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 18, 2010

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.

Today at the American Thoracic Society International Conference in New Orleans, Louisiana, GlaxoSmithKline (GSK) presented two posters containing information from Phase 1 and Phase 2a studies with vilanterol trifenatate (GW642444), the long-acting beta2 agonist (LABA) in RELOVAIR™.  RELOVAIR™ is a next-generation, once-daily combination medicine of vilanterol trifenatate and an inhaled corticosteroid, fluticasone furoate, being developed for the treatment of patients with chronic obstructive pulmonary disorder (COPD) or asthma.  RELOVAIR™ is being developed under the LABA collaboration between GSK and Theravance, Inc.  The two posters are attached hereto as Exhibits 99.1 and 99.2 and are incorporated herein by reference.

Item 9.01 Financial Statements and 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

ABSTRACT

Rationale: GW642444 is a novel inhaled LABA with inherent 24 hour activity in vitro in development for once-daily administration as monotherapy (for COPD) and in combination with an inhaled corticosteroid (for both COPD and asthma). This study was conducted to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and duration of action (FEV1 over 24h) of single doses of GW642444 in COPD patients.

Methods: This was a double-blind, placebo-controlled, crossover study in 20 male and female COPD patients (mean age 62.3 years [range: 48—75]) with a documented clinical history of mild/moderate COPD (FEV1 [% predicted] >40% and <80%, and a smoking history of >10 pack years) who received single inhaled doses of GW642444 (25, 50 and 100mcg) or placebo. Adverse events (AEs), vital signs, ECG (12-lead and Holter monitoring), FEV1 and GW642444 plasma pharmacokinetics (AUC, Cmax and tmax) were determined up to 24h after dosing.

Results: GW642444 (25—100mcg) was well tolerated in COPD patients. The incidence and severity of AEs was comparable to placebo. Following dosing with GW642444 there were no serious AEs or withdrawals due to AEs and no clinically significant laboratory, vital sign or 12-lead ECG, QTc or Holter ECG abnormalities. Increases in FEV1 were seen from as early as 5min after dosing (treatment difference vs. placebo of up to 133mL (95% CI: 25, 241)) and were maintained up to 24h post-dose. At 23—24h after dosing with GW642444 25, 50 and 100mcg adjusted mean FEV1 (95% CI) values were 190mL (88, 292), 206mL (100, 312) and 210mL (67, 354) greater than placebo respectively, indicating a 24h duration of action at all doses. GW642444 was rapidly absorbed into plasma (median tmax at 10min) with systemic exposure increasing in an approximately dose proportional manner across the GW642444 dose range (25—100mcg).

Conclusion: Single doses of inhaled GW642444 (25—100mcg) were well tolerated in COPD patients and were not associated with any clinically significant unwanted systemic effects. GW642444 (25—100mcg) produced rapid bronchodilation which was maintained over 24h suggesting the potential for once daily administration in COPD.

INTRODUCTION

Vilanterol trifenatate (VI; GW642444M) is an inhaled long-acting beta2 agonist (LABA) with inherent 24h activity in vitro which is in development for once-daily administration as monotherapy (for COPD) and in combination with the inhaled corticosteroid fluticasone furoate (for both COPD and asthma).

This study was conducted to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of single inhaled doses of VI in patients with COPD.

OBJECTIVES

Primary

·      To evaluate the safety and tolerability of single inhaled doses of VI (25, 50 and 100mcg) in patients with COPD.

Secondary

·      To evaluate the pulmonary and extra-pulmonary pharmacodynamic effects of single inhaled doses of VI (25, 50 and 100mcg) in patients with COPD.

·      To evaluate the systemic pharmacokinetics following single inhaled doses of VI (25, 50 and 100mcg) in patients with COPD.

METHODS

·      This was a double-blind, randomized, placebo-controlled, dose ascending, incomplete block, crossover study.

·      Male and female (of non-child bearing potential) patients with a documented clinical history of mild/moderate COPD(1), post-bronchodilator FEV1 to forced vital capacity (FVC) ratio (FEV1/FVC) <0.70, % predicted FEV1 >40% and <80% and a smoking history of >10 pack years.

