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):  November 13, 2013

THERAVANCE, INC.

(Exact Name of Registrant as Specified in its Charter)

901 Gateway Boulevard
South San Francisco, California 94080
(650) 808-6000

(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 November 13, 2013 at the 18th Congress of the Asian Pacific Society of Respirology, Yokohama, Japan, GlaxoSmithKline plc (“GSK”) presented an oral presentation on a Phase 3 study of the once-daily treatment combination of fluticasone furoate “FF”, an inhaled corticosteroid, and vilanterol “VI”, a long-acting beta2 agonist, in Asian patients with chronic obstructive pulmonary disease (COPD).  In addition, GSK presented a poster on an ethnic sensitivity assessment of FF/VI in asthma patients in Japan and Korea.  In September 2013, the Japanese Ministry of Health, Labour and Welfare (MHLW) approved FF/VI for the treatment of bronchial asthma (in cases where concurrent use of inhaled corticosteroid and long-acting inhaled beta2 agonist is required).  FF/VI is not indicated for the treatment of COPD in Japan.  The MHLW has approved two doses of FF/VI - 100/25 mcg and 200/25 mcg.  Both strengths will be administered once-daily using the ELLIPTA™, a new dry powder inhaler.  RELVAR® ELLIPTA™ is the trade name in Japan.  FF/VI remains in development elsewhere in the world for the maintenance treatment of asthma and COPD, with pending marketing authorization applications in a number of countries.  FF/VI for the treatment of COPD is approved in the United States and Canada.  FF/VI is not indicated for the relief of acute bronchospasm or the treatment of asthma in the United States or Canada.  FF/VI is not approved or licensed anywhere outside of the United States, Japan and Canada.  FF/VI is in development under the LABA collaboration agreement between Glaxo Group Limited and Theravance, Inc.  The slide presentation and poster are filed as Exhibit 99.1 and 99.2 to this report and are incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d)  Exhibits.

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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.

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EXHIBIT INDEX

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Exhibit 99.1

Exhibit 99.2

POSTER NO. PS272

Ethnic sensitivity assessment of fluticasone furoate (FF)/vilanterol (VI) in asthma patients in Japan and Korea: a pre-specified subgroup analysis

Gross AS(1), Goldfrad C(2), Hozawa S(3), James M(4), Clifton CS(1), Sugiyama Y(5), Jacques L(6)

(1)Clinical Pharmacology Modelling & Simulation, GlaxoSmithKline, Sydney, Australia; (2)Quantitative Sciences Division, GlaxoSmithKline, Uxbridge, UK; (3)Hiroshima Allergy and Respiratory Clinic, Hiroshima, Japan; (4)Medical Affairs, GlaxoSmithKline K.K., Tokyo, Japan; (5)Medicines Development Respiratory, GlaxoSmithKline K.K., Tokyo, Japan; (6)Respiratory Medicines Discovery and Development, GlaxoSmithKline, Uxbridge, UK

INTRODUCTION

·                  Inhaled corticosteroid (ICS)/long-acting beta2-agonist (LABA) combinations are recommended by Japanese(1) and global asthma guidelines(2) for asthma patients uncontrolled on ICS alone.

·                  FF/VI is a once-daily ICS/LABA combination therapy delivered via the ELLIPTATM dry powder inhaler, which is effective for 24h.

·                  Responses to pharmacotherapy can vary across ethnic groups(3),(4) including in Japanese patients.

OBJECTIVES

·                  To establish whether doses of FF/VI recommended from multinational studies are relevant to asthma patients in Japan.

·                    To compare the efficacy, safety, PK and PD data for FF/VI in patients from Japan and/or Korea with data from patients not from Japan or Korea

·                  Patients from Korea were included due to similarities in a range of intrinsic and extrinsic ethnic factors between the populations of Japan and Korea.(5)–(7)

METHODS

·                  A pre-specified subgroup analysis of multicentre, randomised, double-blind, parallel-group international studies that included asthma patients from Japan and/or Korea.

·                  Inclusion criteria: >12 years of age, pre-bronchodilator % predicted forced expiratory volume in one second (FEV1) of 40–90%, FEV1 reversibility of >12% and >200mL.

·           Efficacy results were pooled from three Phase III studies, ranging from 12 to 76 weeks duration, that included patients from Japan (GSK study numbers: HZA106827; HZA106829; HZA106837).

·           Change from baseline in trough FEV1 after 12 weeks with once-daily FF/VI 100/25mcg, once-daily FF 100mcg or placebo was analysed across two studies (HZA106827; HZA106837) and data for once-daily FF/VI 200/25mcg, once-daily FF 200mcg and twice-daily fluticasone propionate (FP) 500mcg were from one study (HZA106829).

·           Safety data were pooled from the three studies noted above and an additional three placebo-controlled Phase IIb studies, ranging from 28 days to 8 weeks duration, that included patients from Korea (B2C109575; FFA109685; FFA109687).

·           PK data were estimated based on a post-hoc analysis of population PK data for FF(8) and of study DB111207 data for VI(9); PD data, including 24h urinary cortisol excretion, were assessed.

