To develop innovative medicines that combat diverse national health security threats, the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) announced on Monday a strategic partnership with Genentech, a member of the Roche Group, of South San Francisco.
The company and ASPR’s Biomedical Advanced Research and Development Authority (BARDA) will jointly manage and share the cost to develop a portfolio of medicines that meet national health security requirements and have commercial uses. The partners will focus first on developing a first-in-class therapeutic for hospitalized influenza patients and a treatment for lung injuries caused by inhaling sulfur mustard gas.
“The United States faces a host of national health security threats requiring innovative solutions,” said BARDA Director Rick Bright, Ph.D. “Partnership agreements like this one allow flexibility to detect, prevent, or treat diverse illness and injury caused by these threats and at the same time decrease costs and maximize efficiency.”
BARDA will contribute $43 million over five years to support a study of the investigational oral medicine baloxavir marboxil in treating severely ill patients hospitalized with seasonal or pandemic influenza viruses. Influenza, or flu, is one of the most common, yet serious, infectious diseases, representing a significant threat to public health. CDC estimates that influenza has resulted in between 140,000 and 900,000 hospitalizations and between 12,000 and 80,000 deaths in the United States annually since 2010.
BARDA also will provide $19 million over 18 months to advance the development of alteplase (tPA) for a new indication to treat acute lung injuries called cast formation caused by inhaling sulfur mustard gas. The medicine, known under the brand name Activase is approved and marketed to treat heart attacks, stroke, and pulmonary embolism.
There are currently no FDA-approved therapeutics for use by severely ill patients hospitalized with influenza or for treatment of inhalational injury due to sulfur mustard.
In addition to sharing development costs, BARDA will have joint oversight, help determine which medicines to develop, and collaborate on decisions about which products enter or leave the partnership’s portfolio.
The agreement also gives BARDA access to Genentech’s extensive portfolio of potential medical countermeasures, including diagnostics, therapeutics for influenza, and medicines to reduce the transmission of influenza, and other products to combat health security threats.
Rather than standard contracts, HHS entered into the agreement using other transaction authority that was granted to HHS under the Pandemic and All Hazards Preparedness Act of 2006. Although not a contract, grant or cooperative agreement, other transaction authority provides a funding and collaboration vehicle to promote innovation in technology for advanced research and development. The new partnership agreement is BARDA’s eighth under other transaction authority.