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Initiating Vaccine Development and Providing Supplies of Antiviral Medicines to China for Investigational Use
NEW BRUNSWICK, N.J., Jan. 29, 2020 /PRNewswire/ — Johnson & Johnson (NYSE: JNJ) today announced that it is mobilizing resources at its Janssen Pharmaceutical Companies to launch a multi-pronged response to the novel coronavirus (also known as 2019-nCoV or Wuhan coronavirus) outbreak. As part of this work, the Company has initiated efforts to develop a vaccine candidate against 2019-nCoV and broadly collaborate with others to screen a library of antiviral therapies. Identifying compounds with antiviral activity against 2019-nCoV may contribute to providing immediate relief to the current outbreak.
“J&J has a long-standing commitment to fight established and emerging epidemics and is supporting global efforts where we can make the greatest impact. We are collaborating with regulators, healthcare organizations, institutions and communities worldwide to help ensure our research platforms, existing science and outbreak expertise can be maximized to stem this public health threat,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “This latest outbreak of a novel pathogen once again reinforces the importance of investing in preparedness, surveillance and response to ensure the world remains ahead of potential pandemic threats.”
The vaccine program will leverage Janssen’s AdVac® and PER.C6® technologies that provide the ability to rapidly upscale production of the optimal vaccine candidate. These are the same technologies that were used in the development and manufacturing of Janssen’s investigational Ebola vaccine, which is currently deployed in the Democratic Republic of the Congo and Rwanda. They were also used to construct the Company’s Zika, RSV and HIV vaccine candidates.
Johnson & Johnson’s multi-pronged approach also includes a review of known pathways in coronavirus pathophysiology to determine whether previously tested medicines can be used to help patients survive a 2019-nCoV infection and reduce the severity of disease in non-lethal cases. In addition, Janssen has donated 300 boxes of its HIV medication PREZCOBIX® (darunavir/cobicistat) to the Shanghai Public Health Clinical Center and Zhongnan Hospital of Wuhan University for use in research to support efforts in finding a solution against the 2019-nCoV. Furthermore, another 50 boxes have been provided to the Chinese Center for Disease Control and Prevention for laboratory-based investigations (drug-screening for antiviral properties against 2019-nCoV). All shipments have been delivered and, if further donations are required, the Company is open to cooperating with all healthcare institutions and agencies to support efforts in finding a solution against 2019-nCoV.
The requests from the Shanghai Public Health Clinical Center and Zhongnan Hospital of Wuhan University follow a recommendation from the Shanghai Institute of Materia Medica, Chinese Academy of Sciences for investigation of 30 potentially effective compounds, including darunavir – the protease inhibitor component of PREZCOBIX – against 2019-nCoV. Based on anecdotal findings, a protease inhibitor has previously shown a potential favorable clinical response against severe acute respiratory syndrome (SARS) associated coronavirus.1
The Company’s expedited research and development schedule is in response to the current 2019-nCoV outbreak in China. The World Health Organization has now confirmed cases of 2019-nCoV across mainland China, with cases also confirmed in countries and territories worldwide, including Australia, Cambodia, Canada, France, Germany, Hong Kong, Japan, Macao, Malaysia, Nepal, Republic of Korea, Singapore, Sri Lanka, Taiwan, Thailand, the U.S.A and Vietnam.2,3 2019-nCoV is from a group of viruses called coronaviruses that attack the respiratory system.
PREZCOBIX is a prescription medicine, licensed in many countries including China, for the treatment of human immunodeficiency virus (HIV-1). It has not been proven safe and effective for the treatment of 2019-nCoV and further investigations are required. Cobicistat is from Gilead Sciences, Inc. For specific indications and prescribing information, please consult your local health authorities.
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. Learn more at www.jnj.com. Follow us at @JNJNews.
About the Janssen Pharmaceutical Companies
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. Learn more at www.janssen.com. Follow us at @JanssenGlobal.
Notice to Investors Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding darunavir/cobicistat and development of potential preventive and treatment regimens for coronavirus. 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 research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including 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 30, 2018, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, 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 undertakes to update any forward-looking statement as a result of new information or future events or developments.
1 Chu CM et al. Role of lopinavir/ritonavir in the treatment of SARS: initial virological and clinical findings. Thorax. 2004;59:252-256.
2 WHO. Novel Coronavirus (2019-nCoV) SITUATION REPORT – 8, 28 JANUARY 2020. Available at: https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200128-sitrep-8-ncov-cleared.pdf?sfvrsn=8b671ce5_2. Last accessed: January 2020.
3 Gov.uk. Wuhan novel coronavirus: epidemiology, virology and clinical features. Available at: https://www.gov.uk/government/publications/wuhan-novel-coronavirus-background-information/wuhan-novel-coronavirus-epidemiology-virology-and-clinical-features. Last accessed: January 2020.
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SOURCE Johnson & Johnson