Vectura Group plc Enerzair(R) Breezhaler(R) receives regulatory approval (2406S)
07 Luglio 2020 - 9:21AM
UK Regulatory
TIDMVEC
RNS Number : 2406S
Vectura Group plc
07 July 2020
Enerzair(R) Breezhaler(R) (QVM149) receives regulatory approval
in Europe and Japan, triggering $6.25 million in milestone payments
to Vectura
Chippenham, UK - 7(th) 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(R) Breezhaler(R) (QVM149;
indacaterol acetate, glycopyrronium bromide and mometasone
furoate). Enerzair(R) Breezhaler(R) , 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 29(th) June, Novartis also announced that
Enerzair(R) Breezhaler(R) 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(R) device.
Additional regulatory filings for QVM149 are currently underway
in multiple countries, including Switzerland and Canada.
For further information on European approval of Enerzair(R)
Breezhaler(R) (QVM149; indacaterol acetate, glycopyrronium bromide
and mometasone furoate), please visit Novartis' website:
https://www.novartis.com/news
- Ends-
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 <MU>g once-daily as a maintenance treatment of
asthma in adult patients not adequately controlled with a
maintenance combination of a long--acting beta(2) --agonist (LABA)
and a high-dose of an inhaled corticosteroid (ICS) who experienced
one or more asthma exacerbations in the previous year(1) . 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).
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
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contact rns@lseg.com or visit www.rns.com.
END
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July 07, 2020 03:21 ET (07:21 GMT)
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