Vectura Group plc Hikma completes FDA response for generic Advair (7668U)
27 Novembre 2019 - 8:01AM
UK Regulatory
TIDMVEC
RNS Number : 7668U
Vectura Group plc
27 November 2019
This contains inside information
Hikma completes its FDA response in respect of generic Advair(R)
(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(R) (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."
- Ends-
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
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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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END
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