Janssen Pharmaceuticals, Inc. (Janssen) will collaborate with Vertex Pharmaceuticals on worldwide development, manufacturing and commercialization of VX-787, an investigational medicine now in Phase II development for the treatment of influenza A. The medication is designed to inhibit replication of the influenza A virus, including recent H1 (pandemic) and H5 (avian) influenza strains, based on in-vitro data. The drug would be offered to fight resistance to existing antivirals for influenza.
"Influenza infection remains one of the most serious public health challenges globally. In addition to the burden of seasonal influenza, the pandemics of the 20th and 21st centuries exemplify the threat the influenza A virus presents," says Johan Van Hoof, Global TA Head Infectious Diseases and Vaccines, Managing Director, Crucell. "This agreement builds on Janssen's legacy of innovation and partnership, and we are proud to collaborate with Vertex on this novel medicine. This treatment has the potential to address a significant unmet medical need and to improve the well-being of patients everywhere."
The license agreement also grants Janssen rights to develop, manufacture and commercialize VX-787's back-up compound, VX-353, as well as rights to develop, manufacture and commercialize certain other back-up compounds for the prevention and/or treatment of influenza. The agreement is subject to the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. Vertex completed a Phase IIA study of VX-787 in 2013. Additional clinical trials are expected to begin over the next few months.
For pharmaceutical companies both large and small, the challenges involved in developing new drugs are growing steadily. Regulatory requirements are becoming more complex, and the processes involved have followed suit. Even more innovative manufactur…