·      LABAs were prohibited from 48h before screening until follow up and tiotropium was prohibited from 2 weeks before screening until follow up. Inhaled corticosteroids were permitted up to a dose of 1000mcg/day of fluticasone propionate or equivalent provided the dose was stable. Inhaled albuterol (salbutamol) could be used during the study but had to be withheld for at least 6h before screening and before each dose of study drug.

·      Single inhaled doses of VI (25, 50 and 100mcg) and placebo were administered as a dry powder from a DISKUS™ device (AM dosing) on separate occasions separated by 7—14 days.

·      FEV1, heart rate, 12-lead ECG (QTc(F) interval), plasma vilanterol concentrations and whole blood potassium and glucose were measured before and at intervals up to 24h after each dose.

·      Adverse events (AEs) were recorded, pre-and post-dose laboratory safety screens were performed and ECG Holter monitoring was conducted for 24h after each dose.

RESULTS

Demographics

·      Patient demographic details are given in Table 1. Twenty patients with COPD participated in the study with 19, 20, 19 and 8 receiving placebo and 25, 50 and 100mcg VI, respectively.

Table 1. Demographic details

Safety and tolerability

·      VI (25—100mcg) administered as single doses was well tolerated. There were no serious AEs or AEs that led to withdrawal.

·      A total of 5 adverse events, all described as ‘mild’, were reported during the study; 2 following placebo (headache and nasopharyngitis), 1 following 25mcg VI (headache) and 2 following 50mcg VI (nasopharyngitis and dysgeusia [‘taste disturbance/sweet’]). There were no AEs at the 100mcg VI dose and no reports of tremor.

·      There were no laboratory safety tests, vital signs ECG (12-lead or 24h Holter ECG) findings of clinical significance.

Pharmacodynamics

·      Increases in FEV1 were seen from as early as 5min after dosing and were maintained up to 24h post-dose (Table 2 and Figure 1), indicating a 24h duration of action at all doses.

·      VI had no effects on heart rate, QTc(F), blood glucose or potassium (Table 3).

Table 2. FEV1 (mL; difference from placebo) at 5 min and 23—24h following single dose VI (25—100 mcg) in COPD patients

Pharmacokinetics

·      Vilanterol was rapidly absorbed into plasma; maximum concentrations were observed at a median time of 10min following 25 and 50mcg doses. Absorption appeared slower following the 100mcg dose (median Tmax 25min), however caution should be taken as only n=8 patients received this dose (Table 4).

Figure 1. Mean FEV1 profile (0—24h) following single dose VI (25—100mcg) and placebo in COPD patients

Table 3. Summary of extra-pulmonary pharmacodynamic data (difference from placebo) following single dose VI (25—100mcg) in COPD patients

·      Plasma vilanterol concentrations rapidly declined from peak and were generally below limits of quantification (30pg/mL) beyond 6h post-inhalation (Figure 2). At the lowest dose able to produce bronchodilation (25mcg) systemic exposure to vilanterol was generally non-quantifiable >1h post-inhalation (Table 4, Figure 2).

·      Approximately dose-proportional increases in systemic exposure were observed as the VI dose was escalated from 25 to 100mcg (Table 4, Figure 2).

·      Systemic exposure was generally consistent with that reported in patients with persistent asthma(2).

Table 4. Summary of selected vilanterol pharmacokinetic parameters in COPD patients

N: represents the number of patients in the pharmacokinetic concentration population

n: represented the number of patients in the pharmacokinetic parameter population

(a)Geometric mean (CV%);

(b)Median (range);

(c)n=17

Figure 2. Median vilanterol plasma concentrations following administration of single dose VI (25, 50 and 100mcg) in COPD patients

CONCLUSIONS

·      Single doses of inhaled vilanterol trifenatate (25—100mcg) were well tolerated in COPD patients and were not associated with any clinically significant unwanted systemic effects.

·      Vilanterol trifenatate (25—100mcg) produced rapid bronchodilation which was maintained over 24h suggesting the potential for once-daily administration in COPD.

REFERENCES

(1)   Celli BR, et al. Eur Respir J 2004;23:932—946.

(2)   Kempsford RD, et al. Presented at ATS International Conference, New Orleans, May 14—19, 2010. Abstract 289.

ACKNOWLEDGEMENTS

·      This study was sponsored by GlaxoSmithKline (ClinicalTrials.gov: NCT00519376; protocol number B2C110165).

