Vectura Group plc Regulatory Update for QVM149 programme
01 Maggio 2020 - 8:01AM
RNS Non-Regulatory
TIDMVEC
Vectura Group plc
01 May 2020
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(R) Breezhaler(R) (QVM149; indacaterol acetate,
glycopyrronium bromide and mometasone furoate). Enerzair(R)
Breezhaler(R) , 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 beta(2)
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(R)
device. If approved, once-daily Enerzair(R) Breezhaler(R) 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(R)
Breezhaler(R) (QVM149; indacaterol acetate, glycopyrronium bromide
and mometasone furoate), please visit Novartis' website:
https://www.novartis.com/news
Enerzair(R) and Breezhaler(R) are registered trademarks of
Novartis AG.
- Ends-
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.
This information is provided by RNS, the news service of the
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END
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