck (NYSE:MRK), known as MSD outside the United States and
Canada, and Afferent Pharmaceuticals announced today that the two
companies have signed a definitive agreement under which Merck will
acquire this privately held pharmaceutical company. Afferent
Pharmaceuticals is a leader in the development of therapeutic
candidates targeting the P2X3 receptor for the treatment of common,
poorly-managed, neurogenic conditions. Afferent’s lead
investigational candidate, AF-219, is a selective, non-narcotic,
orally-administered P2X3 antagonist currently being evaluated in a
Phase 2b clinical trial for the treatment of refractory, chronic
cough as well as in a Phase 2 clinical trial in idiopathic
pulmonary fibrosis (IPF) with cough.
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“Afferent has pioneered the clinical development of novel
investigational candidates selectively targeting the P2X3 receptor,
an exciting area of research,” said Dr. Roger M. Perlmutter,
president, Merck Research Laboratories. “We look forward to
advancing these innovative molecules for patients with conditions
like chronic cough, an area of significant unmet medical need.”
Under terms of the agreement, Merck, through a subsidiary, will
acquire all outstanding stock of Afferent in exchange for an
upfront payment of $500 million in cash. Also, Afferent
shareholders will be eligible to receive a total of up to an
additional $750 million associated with the attainment of certain
clinical development and commercial milestones for multiple
indications and candidates, including AF-219.
“This achievement is a reflection of the talent and hard work of
the experienced Afferent team in advancing the science of P2X3
receptors and the clinical development of our novel therapeutic
candidates,” said Kathleen Sereda Glaub, chief executive officer,
Afferent Pharmaceuticals. “We are very pleased to enter into this
agreement given Merck’s reputation for maximizing opportunities
around novel mechanisms. This agreement with Merck creates
significant value for Afferent shareholders while enhancing the
potential of our portfolio to provide meaningful benefits to
patients globally.”
Data on cough frequency from the first cohort of a Phase 2b
dose-escalation clinical trial of AF-219 in patients with chronic
cough were presented at the 2016 American Thoracic Society (ATS)
International Conference. The results of the second cohort, which
is examining lower doses, are expected to be presented at a future
scientific congress.
The closing of the transaction will be subject to certain
conditions, including the expiration of the waiting period under
the Hart-Scott-Rodino Antitrust Improvements Act and other
customary conditions. The companies anticipate the transaction will
close in the third quarter of 2016.
About P2X3 Receptor-Mediated Sensitization
Afferent’s clinical candidates, AF-219 and AF-130, are orally
available investigational candidates that selectively block P2X3
receptors. P2X3 receptors are believed to play a key role in the
sensitization of certain sensory nerves, notably C-fiber afferents.
These nerves become activated and sensitized under pathological
conditions mediated by a common cellular signal, ATP, when it is
released in high concentrations due to cellular distress following
injury or infection. Afferent’s compounds are designed to
selectively block ATP activation of P2X3 channels, potentially
reducing a range of sensory signs and symptoms.
About Chronic Cough
The prevalence of chronic cough (a cough lasting more than 8
weeks) is estimated to be approximately 10 percent of adults in the
U.S. While an underlying condition may contribute to cough in many
of these patients, in 20-40 percent of cases no underlying
condition can be identified and hence these patients are typically
not responsive to symptomatic treatment. Additionally, many
treatment-responsive patients are not well-controlled for their
cough. There are currently no approved therapies for the treatment
of chronic cough.
About Afferent Pharmaceuticals
Afferent Pharmaceuticals is a clinical-stage biotechnology
company and a leader in the development of novel drugs for the
treatment of a range of neurogenic conditions. These conditions
affect millions of patients who suffer from chronic respiratory and
urologic sensory pathologies, as well as chronic pain and
cardiovascular disorders, and who have limited, if any, treatment
options. These chronic pathologies arise when certain nerves become
hyper-sensitized as a result of inflammation, distress, infection
or tissue injury, which may remain chronically sensitized for
months and even years.
Afferent was founded by Anthony Ford, Ph.D., Pappas Ventures,
Third Rock Ventures, Domain Associates, New Leaf Venture Partners
and Roche Ventures, following the exclusive license of Roche’s P2X3
program to Afferent. The lead molecule, AF-219, is in Phase 2
clinical development for the treatment of chronic cough, and
idiopathic pulmonary fibrosis (IPF) with cough. A second compound,
AF-130, completed Phase 1 clinical testing and is scheduled to
advance to Phase 2 trials in non-respiratory conditions.
For more information on the company, please visit Afferent’s
website at www.afferentpharma.com.
About Merck
For 125 years, Merck has been a global health care leader
working to help the world be well. Merck is known as MSD outside
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 health care through far-reaching policies,
programs and partnerships. For more information, visit
www.merck.com and connect with us on Twitter, Facebook, YouTube and
LinkedIn.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J.,
USA (the “company”) includes “forward-looking statements” within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These statements are
based upon the current beliefs and expectations of the company’s
management and are subject to significant risks and uncertainties.
There can be no guarantees with respect to pipeline products that
the products will receive the necessary regulatory approvals or
that they will prove to be commercially successful. 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 health care
legislation in the United States and internationally; global trends
toward health care cost containment; technological advances, new
products and patents attained by competitors; challenges inherent
in new product development, including obtaining regulatory
approval; the company’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 the company’s patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
The company 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 the company’s 2015
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).
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version on businesswire.com: http://www.businesswire.com/news/home/20160609006459/en/
MerckMedia:Pamela Eisele, 267-305-3558Michael Close,
267-305-1211orInvestors:Teri Loxam, 908-740-1986Justin Holko,
908-740-1879orAfferentMedia:Susan Kinkead,
415-509-3610orInvestors:Dulce Dizon, 650-286-1276
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