1 May 2020 07:01
Vectura provides Regulatory Update for QVM149 programme
Chippenham, UK - 1 May 2020: Vectura Group plc (LSE: VEC) ("Vectura"), an industry-leading inhalation CDMO, today highlights the announcement made by Novartis that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Enerzair® Breezhaler® (QVM149; indacaterol acetate, glycopyrronium bromide and mometasone furoate). Enerzair® Breezhaler®, which utilises Vectura's formulation IP, is a maintenance treatment for uncontrolled asthma in adult patients. Uncontrolled patients are those whose asthma is not adequately controlled with a maintenance combination of a long-acting beta2 agonist (LABA) and a high dose of an inhaled corticosteroid (ICS) who experienced one or more asthma exacerbations in the previous year.
A final decision from the European Commission regarding the grant of a marketing authorisation is expected to be received approximately two months after a CHMP opinion. Upon European regulatory approval, Vectura will be eligible to receive a $5.0 million milestone and thereafter a low-single digit royalty on net sales.
About QVM149
Vectura and Sosei Heptares exclusively licensed glycopyrronium bromide and certain intellectual property relating to its use and formulation to Novartis in April 2005. Novartis is responsible for the development and commercialisation of QVM149.
QVM149 combines the bronchodilation of indacaterol acetate (a LABA) and the antimuscarinic effects of glycopyrronium bromide (a LAMA) with mometasone furoate (an ICS) in a precise once-daily formulation, delivered via the dose-confirming Breezhaler® device. If approved, once-daily Enerzair® Breezhaler® will be the first LABA/LAMA/ICS fixed-dose combination for patients suffering from asthma.
Additional regulatory filings for QVM149 are currently underway in multiple countries, including Switzerland, Japan and Canada.
For further information on the positive opinion for Enerzair® Breezhaler® (QVM149; indacaterol acetate, glycopyrronium bromide and mometasone furoate), please visit Novartis' website: https://www.novartis.com/news
Enerzair® and Breezhaler® are registered trademarks of Novartis AG.
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For more information, please contact:
Vectura Group plc
Elizabeth Knowles - VP Investor Relations +44 (0)7767 160 565
David Ginivan - VP Corporate Communications +44 (0)7471 352 720
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 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.