J&J and HHS Team Up on Flu Vaccine and Drug R&D

On Sep. 15, 2017, the US Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) announced a public-private partnership with Janssen Research & Development, a Johnson & Johnson company, to drive advanced development of a portfolio of therapeutic products to prevent or treat infections caused by emerging infectious diseases, including influenza viruses with pandemic potential.

Under the agreement, the Biomedical Advanced Research and Development Authority (BARDA), part of ASPR, will provide up to $43 million during the partnership’s first year and potentially up to $273 million over five years. Janssen Research and Development will provide an equal investment. Through this partnership, the first of its kind for emerging infectious diseases and pandemic influenza preparedness, BARDA and Janssen will jointly oversee and share the cost of developing new approaches to address influenza.

Initially, the portfolio will include development of Janssen’s small-molecule drug, JNJ-5806. Studies suggest that this drug may interfere with an influenza virus’ ability to reproduce its genetic code and spread in the body. In clinical trials, this molecule worked against influenza virus types A and B, including influenza A viruses with pandemic potential.

Included will be development of an innovative influenza vaccine that could                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   protect users against a broad range of seasonal and pandemic influenza viruses. The vaccine is being designed to act on a part of the influenza virus that seldom changes. If this approach is successful, the vaccine could become a so-called universal vaccine, according to ASPR. Additional products in the portfolio include therapeutic monoclo​nal antibodies. New products could be added to meet US public health and biodefense needs, the agency said.

Rather than a standard agreement, ASPR and Janssen Research and Development will collaborate under an agreement allowed by “other transaction authority” granted to HHS under the Pandemic and All Hazards Preparedness Act of 2006. The other transaction agreement provides a funding and collaboration vehicle to promote innovation in technology for advanced research and development.

This agreement further builds on the collaborations that Janssen and BARDA have already established in influenza (e.g., with pimodivir, the company’s potential first-in-class inhibitor of the PB2 subunit of the influenza A polymerase complex), as well as in response to the 2014 Ebola outbreak in West Africa.

Source: Department of Health and Human Services, Johnson & Johnson