Vectura Group plc Status update on ANDA for generic Advair (VR315) (3397H)
March 12 2018 - 3:02AM
UK Regulatory
TIDMVEC
RNS Number : 3397H
Vectura Group plc
12 March 2018
Vectura Group plc
Status update on ANDA for generic Advair Diskus(R) (VR315)
Chippenham, UK - 12 March 2018: Vectura Group plc (LSE: VEC)
("Vectura" or the "Group"), an industry-leading device and
formulation business for inhaled airways products, announces that
its partner for a US generic version of Advair Diskus(R) (VR315),
Hikma Pharmaceuticals PLC ("Hikma"), has received a response from
the US Food and Drug Administration ("FDA") in relation to the
dispute resolution process for its abbreviated new drug application
("ANDA") for VR315.
Hikma has confirmed that the dispute resolution process has now
concluded. The FDA has upheld its original decision and included a
request that Hikma completes an additional Clinical Endpoint study.
In anticipation of this as one of the potential outcomes, Hikma has
already finalised the planning of a new clinical study and expects
to start patient enrolment in the coming weeks. Hikma anticipates
being able to submit a response to the FDA with new clinical data
as early as possible in 2019.
Hikma and Vectura have had constructive dialogue with the FDA to
resolve the observations made in the Complete Response Letter
("CRL") received on 11(th) May 2017 and they have been able to
address and clarify the majority of the questions raised. As
announced on 9(th) November 2017, Hikma, supported by Vectura,
decided to progress a dispute resolution process regarding the
remaining outstanding issue, namely the different interpretation of
the results from the Clinical Endpoint Study. This process has now
concluded. Both Vectura and Hikma remain confident in the
approvability of the product and are committed to bringing this
cost-effective alternative to Advair Diskus(R) to the market as
quickly as possible.
James Ward-Lilley, Chief Executive Officer, commented:
"Whilst the outcome of the dispute resolution process is
disappointing, we now have a clear pathway forwards, and we and our
partner Hikma remain confident in, and committed to the approval of
VR315. Assuming the successful execution of the new study and a
standard regulatory review, we now expect a potential approval and
launch during 2020.
"Importantly, we are one of the few first movers into this
complex area and in this process we have cleared up a significant
number of issues which we believe has strengthened our insight and
likelihood of success. These learnings support our confidence that
we have the capabilities to achieve US regulatory approval for our
extensive inhaled generic pipeline, which includes versions of the
three current largest US inhaled brands."
The FDA's decision will have no impact on Vectura's revenue or
R&D expectations for the year.
For more information, please contact:
Vectura Group plc +44 (0)7471 352 720
Andrew Derodra - Chief Financial Officer
David Ginivan - VP Corporate Communications
Elizabeth Knowles - Director Investor Relations and Analysis
Julia Wilson - Director Investor Relations
Consilium Strategic Communications +44 (0)20 3709 5700
Mary-Jane Elliott / Chris Welsh / Jessica Hodgson
About Vectura
Vectura, listed on the London Stock Exchange (LSE: VEC), is an
industry-leading device and formulation business for inhaled
airways products offering a uniquely integrated inhaled drug
delivery platform. With our extensive range of device and
formulation technologies, integrated capabilities and
collaborations, we are a leader in the development of inhalation
products, increasing our ability to help patients suffering from
respiratory diseases.
Vectura has eight inhaled, three non-inhaled and ten oral
products marketed by partners with growing global royalty streams.
The Group has a diverse portfolio of drugs in clinical development,
including a number of novel and generic programmes which are
partnered with several global pharmaceutical and biotechnology
companies including Hikma, Novartis, Sandoz, Mundipharma, Kyorin,
Baxter, GSK, UCB, Ablynx, Grifols, Bayer, Chiesi, Almirall,
Janssen, Dynavax and Tianjin KingYork along with two wholly owned
nebulised development programmes.
For further information, please visit Vectura's website at
www.vectura.com.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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