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): September 8, 2015
THERAVANCE, INC.
(Exact Name of Registrant as Specified in its Charter)
Delaware |
| 000-30319 |
| 94-3265960 |
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 September 8, 2015, GlaxoSmithKline plc (GSK) and Theravance, Inc. distributed a press release announcing initial data from the “Study to Understand Mortality and MorbidITy” (“SUMMIT”) survival study of RELVAR®/BREO® ELLIPTA® 100/25mcg (fluticasone furoate/vilanterol or “FF/VI”). The aim of the study was to prospectively evaluate the effect of FF/VI 100/25mcg compared with the placebo on survival in chronic obstructive pulmonary disease (COPD) patients with moderate airflow limitation and a history or risk of cardiovascular disease (CVD).
SUMMIT showed that for the primary end point of the study, the risk of dying was 12.2% lower in patients taking FF/VI 100/25mcg versus placebo however this was not statistically significant (p=0.137). Results from the two secondary endpoints, showed that FF/VI 100/25mcg reduced the rate of lung function decline in FEVI (forced expiratory volume in one second) by 8mL per year compared with placebo (p=0.019) and also reduced the risk of on-treatment cardiovascular (CV) event (CV death, myocardial infarction, stroke, unstable angina and transient ischemic attack) at any time in the same patient population by 7.4% versus placebo (p=0.475). As the primary endpoint was not met, statistical significance cannot be inferred from these results.
FF/VI has been developed under the 2002 Long-Acting Beta 2 Agonist (LABA) collaboration between Glaxo Group Limited and Theravance, Inc. FF/VI 100/25mcg, under the brand name RELVAR® ELLIPTA®, is approved in Europe for the symptomatic treatment of adults with COPD with a FEV1<70% predicted normal (post-bronchodilator) with an exacerbation history despite regular bronchodilator therapy. In the United States, FF/VI 100/25mcg, under the brand name BREO® ELLIPTA®, is indicated for long-term, once-daily, maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema and to reduce exacerbations of COPD in patients with a history of exacerbations.
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 September 8, 2015. |