Janssen to Discontinue Pimodivir Influenza Development Program

NEW BRUNSWICK, N.J., Sept. 2, 2020 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that it has made a strategic decision to discontinue the development of pimodivir, an investigational antiviral treatment for influenza A infection. This decision is based on recent results from pre-planned interim analyses of the pimodivir Phase 3 trial in hospitalized patients with influenza A, that found pimodivir in combination with the standard of care (SOC) was very unlikely to demonstrate added benefit in hospitalized patients with influenza A compared to SOC treatment alone. The study in hospitalized patients with influenza A and the parallel Phase 3 study of pimodivir in outpatients with influenza A will be halted.

"While our goal was to develop an innovative new treatment option for patients at risk of respiratory infections, unfortunately these data show that pimodivir does not offer a benefit above the existing standard of care," said James Merson, Ph.D., Global Therapeutic Area Head for Infectious Diseases at Janssen Research & Development.  "At Janssen, we have a deep heritage of caring for those affected by respiratory infectious diseases and will continue to do so, focusing on clinical development programs that we believe will offer transformational medical innovation to patients."

Pimodivir Phase 3 study was designed to evaluate the safety and efficacy of pimodivir in two Phase 3 trials in combination with standard of care (SOC) treatment in hospitalized adolescent, adult and elderly participants with influenza A infection (NCT03376321, known as 3001), and in non-hospitalized adolescent, adult, and elderly participants with influenza A infection who are at risk of developing complications (NCT03381196, known as 3002). The Company is in the process of informing all study investigators and relevant health authorities.

This decision was reached in consultation with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services and co-funder for the program. The pimodivir development program received funding support from BARDA under contract HHSO100201500014C.

In 2014, Janssen entered into an exclusive license agreement with Vertex for the worldwide development, manufacturing, and commercialization of pimodivir.

About the Janssen Pharmaceutical Companies of Johnson & Johnson
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 www.twitter.com/JanssenGlobal.

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 The Janssen Pharmaceutical Companies of Johnson & Johnson, 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 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 29, 2019, 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.  

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SOURCE Janssen Pharmaceutical Companies of Johnson & Johnson