Janssen to Discontinue Pimodivir Influenza Development Program

The Janssen Pharmaceutical Companies of Johnson & Johnson 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.