NEW BRUNSWICK, N.J., – September 14, 2015 – Johnson & Johnson (NYSE: JNJ) announced today that Crucell Holland B.V., one of its Janssen Pharmaceutical Companies, has been awarded $28.5 million from The Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services, to help accelerate the development of its investigational Ebola prime-boost vaccine regimen. The regimen, which is currently being tested in clinical studies, uses a combination of two components based on AdVac® technology from Crucell Holland B.V. and MVA-BN® technology from Bavarian Nordic.
The agreement involves a 5-year commitment, with options for an additional $40.5 million funding, to optimize manufacturing systems and capacity for the vaccine regimen, including technology transfers to large-scale production facilities, heat-stability studies to verify that the regimen is optimized for use in African countries, and final product manufacturing and quality control activities.
“We are committed to finding a way to support the fight to get to and stay at zero Ebola cases worldwide,” said Paul Stoffels, M.D., Chief Scientific Officer and Worldwide Chairman, Pharmaceuticals, Johnson & Johnson. “Future outbreaks are a real danger, and we need to be prepared for them. This BARDA investment in our prime-boost vaccine approach will help us to further develop and potentially deliver a vaccine with both short and long-term protection.”
Phase I clinical studies of the prime-boost vaccine regimen began in the United Kingdom and United States in December 2014, followed by several sites in Africa. A Phase II study, to be carried out in the U.K. and France, started in July 2015, and plans are well advanced for the commencement of a safety and immunogenicity study in Sierra Leone and additional phase II studies outside the outbreak area in Africa. While clinical studies continue, BARDA will focus on supporting manufacturing development of the regimen’s prime and boost components.
Prime-boost vaccine regimens involve an initial dose that primes the immune system to develop disease-specific antibodies, followed by a booster dose at a later date that can strengthen and optimize the duration of the immune response. A number of widely used vaccines use a multi-dose approach to create stronger and longer-lasting immunity, including some for polio, rotavirus and HPV.
Janssen, in partnership with Bavarian Nordic, has produced drug supply for more than 800,000 regimens and is set-up to be able to produce a total of 2 million regimens of the Ebola vaccine regimen during the course of 2015.
To date, there is no licensed vaccine, treatment or cure for the Ebola virus. The Ebola outbreak in West Africa has put the health care systems of Liberia, Sierra Leone and Guinea under tremendous pressure. As of September 2015, after more than one year of this sustained Ebola outbreak, over 28,100 people have been infected with the virus across the three countries, and over 11,300 have died – including more than 500 healthcare workers. Although the outbreak has been brought under control in recent months, it could easily resurge and preparedness for future outbreaks is essential.
Johnson & Johnson’s Commitment to Combatting Ebola
Janssen’s investigational Ebola vaccine regimen was discovered in a collaborative research program with the National Institutes of Health (NIH), and uses a prime-boost combination of two components that are based on AdVac® technology from Crucell Holland B.V., one of the Janssen Pharmaceutical Companies, and the MVA-BN® technology from Bavarian Nordic, a biotechnology company based in Denmark. This program 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.
In October 2014, Johnson & Johnson announced a commitment to accelerate and significantly expand production of an Ebola vaccine program in development at its Janssen Pharmaceutical Companies.
In January 2015, the Innovative Medicines Initiative (IMI) awarded a consortia of leading global research institutions and non-government organizations working in conjunction with the Janssen Pharmaceutical Companies grants totaling more than €100 million from the Ebola+ programme to support the development, manufacturing and deployment of the vaccine regimen.
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 127,000 employees at more than 265 Johnson & Johnson operating companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
Crucell Holland B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and is focused on research, development and production of vaccines that prevent and/or treat infectious diseases. Crucell has a broad development pipeline, with several product candidates based on its unique AdVac® and PER.C6® production technology.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in infectious diseases and vaccines, oncology, immunology, neuroscience, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world.
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Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development. 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 Crucell Holland B.V. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in new product development, including uncertainty of clinical success and obtaining regulatory approvals; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. 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 December 28, 2014, including in Exhibit 99 thereto, 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. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.