GSK and Theravance Announce Regulatory Submission for ANORO(TM) ELLIPTA(TM) (UMEC/VI) in Japan
(firmenpresse) - 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™ inhaler.
A New Drug Application (NDA) for UMEC/VI (62.5/25mcg and 125/25mcg doses),
with the proposed proprietary name ANORO™ ELLIPTA™, 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).
GSK intends to commence global regulatory submissions for UMEC monotherapy
later this year.
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™ ELLIPTA™ and BREO™
ELLIPTA™), 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™, RELVAR™, BREO™ and ELLIPTA™ are trademarks of the
GlaxoSmithKline group of companies. The use of these brand names is not
approved by any regulatory authorities.
-- 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
- 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™ or BREO™ ELLIPTA™ (FF/VI), ANORO™
ELLIPTA™ (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 .
THERAVANCE®, the Theravance logo, and MEDICINES THAT MAKE A DIFFERENCE®
are registered trademarks of Theravance, Inc.
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.
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)
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Datum: 22.04.2013 - 03:00 Uhr
Sprache: Deutsch
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