8-K 1 theravance8k.htm THERAVANCE, INC. 8-K


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549


FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934

Date of Report: June 30, 2014
(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)

951 Gateway Boulevard, South San Francisco, CA
(Address of principal executive offices)
  94080
(Zip Code)

650-238-9600
(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 (see General Instruction A.2. below):
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))

Item 8.01. Other Events

On June 30, 2014, GlaxoSmithKline plc and Theravance, Inc. issued a press release announcing the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a fixed dose combination of the inhaled corticosteroid, fluticasone furoate and the long-acting beta2 agonist (LABA), vilanterol (FF/VI) as a once-daily treatment for asthma in patients aged 12 years and older, with the brand name of BREO(R) ELLIPTA(R). The sNDA is seeking approval for two dose regimens, 100/25mcg and 200/25mcg, administered once daily using the ELLIPTA(R) dry powder inhaler. FF/VI has been developed under the 2002 LABA collaboration agreement between Glaxo Group Limited and Theravance, Inc. 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
            99.1       Press Release dated June 30, 2014


SIGNATURE

      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.


Dated: June 30, 2014
THERAVANCE, INC.

By:  /s/ Michael W. Aguiar                    
     Michael W. Aguiar
     Chief Financial Officer


Exhibit Index
Exhibit No. Description
99.1 Press Release dated June 30, 2014