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Vectura’s Flutiform flunks phase III COPD test

But new AirFluSal data demonstrates superior patient adherence over GSK’s Seretide/Advair

Vectura Flutiform

Vectura’s hopes of extending the uses of its asthma drug Flutiform into chronic obstructive pulmonary disease (COPD) have been dashed by disappointing phase III data.

The UK pharma group saw its shares fall yesterday on the news that the COPD trial – carried out by licensee Mundipharma – was unable to show a benefit for Flutiform (fluticasone/formoterol) on the rate of COPD exacerbations compared to patients taking single-agent therapy with formoterol.

Mundipharma has indicated it will not continue developing the product for COPD, a large patient population that could have added momentum to Flutiform’s sales growth.

Vectura chief executive James Ward-Lilley put a brave face on the outcome, noting that several other trials have struggled to show any additional benefit when an inhaled corticosteroid (ICS) is added to long-acting beta agonist (LABA) therapy in COPD.

“COPD is a complex and highly variable disease and these trial results highlight the challenge in demonstrating reductions of exacerbations with ICS/LABA combinations in today’s treatment environment,” he said.

Ward-Lilley also pointed to strong growth for the product in asthma. Flutiform sales doubled last year to reach €144m in 2015, and in the first six months of this year grew another 42% to €92m. The product was originally developed by SkyePharma, which merged with Vectura earlier this year. Vectura is scheduled to present its first set of post-merger results in November.

AirFluSal boost
Vectura’s stock has since bounced back from its decline, helped by partner Sandoz reporting positive data on its AirFluSal product.

Novartis’ generics subsidiary has just presented comparative data showing its product is superior to GlaxoSmithKline’s blockbuster COPD drug Seretide/Advair when it comes to keeping COPD patients on treatment.

Both drugs deliver salmeterol and fluticasone propionate, but use different dry powder inhalers. GSK’s product is delivered using its long-established Diskus device, while AirFluSal uses the Vectura-developed Forspiro.

Since the launch of generics such as AirFluSal, Seretide has seen sales slip by around a third from a peak in 2013, coming in at $5.4bn last year.

Phil Taylor
31st August 2016
From: Research
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