TIDMGSK
RNS Number : 1327Z
GlaxoSmithKline PLC
24 May 2016
Issued: Tuesday 24(th) May 2016, London UK - LSE
Announcement
Salford Lung Study results show COPD patients treated with
Relvar(R) Ellipta(R) achieve superior reduction in exacerbations
compared with 'usual care'
Pioneering GSK study provides important new data on the
effectiveness of Relvar Ellipta (FF/VI) when used in everyday
clinical practice
GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ:
INVA) today announced positive headline results from the innovative
Salford Lung Study (SLS) in Chronic Obstructive Pulmonary Disease
(COPD). The study showed that Relvar(R) Ellipta(R) 100/25mcg
(fluticasone furoate 'FF'/vilanterol 'VI' or 'FF/VI') achieved a
superior reduction in exacerbations versus usual care, in patients
with COPD, in an everyday clinical practice setting. Usual care
included long-acting muscarinic antagonists (LAMA), long-acting
beta(2) -agonists (LABA), and inhaled corticosteroids (ICS)
administered as monotherapy, dual or triple combinations.
For the primary effectiveness analysis, in patients treated with
FF/VI 100/25mcg there was a statistically significant reduction of
8.41% (CI 1.12,15.17) in the rate of moderate or severe
exacerbations compared with those receiving usual care
(p=0.025).
Within the intent-to-treat (ITT) population, the incidence of
serious adverse events (SAE) was similar between the groups (29%
FF/VI, 27% usual care). For pneumonia, an SAE of special interest,
FF/VI demonstrated non-inferiority versus usual care (7% FF/VI
versus 6% usual care). This endpoint was a regulatory
post-authorisation measure requested by the European Medicines
Agency (EMA).
Patrick Vallance, President, Pharmaceuticals R&D, GSK,
commented: "In this genuinely ground-breaking study we have worked
closely with the local NHS clinical community to study patients in
their everyday setting. To ensure the results from Salford were as
robust as possible, we made a long-term financial investment in the
study, including supporting local infrastructure and training.
Innovation often means you have to ask challenging questions to
make significant advances, and I believe this is what we have
achieved in these positive results announced today."
Eric Dube, SVP and Head, Global Respiratory Franchise, GSK,
said: "The Salford Lung Study COPD results support the
effectiveness of Relvar. As we move beyond the headline results, we
will learn so much more about the medicine and disease management.
We believe the results could transform understanding of how
patients in everyday clinical practice respond to COPD treatments.
We want to say a big thank you to everyone who has made this unique
study possible."
Lead investigator, Jørgen Vestbo, Professor of Respiratory
Medicine at the Centre for Respiratory Medicine and Allergy,
University Hospital South Manchester NHS Foundation Trust and the
University of Manchester, said: "The Salford Lung Study is a very
important trial to help us understand more about the medicines we
prescribe on a day-to-day basis. This is an important finding; what
we are seeing today is the tip of the iceberg. Over the coming
months we will understand more about the day-to-day effectiveness
of FF/VI and how treatment choice, patient behaviour,
co-morbidities and other factors combine to influence COPD
outcomes. This has been a highly collaborative effort to gather
data that will help improve understanding about the effectiveness
of respiratory medicines when used in usual clinical practice."
Michael W. Aguiar, President and Chief Executive Officer of
Innoviva., said: "We are very pleased that Relvar Ellipta achieved
superiority compared to usual care in SLS, a world-first
effectiveness study in COPD. These data provide a significant body
of evidence in everyday clinical practice and add to the data
generated from other randomized controlled studies. These data are
unique in the world of evidence generation in COPD. We look forward
to disclosing further data and analyses, which we believe will be
of significant value to both physicians and patients."
Analyses remain ongoing and will be the subject of future
publications and presentations. A second Salford Lung Study is
currently being conducted in asthma patients, with results expected
in 2017.
Study Design
The Salford Lung Study is a Phase IIIb multi-centre, open label
randomised controlled trial (RCT). The objective of the study was
to compare the effectiveness and safety profile of FF/VI 100/25mcg
with existing COPD usual care. All suitable patients with COPD at
80 primary care sites in and around Salford and South Manchester
were identified from practice databases, and invited to participate
in the study by their own GP.
