Bausch Health Initiates VIRAZOLE Study in Patients with COVID-19

Bausch Health has initiated a clinical trial program in Canada evaluating an investigational use of VIRAZOLE® (Ribavirin for Inhalation Solution, USP) in combination with standard of care therapy to treat hospitalized adult patients with respiratory distress due to COVID-19. Because ribavirin is a synthetic nucleoside that works to stop viral replication, VIRAZOLE may be effective in reducing the severity of COVID-19 infection.

VIRAZOLE is currently approved in several countries around the world, including the United States and Canada, for the treatment of hospitalized infants and young children with severe lower respiratory tract infections due to respiratory syncytial virus (RSV).

The initial clinical study has been approved by Health Canada and is expected to begin within the next few weeks. The Company is also in discussions with the U.S. Food and Drug Administration and health authorities in multiple countries regarding additional studies to evaluate VIRAZOLE as a treatment for COVID-19 infection. The Bausch Foundation is also continuing to work directly with health authorities in Italy to make VIRAZOLE for inhalation available free of charge in compassionate use in Italian hospitals.

"VIRAZOLE has demonstrated antiviral activity in treating severe pediatric respiratory infections, and we believe it may be a valuable agent in reducing respiratory distress in adults suffering from COVID-19. We are actively pursuing approval of our trial protocol around the world to test the efficacy and safety of VIRAZOLE in this patient population," said Joseph C. Papa, chairman and CEO, Bausch Health. "Bausch Health will remain focused – for as long as necessary – on doing our part to help end this unprecedented global health pandemic, including donating our health care products, conducting research to find new treatment options and supporting patients, health care providers and our employees."

The initial study protocol is an open label, interventional trial that will evaluate the safety and efficacy of VIRAZOLE in hospitalized adult patients, aged 18 or older, who have tested positive for COVID-19, and as a result of their infection, have significant respiratory distress. Two active study arms will compare different dosing regimens of VIRAZOLE in combination with standard of care therapy. More details on the study can be found on the Health Canada Clinical Trials Database and on Health Canada COVID-19 List of Clinical Trials.

VIRAZOLE (ribavirin for inhalation solution, USP) aerosol is indicated only for lower respiratory tract infection due to RSV. Treatment may be initiated while awaiting rapid diagnostic test results. However, treatment should not be continued without documentation of RSV infection.

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