RELVAR(R) ELLIPTA(R) Receives European Marketing Authorisation for the
Treatment of Asthma and COPD
LONDON, UNITED KINGDOM and SOUTH SAN FRANCISCO, CA -- (Marketwired)
-- 11/18/13 -- GlaxoSmithKline plc (GSK) and Theravance, Inc.
(NASDAQ: THRX) announced today that the European Commission has
granted marketing authorisation for RELVAR(R) ELLIPTA(R), which is
now licensed across 31 European countries for the following uses:
Asthma: the regular treatment of asthma in adults and adolescents
aged 12 years and older where use of a combination medicinal product
(long-acting beta2-agonist and inhaled corticosteroid) is
-- patients not adequately controlled with inhaled corticosteroids and
'as needed' inhaled
COPD: the symptomatic treatment of adults with chronic obstructive
pulmonary disease (COPD) with a FEV1 < 70% predicted normal
(post-bronchodilator) with an exacerbation history despite regular
Relvar is a combination of the inhaled corticosteroid (ICS),
fluticasone furoate "FF", and the long-acting beta2-agonist (LABA),
vilanterol "VI" (FF/VI). Two strengths of FF/VI have been licensed
for the treatment of asthma (92/22 mcg and 184/22 mcg) and one
strength has been licensed for the treatment of COPD (92/22 mcg).
Both strengths will be administered once-daily using Ellipta, a new
dry powder inhaler (DPI).
Darrell Baker, SVP & Head, GSK Global Respiratory Franchise, said,
"For many years GSK has been focused on developing a portfolio of new
treatments for patients across the world with asthma and COPD. We are
delighted that Relvar Ellipta is now licensed, which means that
healthcare professionals across Europe will have the option to
prescribe an ICS/LABA that offers 24-hour efficacy from a once-daily
dose, delivered in our new Ellipta inhaler."
"This is yet another important achievement and is testament to our
successful partnership with GSK in respiratory disease," said Rick E
Winningham, Chief Executive Officer of Theravance. "We are delighted
that another significant regulatory body has granted marketing
authorisation for Relvar Ellipta for the treatment of asthma and COPD
and look forward to seeing the benefits of this effective once-daily
treatment option in these patient populations."
Under the terms of the 2002 LABA collaboration agreement, Theravance
is obligated to make a milestone payment to GSK of $15 million (USD)
following marketing authorisation for Relvar Ellipta from the
European Commission. A further $15 million (USD) payment to GSK will
follow the launch of Relvar Ellipta in Europe.
As part of its assessment, the European Medicines Agency reviewed
results of 10 clinical studies in 7,783 patients with COPD and 16
studies in 9,326 patients with asthma.
For the EU Summary of Product Characteristics for Relvar Ellipta,
Prior to the label being posted online, a copy of the label may be
requested from one of the GSK Media or Investor Relations contacts
listed in the "GSK Enquiries" section at the end of this document.
In Europe, the FF/VI strengths of 92/22 mcg and 184/22 mcg are
specified as the delivered doses (emitted from the inhaler). The
lower strength is equivalent to the 100/25 mcg pre-dispensed dose
(contained inside the inhaler) and the higher strength is equivalent
to the 200/25 mcg pre-dispensed dose.
Asthma is a chronic lung disease that inflames and
narrows the airways, causing recurring periods of wheezing, chest
tightness, shortness of breath and coughing which often occurs at
night or early in the morning.(1)
Despite medical advances, more than half of patients continue to
experience poor control and significant symptoms.(2)
The causes of asthma are not completely understood however key risk
factors are inhaled substances that provoke allergic reactions or
irritate the airways. These include smoke and allergens like dust
mites and pets.(1)
Chronic obstructive pulmonary disease is a term referring
to two lung diseases, chronic bronchitis and emphysema, that are
characterised by obstruction to airflow that interferes with normal
Long-term exposure to lung irritants that damage the lungs and the
airways are usually the cause of COPD.(3) Cigarette smoke, breathing
in second hand smoke, air pollution, chemical fumes or dust from the
environment or workplace can all contribute to COPD.(3) Most people
who have COPD are at least 40 years old when symptoms begin.
