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DewDiligence

07/01/15 5:02 PM

#193099 RE: ciotera #185242

GILD submits NDA for TAF/Emtiva/Edurant FDC*, using priority-review voucher:

http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=2064274

See #msg-109435833 for info on the two GILD-JNJ collaborations in HIV.

*GILD refers to this FDC as “R/F/TAF.”
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DewDiligence

09/12/16 10:34 AM

#204235 RE: ciotera #185242

JNJ submits MAA for FDC consisting of Prezista and GILD’s TAF/Emtriva/Cobicistat (a/k/a D/C/F/TAF):

http://finance.yahoo.com/news/janssen-submits-marketing-authorisation-application-113000014.html

By prior agreement with GILD (#msg-109435833), JNJ controls the development and commercialization of this regimen.

(Prezista boosted with Cobicistat in an FDC is already sold under the brand name, Prezcobix in the US (#msg-110465571) and the brand name, Rezolsta in the EU.)