In total, 2802 patients with COPD were randomised 1:1 to receive
FF/VI 100/25mcg, with or without a LAMA, or to continue to receive
usual care. FF/VI was administered once daily via the Ellipta
inhaler. Patients who were taking a LAMA in addition to ICS/LABA
therapy (triple therapy) who were randomised to the FF/VI group
were able to continue to use LAMA therapy in addition to FF/VI.
Usual care was taken as advised by the prescribing clinician, and
could include single or dual long-acting bronchodilator therapy,
inhaled corticosteroid either alone or in combination with a long
acting bronchodilator or triple therapy of a LAMA, a LABA and an
inhaled corticosteroid.
The Salford Lung Study had minimal exclusion criteria and
involved a broad demographic of patients.
At baseline patients had a mean age of 67 years (min 40 - max
93) and were equally split by gender (males vs. females 51/49%). To
enrol in the study, patients were required to have a diagnosis of
COPD and be receiving maintenance therapy; at baseline a total of
86% were receiving an ICS containing regimen, with a total of 52%
on triple therapy. Patients were also required to have at least one
exacerbation in the past 3 years: at baseline 47% of patients had
>= 2 moderate exacerbations, 33% had 1 exacerbation and 20% had
not reported an exacerbation in the prior 12 months.
Patients were followed for a period of 12 months in a normal
clinical practice setting using a single electronic medical record
(EMR), linking primary care, secondary care and pharmacy data.
Throughout the duration of the study physicians were allowed to
modify or switch treatment at any point in the study, as would
happen in normal clinical practice, the only exception being a
switch from usual care to FF/VI.
The study team was able to monitor all hospital admissions,
outpatient and emergency department visits, as well as data from
primary care (including all healthcare contacts, out-of-hours
activity and prescriptions of antibiotics or oral steroids) via the
electronic health-records.
The primary effectiveness endpoint is the mean annual rate of
moderate or severe exacerbations, where a moderate exacerbation is
defined as the subject receiving an exacerbation-related
prescription (given to treat an acute worsening of COPD symptoms)
of oral corticosteroid and/or antibiotic with or without NHS
contact, not requiring hospitalisation. A severe exacerbation is
defined as an exacerbation-related hospitalisation - a direct
result of an acute worsening of symptoms of COPD or a prolonged
hospitalization as a result of a COPD exacerbation.
For the primary effectiveness analysis the patient population
was restricted to patients who had exacerbated in the previous 12
months prior to randomisation (2269), rather than in the previous
three years prior to randomisation, as in the intention to treat
(ITT) group (2799).
About the Study
The Salford Lung Study is intended to enable healthcare
professionals and decision makers to more fully assess the
potential value of FF/VI by providing data collected in a normal
clinical practice setting which is representative of how healthcare
professionals and patients may use the medicine in everyday life.
It will add to the existing data set from randomised clinical
trials (RCTs) for the medicine which, while critical to
establishing the safety and efficacy of a medicine, are conducted
in a highly controlled environment and enrol a more highly selected
patient population than would be expected in everyday clinical
care.
The study is made possible through a unique collaboration
between GSK, North West E-Health (NWEH), The University of
Manchester, Salford Royal NHS Foundation Trust, University Hospital
of South Manchester (UHSM), NHS Salford and GPs and community
pharmacists in Salford, Trafford and South Manchester.
What is COPD?
Chronic obstructive pulmonary disease (COPD) is a disease of the
lungs that includes chronic bronchitis, emphysema or both. COPD is
characterised by obstruction to airflow that interferes with normal
breathing. Cigarette smoke, breathing in second-hand smoke, air
pollution including biomass fuels, chemical fumes and dust from the
environment or workplace can all contribute to COPD.
People with COPD can experience a sudden worsening in symptoms,
known as an exacerbation. Symptoms of an exacerbation can include
an increase in breathlessness, coughing and mucus production, as
well as fever. In these cases, the patient may need to change their
medication or even, in some cases, be admitted to hospital.