COPD-related exacerbations are typically defined as a worsening of
symptoms that require medical intervention.(3)
Important safety information for Relvar Ellipta in Europe
contraindicated in patients with hypersensitivity to either
fluticasone furoate, vilanterol, or any of the excipients.
FF/VI should not be used to treat acute asthma symptoms or an acute
exacerbation in COPD, for which a short-acting bronchodilator is
required. Increasing use of short-acting bronchodilators to relieve
symptoms indicates deterioration of control and patients should be
reviewed by a physician.
Patients should not stop therapy with FF/VI in asthma or COPD,
without physician supervision since symptoms may recur after
Asthma-related adverse events and exacerbations may occur during
treatment with FF/VI. Patients should be asked to continue treatment
but to seek medical advice if asthma symptoms remain uncontrolled or
worsen after initiation of treatment with FF/VI.
Paradoxical bronchospasm may occur with an immediate increase in
wheezing after dosing. This should be treated immediately with a
short-acting inhaled bronchodilator. FF/VI should be discontinued
immediately, the patient assessed and alternative therapy instituted
Cardiovascular effects, such as cardiac arrhythmias e.g.
supraventricular tachycardia and extrasystoles may be seen with
sympathomimetic medicinal products including FF/VI. Therefore
fluticasone furoate/vilanterol should be used with caution in
patients with severe cardiovascular disease.
For patients with moderate to severe hepatic impairment, the 92/22
mcg dose should be used and patients should be monitored for systemic
corticosteroid-related adverse reactions. FF/VI 184/22 mcg is not
indicated for patients with COPD. There is no additional benefit of
the 184/22 mcg dose compared to the 92/22 mcg dose and there is a
potential increased risk of pneumonia and systemic
corticosteroid-related adverse reactions.
An increase in the incidence of pneumonia has been observed in
subjects with COPD receiving FF/VI. There was also an increased
incidence of pneumonias resulting in hospitalisation. In some
incidences these pneumonia events were fatal.
The incidence of pneumonia in patients with asthma was common at the
higher dose. The incidence of pneumonia in patients with asthma
taking FF/VI 184/22 mcg was numerically higher compared with those
receiving FF/VI 92/22 mcg or placebo.
Hyperglycaemia: There have been reports of increases in blood glucose
levels in diabetic patients and this should be considered when
prescribing to patients with a history of diabetes mellitus.
Systemic effects may occur with any inhaled corticosteroid,
particularly at high doses prescribed for long periods. These effects
are much less likely to occur than with oral corticosteroids.
Possible systemic effects include Cushing's syndrome, Cushingoid
features, adrenal suppression, decrease in bone mineral density,
growth retardation in children and adolescents, cataract and glaucoma
and more rarely, a range of psychological or behavioural effects
including psychomotor hyperactivity, sleep disorders, anxiety,
depression or aggression (particularly in children).
FF/VI should be administered with caution in patients with pulmonary
tuberculosis or in patients with chronic or untreated infections.
Data from large asthma and COPD clinical trials were used to
determine the frequency of adverse reactions associated with FF/VI.
Very common adverse reactions (occurring in > 1/10 patients) with
FF/VI were headache and nasopharyngitis. Common adverse reactions
(occurring in > 1/100 to < 1/10 patients) were pneumonia, upper
respiratory tract infection, bronchitis, influenza, candidiasis of
mouth and throat, oropharyngeal pain, sinusitis, pharyngitis,
rhinitis, cough, dysphonia, abdominal pain, arthralgia, back pain,
fractures and pyrexia. Extrasystoles were observed as an uncommon
adverse reaction (occurring in > 1/1,000 to < 1/100 patients). With
the exception of pneumonia and fractures, the safety profile was
similar in patients with asthma and COPD. During clinical studies,
pneumonia and fractures were more frequently observed in patients
Relvar Ellipta licences and indications
FF/VI 100/25 mcg was
licensed by the US Food and Drug Administration for use in patients
with COPD in May 2013 under the trade name BREO(R) ELLIPTA(TM). In
the US, Breo Ellipta is not indicated for the relief of acute
bronchospasm or the treatment of asthma. Full US prescribing
information, including BOXED WARNING and Medication Guide is
available at us.gsk.com or US Prescribing Information Breo Ellipta.
