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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.
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.
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.
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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