Merck to Acquire Afferent Pharmaceuticals

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June 9, 2016 4:07 pm ET

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.

“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,
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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).



Merck
Media:
Pamela Eisele, 267-305-3558
Michael Close, 267-305-1211
or
Investors:
Teri Loxam, 908-740-1986
Justin Holko, 908-740-1879
or
Afferent
Media:
Susan Kinkead, 415-509-3610
or
Investors:
Dulce Dizon, 650-286-1276

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