Clinical Studies of EIDD-2801 for the
Treatment of Patients with COVID-19 are Underway
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, and Ridgeback Biotherapeutics LP, a closely held
biotechnology company, today announced that the companies have
entered into a collaboration agreement to develop EIDD-2801, an
orally available antiviral candidate currently in early clinical
development for the treatment of patients with COVID-19.
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“In addition to our efforts to develop potential vaccines to
SARS-CoV-2, we have also been evaluating our own anti-viral assets
and those from external sources for their potential to treat
individuals with COVID-19,” said Dr. Roger M. Perlmutter,
president, Merck Research Laboratories. “Clinical evaluation of
EIDD-2801 in COVID-19 patients is just beginning, now that phase 1
studies have demonstrated that the compound is well-tolerated.
Since preclinical studies demonstrate that EIDD-2801 has potent
antiviral properties against multiple coronavirus strains including
SARS-CoV-2, we are eager to advance the next phase of clinical
studies as rapidly and responsibly as possible.”
Under terms of the agreement, Merck, through a subsidiary, will
gain exclusive worldwide rights to develop and commercialize
EIDD-2801 and related molecules. Ridgeback Bio will receive an
undisclosed upfront payment, specified milestones and a share of
the net proceeds of EIDD-2801 and related molecules, if approved.
Merck will be responsible for clinical development, regulatory
filings and manufacturing. The transaction is subject to the
expiration or earlier termination of the waiting period under the
Hart-Scott-Rodino Antitrust Improvements Act, and other customary
closing conditions.
“Since the start of the COVID-19 pandemic we have worked closely
with our network of esteemed collaborators to advance EIDD-2801
into the clinic,” says Wendy Holman, chief executive officer,
Ridgeback Biotherapeutics. “This agreement with Merck, a leader in
infectious disease therapeutics, positions us to harness the full
potential of EIDD-2801 and, if approved, deliver it to the patients
that need it globally.”
Merck and Ridgeback are committed to ensure that any medicines
we develop for SARS-CoV-2 will be accessible and affordable
globally.
About EIDD-2801
EIDD-2801 is an investigational, orally-bioavailable form of a
potent ribonucleoside analog that inhibits the replication of
multiple RNA viruses including SARS-CoV-2, the causative agent of
COVID-19. In animal studies of two distinct coronaviruses
(SARS-CoV-1 and MERS), EIDD-2801 has been shown to improve
pulmonary function, decrease body-weight loss and reduce the amount
of virus in the lung. EIDD-2801 was invented at Drug Innovations at
Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly
owned by Emory University.
About Ridgeback Biotherapeutics LP
Headquartered in Miami, Florida, Ridgeback Biotherapeutics is a
privately held, majority woman-owned biotechnology company focused
on orphan and emerging infectious diseases. Initial funding for
Ridgeback Biotherapeutics originated from Wayne and Wendy Holman;
two individuals committed to investing in and supporting
technologies that will make the world a better place. The team at
Ridgeback is dedicated to working toward finding life-saving and
life-changing solutions for patients and diseases that need
champions.
Merck’s Response to Coronavirus (COVID-19)
In response to the COVID-19 pandemic, Merck is focused on
protecting the safety of its employees and their families, ensuring
that our supply of medicines and vaccines reaches our patients and
customers, contributing our scientific expertise to the development
of antiviral and vaccine approaches, and supporting health care
providers and our communities. To learn more, please visit
www.merck.com/COVID-19.
About Merck
For more than 125 years, Merck, known as MSD outside of the
United States and Canada, has been inventing for life, bringing
forward medicines and vaccines for many of the world’s most
challenging diseases in pursuit of our mission to save and improve
lives. We demonstrate our commitment to patients and population
health by increasing access to health care through far-reaching
policies, programs and partnerships. Today, Merck continues to be
at the forefront of research to prevent and treat diseases that
threaten people and animals – including cancer, infectious diseases
such as HIV and Ebola, and emerging animal diseases – as we aspire
to be the premier research-intensive biopharmaceutical company in
the world. For more information, visit www.merck.com and connect
with us on Twitter, Facebook, Instagram, 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 the recent global outbreak of novel coronavirus
disease (COVID-19); 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 2019
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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Merck Media: Patrick Ryan +1 (201) 452-2409 Ian McConnell +1
(973) 901-5722 Merck Investors: Peter Dannenbaum +1 (908) 740-1037
Michael DeCarbo +1 (908) 740-1807 Ridgeback Bio Media +1 (786)
687-2493
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