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

Apr 22 2013 12:00AM

Marketwire

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LONDON and SOUTH SAN FRANCISCO, CA -- (Marketwired) -- 04/22/13 -- GlaxoSmithKline plc(GSK) and Theravance, Inc. (NASDAQ: THRX) today announced the submission ofa regulatory application to the Japanese Ministry of Health, Labour andWelfare (MHLW) for the investigational once-daily LAMA/LABA combinationmedicine, UMEC/VI, for patients with chronic obstructive pulmonary disease(COPD). GSK and Theravance announced the submission of a regulatoryapplication for UMEC/VI for patients with COPD in the United States (US) on18th 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 muscarinicantagonist (LAMA) and vilanterol (VI), a long-acting beta2 agonist (LABA),administered using the ELLIPTA™ inhaler.

Japanese Submission:
A New Drug Application (NDA) for UMEC/VI (62.5/25mcg and 125/25mcg doses),with the proposed proprietary name ANORO™ ELLIPTA™, has beensubmitted to the Japanese Ministry of Health, Labour and Welfare (MHLW) asa maintenance bronchodilator treatment to relieve symptoms of obstructiveairway disorder due to chronic obstructive pulmonary disease (COPD)(chronic bronchitis and emphysema).

Future Regulatory Submissions:
GSK intends to commence global regulatory submissions for UMEC monotherapylater this year.

Other Respiratory Development Programmes:
UMEC/VI is one of several late-stage assets in the GSK respiratorydevelopment portfolio, which includes fluticasone furoate/vilanterol(FF/VI, with proposed brand names RELVAR™ ELLIPTA™ and BREO™ELLIPTA™), VI monotherapy and MABA (GSK961081), developed incollaboration with Theravance, as well as GSK's investigational medicinesFF monotherapy, UMEC monotherapy and anti-IL5 MAb (mepolizumab). Theseinvestigational medicines are not currently approved anywhere in the world.

ANORO™, RELVAR™, BREO™ and ELLIPTA™ are trademarks of theGlaxoSmithKline group of companies. The use of these brand names is notapproved by any regulatory authorities.

GlaxoSmithKline -- one of the world's leading research-basedpharmaceutical and healthcare companies -- is committed to improving thequality of human life by enabling people to do more, feel better and livelonger. For further information please visit www.gsk.com

Theravance - is a biopharmaceutical company with a pipeline ofinternally discovered product candidates and strategic collaborations withpharmaceutical companies. Theravance is focused on the discovery,development and commercialization of small molecule medicines across anumber of therapeutic areas including respiratory disease, bacterialinfections, and central nervous system (CNS)/pain. Theravance's keyprogrammes include: RELVAR™ or BREO™ ELLIPTA™ (FF/VI), ANORO™ELLIPTA™ (UMEC/VI) and MABA (Bifunctional Muscarinic Antagonist-Beta2Agonist), each partnered with GlaxoSmithKline plc, and its oral PeripheralMu Opioid Receptor Antagonist programme. By leveraging its proprietaryinsight of multivalency to drug discovery, Theravance is pursuing abest-in-class strategy designed to discover superior medicines in areas ofsignificant unmet medical need. For more information, please visitTheravance's web site at www.theravance.com.

THERAVANCE®, the Theravance logo, and MEDICINES THAT MAKE A DIFFERENCE®are registered trademarks of Theravance, Inc.

Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projectionsmade by GSK, including those made in this announcement, are subject torisks and uncertainties that may cause actual results to differ materiallyfrom those projected. Factors that may affect GSK' s operations aredescribed under Item 3.D 'Risk factors' in the company's Annual Report onForm 20-F for 2012.

Theravance forward-looking statements
This press release contains certain "forward-looking" statements as thatterm is defined in the Private Securities Litigation Reform Act of 1995regarding, among other things, statements relating to goals, plans,objectives and future events. Theravance intends such forward-lookingstatements to be covered by the safe harbor provisions for forward-lookingstatements contained in Section 21E of the Securities Exchange Act of 1934and the Private Securities Litigation Reform Act of 1995. Examples of suchstatements include statements relating to the status and timing of clinicalstudies, data analysis and communication of results, statements regardingthe potential benefits and mechanisms of action of drug candidates,statements concerning the timing of seeking regulatory approval of ourproduct candidates, statements concerning the enabling capabilities ofTheravance's approach to drug discovery and its proprietary insights andstatements concerning expectations for product candidates throughdevelopment and commercialization. These statements are based on thecurrent estimates and assumptions of the management of Theravance as of thedate of this press release and are subject to risks, uncertainties, changesin circumstances, assumptions and other factors that may cause the actualresults of Theravance to be materially different from those reflected inits forward-looking statements. Important factors that could cause actualresults to differ materially from those indicated by such forward-lookingstatements include, among others, risks related to delays or difficultiesin commencing or completing clinical studies, the potential that results ofclinical or non-clinical studies indicate product candidates are unsafe orineffective, our dependence on third parties in the conduct of our clinicalstudies, delays or failure to achieve regulatory approvals for productcandidates, risks of relying on third-party manufacturers for the supply ofour product and product candidates and risks of collaborating with thirdparties to develop and commercialize products. These and other risks aredescribed in greater detail under the heading "Risk Factors" contained inTheravance's Annual Report on Form 10-K filed with the Securities andExchange Commission (SEC) on February 26, 2013 and the risks discussed inour other period filings with SEC. Given these uncertainties, you shouldnot place undue reliance on these forward-looking statements. Theravanceassumes 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)





Source: Marketwire


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