Vectura and Novartis win FDA approval for COPD combo

The FTSE 250 drug developer and project partner Novartis were given the green light by the US Food and Drug Administration (FDA) for the new dual combination bronchodilator Utibron Neohaler and the stand-alone monotherapy Seebri Neohaler.

Utibron and Seebri are now approved for the long-term maintenance treatment of airflow obstruction in patients with (COPD), including chronic bronchitis and/or emphysema.

The approval triggers a $22.5m milestone payment from Novartis to Vectura, as part of their agreement.

Novartis, which elsewhere in the world saw sales of these products grew 174% to $297m in the first nine months of 2015, expects that Utibron Neohaler and Seebri Neohaler will be available in the US in the first quarter of 2016.

Nearly 27m people in the US are affected by COPD, which ranks as the third leading cause of death in the US and is a major cause of serious long-term disability.

"The launches of Novartis' Ultibro Breezhaler and Seebri Breezhler ex-US have demonstrated the effectiveness of these products and the need for new treatment options for patients with COPD in the US,” said Vectura chief executive James Ward-Lilley.

He added: “Once launched, the products will bring a new royalty stream for Vectura and we look forward to confirmation from our partner in due course on their plans for the commercialisation of these products."

Analysts at N+1Singer said the US FDA approval of Vectura’s key COPD programmes was “an expected but very positive development. We are excited about the prospects of the LABA/LAMA class and believe that Novartis’ Utibron is well placed to gain a leading share of the market alongside GSK’s Anoro”.

Separately, Vectura announced that a €0.75m cash milestone had been triggered from partner Sandoz through the successful achievement of a further development milestone associated with asthma drug VR632 in the EU.

VR632 is a generic, inhaled combination therapy for asthma/COPD delivered using Vectura's proprietary dry powder inhaler and formulation technology.