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Vecntura pdates on generic asthma treatment

11 May 2017 09:34

Vectura said its partner on VR315 US (generic Advair Diskus programme for the treatment of asthma), Hikma, had received a Complete Response Letter (CRL) from the US FDA and believed there was a low likelihood of approval of the VR315 programme this year.

Vectura did not anticipate receiving an approval milestone or sales royalties for VR315 in 2017.

The FDA had categorised the CRL as 'Major'.

Hikma and Vectura would provide an update on its application as soon as practicable once they had completed a review of the CRL and discussed this with the FDA.

Based on the initial assessment no material issues were raised regarding the substitutability of the proposed device, Vectura said.

"Hikma and Vectura are committed to bringing this important product to the US market and have confidence in the future approval of the programme as an AB rated substitutable product," said Vectura.

"Given the nature of the feedback Vectura believe there is a low likelihood of approval of the VR315 programme this year and does not anticipate receiving an approval milestone or sales royalties for VR315 in 2017."

At 9:34am: (LON:VEC) Vectura Group PLC share price was -12.8p at 132.1p

Story provided by StockMarketWire.com

Related Company: VEC

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