Update on the status of the ANDA for generic Advair Diskus®

May 11, 2017 at 7:50 AM

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® 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® (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.

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Vectura Group plc
Andrew Derodra - Chief Financial Officer
Fleur Wood - Director Communications
Elizabeth Knowles - Director Investor Relations and Analysis

+44 (0)1249 667700

Consilium Strategic Communications
Mary-Jane Elliot / Sue Stuart / Jessica Hodgson

+44 (0)20 3709 5700

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

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