LONDON (Alliance News) - Vectura Group PLC on Tuesday said the phase III trial of Flutiform did not meet its primary endpoint and said it will not be allowed to make a regulatory filing for the product in Europe as intended.
Vecutra said its partner, Munidpharma, has informed the business that Flutiform did not meet the primary endpoint of significantly reducing the annualised rates of moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations when compared to mono-component LABA treatment alone.
"Mundipharma is currently undertaking an analysis of the trial's other endpoints but has indicated that the primary endpoint result will not allow it to make a regulatory filing for the COPD indication in Europe," said Vectura.
"Whilst this result is disappointing, flutiform continues to grow strongly based on the approved asthma indication, which continues to underpin our expectations for future growth of the product. Vectura already benefits from sizeable and growing revenues from other partnered products on the market in Europe and elsewhere for the treatment of COPD, including Ultibro and Seebri," said James Ward-Lilley, chief executive of Vectura.
Vectura shares were down 10% to 123.80 pence per share on Tuesday morning.
By Joshua Warner; joshuawarner@alliancenews.com; @JoshAlliance
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