UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549
FORM 8-K CURRENT REPORT
Pursuant to Section 13 or 15(d) of the |
Date of Report: January 09, 2013
(Date of earliest event reported)
Theravance, Inc.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction
of incorporation)
000-30319
(Commission File Number)
94-3265960
(IRS Employer
Identification Number)
901 Gateway Boulevard, South San Francisco, CA
(Address of principal executive offices)
94080
(Zip Code)
650-808-6000
(Registrant's telephone number, including area code)
Not Applicable
(Former Name or Former Address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
- o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
- o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
- o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
- o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
- o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Item 8.01. Other Events On January 9, 2013, GlaxoSmithKline plc (GSK) and Theravance, Inc. (the "Company") issued a press release announcing that a Marketing Authorization Application (MAA) for UMEC/VI with the proposed proprietary name ANORO(TM) has been submitted to the European Medicines Agency (EMA), for the maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease. UMEC/VI is a combination of two investigational bronchodilator molecules - GSK573719 or umeclidinium bromide (UMEC), a long-acting muscarinic antagonist and vilanterol (VI), a long-acting beta2 agonist (LABA), administered once-daily using the ELLIPTA(TM) inhaler. UMEC/VI is currently in development under the LABA collaboration between GSK and the Company. A copy of the press release is filed as Exhibit 99.1 to this report and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Dated: January 09, 2013 |
THERAVANCE, INC.
By: /s/ Michael W. Aguiar |
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| Exhibit No. | Description |
| 99.1 | Press Release of Theravance, Inc. dated January 09, 2013 |
LONDON and SOUTH SAN FRANCISCO, CA -- (Marketwire - January 09, 2013) - 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)