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Vectura Group plc - Hikma completes FDA response for generic Advair

RNS Number : 7668U
Vectura Group plc
27 November 2019

This contains inside information


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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For more information, please contact:

Vectura Group plc

David Ginivan - VP Corporate Communications                +44 (0)7471 352 720

Elizabeth Knowles - VP Investor Relations                          +44 (0)7767 160 565


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

Forward-looking statements

This press release contains forward-looking statements, including statements about the commercialisation of products. Various risks may cause Vectura's actual results to differ materially from those expressed or implied by the forward looking statements, including: commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialise products and services; difficulties or delays in obtaining regulatory


approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialisation activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward looking statements, whether as a result of new information, future events or otherwise.


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