Vertex Pharmaceuticals said today it has licensed its drug candidate VX-787 to Johnson & Johnson’s Janssen Pharmaceuticals, which will co-develop and co-commercialize the first-in-class influenza treatment. The collaboration is expected to net Vertex millions, starting with a $30 million upfront payment.
VX-787, discovered by Vertex investigators, is designed to stop replication of the influenza A virus -- including recent H1 (pandemic) and H5 (avian) influenza strains – with the goal of providing rapid onset of action and an expanded treatment window. VX-787's mechanism differs from neuraminidase inhibitors, the current standard of care for flu treatment.
A Phase IIa study completed last year yielded statistically significant improvements in viral and clinical measurements of influenza infection. The study met its primary endpoint and showed a statistically significant decrease in viral shedding over the seven-day study period. At the highest dosing regimen evaluated in the study, researchers found a statistically significant reduction in the severity and duration of flu-like symptoms.
Patients in the Phase IIa study volunteered to be experimentally exposed to an attenuated form of live H3N2 influenza A virus, the most common flu virus type observed in the U.S. during the 2012/2013 influenza season.
Janssen agreed to pay Vertex the upfront $30 million, and additional payments of undisclosed amount tied to development and commercial milestones. Vertex is also eligible for royalties on future product sales.
Janssen said the license agreement also grants it rights to develop, manufacture and commercialize VX-353, a backup compound to VX-787; as well as rights to develop, manufacture and commercialize other unspecified back-up compounds for preventing and/or treating influenza.
The collaboration, including its related upfront payment, is subject to the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.
"This collaboration provides important support for the continued development of VX-787 in influenza and contributes to our financial strength to enable continued investment in our key development programs for cystic fibrosis and in research aimed at discovering new medicines," Jeffrey Leiden, M.D., Ph.D., Vertex’s chairman, president and CEO, said in a statement.