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Hikma and Vectura make new application for GSK knock-off

The US Food and Drug Administration rejected a previous application lodged in 2017 requesting further data, which has been added to the new submission

Hikma Pharmaceuticals Plc - Hikma Pharmaceuticals and Vectura submit revised asthma drug application to US authorities
Hikma and Vectura are targeting a launch next year

Hikma Pharmaceuticals Plc (LON:HIK) and Vectura Group PLC (LON:VEC) have submitted an updated version of their asthma drug candidate to the US regulator.

The generics giant and the inhaled medicines specialist have developed VR315US, a knock-off version of GlaxoSmithKline PLC’s (LON:GSK) top-selling asthma treatment, Advair Diskus, which generated sales of around US$1bn last year.

The US Food and Drug Administration (FDA) last year rejected a previous application, requesting further data that the companies said has been added to the new submission after the completion of a clinical endpoint study.

The companies are targeting launch in 2020, with Vectura due to receive 16% royalty rate on US sales.

More generic competition

The drug will compete with GSK’s Advair as well as Wixela Inhub, another generic version launched in February 2019 by Dutch firm Mylan NV (NASDAQ:MYL) and UK partner Consort Medical PLC (LON:CSRT).

Mylan said earlier this month it had crossed 30% market share but that revenue will be lower than expected due to “aggressive share retention actions” by GSK.

The consensus forecast for Mylan’s Wixela sales is US$200mln a year, while GSK sales last year were down by over a third because of the pricing pressure.

Consort’s share of Wixela sales is tipped to reach around £30mln at peak, broker Shore Capital told clients, saying this could give an indication of Vectura’s potential for VR315US, with its royalty share suggesting it could expect up to £22mln annually.

Hikma and Vectura shares were little moved on Wednesday morning at 1,930.5p and 83.5p respectively.

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