8-K

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 12, 2013

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 (I.R.S. Employer Identification Number)

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):

oWritten communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

oSoliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

oPre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

oPre-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 12, 2013 at the 18th Congress of the Asian Pacific Society of Respirology, Yokohama, Japan, GlaxoSmithKline plc (“GSK”) presented a poster 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, (FF/VI 200/25 mcg) in asthma patients of Asian ancestry.  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 chronic obstructive pulmonary disease (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 poster is filed as Exhibit 99.1 to this report and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d)Exhibits.

Exhibit	Description
Exhibit 99.1	Efficacy and safety of once-daily fluticasone furoate/vilanterol 200/25mcg compared with twice-daily fluticasone propionate 500mcg in asthma patients of Asian ancestry

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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.

	THERAVANCE, INC.
Date: November 12, 2013	By:	/s/ Michael W. Aguiar
		Michael W. Aguiar
		Chief Financial Officer

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EXHIBIT INDEX

Exhibit No.	Description
99.1	Efficacy and safety of once-daily fluticasone furoate/vilanterol 200/25mcg compared with twice-daily fluticasone propionate 500mcg in asthma patients of Asian ancestry

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EX-99.1

Exhibit 99.1

POSTER NO. PS108

Efficacy and safety of once-daily fluticasone furoate/vilanterol 200/25mcg compared with twice-daily fluticasone propionate 500mcg in asthma patients of Asian ancestry

Jiangtao L(1), Crawford J(2), Jacques L(3), Stone S(3)

(1)Department of Respiratory Diseases, China-Japan Friendship Hospital, Beijing 100029, China

(2)Quantitative Sciences Division, GlaxoSmithKline, Uxbridge, UK

(3)Respiratory Medicines Development Centre, GlaxoSmithKline, Uxbridge, UK

INTRODUCTION

·Fluticasone furoate (FF)/vilanterol (VI) is a novel once-daily ICS/long-acting beta2-agonist (LABA) combination therapy for the treatment of asthma.

·Fluticasone proprionate (FP) is an inhaled corticosteroid (ICS) taken twice daily via the DISKUSTM inhaler for the treatment of asthma.

·FF/VI delivered via the ELLIPTATM dry powder inhaler, has demonstrated 24h effectiveness in asthma patients in global studies(1),(2)

·   The 200/25mcg strength significantly improved lung function versus FP 500mcg twice daily over 24 weeks.(2)

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

OBJECTIVES

·To evaluate the efficacy and safety of once-daily FF/VI 200/25mcg administered in the evening, compared with twice-daily FP 500mcg administered in the morning and evening, in asthma patients of Asian ancestry.

METHODS

·A randomised, double-blind, double-dummy, active-comparator, parallel-group, 12-week multicentre study.

·Inclusion criteria: aged >12 years; FEV1 40–90% predicted; reversibility of >12% and >200mL within 10–40  minutes following 2–4 inhalations of salbutamol; treated with stable high-dose ICS or mid-dose ICS/LABA therapy for >4 weeks prior to Screening.

·Patients were randomised (1:1) to receive FF/VI 200/25mcg once daily via the ELLIPTA device (equivalent to a delivered dose of FF/VI 184/22mcg) or FP 500mcg twice daily via the DISKUS inhaler for 12 weeks.

·Primary endpoint: mean change from baseline in daily evening peak expiratory flow (PEF) averaged over the 12-week treatment period.

·Secondary endpoints (Weeks 1–12, unless stated)

·   Change from baseline in % rescue-free 24h periods

·   Mean change from baseline in morning PEF (averaged over Weeks 1–12)

·   Change from baseline in % symptom-free 24h periods

·   Change from baseline in AQLQ+12 Total score (measured at Week 12).

·A step-down statistical hierarchy was applied to account for multiplicity across endpoints. Testing of each endpoint was dependent on the achievement of significance at the 5% level for the previous endpoint, in the following order

·   Evening PEF > % rescue-free 24h periods > morning PEF > % symptom-free 24h periods > AQLQ score.

·Safety endpoints included incidence of adverse events (AEs), vital signs, electrocardiogram and laboratory evaluations.

