Update on Hikma’s launch of generic Advair Diskus

Vectura highlights update made by Hikma on launch of generic Advair Diskus®

Chippenham, UK - 21 April 2021: Vectura Group plc (LSE: VEC) ("Vectura "), an industry-leading specialist inhalation CDMO, highlights the announcement made today by Hikma Pharmaceuticals PLC regarding its launch of generic Advair Diskus®.

Hikma Pharmaceuticals PLC today posted the following statement:

"Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, announces that it has resumed the launch of its generic version of GlaxoSmithKline's Advair Diskus® in the US following US FDA approval of an amendment Hikma submitted to its Abbreviated New Drug Application in January 2021. The amendment reflected enhanced packaging controls to meet new industry standards adopted since the initial submission of its ANDA.

Hikma will immediately resume launch activities of its generic product for Advair Diskus® (Fluticasone Propionate and Salmeterol Inhalation Powder, USP), 100mcg/50mcg and 250mcg/50mcg doses in the US."

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For more information, please contact:

Vectura Group plc

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

Olivia Manser - Director, Investor Relations +44 (0)7947 758 259

Consilium Strategic Communications +44 (0)20 3709 5700

Mary-Jane Elliott / Melissa Gardiner / David Daley

About Vectura

Vectura is a provider of innovative inhaled drug delivery services 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 thirteen 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 and the successful execution of the Group's strategy to win new customer contracts for development services. Various risks may cause Vectura's actual results to differ materially from those expressed or implied by the forward looking statements, including: failure to successfully win new customer contracts for development services; 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.