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New Merck COVID Efforts-2 Vaccines+Antiviral Drug EIDD-2801; Acquisition & Collaborations
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3 press releases below from Merck.
2 vaccines: 2 separate deals with IAVI & Themos; 3rd deal with Ridgeback for antiviral candidate.
• Merck to acquire Themis Bioscience, a company focused on vaccines and immune-modulation therapies for infectious diseases, including COVID-19;
• IAVI and Merck collaborate to develop vaccine against COVID-19;
• Merck and Ridgeback Bio collaborate to advance development of an oral antiviral candidate for COVID-19, EIDD-2801.
Merck and Ridgeback Bio Collaborate to Advance Development of Novel Antiviral Candidate, EIDD-2801
Clinical Studies of EIDD-2801 for the Treatment of Patients with COVID-19 are Underway
Tuesday, May 26, 2020 6:51 am EDT
KENILWORTH, N.J. & MIAMI--(BUSINESS WIRE)--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.
"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.
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Merck to Announce Multiple Scientific Efforts to Combat COVID-19
Tuesday, May 26, 2020 6:45 am EDT
KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, will today announce three significant scientific initiatives to combat COVID-19: two agreements to develop potential vaccines against SARS-CoV-2, and a research collaboration to advance the development of a novel antiviral candidate. Today's announcements are:
• Merck to acquire Themis Bioscience, a company focused on vaccines and immune-modulation therapies for infectious diseases, including COVID-19;
• IAVI and Merck collaborate to develop vaccine against COVID-19;
• Merck and Ridgeback Bio collaborate to advance development of an oral antiviral candidate for COVID-19, EIDD-2801.
"With our singular legacy and expertise in vaccines and anti-infective medicines, we know Merck has a responsibility to engage in the scientific community's efforts to find new medicines and vaccines to bring this pandemic to an end," said Kenneth C. Frazier, chairman and chief executive officer, Merck. "Merck has been fully committed to developing an effective response to the COVID-19 pandemic since it was first recognized, and we know that success will require global collaboration among countries and companies and more. Today, we are proud to mark the culmination of our swift, conscientious and concerted effort to identify some of the most promising solutions to this global challenge and to put our resources to use in accelerating these efforts. We will ensure that all of these programs have the resources, attention and focus they need - and that the COVID-19 pandemic demands."
"COVID-19 is a global challenge and requires global solutions. Merck intends to make any vaccine or medicine we develop for this pandemic broadly accessible and affordable globally, and we are working now to accomplish this goal as quickly as possible. As we just demonstrated with our Ebola vaccine, when the world needs to come together to tackle new and daunting challenges, Merck can be counted on to do our part. Though the challenge of this pandemic is immense, we know that science and collaboration will triumph, just as they have before. While we cannot predict when this battle will be won, we are confident that science is on our side, that collaboration is already well underway, and that together, we will prevail."
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Merck to Acquire Themis
Merck to Apply its Industry-Leading Vaccine Development Capabilities to SARS-CoV-2 Vaccine Program Originated by Themis and Institut Pasteur
Tuesday, May 26, 2020 6:47 am EDT
KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Themis, a company focused on vaccines and immune-modulation therapies for infectious diseases and cancer, today announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire privately-held Themis.
Themis has a broad pipeline of vaccine candidates and immune-modulatory therapies developed using its innovative measles virus vector platform based on a vector originally developed by scientists at the Institut Pasteur, a world-leading European vaccine research institute, and licensed exclusively to Themis for select viral indications. In March, Themis joined a consortium together with the Institut Pasteur and The Center for Vaccine Research at the University of Pittsburgh, supported by funding from the Coalition for Epidemic Preparedness Innovations (CEPI), to develop a vaccine candidate targeting SARS-CoV-2 for the prevention of COVID-19.
