Biotech Values

[DewDiligence]

GSK/JNJ—FDA approves Juluca—FDC of Tivicay+Edurant:

https://www.prnewswire.com/news-releases/fda-approves-first-two-drug-regimen-for-certain-patients-with-hiv-300560448.html

Juluca is the first complete 2-DAA regimen approved by the FDA for treating (i.e. not preventing) HIV.

An MAA for the same FDC is pending, having been submitted in Jun 2017 (#msg-131862284).

ViiV* (GSK) and JNJ inked the deal for this 2-DAA HIV regimen in Jun 2014 (#msg-103258545).

*ViiV is a JV owned 76.5% by GSK, 13.5% by PFE, and 10% by Shionogi.