Theravance Announces FDA Advisory Committee to Review ANORO(TM) ELLIPTA(TM) (UMEC/VI) for COPD

Theravance Announces FDA Advisory Committee to Review ANORO(TM) ELLIPTA(TM) 
(UMEC/VI) for COPD 
SOUTH SAN FRANCISCO, CA -- (Marketwired) -- 08/01/13 --  Theravance,
Inc. (NASDAQ: THRX) today announced that on September 10, 2013, the
U.S. Food and Drug Administration's Pulmonary-Allergy Drugs Advisory
Committee will discuss the new molecular entity New Drug Application
(NDA) 203975 for umeclidinium bromide and vilanterol dry powder for
inhalation (proposed trade name ANORO(TM) ELLIPTA(TM)), sponsored by
Glaxo Group (d/b/a GSK) for the long-term, once-daily, maintenance
treatment of airflow obstruction in patients with chronic obstructive
pulmonary disease (COPD), including chronic bronchitis and emphysema.
The advanced display of the Federal Register notice on the advisory
committee can be found at:
http://www.ofr.gov/OFRUpload/OFRData/2013-18633_PI.pdf 
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. The
Prescription Drug User Fee Act (PDUFA) goal date is December 18,
2013. UMEC/VI is in development under the LABA collaboration
agreement between Glaxo Group Limited and Theravance, Inc.  
About Theravance 
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) 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 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. 
RELVAR(TM), BREO(TM), ANORO(TM) and ELLIPTA(TM) are trademarks of the
GlaxoSmithKline group of companies. The use of the brand names
ANORO(TM) and RELVAR(TM) has not yet been approved by any regulatory
authority. 
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) 
Contact Information: 
Michael W. Aguiar 
Senior Vice President and Chief Financial Officer
650-808-4100
investor.relations@theravance.com 
 
 
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