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

Tue Feb 19, 2013 7:00am EST

* Reuters is not responsible for the content in this press release.

(Marketwire) -- 
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

    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.

    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.



GlaxoSmithKline Enquiries: 

UK Media enquiries: 
David Mawdsley 
+44 (0) 20 8047 5502 

Stephen Rea 
+44 (0) 20 8047 5502 

Sarah Spencer 
+44 (0) 20 8047 5502 

David Daley 
+44 (0) 20 8047 5502 

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 

Analyst/Investor enquiries: 
Sally Ferguson 
+44 (0) 20 8047 5543 

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 
(650) 808 4100 
(San Francisco) 

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