·      Editorial support was provided by Geoffrey Weller and David Cutler at Gardiner-Caldwell Communications Ltd and was funded by GlaxoSmithKline.

·      The study was conducted in Germany by Parexel (Berlin), INSAF (Wiesbaden), Johannes Gutenberg Universitaet (Mainz) and Institut Medars (Berlin).

Presented at the Annual Conference of the American Thoracic Society (ATS), New Orleans, LA, USA, 14—19 May 2010

Exhibit 99.2

ABSTRACT

Rationale: GW642444 is a novel inhaled LABA with inherent 24 hour activity in vitro in development for once-daily administration as monotherapy (for COPD) and in combination with an inhaled corticosteroid (for both COPD and asthma). This study was conducted to determine the safety, tolerability, pharmacokinetics, pharmacodynamics of repeat dose GW642444 inhalation in healthy subjects.

Methods: This was a double-blind, randomized, placebo-controlled, dose-ascending, parallel group study. Male and female healthy subjects (n=36) aged 19—53 years received single doses of GW642444 (25, 50 and 100mcg) or placebo (9 subjects/ treatment) once daily for 14 days. Heart rate (HR), 12-lead ECG (QTc interval), blood pressure and plasma GW642444 concentrations (0—24h post dose) and whole blood potassium (K+) and glucose (0—4h post dose) were determined on Days 1, 7 and 14. All adverse events (AEs) were recorded and pre- and post-dose laboratory safety screens were performed.

Results: GW642444 (25—100mcg) administered for 14 days was well tolerated. All AEs were described as ‘mild’ or ‘moderate’ with a similar total incidence after GW642444 (33—67%) and placebo (67%). The most frequently reported AE was headache (0—22% after GW642444 and 56% after placebo). There were no serious AEs or withdrawals due to AEs. On Day 14 there were no treatment differences vs. placebo (95% CIs included zero) for the effects of repeat dose 25—100mcg GW642444 on HR (0—4h maximum adjusted mean difference from placebo <3bpm) or K+ (0—4h minimum adjusted mean difference from placebo <0.02mmol/L). There were no effects on Day 14 QTcF and blood glucose except with 100mcg GW642444 (adjusted mean difference in 0—4h maximum QTcF 9.1msec (95% CI: 2.1, 16.1) and adjusted mean difference in 0—4h maximum glucose 0.41mmol/L (95% CI: 0.06, 0.76)); these differences were not considered clinically significant. GW642444 was rapidly absorbed into the plasma (median tmax at 5 minutes) with approximate dose-proportional increases in Cmax across the dose range. There was some evidence of GW642444 accumulation (<30%) on repeat dosing with steady-state achieved by Day 7.

Conclusion: Repeat dosing of inhaled GW642444 (25—100mcg) once daily for 14 days was well tolerated in healthy subjects and was not associated with any clinically significant unwanted systemic effects. GW642444 was rapidly absorbed and showed approximately linear pharmacokinetics and marginal accumulation on repeat dosing.

INTRODUCTION

·                 Vilanterol trifenatate (VI; GW642444M) is an inhaled long-acting beta2 agonist (LABA) with inherent 24 hour activity in vitro which is in development for once-daily administration as monotherapy for COPD and in combination with the inhaled corticosteroid fluticasone furoate (for both COPD and asthma).

OBJECTIVES

Primary

·                 To evaluate the safety and tolerability of VI (25, 50 and 100mcg) administered once daily (AM dosing) for 14 days in healthy subjects.

Secondary

·                 To evaluate any extra-pulmonary systemic pharmacodynamic effects of VI administered once daily (25, 50 and 100mcg; AM dosing) for 14 days in healthy subjects.

·                 To evaluate the systemic pharmacokinetics of vilanterol following inhaled administration once daily (25, 50 and 100mcg; AM dosing) for 14 days in healthy subjects.

METHODS

·                 This was a double-blind, randomized, placebo-controlled, dose-ascending, parallel group study.

·                 Healthy male subjects and female subjects of non-child bearing potential with FEV1 >80% predicted and FEV1/FVC ratio >70% received single AM doses of VI (25, 50 and 100mcg) or placebo (9 subjects/ treatment) once daily for 14 days.

·                 VI and matching placebo (lactose alone) were administered as single or double inhalations from the DISKUS™ dry powder device.

