Vectura Group plc $2.5m milestone payment for QVM149 submission (0548A)

TIDMVEC

RNS Number : 0548A

Vectura Group plc

24 May 2019

Vectura receives $2.5m milestone payment for the European regulatory submission of QVM149

Chippenham, UK - 24 May 2019: Vectura Group plc (LSE: VEC) ("Vectura" or "the Group"), announced today that it will receive a $2.5million milestone payment under an exclusive licence agreement with Novartis AG. The payment was triggered following the acceptance of Novartis' valid Marketing Authorisation Application (MAA) by the EU Regulatory Authorities for the regulatory approval of QVM149. QVM149 is a potential new inhaled combination therapy for inadequately controlled asthma.

Vectura's Chief Executive Officer, James Ward-Lilley, said: "We are pleased to see the progression of the QVM149 program and the acceptance of the EU registration dossier ahead of its original timeline. Based on the strong Phase II study results for QVM149 presented at ATS this week, we believe this new asthma treatment has the potential to have a competitive profile and provide an important and compelling additional option for physicians and patients."

QVM149 combines comprehensive bronchodilation of indacaterol acetate (a LABA [long-acting beta agonist]) and glycopyrronium bromide (a LAMA [long-acting muscarinic receptor antagonists) with mometasone furoate (an inhaled corticosteroid) in a precise once-daily formulation delivered in a dry-powder inhaler device. 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.

Vectura is due to receive a further milestone payment of $5.0 million on European regulatory approval of the product and thereafter royalties on net sales from launch.

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For more information, please contact:

 
Vectura Group plc 
David Ginivan - VP Corporate Communications                        [phone] 
 Elizabeth Knowles - VP Investor Relations                          [phone] 
 Consilium Strategic Communications                                 [phone] 
Mary-Jane Elliott / Jessica Hodgson / Susan Stuart / David Daley 
 

Forward-looking statements

This press release contains forward-looking statements, including statements about the discovery, development and 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: adverse results in clinical development programmes; failure to obtain patent protection for inventions; 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.

About Vectura

Vectura is an industry-leading inhaled product formulation, device design and development business offering a uniquely integrated inhaled drug delivery platform. We develop inhalation products to help patients suffering from airways diseases.

Vectura has ten 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 divison of Novartis AG), Mundipharma, Kyorin, Baxter, GSK, UCB, Bayer, Chiesi, Almirall, Dynavax and Tianjin KingYork.

Vectura's strategy is to fully leverage its differentiated technology and skills, maximising value by enhancing the delivery and performance of inhaled products, and through the development of high-quality generic alternatives to branded therapies.

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

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May 24, 2019 02:00 ET (06:00 GMT)