"Building on the pioneering work of the Institut Pasteur, the Themis team has established specialized expertise that complements Merck's own capabilities in the discovery, development, manufacturing and global distribution of vaccines," said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. "We are eager to combine our strengths both to develop an effective COVID-19 vaccine in the near term and to build a pandemic preparedness capability directed toward emerging agents that pose a future epidemic threat."
The planned acquisition builds upon an ongoing collaboration between the two companies to develop vaccine candidates using the measles virus vector platform, and is expected to accelerate the development of Themis' COVID-19 vaccine candidate. The vaccine candidate is in pre-clinical development, and clinical studies are planned to start later in 2020.
Under terms of the agreement, Merck, through a subsidiary, will acquire all outstanding shares of Themis in exchange for an undisclosed cash payment. Upon completion of the deal Themis will become a wholly-owned subsidiary of Merck.
"This acquisition by Merck, a global leader in vaccine development, reflects Themis' success in applying our versatile immune-modulation platform that builds on the original discoveries from the Institut Pasteur," said Dr. Erich Tauber, chief executive officer, Themis. "We are excited for the next phase of our relationship with Merck and in the near-term look forward to focusing resources toward the development and global scale-up of our candidate SARS-CoV-2 vaccine."
"I am delighted that the vaccine technology initially developed at the Institut Pasteur, and enhanced in partnership with Themis, will now be leveraged by Merck to develop candidate vaccines designed to prevent and control emerging infectious diseases, notably COVID-19. This is an exciting and impactful development for global public health," commented Prof. Stewart Cole, president of Institut Pasteur.
Investments by CEPI were important to advancing the Themis technology platform and associated programs. Merck looks forward to continued collaboration with CEPI and other international organizations as we work together toward global access to potential SARS-CoV-2 vaccines.
Closing of the transaction is subject to the expiration or earlier termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, merger control clearance in Austria, and other customary conditions. In connection with the transaction, Institut Pasteur, CEPI and Merck have entered into a memorandum of understanding that reflects the parties' commitments to address the COVID-19 pandemic by developing, manufacturing and distributing the vaccine on a global basis and with pricing that makes the vaccine both available around the world and accessible to those who need it, including low-income, middle-income and high-income countries based on the medical need when the vaccine may become available.
Merck is a global leader in infectious diseases and vaccines, with a long history of researching, developing, manufacturing and distributing vaccines for children, adolescents and adults. Merck is committed to ensuring that any vaccines we develop for SARS-CoV-2 will be accessible and affordable globally, and plans to manufacture the vaccine at sites in the U.S. and Europe.
Measles Vector Platform
The measles vector platform is being evaluated across a wide range of infectious disease and immunology indications. It uses a modified measles vaccine virus as a vector and can be engineered to express a wide range of antigens. The measles vector is designed to provide a vehicle to deliver antigens to the immune system capable of triggering a protective memory response. It has been incorporated into vaccine development programs against infectious diseases including SARS, Chikungunya, MERS, and Lassa fever. Originally developed at the Institut Pasteur, the technology platform was first licensed to Themis in 2010.
Merck's response to coronavirus (COVID-19)
As a company dedicated to saving and improving lives, Merck recognizes that we have a special responsibility to help. 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. We thank the many health care providers and volunteers, including our own employees, who are doing so much to help affected patients and communities. To learn more, please visit www.merck.com/COVID-19.
About Themis
Themis is developing immunomodulation therapies for infectious diseases and cancer. Through advanced understanding of immune system mechanisms, the company has built a sophisticated and versatile technology platform for the discovery, development and production of vaccines as well as other immune system activation approaches. Initially focused on preventing infectious diseases, Themis has demonstrated the potential of its versatile platform through the rapid and successful completion of Phase 2 and progress towards Phase 3 clinical development for a vaccine against Chikungunya, a debilitating disease with global outbreak potential. By leveraging its platform knowledge, Themis is currently approaching a rapid entry to Phase I trials for COVID-19. Funded to date by leading global venture capital firms, Themis has also gained prestigious non-dilutive funding for emerging infectious disease indications. For more information, visit http://www.themisbio.com.