·                 Heart rate, 12-lead ECG (QTc(F) interval), blood pressure, whole blood potassium and glucose (all 0—4h post dose), FEV1 (0—24h post dose) and plasma vilanterol concentrations (0—24h post dose) were determined on Days 1, 7 and 14.

·                 All adverse events (AEs) were recorded and pre- and post-dose laboratory safety screens were performed.

RESULTS

Demographics

·                 Subject demographic details are given in Table 1. Thirty six healthy subjects (35 male: 1 female) participated in the study.

Table 1. Demographic details

Safety and tolerability

·                 VI (25—100mcg) administered for 14 days was well tolerated. All subjects received their allocated treatments for 14 days. There were no serious AEs or withdrawals.

·                 A total of 37 AEs were reported during the study, with 21 judged related to study drug.

·                 All AEs were described as ‘mild’ or ‘moderate’ with a similar total incidence after VI (33—67%) and placebo (67%).

·                 There was no evidence of a VI dose-related increase in AE incidence.

·                 Following administration of VI the most frequently reported AEs were headache (0—22%), throat irritation (0—22%) and upper respiratory tract infection (0—22%). There were no reports of tremor or palpitations. The most frequently reported adverse events are listed in Table 2.

·                 There were no clinical laboratory, vital sign or 12-lead abnormalities of clinical significance or falls in FEV1 immediately after dosing.

Table 2. Summary of most frequently
reported adverse events

Data represents the number of subjects (%) reporting an adverse event

Systemic pharmacodynamics (Table 3)

·                 Heart rate: there was no effect of once-daily repeat dose VI (25, 50 or 100mcg) on heart rate. For maximum heart rate (0—4h) the Day 14 adjusted mean differences from placebo were all <3bpm and the 95% CIs included zero.

·                 Blood potassium: there was no effect of once-daily repeat dose VI (25, 50 or 100mcg) on blood potassium. For minimum potassium (0—4h; Day 14) adjusted mean differences from placebo were all <0.02mmol/L and the 95% CIs included zero.

·                 Blood glucose: there were no effects on Day 14 blood glucose except with 100mcg VI (adjusted mean difference in 0—4h maximum glucose 0.41mmol/L [95% CI: 0.06, 0.76]); this difference was not considered to be clinically significant.

·                 QTc(F): there were no effects on Day 14 QTcF except with 100mcg VI (adjusted mean difference in 0—4h maximum QTc(F) 9.1msec [95% CI: 2.1, 16.1]); this difference was not considered to be clinically significant.

Table 3. Summary of pharmacodynamic
data following repeat dosing with
vilanterol trifenatate for 14 days

Pharmacokinetics

·                 Vilanterol was rapidly absorbed into the plasma (median tmax at 5min) with approximate dose-proportional increases in Cmax across the dose range (Table 4).

·                 Vilanterol plasma concentration/time data is given in Figure 1.

·                 There was some evidence of accumulation of vilanterol (<30%; Table 5) on repeat dosing with steady-state achieved by Day 7.

Figure 1. Median vilanterol plasma
concentrations following repeat dose
administration of 25, 50 and 100mcg
VI. Day 14 data (n=9/group)

Table 4. Summary of selected repeat dose
vilanterol pharmacokinetic parameters (Day 14)

(a) Geometric mean (CV%)

(b) Median (range)

Table 5. Summary of vilanterol accumulation
following repeat dosing for 14 days

ND: Not determined (AUC too limited to assess accumulation)

*AUC(0-t’) (to common time-point) to account for LLQ censoring

CONCLUSIONS

·                 Repeat dosing with inhaled vilanterol trifenatate (25—100mcg) once daily for 14 days was well tolerated in healthy subjects and was not associated with any clinically significant unwanted systemic effects.

·                 Vilanterol (25—100mcg) was rapidly absorbed and showed approximately linear pharmacokinetics and marginal accumulation on repeat dosing.

ACKNOWLEDGEMENTS

·                 This study was sponsored by GlaxoSmithKline (ClinicalTrials.gov: NCT00463697; protocol number B2C108784).

·                 Editorial support was provided by Geoffrey Weller and David Cutler at Gardiner-Caldwell Communications Ltd and was funded by GlaxoSmithKline.

·                 The study was conducted by Hammersmith Medicines Research (London, UK).