17 Aug 2017 07:06
Vectura Group plc
Hikma Interim Results statement on its ANDA for generic Advair Diskus® (VR315)
Chippenham, UK - 17 August 2017: Vectura Group plc (LSE: VEC) ("Vectura"), an industry-leading device and formulation business for inhaled airways products, today confirms the statement made by its partner Hikma Pharmaceuticals PLC ("Hikma") in its interim results statement in respect of its abbreviated new drug application ("ANDA") filing for a US generic version of Advair Diskus® (VR315):
"We announced on 11 May 2017 that the US Food and Drug Administration (FDA) had issued a complete response letter (CRL) 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 have been able to clarify and resolve a number of the questions raised. The discussions with the FDA have confirmed the initial assessment that there are no material issues regarding the substitutability of the proposed device.
We are in ongoing discussions with the FDA to address the remaining questions and will provide a more detailed update to the market as soon as we are able to do so."
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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, 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.