Hikma Trading Update, statement on its ANDA for generic Advair Diskus® (VR315)

November 09, 2017 at 7:00 AM

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® (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® (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® to the market as quickly as possible."

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Vectura Group plc

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 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

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