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Vectura Group plc - $11m milestone on US FDA Generic Advair approval

RNS Number : 0796J
Vectura Group plc
17 December 2020


- This announcement contains inside information -


Vectura earns $11m milestone as Hikma receives US FDA approval for generic Advair Diskus®

Chippenham, UK - 17 December 2020: Vectura Group plc (LSE: VEC) ("Vectura"), an industry-leading specialist inhalation CDMO, today announces that its partner Hikma Pharmaceuticals has launched its generic version of GlaxoSmithKline's Advair Diskus®1 (fluticasone propionate and salmeterol inhalation powder), 100mcg/50mcg and 250mcg/50mcg doses, in the US. The launch of the product follows approval by the US Food and Drug Administration (FDA).

As a result of this approval, Vectura will receive a milestone payment of $11m which will be recognised in 2020, and will earn a mid-teen royalty on net sales of the product.

Hikma's fluticasone propionate and salmeterol inhalation powder is indicated for the treatment of asthma, the maintenance treatment of airflow obstruction, and for reducing exacerbations in patients with chronic obstructive pulmonary disease. It is delivered using Vectura's proprietary lever-operated multi-dose inhaler ("LOMI") device technology. 

This marks the first US FDA approval of a Vectura dry powder inhaler and joins the growing Vectura franchise of approved inhalation devices in Europe and Rest of World such as GyroHaler® and FOX®

Will Downie, Chief Executive Officer of Vectura, said, "This is excellent news for Vectura and for people living with asthma and COPD in the US. Approval of this high quality substitutable generic product for Advair Diskus® validates Vectura's rare, industry-leading development capabilities and the strong partnership we have with Hikma.

"Approval of this product paves the way for our substitutable drug-device combination programme, also partnered with Hikma, for generic versions of the GSK Ellipta® portfolio, in the coming years."

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For more information, please contact:

Vectura Group plc

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

Elizabeth Knowles - VP Investor Relations                         +44 (0)7767 160 565


Consilium Strategic Communications                              +44 (0)20 3709 5700

Mary-Jane Elliott / Sue Stuart / David Daley


About Vectura

Vectura is a provider of innovative inhaled drug delivery solutions that enable partners and customers 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, Bayer, Chiesi, Almirall, and Tianjin KingYork.

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

About Hikma
For more than 40 years, they've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, they are a global company with a local presence across the United States (US), the Middle East and North Africa (MENA) and Europe, and they use their unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. They're committed to their customers, and the people they care for, and by thinking creatively and acting practically, they provide them with a broad range of branded and non-branded generic medicines. Their 8,600 colleagues are helping to shape a healthier world that enriches all their communities. Hikma are a leading licensing partner, and through their venture capital arm, they are helping bring innovative health technologies to people around the world. For more information, please visit: www.hikma.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.

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