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

LONDON and SOUTH SAN FRANCISCO, CA, Jan 09
(Marketwire) --
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 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.

GlaxoSmithKline 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 '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
(London)

Sarah Spencer
+44 (0) 20 8047 5502
(London)

David Daley
+44 (0) 20 8047 5502
(London)

Catherine Hartley
+44 (0) 20 8047 5502
(London)

Alex Harrison
+44 (0) 20 8047 5502
(London)

US Media enquiries:
Stephen Rea
+1 215 751 4394
(Philadelphia)

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
(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)

Ziba Shamsi
+ 44 (0) 20 8047 3289
(London)

Theravance Inc. Enquiries:
Michael W. Aguiar
investor.relations@theravance.com
+1 650 808 4100
(San Francisco)

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