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Anoro(R) (Umeclidinium/Vilanterol) Gains Marketing Authorisation in Europe for the Treatment of COPD

Anoro(R) (Umeclidinium/Vilanterol) Gains Marketing Authorisation in Europe for 
the Treatment of COPD 
LONDON, UNITED KINGDOM and SOUTH SAN FRANCISCO, CA -- (Marketwired)
-- 05/08/14 --  GlaxoSmithKline plc (LSE: GSK) (NYSE: GSK) and
Theravance, Inc. (NASDAQ: THRX) today announced that the European
Commission has granted marketing authorisation for Anoro(R)
(umeclidinium/vilanterol) as a once-daily, maintenance bronchodilator
treatment to relieve symptoms in adult patients with chronic
obstructive pulmonary disease (COPD).  
Anoro is a once-daily combination treatment comprising two
bronchodilators, umeclidinium (UMEC), a long-acting muscarinic
antagonist (LAMA), and vilanterol (VI), a long-acting beta2 agonist
(LABA), in a single inhaler, the Ellipta(R). The licensed strength in
Europe is UMEC/VI 55mcg / 22mcg.  
Darrell Baker, SVP & Head, GSK Global Respiratory Franchise, said,
"There are many people across Europe living with COPD who experience
a variety of symptoms and for whom the disease represents a
significant burden. GSK is committed to developing a range of new
therapeutic options that provide physicians with treatment choices
when considering individual patient needs. We are delighted by
today's marketing authorisation for Anoro Ellipta which provides a
new alternative for COPD patients for whom dual bronchodilator
treatment in a single inhaler may be appropriate." 
"We are very pleased that Anoro Ellipta is now licensed across 31
European countries for the treatment of COPD," said Rick E
Winningham, Chief Executive Officer of Theravance. "We believe this
will be an important treatment option for appropriate patients with
COPD and is a further positive outcome from the collaboration between
Theravance and GSK to bring to market new respiratory medicines that
meet patient needs."  
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 UMEC/VI by the European
Commission. A further $15 million (USD) payment to GSK will follow
the launch of UMEC/VI in Europe.  
The first launch is expected to take place in Europe in Q2-3 2014
with additional launches to follow thereafter. 
The EMA assessment of UMEC/VI included a review of eight phase III
clinical trials which included over 6,000 COPD patients. Within this,
1,296 patients received the recommended dose of UMEC/VI 55/22mcg
once-daily. 
For the EU Summary of Product Characteristics for Anoro, please
visit:
http://ec.europa.eu/health/documents/community-register/index_en.htm.
Prior to the prescribing information being posted online, a copy 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. 
About COPD
 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. COPD is thought to
affect 4-10% of the adult population in Europe.(i) 
Long-term exposure to lung irritants that damage the lungs and the
airways are usually the cause of COPD. Cigarette smoke, breathing in
second hand smoke, air pollution, chemical fumes or dust from the
environment or workplace can all contribute to COPD. Most people who
have COPD are at least 40 years old when symptoms begin.(ii) 
Important Safety Information for Anoro
 The following Important
Safety Information is based on a summary of the Summary of Product
Characteristics for Anoro. Please consult the full Summary of Product
Characteristics for all the safety information for Anoro.  
UMEC/VI is contraindicated in patients with hypersensitivity to
either umeclidinium, vilanterol, or any of the excipients.  
UMEC/VI should not be used in patients with asthma since it has not
been studied in this patient population. Administration of UMEC/VI
may produce paradoxical bronchospasm that may be life-threatening.
UMEC/VI is not indicated for the treatment of acute episodes of
bronchospasm.  
In the event of deterioration of COPD during treatment with UMEC/VI,
a re-evaluation of the patient and of the COPD treatment regimen
should be undertaken. 
Cardiovascular effects, such as cardiac arrhythmias e.g. atrial
fibrillation and tachycardia, may be seen after the administration of
muscarinic receptor antagonists and sympathomimetics, including
UMEC/VI. Patients with clinically significant uncontrolled
cardiovascular disease were excluded from clinical studies.
Therefore, UMEC/VI should be used with caution in patients with
severe cardiovascular disease. 
Consistent with its antimuscarinic activity, UMEC/VI should be used
with caution in patients with urinary retention or with narrow-angle
glaucoma. 