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IAVI and Merck Collaborate to Develop Vaccine Against SARS-CoV-2
New Collaboration to Leverage Complementary Expertise and Capabilities with rVSV Technology to Advance Novel Vaccine Candidate
Tuesday, May 26, 2020 6:49 am EDT
KENILWORTH, N.J. & NEW YORK--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, and IAVI, a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges, today announced a new collaboration to develop an investigational vaccine against SARS-CoV-2 to be used for the prevention of COVID-19. This vaccine candidate will use the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for Merck's Ebola Zaire virus vaccine, ERVEBO® (Ebola Zaire Vaccine, Live), which was the first rVSV vaccine approved for use in humans. Merck has also signed an agreement with the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response within an agency of the United States Department of Health and Human Services, to provide initial funding support for this effort.
Under the agreement IAVI and Merck will work together to advance the development and global clinical evaluation of a SARS-CoV-2 vaccine candidate designed and engineered by IAVI scientists. The vaccine candidate is in preclinical development, and clinical studies are planned to start later in 2020. Merck will lead regulatory filings globally. Both organizations will work together to develop the vaccine and make it accessible and affordable globally, if approved.
"COVID-19 is an enormous scientific, medical, and global health challenge. Merck is collaborating with organizations around the globe to develop anti-infectives and vaccines that aim to alleviate suffering caused by SARS-CoV-2 infection," said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. "Merck and IAVI are eager to combine our respective strengths to accelerate development of an rVSV vaccine candidate, with the goal of blunting the trajectory of the COVID-19 pandemic."
"We believe an rVSV-based vaccine strategy represents a promising approach to combating the novel coronavirus pandemic and look forward to implementing an accelerated development program, together with Merck, to evaluate the potential of our vaccine candidate against SARS-CoV-2. The collaboration between Merck and IAVI represents an innovative partnership model and approach to utilize our joint capabilities in complementary and synergistic ways to address this difficult global health challenge," said Dr. Mark Feinberg, IAVI president and CEO.
"A safe, effective vaccine will help prevent future outbreaks of SARS-CoV-2," said BARDA Acting Director Gary Disbrow, Ph.D. "We are encouraged by the willingness of our private sector counterparts to come together as force multipliers to expedite vaccine development and to help save lives."
Merck is a global leader in infectious diseases and vaccines, with a decades-long history of researching, developing, manufacturing and distributing vaccines for children, adolescents and adults. 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.
IAVI's rVSV vaccine preclinical development, including work on the SARS-CoV-2 vaccine candidate, is being done by scientists at IAVI's Design and Development Laboratory (DDL) in Brooklyn, New York. This program is part of a long-standing effort to develop rVSV vaccines for HIV as well as other emerging infectious diseases such as Lassa fever, Marburg, and Ebola Sudan disease, under the leadership of Dr. Swati Gupta, head of Emerging Infectious Diseases and Scientific Strategy, IAVI.
About the rVSV Vaccine Platform
The recombinant vesicular stomatitis virus (rVSV) vaccine platform uses an attenuated strain of vesicular stomatitis virus, a common animal virus that has been modified to express proteins that stimulate an immune response. IAVI and Merck will leverage experience gained with this platform during the development of Merck's rVSV-based vaccine for Ebola Zaire.
About IAVI
IAVI is a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges including HIV and tuberculosis. Its mission is to translate scientific discoveries into affordable, globally accessible public health solutions. Read more at iavi.org.
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).
Contact:
Merck Media:
Patrick Ryan
+1 (201) 452-2409
Imraan Munshi
+1 (267) 884-1358
Merck Investors:
Peter Dannenbaum
+1 (908) 740-1037
Michael DeCarbo
+1 (908) 740-1807
IAVI Media:
Karie Youngdahl
+1 (212) 847-1051
kyoungdahl@iavi.org
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