GSK and Theravance Announce FDA Acceptance of New Drug Application (NDA) Submission in the US for ANORO ELLIPTA(TM) for COPD

GSK and Theravance Announce FDA Acceptance of New Drug Application (NDA) 
Submission in the US for ANORO ELLIPTA(TM) for COPD 
LONDON and SOUTH SAN FRANCISCO, CA -- (Marketwire) -- 02/19/13 -- 
GlaxoSmithKline plc (LSE: GSK) and Theravance, Inc. (NASDAQ: THRX)
today announced that the New Drug Application (NDA) for the
investigational once-daily LAMA/LABA combination medicine, UMEC/VI,
for patients with chronic obstructive pulmonary disease (COPD), has
been accepted by the U.S. Food and Drug Administration (FDA)
indicating that the application is sufficiently complete to permit a
substantive review. The Prescription Drug User Fee Act (PDUFA) goal
date has also been confirmed as 18 December 2013. 
In December 2012 and January 2013, GSK and Theravance announced the
submission by GSK of regulatory applications in the United States and
the European Union, respectively, for UMEC/VI for patients with COPD.
The Marketing Authorisation Application (MAA) for UMEC/VI has been
validated for assessment by the European Medicines Agency (EMA). 
UMEC/VI, with proposed brand name ANORO(TM), 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.  
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, administered using the ELLIPTA(TM) inhaler, for
COPD patients 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 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(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
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
 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 'Business Review' in the company' s Annual Report on Form 20-F
for 2011. 
Theravance forward-looking statement
 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 the discovery, development and commercialization of
our product candidates. 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 and non-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 discover,
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
in Theravance's prospectus supplement filed with the SEC on January
18, 2013 pursuant to Rule 424(b)(5). 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)  
GlaxoSmithKline Enquiries:  
UK Media enquiries: 
David Mawdsley 
+44 (0) 20 8047 5502 
(London)  
Stephen Rea 
+44 (0) 20 8047 5502 
(London)  
Sarah Spencer 
+44 (0) 20 8047 5502 
(London)  
David Daley 
+44 (0) 20 8047 5502 
(London)  
US Media enquiries: 
Kevin Colgan 
+1 919 483 2933 
(North Carolina)  
Melinda Stubbee 
+1 919 483 2510 
(North Carolina)  
Sarah Alspach 
+1 202 715 1048 
(Washington, DC)  
Jennifer Armstrong 
+1 215 751 5664 
(Philadelphia)  
Analyst/Investor enquiries: 
Sally Ferguson 
+44 (0) 20 8047 5543 
(London)  
Tom Curry 
+ 1 215 751 5419 
(Philadelphia)  
Gary Davies 
+ 44 (0) 20 8047 5503 
(Londo
n)  
James Dodwell 
+ 44 (0) 20 8047 2406 
(London)  
Jeff McLaughlin 
+ 1 215 751 7002 
(Philadelphia)  
Ziba Shamsi 
+ 44 (0) 20 8047 3289 
(London)  
Theravance Inc. Enquiries 
Michael W. Aguiar 
Investor.relations@theravance.com 
(650) 808 4100 
(San Francisco) 
 
 
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