VEC.L Regulatory News (VEC)

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

Chippenham, UK - 15 January 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®[1].

Hikma Pharmaceuticals PLC today posted the following statement:

"Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, announces that it has temporarily paused the launch of its generic version of GlaxoSmithKline's Advair Diskus®.

Following the US FDA's approval of Hikma's Abbreviated New Drug Application (ANDA) for generic Advair Diskus® in December 2020, Hikma has submitted to the US FDA an amendment to its application. The amendment reflects enhanced packaging controls to meet new industry standards adopted since the initial submission of its ANDA application. This amendment will be classified as a Prior Approval Supplement and will not affect the approved status of Hikma's ANDA for generic Advair Diskus®.

Hikma will work closely with the FDA in its review and will commence distribution of the product once the review has been completed." 

This update does not impact Board expectations regarding Vectura's 2020 financial performance.

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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 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.