RESULTS

Table 1. Demographic and baseline characteristics
(ITT population)

	FF/VI 200/25	FP 500
	OD N=155	BD N=154	Total N=309
Age (years)	46.9 (12.93)	48.8 (13.41)	47.9 (13.19)
Male, n (%)	59 (38)	68 (44)	127 (41)
Duration of asthma	12.39	13.44	12.91
(years)	(12.857)	(13.551)	(13.196)
Lung function parameters
FEV1 (L)	1.78 (0.493)	1.77 (0.552)	1.77 (0.523)
% predicted FEV1	67.51	67.55	67.53
	(13.249)	(13.432)	(13.319)
% reversibility FEV1	27.31	26.98	27.14
at screening	(14.570)	(14.262)	(14.395)

Data are mean (SD) unless otherwise stated; OD=once daily; BD=twice daily

RESULTS

Efficacy

·FF/VI and FP improved evening PEF compared with baseline
(Figure 1)

·   Change from baseline with FF/VI was 39.1L/min (standard error=3.01) and with FP was 10.5L/min (3.03)

·   The effect was statistically significantly better (p<0.001) with FF/VI compared with FP (28.5L/min; 95% confidence interval [CI]: 20.1, 36.9).

·Improvements in % rescue-free 24h periods were similar for FF/VI and FP

·   The equivalent number of rescue-free days per week was 2.3 with FF/VI and 2.2 with FP

·   The adjusted treatment difference (1.0%; 95% CI: —7.3, 9.2) was not statistically significant (p=0.821) (Figure 2).

·Due to the statistical hierarchy, significance for remaining endpoints could not be inferred.

·There were numerical improvements in the remaining secondary endpoints for FF/VI compared with FP (Figure 2).

RESULTS

Safety

·Incidence of AEs, treatment-related AEs and serious AEs was low and similar for FF/VI and FP (Table 2).

·There were no fatal AEs.

·The only treatment-related SAE was asthma (FP 500mcg).

·Pneumonia was reported by two patients (both with FF/VI 200/25mcg); neither required hospitalisation.

·There were no clinically significant changes in vital signs, electrocardiogram parameters or clinical laboratory evaluations.

Table 2. Summary of adverse events (ITT population)

	FF/VI 200/25	FP 500
	OD	BD
	N=155	N=154
All AEs
On-treatment	40 (26)	41 (27)
On-treatment, treatment-related	5 (3)	5 (3)
On-treatment leading to withdrawal	2 (1)	2 (1)
Post-treatment	0	1 (<1)
SeriousAEs
On-treatment	1 (<1)	2 (1)
On-treatment, treatment-related	0	1 (<1)
Most frequent(a) on-treatment AEs
Upper respiratory tract infection	13 (8)	18 (12)
Nasopharyngitis	6 (4)	6 (4)
Rhinitis allergic	5 (3)	2 (1)
Oropharyngeal pain	4 (3)	1 (<1)

(a)Occurring in >3% of patients in either treatment group

CONCLUSIONS

·FF/VI 200/25mcg once daily demonstrated clinically and statistically significant improvements in evening PEF compared with FP 500mcg twice daily in Asian asthma patients uncontrolled on high-dose ICS or mid-dose ICS/LABA.

·There were numerical improvements across the secondary endpoints with FF/VI 200/25mcg versus FP 500mcg.

·The safety profile of FF/VI 200/25mcg was broadly similar to that of FP 500mcg.

·The results are generally consistent with a previously published global study that compared FF/VI 200/25mcg with FP 500mcg.(2)

REFERENCES

(1)Woodcock A, et al. Chest 2013;144:1222–9.

(2)O’Byrne PM, et al. Eur Respir J 2013;Oct 17:ePub ahead of print.

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

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

ACKNOWLEDGMENTS

·The presenting author, Dr Jiangtao Lin has received speaker’s honoraria from AstraZeneca, GlaxoSmithKline and MSD, and has been a member of global advisory boards for Boehringer Ingelheim.

·The study was funded by GlaxoSmithKline (GSK study code HZA113714 (clinicaltrials.gov registration number: NCT01498653).

·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.

       

DISKUS™ and ELLIPTA™ are trade marks of the GlaxoSmithKline group of companies

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