Vectura Group plc - $11m milestone on US FDA Generic Advair approval
- This announcement contains inside information -
As a result of this approval, Vectura will receive a milestone payment of
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
"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
Consilium Strategic Communications +44 (0)20 3709 5700
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
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
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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