Exacerbations are common; one in three patients with severe COPD
and almost half of patients with very severe COPD had frequent
exacerbations (two or more in the first year following diagnosis).
Every exacerbation can cause permanent lung damage and repeated
exacerbations can accelerate the progression of the disease. People
with frequent exacerbations have a poorer quality of life and may
have an increased risk of death.
The study is listed on www.clinicaltrials.gov.
Relvar(R) Ellipta(R) is known as Breo(R) Ellipta(R) in the
United States.
About FF/VI 100/25
FF/VI 100/25mcg, under the brand name Breo(R) Ellipta(R)
100/25mcg is licensed in the US for:
-- The long-term, once-daily, maintenance treatment of airflow
obstruction in patients with chronic obstructive pulmonary disease
(COPD), including chronic bronchitis and/or emphysema and to reduce
exacerbations of COPD in patients with a history of exacerbations.
Breo(R) Ellipta(R) 100/25mcg is the only strength indicated for the
treatment of COPD.
-- Breo Ellipta100/25mcg is not indicated for the relief of acute bronchospasm.
Full US prescribing information, including BOXED WARNING and
Medication Guide is available at us.gsk.com or US Prescribing
Information Breo Ellipta.
FF/VI 100/25mcg, under the brand name Relvar(R) Ellipta(R) is
approved in Europe for:
-- the symptomatic treatment of adults with chronic obstructive
pulmonary disease (COPD) with a FEV(1) <70% predicted normal
(post-bronchodilator) with an exacerbation history despite regular
bronchodilator therapy.
For the EU Summary of Product Characteristics for Relvar
Ellipta, please visit:
http://ec.europa.eu/health/documents/community-register/html/h886.htm
Important Safety Information (ISI) for FF/VI (Breo Ellipta) in
the US
The following ISI is based on the Highlights section of the US
Prescribing Information for Breo Ellipta. Please consult the full
Prescribing Information for all the labelled safety information for
Breo Ellipta.
Long-acting beta(2) -adrenergic agonists (LABA), such as
vilanterol, one of the active ingredients in BREO ELLIPTA, increase
the risk of asthma-related death. A placebo-controlled trial with
another LABA (salmeterol) showed an increase in asthma-related
deaths. This finding with salmeterol is considered a class effect
of all LABA. Currently available data are inadequate to determine
whether concurrent use of inhaled corticosteroids (ICS) or other
long-term asthma control drugs mitigates the increased risk of
asthma-related death from LABA.
Breo Ellipta is contraindicated for primary treatment of status
asthmaticus or other acute episodes of COPD or asthma where
intensive measures are required and in patients with severe
hypersensitivity to milk proteins or who have demonstrated
hypersensitivity to either fluticasone furoate, vilanterol, or any
of the excipients.
Breo Ellipta should not be initiated in patients during rapidly
deteriorating or potentially life-threatening episodes of COPD or
asthma, or used for the relief of acute symptoms, i.e., as rescue
therapy for the treatment of acute episodes of bronchospasm. Acute
symptoms should be treated with an inhaled, short-acting beta(2)
-agonist.
Breo Ellipta should not be used more often than recommended, at
higher doses than recommended, or in conjunction with other
medications containing LABAs, as an overdose may result.
Oropharyngeal candidiasis has occurred in patients treated with
Breo Ellipta. Patients should be advised to rinse their mouth with
water without swallowing after inhalation to help reduce this
risk.
An increase in the incidence of pneumonia has been observed in
subjects with COPD receiving the fluticasone furoate/vilanterol
combination, including Breo Ellipta 100 mcg/25 mcg, in clinical
trials. There was also an increased incidence of pneumonias
resulting in hospitalisation. In some incidences these pneumonia
events were fatal.
Patients who use corticosteroids are at risk for potential
worsening of existing tuberculosis; fungal, bacterial, viral, or
parasitic infections; or ocular herpes simplex. A more serious or
even fatal course of chickenpox or measles may occur in susceptible
patients.
