VEC.L Regulatory News (VEC)

Vectura Group plc

Status update on ANDA for generic Advair Diskus® (VR315)

Chippenham, UK - 12 March 2018: Vectura Group plc (LSE: VEC) ("Vectura" or the "Group"), an industry-leading device and formulation business for inhaled airways products, announces that its partner for a US generic version of Advair Diskus® (VR315), Hikma Pharmaceuticals PLC ("Hikma"), has received a response from the US Food and Drug Administration ("FDA") in relation to the dispute resolution process for its abbreviated new drug application ("ANDA") for VR315.

Hikma has confirmed that the dispute resolution process has now concluded. The FDA has upheld its original decision and included a request that Hikma completes an additional Clinical Endpoint study. In anticipation of this as one of the potential outcomes, Hikma has already finalised the planning of a new clinical study and expects to start patient enrolment in the coming weeks. Hikma anticipates being able to submit a response to the FDA with new clinical data as early as possible in 2019.

Hikma and Vectura have had constructive dialogue with the FDA to resolve the observations made in the Complete Response Letter ("CRL") received on 11th May 2017 and they have been able to address and clarify the majority of the questions raised. As announced on 9th November 2017, Hikma, supported by Vectura, decided to progress a dispute resolution process regarding the remaining outstanding issue, namely the different interpretation of the results from the Clinical Endpoint Study. This process has now concluded. Both Vectura and Hikma remain confident in the approvability of the product and are committed to bringing this cost-effective alternative to Advair Diskus® to the market as quickly as possible.

James Ward-Lilley, Chief Executive Officer, commented:

"Whilst the outcome of the dispute resolution process is disappointing, we now have a clear pathway forwards, and we and our partner Hikma remain confident in, and committed to the approval of VR315. Assuming the successful execution of the new study and a standard regulatory review, we now expect a potential approval and launch during 2020.

"Importantly, we are one of the few first movers into this complex area and in this process we have cleared up a significant number of issues which we believe has strengthened our insight and likelihood of success. These learnings support our confidence that we have the capabilities to achieve US regulatory approval for our extensive inhaled generic pipeline, which includes versions of the three current largest US inhaled brands."

The FDA's decision will have no impact on Vectura's revenue or R&D expectations for the year. 

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About Vectura

Vectura, 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, three 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 programmes.

For further information, please visit Vectura's website at www.vectura.com.