GSK and Theravance Announce Regulatory Submission for ANORO(TM) ELLIPTA(TM) (UMEC/VI) in Japan

GSK and Theravance Announce Regulatory Submission for ANORO(TM) ELLIPTA(TM) 
(UMEC/VI) in Japan 
LONDON and SOUTH SAN FRANCISCO, CA -- (Marketwired) -- 04/22/13 -- 
GlaxoSmithKline plc (GSK) and Theravance, Inc. (NASDAQ: THRX) today
announced the submission of a regulatory application to the Japanese
Ministry of Health, Labour and Welfare (MHLW) for the investigational
once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with
chronic obstructive pulmonary disease (COPD).  GSK and Theravance
announced the submission of a regulatory application for UMEC/VI for
patients with COPD in the United States (US) on 18th December 2012
and in Europe on 9th January 2013. 
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. 
Japanese Submission:
 A New Drug Application (NDA) for UMEC/VI
(62.5/25mcg and 125/25mcg doses), with the proposed proprietary name
ANORO(TM) ELLIPTA(TM), has been submitted to the Japanese Ministry of
Health, Labour and Welfare (MHLW) as a maintenance bronchodilator
treatment to relieve symptoms of obstructive airway disorder due to
chronic obstructive pulmonary disease (COPD) (chronic bronchitis and
emphysema). 
Future Regulatory Submissions:
 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) ELLIPTA(TM) and BREO(TM) ELLIPTA(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 healthca
re 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
programmes include: RELVAR(TM) or BREO(TM) ELLIPTA(TM) (FF/VI),
ANORO(TM) ELLIPTA(TM) (UMEC/VI) and MABA (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
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. 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. 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 Annual Report on
Form 10-K filed with the Securities and Exchange Commission (SEC) on
February 26, 2013 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. 
(THRX-G) 
GlaxoSmithKline Enquiries:
UK Media enquiries:
David Mawdsley
+44 (0) 20 8047 5502
(London) 
David Daley
+44 (0) 20 8047 5502
(London) 
Catherine Hartley
+44 (0) 20 8047 5502
(London) 
US Media enquiries:
Stephen Rea
+1 215 751 4394
(Philadelphia) 
Kevin Colgan
+1 919 483 2933
(North Carolina) 
Melinda Stubbee
+1 919 483 2510
(North Carolina) 
Mary Anne Rhyne
+1 919 483 0492
(North Carolina) 
Sarah Alspach
+1 202 715 1048
(Washington, DC) 
Jennifer Armstrong
+1 215 751 5664
(Philadelphia) 
Analyst/Investor enquiries:
Ziba Shamsi
+ 44 (0) 20 8047 3289
(London) 
Lucy Budd
+44 (0) 20 8047 2248
(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) 
Theravance Inc. Enquiries:
Michael W. Aguiar
+1 650 808 4100
investor.relations@theravance.com
(San Francisco)
 
 
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