Particular care is needed for patients who have been transferred
from systemically active corticosteroids to inhaled corticosteroids
because deaths due to adrenal insufficiency have occurred in
patients with asthma during and after transfer from systemic
corticosteroids to less systemically available inhaled
corticosteroids.
Hypercorticism and adrenal suppression may occur with very high
dosages or at the regular dosage of inhaled corticosteroids in
susceptible individuals.
Caution should be exercised when considering the
coadministration of Breo Ellipta with long--term ketoconazole and
other known strong CYP3A4 inhibitors because increased systemic
corticosteroid and cardiovascular adverse effects may occur.
Breo Ellipta can produce paradoxical bronchospasm which may be
life-threatening.
Hypersensitivity reactions such as anaphylaxis, angioedema,
rash, and urticaria may occur after administration of Breo
Ellipta.
Vilanterol, the LABA in Breo Ellipta, can produce clinically
significant cardiovascular effects in some patients as measured by
increases in pulse rate, systolic or diastolic blood pressure, and
also cardiac arrhythmias. Breo Ellipta should be used with caution
in patients with cardiovascular disorders.
Decreases in bone mineral density have been observed with
long-term administration of products containing inhaled
corticosteroids, as have glaucoma, increased intraocular pressure,
and cataracts.
Breo Ellipta should be used with caution in patients with
convulsive disorders, thyrotoxicosis, diabetes mellitus,
ketoacidosis, and in patients who are unusually responsive to
sympathomimetic amines.
Beta-adrenergic agonist medicines may produce significant
hypokalemia in some patients. Beta-adrenergic agonist medicines may
produce transient hyperglycemia in some patients.
For COPD, the most common adverse reactions (>=3% and more
common than in placebo) reported in two 6-month clinical trials
with Breo Ellipta 100/25 (and placebo) were nasopharyngitis, 9%
(8%); upper respiratory tract infection, 7% (3%); headache, 7%
(5%); and oral candidiasis, 5% (2%). In addition to the reactions
reported in the 6-month studies, adverse reactions occurring in
>=3% of the subjects treated with Breo Ellipta 100/25 in two
1-year studies included back pain, pneumonia, bronchitis,
sinusitis, cough, oropharyngeal pain, arthralgia, influenza,
pharyngitis, and pyrexia.
RELVAR(R) , BREO(R) and ELLIPTA(R) are trade marks of the
GlaxoSmithKline group of companies.
GSK - one of the world's leading research-based pharmaceutical
and healthcare companies - is committed to improving the quality of
human life by enabling people to do more, feel better and live
longer. For further information please visit www.gsk.com.
Innoviva - Innoviva is focused on bringing compelling new
medicines to patients in areas of unmet need by leveraging its
significant expertise in the development, commercialization and
financial management of bio-pharmaceuticals. Innoviva's portfolio
is anchored by the respiratory assets partnered with Glaxo Group
Limited (GSK), including RELVAR(R)/BREO(R) ELLIPTA(R) and ANORO(R)
ELLIPTA(R), which were jointly developed by Innoviva and GSK. Under
the agreement with GSK, Innoviva is eligible to receive associated
royalty revenues from RELVAR(R)/BREO(R) ELLIPTA(R), ANORO(R)
ELLIPTA(R) and, if approved and commercialized, VI monotherapy, as
well. In addition, Innoviva retains a 15 percent economic interest
in future payments made by GSK for earlier-stage programs partnered
with Theravance BioPharma, Inc. For more information, please visit
Innoviva's website at www.inva.com. RELVAR(R), BREO(R), ANORO(R)
and ELLIPTA(R) are trademarks of the GlaxoSmithKline group of
companies.
