New Brunswick, N.J., (Oct. 22, 2014) – Johnson & Johnson (NYSE: JNJ) today announced that it has made a commitment of up to $200 million to accelerate and significantly expand the production of an Ebola vaccine program in development at its Janssen Pharmaceutical Companies. The company is closely collaborating with the World Health Organization (WHO), the National Institute of Allergy and Infectious Diseases (NIAID), as well as other key stakeholders, governments, and public health authorities on the clinical testing, development, production and distribution of the vaccine regimen.
The vaccine regimen, which was discovered in a collaborative research program with the National Institutes of Health (NIH), combines a Janssen preventative vaccine with a vaccine from Bavarian Nordic, a biotechnology company based in Denmark. This combination vaccine regimen has shown promising results in preclinical studies, and is now planned to be tested for safety and immunogenicity in healthy volunteers in Europe, the United States of America and Africa starting in early January. Janssen is targeting production of more than one million doses of the vaccine regimen in 2015, 250,000 of which are expected to be released for broad application in clinical trials by May 2015.
The regimen consists of two vaccine components that are based on AdVac® technology from Crucell Holland B.V., which is part of the Janssen Pharmaceutical Companies, and the MVA-BN® technology from Bavarian Nordic. The research collaboration for a monovalent vaccine targeting the Zaire strain of the Ebola virus is part of an ongoing development program for a multivalent vaccine against other virus strains that cause disease in humans, including Ebola and Marburg viruses.
As part of an overall commitment to advance innovations that address unmet medical needs worldwide, a team of dedicated experts has been assigned to focus on bringing this preventative vaccine to people in need. The commitment by Johnson & Johnson includes an equity investment in Bavarian Nordic to provide capital for the development, testing and production of Bavarian Nordic's vaccine. Janssen will take the lead in funding and developing both components of the combination vaccine regimen.
"We are urgently working to provide our vaccine expertise, production capabilities, our people and resources to address the Ebola crisis," said Alex Gorsky, Chairman and CEO, Johnson & Johnson. "Our innovation model enables us to quickly mobilize our extensive resources to collaborate with health authorities and governments and other experts to help contain this disease, save lives, and protect the health and lives of those at risk. We have an important responsibility as a leading global healthcare company to do all we can to address this urgent unmet medical need."
"Our goal to produce more than a million vaccines in the next few months is within reach," says Paul Stoffels, M.D., Chief Scientific Officer of Johnson & Johnson and Worldwide Chairman, Pharmaceuticals. "Ebola is a significant and growing threat to the people of West Africa and it has the potential to impact people around the world. We are committed to bringing our science, technology, innovation and resources to help prevent and treat this deadly disease."
"In preclinical testing conducted in partnership with the National Institutes of Health, the combination vaccine regimen has shown complete protection against Ebola," said Johan Van Hoof, M.D., Global Head, Infectious Diseases and Vaccines, Janssen. "Using our PER.C6® high density cell production technology, we have been able to produce large quantities of the Janssen component of the vaccine regimen in testing batches, and we have already started production toward our goal to have these vaccines available for clinical testing in the next several months."
In September, Johnson & Johnson and Bavarian Nordic first announced they would fast-track the development and clinical testing of the vaccine program, which features a prime-boost regimen in which one vector is used to prime and the other to boost the immune response.
The program has received direct funding from, and is also using, preclinical services from the NIAID, part of NIH under Contract Numbers HHSN272200800056C, HHSN272201000006I and HHSN272201200003I. Preclinical experiments conducted at the NIH of the combination vaccine regimen demonstrated that when both vaccines were administered two months apart, complete protection was achieved against the Kikwit Zaire strain of Ebola, which is highly similar to the virus that is the cause of the current outbreak in Western Africa.
The emergence of Ebola in West Africa has strained the health care systems of Liberia, Sierra Leone and Guinea. The company's long tradition of disaster response has prompted support of Direct Relief International's efforts in this area as well as the efforts of other relief organizations. Johnson & Johnson is also participating in the ongoing efforts by public health authorities, including the Centers for Disease Control and Prevention and the WHO, to mount a coordinated world response to address the immediate needs raised by the Ebola outbreak. The company is also seeking to secure additional partners and resources to assist in its efforts to increase vaccine production and further speed up the clinical trial program.
The Ebola virus belongs to a virus family called Filoviridae and can cause severe hemorrhagic fever in humans and nonhuman primates. Ebola has a mortality rate ranging from 50% to 90% according to the World Health Organization. The virus is highly prioritized by the U.S. Government, who has defined the virus as a "Category A" agent, due to its high mortality rate. Currently, no licensed vaccine, treatment or cure exists for this disease.
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 126,000 employees at more than 270 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 is part of the Janssen Pharmaceutical Companies of Johnson & Johnson, and is focused on research, development and production of vaccines, proteins and antibodies that prevent and/or treat infectious diseases. Crucell is a major supplier of vaccines to UNICEF and the developing world. Crucell was the first manufacturer to launch a fully-liquid pentavalent vaccine named QUINVAXEM®. With this innovation, Crucell has become a major partner in protecting children in developing countries against major infectious diseases. Crucell has a broad development pipeline, with several product candidates based on its unique AdVac® and/or 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.
Note on Forward Looking Statements
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995, including regarding product development and production. 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., any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, challenges and uncertainties inherent in product development, including the uncertainties of clinical success and the timeline for the availability of a potential vaccine against Ebola, and the risks and uncertainties involved in large-scale production of a vaccine. 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 29, 2013, 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 nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)