Johnson & Johnson Advances Investigational Ebola Prime-boost Vaccine Regimen with New Partnership

Johnson & Johnson (NYSE: JNJ) announced today that Janssen Vaccines & Prevention B.V., one of its Janssen Pharmaceutical Companies, will further advance its investigational Ebola vaccine regimen with a new award from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services. The collaborative partnership with BARDA will support the company’s ongoing commitment to develop a novel prime-boost vaccine regimen to help prevent the spread of Ebola. The funding represents one of the first of BARDA’s Project BioShield awards for investigational Ebola vaccines and drugs.

“Developing effective Ebola vaccines will be critical if we are to combat potential future outbreaks and protect frontline healthcare workers as well as the families and friends of Ebola victims,” said Paul Stoffels, M.D., Chief Scientific Officer of Johnson & Johnson. “This award underscores the importance of public-private partnerships in tackling global health challenges. Our effort to accelerate the development of Janssen’s Ebola vaccine candidate to date would not have been possible without support from a wide range of global funders, including the National Institutes of Health (NIH), Europe’s Innovative Medicines Initiative (IMI), and the U.S. Department of Defense (DoD).”

Under the agreement, BARDA will provide funding of US$44.7 million, with options for additional funding, over five years to help support the development and potential licensure of the vaccine candidate. The novel regimen involves an initial dose that primes the immune system to develop disease-specific immune responses, followed by a booster dose with the goal of potentially strengthening and optimizing the duration of the response. The regimen uses a combination of two components based on AdVac^® technology from Janssen Vaccines & Prevention B.V., and MVA-BN^® technology from Bavarian Nordic.

Janssen first began work on Ebola vaccine development in collaboration with the NIH. Then during the 2014-2016 Ebola outbreak in West Africa, Johnson & Johnson accelerated Janssen’s vaccine program with a company commitment in excess of US$200M, and additional grants totaling more than €100M in funding from IMI/European Commission to support multiple clinical trials. BARDA previously awarded funding in 2015 and 2016 that focuses on optimizing manufacturing processes for the vaccine, and the new agreement will strengthen support for the program.

“Never before has Johnson & Johnson mobilized resources so rapidly to accelerate a vaccine candidate – supporting the initiation of multiple clinical trials across three continents in just one year,” said Johan Van Hoof, M.D., Global Head of Infectious Diseases & Vaccines, Janssen. “Thankfully, the Ebola crisis in West Africa is over, but we and other vaccine manufacturers remain determined to ensure that Ebola vaccines are successfully developed and made available to the world.”

A total of 11 Janssen-sponsored phase 1, 2 and 3 clinical studies of the Ebola vaccine regimen are being conducted across Europe, the United States and Africa. Final clinical data from a Phase 1 study conducted in the UK were published in March 2017 in JAMA: The Journal of the American Medical Association, following publication of preliminary results in the Journal in April 2016.^1,2 In this study, 100 percent of healthy volunteers receiving the vaccine regimen generated an Ebola virus-specific antibody response that was sustained to at least 1 year following vaccination. In September 2016, based in part on these data, the company filed for Emergency Use and Assessment Listing (EUAL) for the vaccine regimen with the World Health Organization, which is under review.

The 2014-2016 Ebola virus outbreak in West Africa was the largest outbreak since the virus was discovered 40 years ago. The outbreak caused over 11,000 deaths, including more than 500 health care workers.

“History teaches us that Ebola will return – as we recently saw in the Democratic Republic of Congo,” said Professor Peter Piot, Director of the London School of Hygiene & Tropical Medicine (LSHTM) and part of the team that first isolated Ebola virus. “These ongoing outbreaks demonstrate the importance of disease surveillance and management, the value of strong health systems, and the need to finish the job of developing safe and effective vaccines to help protect communities and prevent a resurgence of the virus. It is within our power, working in partnership, to prevent a future pandemic.” LSHTM is one of Janssen’s partners in the Ebola vaccine clinical research program.

