Glaxo wins new re­prieve on Ad­vair

Yorkshire Post - Business - - BUSINESS -

GLAX­O­SMITHK­LINE HAS won a fur­ther re­prieve for its block­buster Ad­vair lung drug af­ter US reg­u­la­tors in­sisted Hikma Phar­ma­ceu­ti­cals con­duct a fur­ther clin­i­cal study eval­u­at­ing its generic ver­sion of the drug.

The Jor­dan-based firm said on Mon­day it ex­pected to sub­mit a re­sponse to the US Food and Drug Ad­min­is­tra­tion (FDA) with new clin­i­cal data in 2019.

Hikma’s part­ner on the pro­ject, Vec­tura, said this meant a po­ten­tial ap­proval and launch of the generic in­haled med­i­ca­tion could come in 2020 if all goes well.

Hikma al­ready faced a de­lay in US ap­proval for its Ad­vair generic in 2017, as did ri­val gener­ics com­pany My­lan, and last month a third Ad­vair copy from No­var­tis’s San­doz di­vi­sion also got knocked back by the FDA.

Hikma had dis­puted the FDA’s de­mand that it to con­duct a fresh clin­i­cal end­point study, but the agency up­held its original de­ter­mi­na­tion.

Af­ter Hikma and My­lan’s prob­lems in 2017, most in­dus­try an­a­lysts ex­pected the generic threat had been pushed back un­til mid2018. The lat­est snags mean GSK may en­joy more Ad­vair prof­its for longer, al­though My­lan still has a chance to win a US green light for its ver­sion of generic Ad­vair in 2018.

The tim­ing of the ar­rival of generic Ad­vair in the US is crit­i­cal to GSK’s near-term earn­ings out­look. The drug­maker ex­pects its 2018 earn­ings to be flat to down 3 per cent if generic Ad­vair launches in the US mar­ket by mid-year.

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