Vectura Group plc Statement re Hikma Pharmaceuticals PLC update (9172L)
January 15 2021 - 11:26AM
UK Regulatory
TIDMVEC
RNS Number : 9172L
Vectura Group plc
15 January 2021
Vectura highlights update made by Hikma on launch of generic
Advair Diskus(R)
Chippenham, UK - 15 January 2021 : Vectura Group plc (LSE: VEC)
("Vectura "), an industry-leading specialist inhalation CDMO,
highlights the announcement made today by Hikma Pharmaceuticals PLC
regarding its launch of generic Advair Diskus(R) [1] .
Hikma Pharmaceuticals PLC today posted the following
statement:
"Hikma Pharmaceuticals PLC (Hikma), the multinational
pharmaceutical company, announces that it has temporarily paused
the launch of its generic version of GlaxoSmithKline's Advair
Diskus(R) .
Following the US FDA's approval of Hikma's Abbreviated New Drug
Application (ANDA) for generic Advair Diskus(R) in December 2020,
Hikma has submitted to the US FDA an amendment to its application.
The amendment reflects enhanced packaging controls to meet new
industry standards adopted since the initial submission of its ANDA
application. This amendment will be classified as a Prior Approval
Supplement and will not affect the approved status of Hikma's ANDA
for generic Advair Diskus(R) .
Hikma will work closely with the FDA in its review and will
commence distribution of the product once the review has been
completed."
This update does not impact Board expectations regarding
Vectura's 2020 financial performance.
- 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 +44 (0)20 3709 5700
Mary-Jane Elliott / Jessica Hodgson / Susan Stuart / David Daley
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 thirteen 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 and
the successful execution of the Group's strategy to win new
customer contracts for development services. Various risks may
cause Vectura's actual results to differ materially from those
expressed or implied by the forward looking statements, including:
failure to successfully win new customer contracts for development
services; 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.
[1] Advair(R) and Advair Diskus(R) are registered trademarks of
GSK group of companies.
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END
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