The BARDA agreement is the latest collaboration that the Johnson & Johnson Family of Companies has engaged in to combat a wide range of infectious diseases with pandemic potential, including Zika, Influenza, HIV and TB.

About the Janssen Ebola Vaccine Regimen

The heterologous prime-boost Ebola vaccine regimen contains two components: Janssen’s AdVac^® technology (based on adenovirus type 26) and MVA-BN^®technology from Bavarian Nordic A/S (based on Modified Vaccinia Ankara virus). These vaccines both use a viral vector approach, where a virus is genetically modified so that it cannot replicate, but is used to safely express key proteins of the target virus, in this case Ebola virus. Prime-boost vaccination is an established approach for the prevention of other infectious diseases.

Janssen’s investigational Ebola vaccine regimen was developed in a collaborative research program with the National Institutes of Health (NIH) and received direct funding and preclinical services from the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, under Contract Numbers HHSN272200800056C, and HHSN272201000006I and HHSN272201200003I, respectively. The MVA-BN-Filo material used in Phase 1 studies was produced under NIAID/Fisher BioServices contract #FBS-004-009 and NIH contract HHSN272200800044C.

BARDA previously awarded Janssen a total of US$44.6 million in 2015 and 2016 under contract HHSO100201500008C to help optimize manufacturing systems and capacity for the vaccine regimen, including heat-stability studies to verify that the regimen was optimized for use in African countries, and final product manufacturing and quality control activities. The U.S. Department of Defense (DoD) is also supporting the vaccine clinical program, with the United States Military HIV Research Program (MHRP) at the Walter Reed Army Institute of Research (WRAIR), with the Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) conducting one of the Phase 2 studies.

The Innovative Medicines Initiative (IMI), which is supported by the European Commission, provided funding of more than €100M through the IMI Ebola+ Programme to support a number of consortia that are conducting multiple clinical trials and other vaccine development activities. Janssen’s partners in these consortia include the London School of Hygiene and Tropical Medicine, Inserm, Inserm Transfert, University of Oxford, Le Centre Muraz, Bavarian Nordic A/S, Vibalogics, Grameen Foundation and World Vision of Ireland. The consortia funded by the Innovative Medicines Initiative 2 (IMI2) Joint Undertaking are EBOVAC1 (grant nr. 115854), EBOVAC2 (grant nr. 115861), EBOMAN (grant nr. 115850) and EBODAC (grant nr. 115847). This Joint Undertaking receives support from the EU’s Horizon 2020 research and innovation programme and the European Federation of Pharmaceutical Industries and Associations (EFPIA).

About Johnson & Johnson

Caring for the world, one person at a time, inspires and unites the people of Johnson & Johnson. We embrace research and science – bringing innovative ideas, products and services to advance the health and well-being of people. Our approximately 132,500 employees at more than 250 Johnson & Johnson operating companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

Our Commitment to Global Public Health

For 130 years, Johnson & Johnson has been committed to improving the health of individuals, families and communities around the world, including the most vulnerable populations. Today, our vibrant, entrepreneurial and committed employees bring business acumen and their collaborative spirit to help solve some of the most complex global health problems. By harnessing our collective breadth and scale, and our employees’ passion and purpose, we strive to advance health care and positively impact the lives of all people.

About the Janssen Pharmaceutical Companies

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us at @JanssenGlobal.

Cautions Concerning Forward Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995, regarding a collaboration to advance development of an investigational Ebola vaccine regimen. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Vaccines & Prevention B.V., any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: the potential that the expected benefits and opportunities related to the collaboration may not be realized or may take longer to realize than expected; challenges inherent in new product development, including the uncertainty of clinical success, obtaining regulatory approvals and of the overall timeline for the availability of a potential vaccine against Ebola; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; challenges to patents; changes to applicable laws and regulations, including global health care reforms; trends toward health care cost containment and the uncertainty of the level of demand for a vaccine against Ebola. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 1, 2017, including under “Item 1A. Risk Factors,” its most recently filed Quarterly Report on Form 10-Q, including under the caption “Cautionary Note Regarding Forward-Looking Statements,” and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.