ANORO(TM) ELLIPTA(TM) Approved as First Once-Daily Dual Bronchodilator for the Treatment of COPD in the US

ANORO(TM) ELLIPTA(TM) Approved as First Once-Daily Dual Bronchodilator for the 
Treatment of COPD in the US 
LONDON, UK and SOUTH SAN FRANCISCO, CA -- (Marketwired) -- 12/18/13
--  GlaxoSmithKline plc (LSE: GSK) (NYSE: GSK) and Theravance, Inc.
(NASDAQ: THRX) today announced that the US Food and Drug
Administration (FDA) has approved ANORO(TM) ELLIPTA(TM) as a
combination anticholinergic/long-acting beta2-adrenergic agonist
(LABA) indicated 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. Anoro
Ellipta is not indicated for the relief of acute bronchospasm or for
the treatment of asthma. 
Anoro Ellipta (umeclidinium and vilanterol inhalation powder) is the
first once-daily product approved in the US that combines two
long-acting bronchodilators in a single inhaler for the maintenance
treatment of COPD. The FDA-approved strength is
umeclidinium/vilanterol 62.5 mcg/25 mcg. 
Darrell Baker, SVP & Head, GSK Global Respiratory Franchise, said:
"We believe Anoro Ellipta will be an important treatment option for
appropriate patients with COPD. It is the first combination product
approved in the US that delivers two once-daily bronchodilators in a
single inhaler. This approval is a significant achievement for GSK." 
"We are very pleased that Anoro Ellipta has become the first
once-daily dual bronchodilator approved in the US for the treatment
of COPD," said Rick E Winningham, Chief Executive Officer of
Theravance. "This is a significant milestone for Theravance and GSK
and is testament to our ongoing partnership and shared commitment to
the development of respiratory medicines." 
Following this approval by the FDA, it is anticipated that launch
activities in the US will commence during the first quarter of 2014.
Under the terms of the 2002 LABA collaboration agreement, Theravance
is obligated to make a milestone payment of $30 million (USD) to GSK
following FDA approval of Anoro Ellipta. A further $30 million (USD)
payment to GSK will follow the launch of Anoro Ellipta in the US. 
The phase III pivotal programme for Anoro Ellipta included seven
clinical studies with almost 6,000 patients with COPD. 
About 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. The National Heart, Lung and Blood Institute
(NHLBI) estimates that nearly 27 million people in the US alone are
affected by COPD.(i) 
According to the NHLBI, long-term exposure to lung irritants that
damage the lungs and the airways are usually the cause of COPD. In
the United States, the most common irritant that causes COPD is
cigarette smoke. Breathing in second hand smoke, air pollution,
chemical fumes or dust from the environment or workplace also can
contribute to COPD. Most people who have COPD are at least 40 years
old when symptoms begin.  
About Anoro Ellipta
 Anoro Ellipta is the first once-daily
anticholinergic/LABA combination product approved 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. Anoro Ellipta is not indicated
for the relief of acute bronchospasm or for the treatment of asthma.
Anoro contains 62.5 mcg umeclidinium, an anticholinergic, and 25 mcg
vilanterol, a LABA, in a single inhaler, the Ellipta. 
Full US Prescribing Information, including BOXED WARNING and
Medication Guide will be available soon at: 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 Inquiries" section at the end of this document. 
Important Safety Information for Anoro Ellipta
 The following
Important Safety Information (ISI) is based on the Highlights section
of the Prescribing Information for Anoro Ellipta. Please consult the
full Prescribing Information for all the labeled safety information
for Anoro Ellipta. 
Long-acting beta2-adrenergic agonists (LABAs), such as vilanterol,
one of the active ingredients in Anoro Ellipta, increase the risk of
asthma-related death. A placebo-controlled trial with another LABA
(salmeterol) showed an increase in asthma-related deaths in subjects
receiving salmeterol. This finding with salmeterol is considered a
class effect of all LABAs, including vilanterol. The safety and
efficacy of Anoro Ellipta in patients with asthma have not been
established. Anoro Ellipta is not indicated for the treatment of
Anoro Ellipta is contraindicated in patients with severe
hypersensitivity to milk proteins or who have demonstrated
hypersensitivity to either umeclidinium, vilanterol, or any of the
other ingredients.  
Anoro Ellipta should not be initiated in patients during rapidly
deteriorating or potentially life-threatening episodes of COPD, or as
rescue therapy for the treatment of acute episodes of bronchospasm,
which should be treated with an inhaled, short-acting beta2-agonist. 
Anoro Ellipta should not be used more often than recommended, at
higher doses than recommended, or in conjunction with additional
medicine containing a LABA, as an overdose may result. 
Anoro Ellipta should be used with caution when considering
coadministration with long-term ketoconazole and other known strong
cytochrome P450 3A4 inhibitors because increased cardiovascular
adverse effects may occur. 
As with other inhaled medicines, Anoro Ellipta can produce
paradoxical bronchospasm, which may be life-threatening.  
