7 Jul 2020 08:21
Enerzair® Breezhaler® (QVM149) receives regulatory approval in Europe and Japan, triggering $6.25 million in milestone payments to Vectura
Chippenham, UK - 7th July 2020: Vectura Group plc (LSE: VEC) ("Vectura" or "the Group"), an industry-leading inhalation CDMO, today confirms the announcement made by Novartis that the European Commission has approved Enerzair® Breezhaler® (QVM149; indacaterol acetate, glycopyrronium bromide and mometasone furoate). Enerzair® Breezhaler®, which utilises Vectura's formulation IP, is a first-in-class LABA/LAMA/ICS fixed-dose combination maintenance treatment for patients whose asthma is uncontrolled with LABA/ICS[1].
European regulatory approval has triggered a $5.0m milestone to Vectura from Novartis. On 29th June, Novartis also announced that Enerzair® Breezhaler® was approved for use in Japan. This approval triggered a further $1.25m milestone payment to Vectura and the Group will receive a low-single digit royalty on net sales of the product in both territories.
Will Downie, Chief Executive Officer of Vectura, said:
"This is an important regulatory approval for asthma patients in Europe and Japan. Novartis has developed a product with the potential to provide a significant and compelling additional treatment option for patients with uncontrolled asthma. Vectura's revenue stream will benefit from $6.25 million in milestone payments in 2020, plus a low-single digit royalty on future net sales of the product."
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 in a precise once-daily formulation, delivered via the dose-confirming Breezhaler® device.
Additional regulatory filings for QVM149 are currently underway in multiple countries, including Switzerland and Canada.
For further information on European approval of Enerzair® Breezhaler® (QVM149; indacaterol acetate, glycopyrronium bromide and mometasone furoate), please visit Novartis' website: https://www.novartis.com/news
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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 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.
[1] The EC approved high-dose Enerzair Breezhaler (IND/GLY/MF) 150/50/160 μg once-daily as a maintenance treatment of asthma in adult patients 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 year1. This formulation combines the bronchodilation of indacaterol acetate (a LABA) and glycopyrronium bromide (a LAMA) with mometasone furoate (ICS) in a precise once-daily formulation, delivered via the dose-confirming Breezhaler device. Glycopyrronium bromide certain use and formulation intellectual property were exclusively licensed to Novartis in April 2005 by Sosei Heptares and Vectura. Mometasone furoate is exclusively licensed to Novartis from a subsidiary of Merck & Co., Inc, Kenilworth, NJ, USA, for use in IND/GLY/MF (worldwide excluding the US).