NEW BRUNSWICK, N.J. – Jan. 16, 2015 – Johnson & Johnson (NYSE: JNJ) is pleased to announce the formation of consortia with leading global research institutions and non-government organizations to work in conjunction with Janssen Pharmaceutical Companies to accelerate the development of its Ebola vaccine regimen. The Innovative Medicines Initiative (IMI) plans to award these consortia grants totaling more than €100 million from the Ebola+ programme to support the development, manufacturing and patient education for the vaccine regimen.
The IMI is Europe's largest public-private initiative aiming to speed up the development of better and safer medicines for patients. Funding for the IMI Ebola+ programme comes in part from Horizon 2020, the European Union’s research and innovation programme, and in part in the form of in-kind contributions from the European Federation of Pharmaceutical Industries and Associations (EFPIA) partners in the projects.
"In the face of the global challenge of Ebola, bringing together the expertise and capabilities of the pharmaceutical industry, academic centers and NGOs will be critical to help solve this crisis," said Paul Stoffels, M.D., Chief Scientific Officer and Worldwide Chairman, Pharmaceuticals, Johnson & Johnson. "The European Commission's support through IMI bolsters collaboration that should significantly accelerate efforts to help address this humanitarian crisis."
"It is great to see the multiple partners come together to accelerate the development of an effective vaccine both for the current epidemic and future outbreaks," said Professor Peter Piot, M.D., director of the London School of Hygiene & Tropical Medicine, one of the consortia partners. "This is an opportunity to make sure that this is the last Ebola epidemic in which our only tools to control it are isolation and quarantine."
The funds were announced to support several consortia working together on a total of four projects. Three of the projects are designed to address the need to accelerate Phase I, II and III trials and scale up production of the prime-boost vaccine regimen. A Phase I trial led by Oxford Vaccines Group is currently underway with trials in Africa being planned. The Phase II and III trials in Europe and Africa, subject to review of the preliminary Phase I data, will be carried out in parallel. A fourth project will investigate innovative ways and technology to raise awareness and acceptance of vaccination campaigns. A total of eight projects are being funded under this round of the IMI's Ebola+ programme.
"With people still contracting this disease, there is still a risk that Ebola will continue to spread and that we could have another major outbreak in the future," said Johan Van Hoof, M.D., Global Head of Infectious Diseases and Vaccines, Janssen. "We highly appreciate the European Commission’s support and are pleased to be joined by them and our distinguished partners in further accelerating our goal of bringing this vaccine, if approved, to families and frontline health care professionals as fast as possible."
Professor Andrew Pollard and Dr Matthew Snape, who are leading the Phase I and II Ebola vaccine trials at the University of Oxford for IMI, said "the initial testing of vaccines for Ebola is already underway at the University with an astonishing response from the public to volunteer for the trials, to provide the earliest possible information to guide further studies of a prime boost vaccine, that if approved, may help control the Ebola outbreak in West Africa."
Organizations joining Janssen include the London School of Hygiene & Tropical Medicine, University of Oxford, Institut National de la Santé et de la Recherche Médicale (INSERM), La Centre Muraz, Bavarian Nordic A/S, Vibalogics, Grameen Foundation and World Vision of Ireland.
On January 6, Johnson & Johnson announced the start of a Phase I, first-in-human clinical trial of a preventive Ebola vaccine in development at its Janssen Pharmaceutical Companies. The trial is being led by the Oxford Vaccine Group, part of the University of Oxford Department of Paediatrics. Johnson & Johnson also announced that Janssen, in partnership with Bavarian Nordic A/S, has produced more than 400,000 regimens of the prime-boost vaccine for use in large-scale clinical trials by April 2015. A total of 2 million regimens is projected to be available through the course of 2015, with the ability to quickly scale up to a projected 5 million regimens, if required, over a 12- to 18-month period.
In October 2014, Johnson & Johnson announced a commitment of up to $200 million to accelerate and significantly expand production of an Ebola vaccine program in development at its Janssen Pharmaceutical Companies. The company has been seeking to share the financial risk of these vaccine and development clinical trial costs by pursuing governmental and non-governmental funding sources.
The Ebola+ programme has received funding from the Innovative Medicines Initiative 2 Joint Undertaking. This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation programme and the European Federation of Pharmaceutical Industries and Associations (EFPIA).
About Janssen funded IMI Ebola+ projects and consortia members
- Topic 1: Vaccine development; in Phase I, II, and III (EBOVAC 1 & 2)
- Consortium members: Janssen,London School of Hygiene and Tropical Medicine, Oxford University, Institut National de la Santé et de la Recherche Médicale (INSERM), La Centre Muraz
- Topic 2: Manufacturing capability (EBOMAN)
- Consortium members: Janssen, Bavarian Nordic A/S, Vibalogics
- Topic 4: Deployment and compliance of vaccination regimens (EBODAC)
- Consortium members: Janssen, London School of Hygiene & Tropical Medicine, Grameen Foundation, World Vision of Ireland
Further details of the projects are available on: http://www.imi.europa.eu/
Editor’s Note: The Grant Agreements for all IMI projects involving Janssen under the first call of the Ebola+ programme are still being finalised. Final information on all selected projects, including full budget details, will be published once, and if, the Grant Agreements have been signed.
About the Ebola Vaccine Regimen
The vaccine regimen, which was discovered in a collaborative research program with the National Institutes of Health (NIH), 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.
The Crucell Holland B.V. 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. Preclinical experiments of the prime-boost vaccine regimen conducted by the NIH demonstrated that when either vaccines were administered two months apart, complete protection from death due to Ebola was achieved against the Kikwit Zaire strain, which is similar to the virus that is the cause of the current outbreak in West Africa. 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 all virus strains that cause disease in humans, including Ebola and Marburg viruses based on the Ad26 and Ad35 vectors.
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 Holland B.V. is part 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. We have a broad development pipeline, with several product candidates based on our 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.
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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 the 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; the challenges and risks involved in large-scale production of a vaccine; 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 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.)