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
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.