Vectura Group plc Hikma statement on ANDA for generic Advair(VR315) (9919V)
09 November 2017 - 6:05PM
UK Regulatory
TIDMVEC
RNS Number : 9919V
Vectura Group plc
09 November 2017
Vectura Group plc
Hikma Trading Update, statement on its ANDA for generic Advair
Diskus(R) (VR315)
Chippenham, UK - 9 November 2017: Vectura Group plc (LSE: VEC)
("Vectura"), an industry-leading device and formulation business
for inhaled airways products, confirms the following statement made
today by its partner Hikma Pharmaceuticals PLC ("Hikma") in its
trading update in respect of its abbreviated new drug application
("ANDA") filing for a US generic version of Advair Diskus(R)
(VR315):
"On 11 May 2017, we announced the receipt of a complete response
letter (CRL) from the US Food and Drug Administration (FDA) in
relation to our abbreviated new drug application (ANDA) for our
generic version of GlaxoSmithKline's Advair Diskus(R) (fluticasone
propionate and salmeterol inhalation powder). Since then we,
supported by our partner Vectura, have had constructive discussions
with the FDA and we have been able to clarify and address the
majority of the questions raised.
However, there remains an outstanding issue regarding our
Clinical Endpoint (CEP) study. We firmly disagree with the FDA's
position and we are progressing with a dispute resolution process.
We now expect this process to be completed in the first quarter of
2018, at which point we will update the market and provide further
details on timelines.
Hikma and Vectura remain confident in the approvability of our
product and are committed to bringing this cost-effective
alternative to Advair Diskus(R) to the market as quickly as
possible."
- Ends -
Enquiries
Vectura Group plc +44 (0)1249 667700
Andrew Derodra - Chief Financial Officer
Fleur Wood - Director Communications
Elizabeth Knowles - Director Investor Relations and Analysis
Consilium Strategic Communications +44 (0)20 3709 5700
Mary-Jane Elliot / Jessica Hodgson / Chris Welsh
About Vectura
Vectura, a FTSE250 company 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, four 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
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
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