Janssen Collaborates With Vertex Pharmaceuticals On VX-787 For Influenza A
By Cyndi Root
Janssen Pharmaceuticals, Inc. announced in a press release that it has partnered with Vertex Pharmaceuticals on VX-787, a novel medicine for influenza A. The exclusive license agreement advances both parties’ goals of providing additional treatment options for patients due to growing antiviral resistance. Based on in-vitro data, the investigational agent inhibits influenza A virus replication including the H1 strain. Johan Van Hoof, Global Head of Infectious Diseases and Vaccines, Managing Director of Crucell (a subsidiary of Johnson & Johnson), said, “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.”
Janssen and Vertex Collaboration
Janssen and Vertex have agreed to worldwide development of VX-787, now in Phase II studies. Vertex finished a Phase IIA study in 2013 and the two intend to conduct further trials soon. The two companies intend to develop, manufacture, and commercialize the medication. They will also develop VX-353 and other compounds to treat influenza. The new agreement will take effect after a waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.
VX-787
VX-787 is an oral polymerase inhibitor with potent and rapid in-vitro antiviral activity. Its novel mode of action (MOA) works on the PB2 polymerase subunit. Vertex has tested the compound on all influenza A strains including Tamiflu (oseltamivir) resistant strains. VX-787’s pharmacokinetic profile supports once daily dosing. Phase I studies showed favorable tolerability and Phase IIA studies demonstrated statistically significant improvements in influenza A infection.
Vertex Pipeline
Vertex investigators use a cross-disciplinary approach in drug development. Its pipeline is diverse and includes potential medicines for cystic fibrosis (CF), viral infections, autoimmune diseases, cancer, and neurological disorders. In cystic fibrosis, VX-809 is in Phase III trials and VX-661 is in Phase II. In hepatitis C, VX-661 is in Phase II. In autoimmune diseases, VX-509 is in Phase II.
In January 2014, Vertex outlined its strategy, which included making its treatment for CF, Kalydeco (ivacaftor), available worldwide. The company also intends to seek new indications for ivacaftor as additional people with CF may benefit from treatment. Studies include gating mutation studies, R117H mutation studies, gating mutation studies in children 2 to 5 years of age, and a residual function study.