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Published On: Wed, Jun 18th, 2014

Janssen Announces License Agreement With Vertex for development of VX-787, a novel influenza A drug

PRESS RELEASE

TITUSVILLE, NJ, July 18, 2014 – Janssen Pharmaceuticals, Inc. (Janssen) announced today that it has entered into an exclusive license agreement with Vertex Pharmaceuticals for the worldwide development, manufacturing and commercialization of VX-787, a novel medicine in Phase II development for the treatment of influenza A.

Generic influenza virion Image/CDC

Generic influenza virion
Image/CDC

VX-787 is an investigational medicine designed to directly inhibit replication of the influenza A virus, including recent H1 (pandemic) and H5 (avian) influenza strains, based on in-vitro data. Influenza is an acute viral infection that spreads easily through respiratory droplets produced when an infected person coughs or sneezes, or through contaminated hands and surfaces. Universally, resistance has emerged to existing antivirals for influenza and, through the development of VX-787, Janssen hopes to provide an additional treatment option for patients.

“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. The parties expect additional clinical trials to begin in the coming months.

About VX-787
VX-787 is a first-in-class, influenza A-specific, oral polymerase inhibitor. It is the first and most advanced example of a novel mode of action (MOA) direct acting antiviral working through the influenza virus PB2 polymerase subunit. Targeting an alternative part of the viral replication process may help ensure that this new medicine can successfully treat strains of the influenza virus which may be resistant to existing antiviral drugs with other MOAs.

VX-787 has demonstrated potent and rapid in-vitro antiviral activity on all Vertex tested influenza A strains to date, including oseltamivir (Tamiflu®) resistant strains. Initial clinical assessments of VX-787 have also been promising. Phase I studies demonstrated the molecule was well tolerated in healthy volunteers providing a pharmacokinetic profile supportive of once daily dosing.  Vertex has also completed a Phase IIA challenge study that showed statistically significant improvements in viral and clinical measurements of influenza A infection and demonstrated clinical proof of concept.

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  1. News Canada Binary - Janssen Announces License Agreement With Vertex to Develop Novel Treatment for Influenza A | News Canada Binary says:

    […] Janssen Announces License Agreement With Vertex for development of VX-787, a novel influenza A drug […]

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