GSK enquiries:
UK Media enquiries: David Mawdsley +44 (0) 20 8047 (London)
5502
Simon Steel +44 (0) 20 8047 (London)
5502
David Daley +44 (0) 20 8047 (London)
5502
Catherine Hartley +44 (0) 20 8047 (London)
5502
Sarah Spencer +44 (0) 20 8047 (London)
5502
Claire Brough +44 (0) 20 8047 (London)
5502
US Media enquiries: Sarah Alspach +1 202 715 1048 (Washington,
DC)
Mary Anne Rhyne +1 919 483 0492 (North Carolina)
Melinda Stubbee +1 919 483 2510 (North Carolina)
Jenni Ligday +1 202 715 1049 (Washington,
DC)
Karen Hagens +1 919 483 2863 (North Carolina)
Gwynn Oosterbaan +1 215 751 7468 (Philadelphia)
Analyst/Investor enquiries: Ziba Shamsi +44 (0) 20 8047 (London)
5543
Tom Curry + 1 215 751 5419 (Philadelphia)
Gary Davies +44 (0) 20 8047 (London)
5503
James Dodwell +44 (0) 20 8047 (London)
2406
Jeff McLaughlin +1 215 751 7002 (Philadelphia)
Innoviva, Inc. enquiries:
Investor Relations Eric d'Esparbes +1 650 238 9640 (San Francisco)
investor.relations@inva.com
Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or
projections made by GSK, including those made in this announcement,
are subject to risks and uncertainties that may cause actual
results to differ materially from those projected. Such factors
include, but are not limited to, those described under Item 3.D
'Risk factors' in the company's Annual Report on Form 20-F for
2015.
Innoviva forward-looking statements
This press release contains certain "forward-looking" statements
as that term is defined in the Private Securities Litigation Reform
Act of 1995 regarding, among other things, statements relating to
goals, plans, objectives and future events. Innoviva intends such
forward-looking statements to be covered by the safe harbor
provisions for forward-looking statements contained in Section 21E
of the Securities Exchange Act of 1934 and the Private Securities
Litigation Reform Act of 1995. Such forward-looking statements
involve substantial risks, uncertainties and assumptions. Examples
of such statements include statements relating to: the future use
or importance of the SLS trial results, prescription and market
share trends, payor coverage, the strategies, plans and objectives
of the company, the timing, manner and amount of anticipated
potential capital returns to stockholders (including without
limitation, expectations of future share repurchases or cash
dividends), the status and timing of clinical studies, data
analysis and communication of results, the potential benefits and
mechanisms of action of product candidates, expectations for
products, and projections of revenue, expenses and other financial
items. These statements are based on the current estimates and
assumptions of the management of Innoviva as of the date of this
press release and are subject to risks, uncertainties, changes in
circumstances, assumptions and other factors that may cause the
actual results of Innoviva to be materially different from those
reflected in the forward-looking statements. Important factors that
could cause actual results to differ materially from those
indicated by such forward-looking statements include, among others,
risks related to: lower than expected future royalty revenue from
respiratory products partnered with GSK, delays or difficulties in
commencing or completing clinical studies, the potential that
results from clinical or non-clinical studies indicate product
candidates are unsafe or ineffective, dependence on third parties
to conduct its clinical studies, delays or failure to achieve and
maintain regulatory approvals for product candidates, and risks of
collaborating with third parties to discover, develop and
commercialize products. Other risks affecting Innoviva are
described under the headings "Risk Factors" and "Management's
Discussion and Analysis of Financial Condition and Results of
Operations" contained in Innoviva's Annual Report on Form 10-K for
the year ended December 31, 2015 and Innoviva's Quarterly Report on
Form 10-Q for the quarter ended March 31, 2016, which are on file
with the Securities and Exchange Commission (SEC) and available on
the SEC's website at www.sec.gov. In addition to the risks
described above and in Innoviva's other filings with the SEC, other
unknown or unpredictable factors also could affect Innoviva's
results. Past performance is not necessarily indicative of future
results. No forward-looking statements can be guaranteed and actual
results may differ materially from such statements. Given these
uncertainties, you should not place undue reliance on these
forward-looking statements. Innoviva assumes no obligation to
update its forward-looking statements on account of new
information, future events or otherwise, except as required by law.
(INVA-G)
Registered in England & Wales:
No. 3888792
Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
This information is provided by RNS
The company news service from the London Stock Exchange
END
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