TIDMVEC
RNS Number : 1035U
Vectura Group plc
19 October 2017
Vectura Group plc
Launch of Seebri(TM) Neohaler(R) in the US
Chippenham, UK - 19 October 2017: Vectura Group plc (LSE: VEC)
("Vectura", "the Group"), an industry-leading device and
formulation business for inhaled airways products, confirms that
Sunovion Pharmaceuticals Inc. ("Sunovion"), the US licensee of the
Group's partner Novartis AG ("Novartis"), has launched the
twice-daily long acting muscarinic inhibitor (LAMA) Seebri(TM)
Neohaler(R) (glycopyrrolate 15.6mcg), in the US.
Sunovion entered into an exclusive license agreement with
Novartis for the US commercialisation rights to three of Novartis'
COPD treatments, including Seebri(TM) Neohaler(R) and Utibron(TM)
Neohaler(R) , on 21 December 2016 and in April 2017 Sunovion
confirmed it had launched the dual long acting bronchodilator and
muscarinic combination therapy (LABA-LAMA) Utibron(TM) Neohaler(R)
, in the US.
Vectura is eligible to receive royalties from Novartis on net
sales of the product as well as certain milestones based on global
calendar year combined net sales of Utibron(TM) Neohaler(R) ,
Seebri(TM) Neohaler(R) , Ultibro(R) Breezhaler(R) and Seebri(R)
Breezhaler(R) . The royalties earned upon net sales of Seebri(TM)
Neohaler(R) are the same as those for Seebri(R) Breezhaler(R) .
James Ward-Lilley, Chief Executive Officer of Vectura:
"Following the launch of Utibron in April we are pleased with
the confirmation of launch of Seebri in the US. Whilst the
commercial priority for 2017 has been securing market access and
product listings we remain confident that Sunovion will be
effective in the commercialisation of these products given its
strong US respiratory track record and look forward to this being
reflected in strong revenue growth in the US for these two
products."
Ultibro(R) Breezhaler(R) Seebri(R) Breezhaler(R) ,Utibron(TM)
Neohaler(R) , Seebri(TM)Neohaler(R) are trademarks of Novartis
AG.
- Ends -
Enquiries
Vectura Group plc +44 (0)1249 667 700
Andrew Derodra - Chief Financial Officer
Fleur Wood - Director Communications
Elizabeth Knowles - Director Investor Relations and Analysis
Consilium Strategic Communications +44 (0)20 3709 5700
Mary-Jane Elliott / Sue Stuart / Jessica Hodgson vectura@consilium-comms.com
About Vectura
Vectura, a FTSE250 company listed on the London Stock Exchange
(LSE: VEC), is an industry-leading device and formulation business
for inhaled airways products offering a uniquely integrated inhaled
drug delivery platform. With our extensive range of device and
formulation technologies, integrated capabilities and
collaborations, we are a leader in the development of inhalation
products, increasing our ability to help patients suffering from
respiratory diseases.
Vectura has eight inhaled, four non-inhaled and ten oral
products marketed by partners with growing global royalty streams.
The Group has a diverse portfolio of drugs in clinical development,
including a number of novel and generic programmes which are
partnered with several global pharmaceutical and biotechnology
companies including Hikma, Novartis, Sandoz, Mundipharma, Kyorin,
Baxter, GSK, UCB, Ablynx, Grifols, Bayer, Chiesi, Almirall,
Janssen, Dynavax and Tianjin KingYork along with two wholly owned
nebulised development programmes.
About Seebri(TM) Neohaler(R) (glycopyrrolate) Inhalation
Powder
Seebri(TM) Neohaler(R) (glycopyrrolate) Inhalation Powder, 15.6
mcg twice daily, is a long-acting muscarinic antagonist (LAMA)
approved in the U.S. for the long-term maintenance treatment of
airflow obstruction in people with COPD, including chronic
bronchitis and/or emphysema. SEEBRI NEOHALER is delivered by a dry
powder inhaler (DPI), and its active ingredient, glycopyrrolate,
has an established safety and efficacy profile. In clinical trials,
SEEBRI NEOHALER improved lung function and showed reduced use of
rescue medication and improvements in health-related quality of
life, as measured by the St. George's Respiratory Questionnaire
(SGRQ) total score, which is a composite of patient-reported
symptoms, activities and impact on daily living.
