UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
Current Report Pursuant
to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event Reported): March 20, 2015
THERAVANCE, INC.
(Exact Name of Registrant as Specified in its Charter)
Delaware (State or Other Jurisdiction of |
|
000-30319 (Commission File Number) |
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94-3265960 (I.R.S. Employer Identification Number) |
951 Gateway Boulevard
South San Francisco, California 94080
(650) 238-9600
(Addresses, including zip code, and telephone numbers, including area code, of principal executive offices)
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 March 20, 2015, GlaxoSmithKline (GSK) and Theravance, Inc. announced the launch of Revlar® Ellipta® in Italy following the recent approval by the Italian regulatory authorities in December 2014. Relvar® is a fixed dose combination of the inhaled corticosteroid (ICS), fluticasone furoate FF, and the long-acting beta2-agonist (LABA), vilanterol VI (FF/VI). The components will be administered using the Ellipta®, a dry powder inhaler (DPI). In Italy, the product is indicated for:
· Asthma: For the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate.
· COPD: For the symptomatic treatment of adults with Chronic Obstructive Pulmonary Disease (COPD) with a FEV1<70% predicted normal (post-bronchodilator) with an exacerbation history despite regular bronchodilator therapy.
Relvar® Ellipta® has been developed under the LABA collaboration agreement between Glaxo Group Limited and Theravance, Inc.