Hikma completes its FDA response in respect of generic Advair® (VR315US)
Submission follows completion of a Clinical Endpoint study
Chippenham, UK – 27 November 2019: Vectura Group plc (LSE: VEC) notes today’s announcement by Hikma Pharmaceuticals PLC ("Hikma"), its partner in the development of an AB rated substitutable US generic version of Advair Diskus® (VR315US), that it has submitted responses to the US Food and Drug Administration (“FDA”) for review, which includes data from a further Clinical Endpoint study requested by the FDA in a Complete Response Letter (“CRL”).
Will Downie, Chief Executive Officer of Vectura, commented: “Hikma’s submission is an important milestone in our generic Advair programme. We believe the submission addresses the outstanding questions raised by the FDA in its CRL and remain confident in the prospects for the approval of VR315US. We continue to see a large market opportunity for VR315US and look forward to working with Hikma to bring this product to the market as quickly as possible.”
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Vectura Group plc
David Ginivan - VP Corporate Communications +44 (0)7471 352 720
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Consilium Strategic Communications
Mary-Jane Elliott / Sue Stuart / David Daley +44 (0)20 3709 5700
About Vectura
Vectura is a provider of innovative inhaled drug delivery solutions that enable partners to bring their medicines to patients. With differentiated proprietary technology and pharmaceutical development expertise, Vectura is one of the few companies globally with the device, formulation and development capabilities to deliver a broad range of complex inhaled therapies.
Vectura has ten key inhaled and eleven non-inhaled products marketed by partners with global royalty streams, and a diverse partnered portfolio of drugs in clinical development. Our partners include Hikma, Novartis, Sandoz (a division of Novartis AG), Mundipharma, Kyorin, GSK, Bayer, Chiesi, Almirall, and Tianjin KingYork.
For further information, please visit Vectura's website at www.vectura.com
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