Beta2-adrenergic agonists may produce significant hypokalaemia in
some patients, which has the potential to produce adverse
cardiovascular effects. The decrease in serum potassium is usually
transient, not requiring supplementation. No clinically relevant
effects of hypokalaemia were observed in clinical studies with
UMEC/VI at the recommended therapeutic dose of 55mcg/22mcg. Caution
should be exercised when UMEC/VI is used with other medicinal
products that also have the potential to cause hypokalaemia. 
Beta2-adrenergic agonists may produce transient hyperglycemia in some
patients. No clinically relevant effects on plasma glucose were
observed in clinical studies with UMEC/VI at the recommended
therapeutic dose of 55mcg/22mcg. Upon initiation of treatment with
UMEC/VI, plasma glucose should be monitored more closely in diabetic
patients. 
UMEC/VI should be used with caution in patients with convulsive
disorders or thyrotoxicosis and in patients who are unusually
responsive to beta2-adrenergic agonists. 
This medicinal product contains lactose. Patients with rare
hereditary problems of galactose intolerance, the Lapp lactase
deficiency or glucose-galactose malabsorption should not take
UMEC/VI. 
The most frequently reported adverse reaction with UMEC/VI was
nasopharyngitis (9%). Other common adverse reactions (reported with a
frequency of &#8805;1/100 to < 1/10) include: urinary tract
infection, sinusitis, pharyngitis, upper respiratory tract infection,
headache, cough, oropharyngeal pain, constipation and dry mouth. 
Other Anoro Ellipta Regulatory Activity:
 Since December 2013, Anoro
Ellipta has been licensed for use in appropriate patients with COPD
in several countries, including the US and Canada. In the US, Anoro
Ellipta is 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. Full US prescribing
information, including BOXED WARNING and Medication Guide are
available at: http://us.gsk.com/products/assets/us_anoro_ellipta.pdf. 
In Europe, the UMEC/VI strength of 55mcg / 22mcg is specified as the
delivered dose (emitted from the inhaler) which is equivalent to the
62.5mcg / 25mcg pre-dispensed dose (contained inside the inhaler)
authorised in the US and Canada. 
Regulatory applications for UMEC/VI have been submitted and are
undergoing assessment in a number of other countries, including
Japan. 
Anoro(R) and Ellipta(R) 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 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 programs include: RELVAR(R)/BREO(R) ELLIPTA(R)
(FF/VI), ANORO(R) ELLIPTA(R) (UMEC/VI) and MABA (Bifunctional
Muscarinic Antagonist-Beta2 Agonist) GSK961081, each partnered with
GlaxoSmithKline plc (GSK), and its Long-Acting Muscarinic Antagonist
program. 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. 
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 2013. 
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 May 7, 2014 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. (THRX-G) 
References 
(i) European COPD Coalition. COPD Key Facts. Accessed March 2014.
Available at: http://www.copdcoalition.eu/about-copd/key-facts 
(ii) National Heart Lung and Blood Institute. Who is at risk for
COPD? Accessed March 2014. Available at:
https://www.nhlbi.nih.gov/health/health-topics/topics/copd/atrisk.html 
GSK enquiries:
UK Media enquiries: 
David Mawdsley 
+44 (0) 20 8047 5502
(London) 
Simon Steel 
+44 (0) 20 8047 5502
(London) 
David Daley 
+44 (0) 20 8047 5502
(London) 
Catherine Hartley 
+44 (0) 20 8047 5502
(London) 
Sarah Spencer 
+44 (0) 20 8047 5502
(London) 
US Media enquiries: 
Melinda Stubbee 
+1 919 483 2510
(North Carolina)  
Robin Gaitens 
+1 919 483 2678
(North Carolina)  
Juan Carlos Molina 
+1 919 483 0471
(North Carolina)  
Bradd Pavur 
+1 919 483 0044
(North Carolina)  
Karen Collins 
+1 919 483 2527
(North Carolina) 
Analyst/Investor enquiries: 
Ziba Shamsi 
+44 (0) 20 8047 5543
(London) 
Kirsty Collins (SRI & CG) 
+44 (0) 20 8047 5534
(London) 
Tom Curry 
+ 1 215 751 5419 
(Philadelphia) 
Gary Davies 
+44 (0) 20 8047 5503
(London) 
James Dodwell 
+44 (0) 20 8047 2406
(London) 
Jeff McLaughlin 
+1 215 751 7002
(Philadelphia) 
Lucy Singah 
+44 (0) 20 8047 2248
(London) 
Theravance, Inc. enquiries: 
Investor Relations 
Michael W. Aguiar 
+1 650 808 4100
(San Francisco)
investor.relations@theravance.com 
 
 
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