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Merck to Acquire Afferent Pharmaceuticals

KENILWORTH, N.J. & SAN MATEO, Calif.--(BUSINESS WIRE)--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, 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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