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): May 24, 2016
INNOVIVA, INC.
(Exact Name of Registrant as Specified in its Charter)
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Delaware |
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000-30319 |
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94-3265960 |
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(State or Other Jurisdiction of |
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(Commission File Number) |
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(I.R.S. Employer Identification Number) |
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Incorporation) |
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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 May 24, 2016, GlaxoSmithKline plc (“GSK”) and Innoviva, Inc. distributed a press release announcing headline data from the Salford Lung Study (“SLS”) of RELVAR® ELLIPTA® 100/25mcg (fluticasone furoate/vilanterol or “FF/VI”) in Chronic Obstructive Pulmonary Disease (“COPD”). SLS is a Phase IIIb multi-center, open label randomized controlled trial. The objective of SLS was to compare the effectiveness and safety profile of FF/VI 100/25mcg with existing COPD usual care.
SLS showed that for the primary effectiveness analysis in patients treated with FF/VI 100/25mcg there was a significant reduction of 8.4% (Cl 1.12, 15.17) in the rate of moderate or severe exacerbations compared with those receiving usual care (p=0.025).
FF/VI has been developed under the 2002 Long-Acting Beta 2 Agonist (LABA) collaboration between Glaxo Group Limited and Innoviva, 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
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99.1 |
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Press Release dated May 24, 2016. |