Regulatory Update: Fluticasone Furoate / Vilanterol Submission in Japan

Regulatory Update: Fluticasone Furoate / Vilanterol Submission in Japan 
LONDON and SOUTH SAN FRANCISCO, CA -- (Marketwired) -- 07/12/13 -- 
GlaxoSmithKline (GSK) and Theravance, Inc. (NASDAQ: THRX) today
announced that the licence application for the use of fluticasone
furoate (FF) and vilanterol (VI) (proposed brand name RELVAR(TM)
ELLIPTA(TM)) in patients with chronic obstructive pulmonary disease
(COPD) has been withdrawn from the current Japanese New Drug
Application (JNDA). The review of FF/VI for use in patients with
asthma is continuing to progress through the normal Japanese
regulatory process as part of this JNDA. 
The submission for the once-daily investigational medicine FF/VI
contained data from six studies in over 6,000 COPD patients. Japanese
patient specific efficacy data were generated from two 6-month
efficacy (lung function) studies. These studies demonstrated the
benefit of the combination FF/VI compared with placebo on the
co-primary endpoints of 0-4 hour weighted mean FEV1 and trough FEV1.
However, in an assessment of the contribution of each of the
individual components, while VI achieved a statistically significant
improvement in weighted mean FEV1 the contribution of FF on
improvement of lung function did not achieve statistical significance
in these studies.  
As no Japanese patients were enrolled in either of the 52-week
exacerbation studies also conducted with FF/VI, GSK believes that the
data from the 6-month studies alone may be insufficient to support
the efficacy of the combination and its components in this specific
patient group. As a result, a decision has been taken to withdraw
COPD from the current JNDA at this time. The application for FF/VI as
a potential treatment for asthma remains under review in Japan.  
GSK and Theravance are currently determining next steps and possible
clinical studies of FF/VI for the treatment of Japanese patients with
COPD to support the resubmission. Further details will be provided in
due course.  
RELVAR(TM) and ELLIPTA(TM) are trademarks of the GlaxoSmithKline
group of companies. The use of the brand name RELVAR(TM) is not
approved by any regulatory authority.  
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 programmes include: RELVAR(TM) ELLIPTA(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 and projections of revenue, expenses and other
financial items. 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 Quarterly Report
on Form 10-Q filed with the Securities and Exchange Commission (SEC)
on May 1, 2013 and the risks discussed in our other periodic filings
with the 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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