The most common adverse reactions (>=1% and more common than
placebo) reported in two 12-week clinical trials with SEEBRI
NEOHALER (and placebo) were: upper respiratory tract infection,
3.4% (2.3%); nasopharyngitis, 2.1% (1.9%); urinary tract infection,
1.4% (1.3%); sinusitis, 1.4% (0.7%); oropharyngeal pain, 1.8%
(1.2%).
About Long-Acting Muscarinic Antagonists (LAMAs)
A long-acting muscarinic antagonist (LAMA) is a type of
long-acting bronchodilator, along with long-acting beta(2) agonists
(LABAs). According to the GOLD report, these are currently the
first-line standard of care maintenance therapy for symptomatic
patients with COPD, and help the muscles around the airways in
lungs stay relaxed to prevent symptoms such as wheezing, coughing,
chest tightness and shortness of breath.[i] LAMAs and LABAs are
widely used and
important therapeutic approaches for people with COPD.
About COPD
Chronic obstructive pulmonary disease (COPD) is a common,
preventable and treatable disease that is characterized by
persistent respiratory symptoms and airflow limitation that is due
to airway and/or lung abnormalities usually caused by significant
exposure to toxic particles or gases. The main risk factor for COPD
is tobacco smoking, but other environmental exposures may
contribute.(i) Approximately 15.7 million adults in the U.S. report
that they have been diagnosed with COPD.[ii] It is estimated that
several million more adults have undiagnosed COPD.[iii] COPD is
responsible
for over 120,000 deaths per year, making it the third leading
cause of death in the U.S.(iii) COPD develops slowly and the
symptoms often worsen over time, potentially limiting the ability
to perform routine activities.(ii) Symptoms of COPD include
coughing, wheezing, shortness of breath, excess production of mucus
in the lungs, the inability to breathe deeply and the feeling of
being unable to breathe.[iv] The symptoms of COPD can be most
severe during the night and early morning.[v] Morning symptoms can
be associated with limitation of activities during the day,
impaired health status and increased risk of exacerbation.[vi]
Night-time symptoms disturb sleep, reduce sleep quality and, in the
long term, may be associated with development or worsening of
cardiovascular diseases, cognition, depression and increased
mortality.[vii]
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.
[i] GOLD Guidelines 2017.
http://www.goldcopd.org/guidelines-global-strategy-for-diagnosis-management.html.
Accessed: March 16, 2017.
[ii] MMWR: Morbidity and Mortality Weekly Report. Employment and
Activity Limitations Among Adults with Chronic Obstructive
Pulmonary Disease - United States, 2013. March 27,
2015; 64(11). Available at http://www.cdc.gov/mmwr/
[iii] National Heart, Lung, and Blood Institute. "What is COPD?"
Available at:
http://www.nhlbi.nih.gov/health/educational/copd/what-is-copd/index.htm.
Accessed: March 2, 2016
[iv] National Heart, Lung and Blood Institute. (2013). What Are
the Signs and Symptoms of COPD? Retrieved from
https://www.nhlbi.nih.gov/health/health-topics/topics/copd/signs.
[v] Partridge MR, Karlsson N, Small IR. Patient insight into the
impact of chronic obstructive pulmonary disease in the morning: an
internet survey. Curr Med Res Opin. 2009;25:2043-8.
[vi] Roche N, Small M, Broomfield S, Higgins V, Pollard R. Real
world COPD: association of morning symptoms with clinical and
patient reported outcomes. COPD. 2013;10:679-86.
[vii] Agusti A, Hedner J, Marin JM, Barbé F, Cazzola M, Rennard
S. Night-time symptoms: a forgotten dimension of COPD. Eur Respir
Rev. 2011;20:183-94.
This information is provided by RNS
The company news service from the London Stock Exchange
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