RESULTS

Table 1. Demographic and baseline characteristics

Demographic and baseline characteristics (Efficacy population)

Demographic characteristics (Safety population)

(1)Mean (SD); (2)n=147; (3)n=3059; (4)n=3206; (5)n=4036; (6)n=4230

Efficacy

·                    Efficacy data were compared between patients (N=3214) from Japan and ‘Not-Japan’; 85% (N=2739) completed the studies.

·                    Improvements in trough FEV1 were reported in all populations for FF/VI 100/25mcg and FF 100mcg versus placebo and for FF/VI 100/25mcg versus FF 100mcg (Table 2)

·                  There was no evidence of a statistically significant difference in treatment effect between patients from Japan and Not-Japan (p=0.403).

·                    Changes from baseline in FEV1 were similar with FF/VI 200/25mcg and FF 200mcg in patients from Japan and the overall population (Figure 1)

·                  Improvements were greater than with twice-daily FP 500mcg.

Table 2. Comparison of change from baseline in trough FEV1 at Week 12 between treatment arms (Efficacy population)

Least squares mean change (95% confidence interval). Studies included: HZA106827, HZA106837. Data were analysed using a Last Observation Carried Forward Analysis of Covariance model, with terms for baseline FEV1, region, gender, age, treatment group, study & region by treatment interaction. 1n=193; 2n=18, 3n=175

Figure 1. Box plot of change from baseline in trough FEV1 at Week 12 by geographic region (Efficacy population)

Safety

·                    Safety data were compared between patients (N=4231) from Japan/Korea and Not-Japan/Korea; N=3584 (85%) completed the studies.

·                    In all active treatment groups, a greater proportion of patients from Japan/Korea versus Not-Japan/Korea reported on-treatment adverse events; this trend was also observed in the placebo group, suggesting that this is not related to FF or VI (Table 3).

Table 3. Summary of on-treatment adverse events and serious adverse events (Safety population)

Data presented as number of patients with an adverse event/number of patients in population group (%);

(1)Only subjects from Japan;

(2)One additional subject (South East Asian) died during follow-up

Safety (cont’d)

·                    Serious adverse events reported for patients from Japan+Korea (1 FF/VI 100/25mcg, 1 FF 100mcg: both subarachnoid haemorrhage) were not considered drug related.

PK/PD

·                    Estimated FF AUC(0-24) and VI Cmax were higher in Japanese versus White/Caucasian patients (Table 4).

PK/PD (cont’d)

·                    No clinically relevant effects on cortisol concentrations (Figure 2) or heart rate were observed.

·                    The PK profile of FF at clinical doses (<200mcg) did not differ when administered simultaneously with VI 25mcg compared with FF alone for either Japanese or White/Caucasian patients.

Table 4. Model predicted PK parameters

Geometric mean (95% confidence interval); FF data from post-hoc analysis of population PK data(8); VI data from post-hoc analysis of study DB111207(9)

Figure 2. Ratio of 24h urinary cortisol excretion to baseline at the end of treatment  (Urinary cortisol population(1))

(1)Urinary cortisol population: subset of patients from Safety population, that were not considered to have confounding factors, and for whom urine samples were available;

(2)Only subjects from Japan

CONCLUSIONS

·                    The efficacy and safety profile of FF/VI is similar in asthma patients from Japan+Korea and Not-Japan+Korea.

·                    The FF/VI clinical doses recommended based on global studies are also suitable for asthma patients in Japan.

REFERENCES

(1)         Ohta K, et al. Allergol Int. 2011;60:115–45.

(2)         Global Initiative for Asthma. Global Burden of Asthma. Available at: http://www.ginasthma.org/ local/uploads/files/GINABurdenReport_1.pdf. Last accessed: 10 Sept 2013.

(3)         Bjornsson TD, et al. J Clin Pharmacol 2003;43:943–67.

(4)         Huang SM, et al. Clin Pharmacol Ther 2008;84:287–94.

(5)         Jin HJ, et al. PLoS ONE 2009;4:1–10.

(6)        HUGO Pan-Asian SNP Consortium, et al. Science 2009;326:1541–45.

(7)         Chowbay B, et al. Drug Metab Rev 2005;37:327–78.

(8)         GSK data on file.

(9)         Nakahara N, et al. Int J Clin Pharmacol Ther 2013;51:660–72

ACKNOWLEDEGMENTS

·                    The presenting author, Yutaro Sugiyama, is employed by GlaxoSmithKline.

·                    The authors acknowledge the contributions of the following employees of GlaxoSmithKline: Dr Romina Nand, Dr Carol Lee and Dr Ann Allen.

·                    These studies were funded by GlaxoSmithKline (GSK study codes HZA106827 (cllinicaltrial.gov registration number: NCT01165138); HZA106829 (NCT01134042); HZA106837 (NCT01086384); B2C109575 (NCT00600171); FFA109685 (NCT00603278); FFA109687 (NCT00603382); DB111207 (NCT00964249).

·                    Editorial support (in the form of writing assistance, assembling tables and figures, collating author comments, grammatical editing and referencing) was provided by Laura Maguire, MChem, at Gardiner-Caldwell Communications (Macclesfield, UK) and was funded by GlaxoSmithKline.

ELLIPTATM is a trade mark of the GlaxoSmithKline group of companies

Presented at the 18th Congress of the Asian Pacific Society of Respirology, Yokohama, Japan, 11–14 November 2013