GSK and Theravance Announce Regulatory Submission for ANORO(TM)

GSK and Theravance Announce Regulatory Submission for ANORO(TM)
(UMEC/VI) in Europe 
LONDON and SOUTH SAN FRANCISCO, CA -- (Marketwire) -- 01/09/13 -- 
GlaxoSmithKline plc (LSE: GSK) and Theravance, Inc. (NASDAQ: THRX)
today announced the submission of a regulatory application in the
European Union for the investigational once-daily LAMA/LABA
combination medicine, UMEC/VI, for patients with chronic obstructive
pulmonary disease (COPD). On 18th December 2012, GSK and Theravance
announced the submission of a regulatory application in the United
States (US) for UMEC/VI, for patients with COPD. 
UMEC/VI is a combination of two investigational bronchodilator
molecules -- GSK573719 or umeclidinium bromide (UMEC), a long-acting
muscarinic antagonist (LAMA) and vilanterol (VI), a long-acting beta2
agonist (LABA), administered using the ELLIPTA(TM) inhaler.  
European Submission:
 A Marketing Authorisation Application (MAA) for
UMEC/VI (55/22mcg and 113/22mcg doses), with the proposed proprietary
name ANORO(TM), has been submitted to the European Medicines Agency
(EMA) as a maintenance bronchodilator treatment to relieve symptoms
in adult patients with COPD. The UMEC/VI doses of 55/22mcg and
113/22mcg are specified as the delivered doses (emitted from the
inhaler) which are equivalent to the 62.5/25mcg and 125/25mcg
pre-dispensed doses (contained inside the inhaler) submitted for
approval in the US.  
Future Regulatory Submissions: 
 Regulatory submissions for UMEC/VI
are planned in other countries during the course of 2013. In
addition, GSK intends to commence global regulatory submissions for
UMEC monotherapy later this year. 
Other Respiratory Development Programmes: 
 UMEC/VI is one of several
late-stage assets in the GSK respiratory development portfolio, which
includes fluticasone furoate/vilanterol (FF/VI, with proposed brand
names RELVAR(TM) and BREO(TM)), 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(TM), RELVAR(TM), BREO(TM) and ELLIPTA(TM) are trademarks of the
GlaxoSmithKline group of companies. The use of these brand names is
not approved by any regulatory authorities.  
GlaxoSmithKline -- 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 programs include: RELVAR(TM) or BREO(TM) (FF/VI),
ANORO(TM) (UMEC/VI) and MABA (Bifunctional Muscarinic
Antagonist-Beta2 Agonist), each partnered with GlaxoSmithKline plc,
and its oral Peripheral Mu Opioid Receptor 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   
THERAVANCE(R), the Theravance logo, and MEDICINES THAT MAKE A
DIFFERENCE(R) are registered trademarks of Theravance, Inc. 
GlaxoSmithKline cautionary statement regarding forward-looking
 Under the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995, 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. Factors that may affect GSK' s operations are
described under 'Risk factors' in the 'Financial review & risk'
section in the company's Annual Report 2011 included as exhibit 15.2
to the company's Annual Report on Form 20-F for 2011.  
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 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. 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, the potential that
results of clinical or non-clinical studies indicate product
candidates are unsafe or ineffective, 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 October 31, 2012 and the risks
discussed in our other period filings with 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. 
GlaxoSmithKline Enquiries: 
UK Media enquiries:
David Mawdsley
+44 (0) 20 8047 5502
Sarah Spencer
+44 (0) 20 8047 5502
David Daley
+44 (0) 20 8047 5502
Catherine Hartley
+44 (0) 20 8047 5502
Alex Harrison
+44 (0) 20 8047 5502
US Media enquiries:
Stephen Rea
+1 215 751 4394
Mary Rhyne
+1 919 483 0492
(North Carolina) 
Sarah Alspach
+1 202 715 1048
(Washington, DC) 
Analyst/Investor enquiries:
Sally Ferguson
+44 (0) 20 8047 5543
Lucy Budd
+44 (0) 20 8047 2248
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
Theravance Inc. Enquiries:
Michael W. Aguiar
+1 650 808 4100
(San Francisco) 
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