FF/VI 100/25 mcg was also licensed for the treatment of COPD by
Health Canada in July 2013 under the same trade name. In September
2013, FF/VI strengths of 100/25 mcg and 200/25 mcg were licensed by
the Japanese Ministry of Health Labour and Welfare for the treatment
of asthma under the trade name Relvar Ellipta.
RELVAR(R), BREO(R) and ELLIPTA(R) are trademarks 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.
Theravance - is a biopharmaceutical company with a pipeline of
internally discovered product candidates and strategic collaborations
with pharmaceutical companies. Theravance is focused on the
discovery, development and commercialization of small molecule
medicines across a number of therapeutic areas including respiratory
disease, bacterial infections, and central nervous system (CNS)/pain.
Theravance's key programmes include: RELVAR(R) ELLIPTA(R) or BREO(R)
ELLIPTA(TM) (FF/VI), ANORO(TM) ELLIPTA(TM) (UMEC/VI) and MABA
(Bifunctional Muscarinic Antagonist-Beta2 Agonist), GSK961081, each
partnered with GlaxoSmithKline plc, and its oral Peripheral Mu Opioid
Receptor Antagonist programme. By leveraging its proprietary insight
of multivalency to drug discovery, Theravance is pursuing a
best-in-class strategy designed to discover superior medicines in
areas of significant unmet medical need. For more information, please
visit Theravance's web site at www.theravance.com.
THERAVANCE(R), the Theravance logo, and MEDICINES THAT MAKE A
DIFFERENCE(R) are registered trademarks of Theravance, Inc.
GSK Cautionary statement regarding forward-looking statements
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. Factors that may affect GSK' s
operations are described under Item 3.D 'Risk factors' in the
company's Annual Report on Form 20-F for 2012.
Theravance 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. Theravance 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.
Examples of such statements include statements relating to the status
and timing of clinical studies, data analysis and communication of
results, statements regarding the potential benefits and mechanisms
of action of drug candidates, statements concerning the timing of
seeking regulatory approval of our product candidates, statements
concerning the enabling capabilities of Theravance's approach to drug
discovery and its proprietary insights and statements concerning
expectations for product candidates through development and
commercialization and projections of revenue, expenses and other
financial items. These statements are based on the current estimates
and assumptions of the management of Theravance 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 Theravance to be materially different from those
reflected in its 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 delays or difficulties in commencing or completing
clinical studies, the potential that results of clinical or
non-clinical studies indicate product candidates are unsafe or
ineffective, our dependence on third parties in the conduct of our
clinical studies, delays or failure to achieve regulatory approvals
for product candidates, risks of relying on third-party manufacturers
for the supply of our product and product candidates and risks of
collaborating with third parties to develop and commercialize
products. These and other risks are described in greater detail under
the heading "Risk Factors" contained in Theravance's Quarterly Report
on Form 10-Q filed with the Securities and Exchange Commission (SEC)
on November 1, 2013 and the risks discussed in our other periodic
filings with the SEC. Given these uncertainties, you should not place
undue reliance on these forward-looking statements. Theravance
assumes no obligation to update its forward-looking statements.
(1) Global Initiative for Asthma. Pocket Guide
for asthma management and prevention. Updated 2012.
(2) Demoly et
al. Eur Respir Rev. 2012 Mar 1;21(123):66-74. doi:
(3) Global Initiative for Chronic
Obstructive Lung Disease (GOLD). Pocket guide to COPD diagnosis,
management and prevention
UK Media enquiries:
+44 (0) 20 8047 5502
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US Media enquiries:
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Mary Anne Rhyne
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Theravance, Inc. enquiries:
Michael W. Aguiar
+1 650 808 4100
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