Generic Advair Update

- This announcement contains inside information -

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

Chippenham, UK - 22nd September 2020: Vectura Group plc (LSE: VEC) ("Vectura"), an industry-leading inhalation CDMO, confirms the announcement made today by its partner Hikma Pharmaceuticals PLC, ("Hikma"). Hikma has received a minor complete response letter (CRL) from the US Food and Drug Administration (FDA) in relation to its abbreviated new drug application (ANDA) for its US generic version of GlaxoSmithKline's Advair Diskus®1 (VR315 (US)).

Hikma is working closely with the FDA to quickly address the small number of questions raised in the minor CRL. Once answered, Hikma can expect to receive a response from the FDA within 90 days. Both Hikma and Vectura are committed to bringing this important product to the US market and remain confident in the submission.

Hikma has stated that it now expects to receive approval for its generic Advair Diskus® in early 2021. Approval of VR315 (US) will trigger milestones to Vectura of $11m, with a mid-teen percentage royalty on net sales of the product.

Aside from VR315 (US), all other Vectura guidance for 2020 remains unchanged.

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Vectura Group plc

David Ginivan, VP Corporate Communications +44 (0) 7471 352 720

Elizabeth Knowles, VP Investor Relations +44 (0) 7767 150 565

About Vectura

Vectura is a provider of innovative inhaled drug delivery solutions that enable partners to bring their medicines to patients. With differentiated proprietary technology and pharmaceutical development expertise, Vectura is one of the few companies globally with the device, formulation and development capabilities to deliver a broad range of complex inhaled therapies. 

Vectura has eleven key inhaled and eleven non-inhaled products marketed by partners with global royalty streams, and a diverse partnered portfolio of drugs in clinical development. Our partners include Hikma, Novartis, Sandoz (a division of Novartis AG), Mundipharma, Kyorin, GSK, Bayer, Chiesi, Almirall, and Tianjin KingYork.

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

Forward-looking statements

This press release contains forward-looking statements, including statements about the commercialisation of products. Various risks may cause Vectura's actual results to differ materially from those expressed or implied by the forward looking statements, including: commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialise products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialisation activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward looking statements, whether as a result of new information, future events or otherwise.

[1] Advair® and Advair Diskus® are registered trademarks of Glaxo Group Limited.