Vectura Group plc Status update of ANDA for generic Advair Diskus® (8290E)
May 11 2017 - 1:50AM
UK Regulatory
TIDMVEC
RNS Number : 8290E
Vectura Group plc
11 May 2017
Vectura Group plc
Update on the status of the ANDA for generic Advair
Diskus(R)
Chippenham, UK - 11 May 2017: Vectura Group plc (LSE: VEC)
("Vectura"), an industry-leading device and formulation business
for inhaled airways products, announces that its partner on VR315
US (generic Advair Diskus(R) programme), Hikma Pharmaceuticals PLC
("Hikma") has confirmed it has received a Complete Response Letter
("CRL") from the US Food and Drug Administration ("FDA") in
relation to its abbreviated new drug application ("ANDA") for its
generic version of GlaxoSmithKline's Advair Diskus(R) (fluticasone
propionate and salmeterol inhalation powder).
The FDA has categorised the CRL as 'Major'. Hikma and Vectura
will provide an update on its application as soon as practicable
once we have completed our review of the CRL and discussed this
with the FDA. Based on the initial assessment no material issues
were raised regarding the substitutability of the proposed
device.
Hikma and Vectura are committed to bringing this important
product to the US market and have confidence in the future approval
of the programme as an AB rated substitutable product.
Given the nature of the feedback Vectura believe there is a low
likelihood of approval of the VR315 programme this year and does
not anticipate receiving an approval milestone or sales royalties
for VR315 in 2017.
West-Ward's fluticasone propionate and salmeterol inhalation
powder is indicated for the treatment of asthma and the maintenance
treatment of airflow obstruction and reducing exacerbations in
patients with chronic obstructive pulmonary disease and is
delivered using Vectura's proprietary dry powder inhaler and
formulation technology.
- 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 / Sue Stuart / Jessica Hodgson
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 seven inhaled, four non-inhaled and ten oral
products marketed by partners with growing global royalty streams,
and a portfolio of drugs in clinical development, a number of which
have licence agreements with several global pharmaceutical and
biotechnology companies including Hikma, Novartis, Sandoz,
Mundipharma, Kyorin, Baxter, GSK, UCB, Ablynx, Grifols, Bayer,
Chiesi, Almirall, Janssen, and Tianjin KingYork.
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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