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  5. Johnson & Johnson Announces New Collaboration to Advance Novel Vaccine for MERS

Johnson & Johnson Announces New Collaboration to Advance Novel Vaccine for MERS

– New collaboration with Coalition for Epidemic Preparedness Innovations (CEPI) and The Jenner Institute is latest example of Johnson & Johnson’s ongoing commitment to global pandemic preparedness efforts –

New Brunswick, N.J., September 27, 2018 – Johnson & Johnson announced today a new collaboration between Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, the Coalition for Epidemic Preparedness Innovations (CEPI) and The Jenner Institute at the University of Oxford to develop and manufacture a vaccine against Middle East Respiratory Syndrome Coronavirus (MERS-CoV). The collaboration, which seeks to leverage Janssen’s expertise and technology in vaccines development, will also work to advance novel vaccines against the Lassa and Nipah viruses.

“In our increasingly interconnected world, infectious diseases with pandemic potential pose a significant threat to global health, and new vaccines are urgently needed to ensure we are fully prepared for them,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “Johnson & Johnson is a strong supporter of CEPI’s vision because cross-sector collaborations will be essential to develop the tools we need to stay one step ahead. We hope that, together with The Jenner Institute, we can help advance the world’s first vaccines against the continuing viral threats of MERS, Lassa and Nipah.”

Under the new collaboration, CEPI will provide funding to Janssen and The Jenner Institute to advance an adenovirus-vectored MERS-CoV vaccine (ChAdOx1) that is currently in development at the Institute. CEPI’s $14.6 million contribution will facilitate ongoing clinical development of the vaccine through phase 1 studies and manufacturing of clinical trial supplies. Dependent on results of these studies, CEPI will have the option to provide additional funding for phase 2 development and manufacturing of an investigational vaccine stockpile available for use in the event of a MERS outbreak.

It is envisioned that Janssen’s proprietary PER.C6® vaccine manufacturing platform will be a fundamental pillar to enable the rapid scale-up of vaccine production and the creation of this stockpile. PER.C6® technology has the potential to enable high capacity, high speed and low cost manufacturing for multiple types of vaccines, including viral vector-based vaccines.

CEPI will provide an additional $4.1 million of funding to support early-stage, preclinical development of candidate vaccines for the Lassa and Nipah viruses.

“We are delighted to work with CEPI and The Jenner Institute on this important project, and look forward to bringing Janssen’s leading expertise in adenovirus-vectored vaccines, as well as Janssen’s manufacturing capabilities, to accelerate the development of a MERS vaccine,” said Johan Van Hoof, M.D., Global Therapeutic Area Head Infectious Diseases & Vaccines, Janssen, and Managing Director, Janssen Vaccines & Prevention B.V. “We hope this collaboration will serve as a model for how the private and non-profit sectors can successfully work together to develop urgently needed vaccines in disease areas with high unmet need.”

There are currently no vaccines to protect against the MERS, Lassa, and Nipah viruses, all of which can cause serious complications and are associated with significant mortality rates. Since MERS was discovered in Saudi Arabia in 2012, 27 countries have reported cases of this severe acute respiratory illness, and 35 percent of patients have died. Lassa is a hemorrhagic fever, like Ebola, that is difficult to diagnose. It can be especially dangerous for pregnant women, causing spontaneous abortion or maternal death. Nipah virus can cause encephalitis and severe respiratory symptoms, with a case fatality rate of up to 75 percent. In the past year, there have been serious outbreaks of Lassa fever and Nipah virus infection in Nigeria and India, respectively.

“CEPI’s collaboration with The Jenner Institute at the University of Oxford and Janssen Vaccines represents exactly what our coalition was set up to do: to drive development of vaccines to protect humanity against threats posed by emerging infectious diseases and to bring together the expertise of academia and the public and private sectors,” said Dr. Richard Hatchett, CEO of CEPI.

MERS-CoV, Lassa, and Nipah are cited by the World Health Organization in its 2018 list of priority diseases for which new innovations are urgently needed due to their epidemic potential.

Commitment to Pandemic Preparedness

The collaboration with CEPI and The Jenner Institute is the latest example of Johnson & Johnson’s ongoing commitment to global pandemic preparedness efforts. We are one of the few innovative healthcare companies in the world today that is actively engaged across multiple disease areas that are central to this challenge. Through our Janssen Pharmaceutical Companies, we are actively engaged in developing new vaccines and/or treatments to combat a wide range of infectious diseases that are already pandemics, such as HIV and tuberculosis (TB), or that have pandemic potential, including Ebola, Zika, and influenza.

During the 2014-2016 Ebola epidemic in West Africa, Johnson & Johnson accelerated development of Janssen’s investigational Ebola vaccine program with a significant company commitment and global public-private collaborations that have supported numerous clinical trials across three continents. Four years on from the worst Ebola outbreak in history, outbreaks of the disease have continued, including one that is currently ongoing in the Democratic Republic of the Congo (DRC). We remain committed to working with collaboration partners to develop and achieve licensure for the Janssen Ebola vaccine regimen and are also maintaining a stockpile of two million regimens in support of outbreak preparedness.

In January 2017 at Davos, Johnson & Johnson joined the World Economic Forum, the Bill & Melinda Gates Foundation, the Wellcome Trust, the governments of Norway and Germany and other organizations for the launch of CEPI. Building on lessons learned during recent Ebola and Zika outbreaks, CEPI’s mission is to help stimulate and finance the development of new vaccines for emerging infectious diseases with epidemic potential by bringing together the expertise and resources of the public, private and academic sectors. CEPI identified MERS-CoV, Lassa, and Nipah viruses as its initial priority pathogens for vaccine development.

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About Johnson & Johnson

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity.

About the Janssen Pharmaceutical Companies of Johnson & Johnson

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.

Janssen Vaccines & Prevention B.V. is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 related to a new collaboration and 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 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 and obtaining regulatory approvals; competition, including technological advances, new products and patents attained by competitors; uncertainty of commercial success for new products; the ability of the company to successfully execute strategic plans; impact of business combinations and divestitures; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; and global health care reforms and trends toward health care cost containment. A further list and descriptions 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 31, 2017, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” in the company’s most recently filed Quarterly Report on Form 10-Q and in 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.

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