Anoro Ellipta should be used with caution in patients with
cardiovascular disorders, especially coronary insufficiency, cardiac
arrhythmias, and hypertension. 
Anoro 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. 
Anoro Ellipta should be used with caution in patients with
narrow-angle glaucoma. Instruct patients to contact a physician
immediately should any signs or symptoms of narrow-angle glaucoma
Anoro Ellipta should be used with caution in patients with urinary
retention, especially in patients with prostatic hyperplasia or
bladder neck obstruction. Instruct patients to contact a physician
immediately should any signs or symptoms of urinary retention occur. 
Beta-adrenergic agonist medicines may produce significant hypokalemia
and transient hyperglycemia in some patients.  
The most common adverse reactions (incidence ≥ 1% and more
common than placebo) reported in four 6-month clinical trials with
Anoro Ellipta (and placebo) were pharyngitis, 2% ( < 1%); sinusitis
1% ( < 1%); lower respiratory tract infection, 1% ( < 1%);
constipation, 1% ( < 1%); diarrhea, 2% (1%); pain in extremity 2%
(1%); muscle spasms, 1% ( < 1%); neck pain, 1% ( < 1%); and chest
pain 1% ( < 1%). In addition to the 6-month efficacy trials with
Anoro Ellipta, a 12-month trial evaluated the safety of
umeclidinium/vilanterol 125 mcg/25 mcg in subjects with COPD. Adverse
reactions (incidence &#8805; 1% and more common than placebo) in
subjects receiving umeclidinium/vilanterol 125 mcg/25 mcg were:
headache, back pain, sinusitis, cough, urinary tract infection,
arthralgia, nausea, vertigo, abdominal pain, pleuritic pain, viral
respiratory tract infection, toothache, and diabetes mellitus. 
Use of beta2-agonists, such as vilanterol should be administered with
extreme caution to patients being treated with monoamine oxidase
inhibitors, tricyclic antidepressants, or drugs known to prolong the
QTc interval or within 2 weeks of discontinuation of such agents,
because the effect of adrenergic agonists on the cardiovascular
system may be potentiated. 
Use beta-blockers with caution as they not only block the pulmonary
effect of beta-agonists, such as vilanterol, but may produce severe
bronchospasm in patients with COPD.  
Use with caution in patients taking non-potassium-sparing diuretics,
as electrocardiographic changes and/or hypokalemia associated with
non-potassium-sparing diuretics may worsen with concomitant
Avoid co-administration of Anoro Ellipta with other
anticholinergic-containing drugs as this may lead to an increase in
anticholinergic adverse effects such as cardiovascular effects,
worsening of narrow-angle glaucoma, and worsening of urinary
Other Umeclidinium/Vilanterol Regulatory Activity:
applications for UMEC/VI have been submitted and are undergoing
assessment in a number of countries, including across the European
Union and Japan. Umeclidinium/vilanterol is not licensed anywhere
outside of the US. 
Other Respiratory Development Programmes: 
 The GSK respiratory
development portfolio also includes VI monotherapy and MABA
(GSK961081), developed in collaboration with Theravance, as well as
GSK's investigational medicines FF monotherapy, UMEC monotherapy and
anti-IL5 MAb (mepolizumab). These investigational medicines are not
currently approved anywhere in the world. 
ANORO and ELLIPTA are trademarks of the GSK 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 
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)
(Bifunctional Muscarinic Antagonist-Beta2 Agonist), 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  
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
 (i) National Heart, Lung, and Blood
Institute. 2012 Chart Book on Cardiovascular, Lung, and Blood
Diseases. February 2012 
GSK enquiries: 
UK Media enquiries: 
David Mawdsley 
+44 (0) 20 8047 5502 
Simon Steel 
+44 (0) 20 8047 5502 
David Daley 
+44 (0) 20 8047 5502 
Catherine Hartley 
+44 (0) 20 8047 5502 
US Media enquiries: 
Juan Carlos Molina 
+1 919 483 0471 
(North Carolina) 
Karen Collins 
+1 919 483 2527 
(North Carolina) 
Bradd Pavur 
+1 919 483 0044 
(North Carolina) 
Mary Anne Rhyne
+1 919 483 0492 
(North Carolina) 
Stephen Rea 
+1 215 751 4394 
Analyst/Investor enquiries: 
Sally Jackson 
+44 (0) 20 8047 5543 
Kirsty Collins 
(SRI & CG) 
+44 (0) 20 8047 5534 
Tom Curry 
+ 1 215 751 5419 
Gary Davies 
+44 (0) 20 8047 5503 
James Dodwell 
+44 (0) 20 8047 2406 
Jeff McLaughlin 
+1 215 751 7002 
Ziba Shamsi 
+44 (0) 20 8047 3289 
Lucy Singah 
+44 (0) 20 8047 2248 
Theravance Inc. Inquiries: 
Investor Relations 
Michael W. Aguiar 
+1 650 808 4100 
(San Francisco) 
Press spacebar to pause and continue. Press esc to stop.