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):  October 25, 2008

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 BoulevardSouth 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.

At the 48th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and the Infectious Diseases Society of America (IDSA) 46th Annual Meeting held in Washington, D.C. between October 25 and 28, telavancin, an investigational lipoglycopeptide with bactericidal activity in vitro against Gram-positive pathogens including methicillin-resistant Staphylococcus aureus, is being featured in twenty-five posters or podium presentations.  A text version of two posters containing new telavancin data, which were shown on October 25, 2008 at the joint ICAAC/IDSA conference, are attached hereto as Exhibits 99.1 and 99.2 and are incorporated herein by reference.

ITEM 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit	Description
Exhibit 99.1	Poster entitled “Telavancin for the Treatment of Hospital-Acquired Pneumonia in Severely Ill and Older Patients: The ATTAIN Studies”
Exhibit 99.2	Poster entitled “Telavancin for Treatment of Hospital-Acquired Pneumonia Caused by MRSA and MSSA: The ATTAIN Studies”

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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: October 27, 2008	By:	/s/ Michael W. Aguiar
		Michael W. Aguiar
		Chief Financial Officer

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EXHIBIT INDEX

Exhibit	Description
Exhibit 99.1	Poster entitled “Telavancin for the Treatment of Hospital-Acquired Pneumonia in Severely Ill and Older Patients: The ATTAIN Studies”
Exhibit 99.2	Poster entitled “Telavancin for Treatment of Hospital-Acquired Pneumonia Caused by MRSA and MSSA: The ATTAIN Studies”

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EX-99.1

Exhibit 99.1

Telavancin for the Treatment of Hospital-Acquired

Pneumonia in Severely Ill and Older Patients:

The ATTAIN Studies

E Rubinstein,(1) GR Corey,(2) HW Boucher,(3) MS Niederman,(4) AF Shorr,(5) A Torres,(6) SL Barriere,(7) HD Friedland(7); On behalf of the ATTAIN Study Group

(1)University of Manitoba, Winnipeg, Canada; (2)Duke University Medical Center, Durham, NC, USA; (3)Tufts Medical Center, Boston, MA, USA; (4)SUNY, Stony Brook, NY, USA; (5)Georgetown University, Washington, DC, USA; (6)Hospital Clínic de Barcelona, Barcelona, Spain; (7)Theravance, Inc., South San Francisco, CA, USA

Presented at the 48th Annual ICAAC/IDSA 46th Annual Meeting, Washington, DC, October 25-28, 2008.

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ABSTRACT (REVISED)

Background. Telavancin (TLV) is an investigational lipoglycopeptide with potent bactericidal activity in vitro against Gram-positive pathogens including methicillin-resistant Staphylococcus aureus (MRSA). The ATTAIN program studied TLV for the treatment of hospital-acquired pneumonia (HAP). In this analysis, we compared the clinical cure rates achieved with TLV or vancomycin (VAN) for severely ill and older patients.

Methods. ATTAIN 1 and 2 were methodologically identical, randomized, double-blind, Phase 3 studies. Patients (>18 years of age) with HAP caused by suspected or confirmed Gram-positive pathogens were randomized to TLV 10 mg/kg intravenous (IV) q24 h or VAN 1 g IV q12 h for 7 to 21 days. Test-of-cure (TOC) visit was conducted 7 to 14 days after end-of-study treatment. Clinically evaluable (CE) patients were those who met prespecified criteria for evaluability.

Results. Pooled clinical cure rates at TOC for several clinically relevant subgroups including the elderly as well as patients with severe HAP at baseline are presented in the Table. The overall incidence of treatment-emergent adverse events was comparable between treatment groups.

Conclusions. TLV achieved numerically higher cure rates than conventional therapy for treatment of HAP in severely ill and older patients with comparable treatment-emergent adverse events.

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INTRODUCTION

·In the United States, pneumonia is the leading cause of death among patients with health care-associated infections.(1)

·A recent survey of culture-positive pneumonia identified Staphylococcus aureus as a dominant pathogen for all types of pneumonia, including hospital-acquired pneumonia (HAP), and the only pathogen that correlates with mortality.(2)

·Conventional treatment is associated with high mortality among patients with bacteremic HAP due to S. aureus.(3)

·Telavancin is an investigational, rapidly bactericidal lipoglycopeptide with a potent multifunctional mechanism of action against clinically relevant Gram-positive pathogens, including methicillin-resistant S. aureus.(4)

·In Phase 3 clinical trials for complicated skin and skin structure infections and HAP, telavancin achieved its objective of noninferiority in the all-treated (AT) and clinically evaluable (CE) patient populations.(5),(6)

·In this analysis, we compared telavancin and vancomycin for treatment of HAP in severely ill or older patients from the Assessment of Telavancin for Hospital-acquired Pneumonia (ATTAIN) studies.

METHODS

Patients

Major inclusion criteria

·Men and nonpregnant women >18 years of age.

·Clinical signs and symptoms consistent with pneumonia acquired after 48 hours in an inpatient acute- or chronic-care facility, or acquired within 7 days after being discharged following >3 days of hospital stay.

·Radiographic and laboratory findings consistent with bacterial pneumonia.

·Adequate respiratory specimen for Gram stain and culture.

Major exclusion criteria

·Receipt of potentially effective systemic antibiotic therapy for Gram-positive pneumonia for more than 24 hours immediately prior to randomization.

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·Respiratory tract specimens with only Gram-negative bacteria seen on Gram stain or culture.

·An infection due to organisms known to be resistant to either of the study medication regimens or suspected pulmonary disease that precluded evaluation of therapeutic response.

·Documented or suspected meningitis, endocarditis, osteomyelitis, or evidence for compromised host immune response.

Study design

·ATTAIN 1 and 2 were methodologically identical, randomized, double-blind, comparator-controlled, parallel-group Phase 3 studies conducted at 275 sites in 38 countries.

·Enrollment took place between January 2005 and June 2007.

·Patients were randomized (1:1) to receive telavancin 10 mg/kg intravenous (IV) every 24 hours or vancomycin 1 g IV every 12 hours for 7 to 21 consecutive days.

·Telavancin dose was adjusted in patients with creatinine clearance of <50 mL/min.

·Vancomycin dose was adjusted per site-specific guidelines.

·Switching to antistaphylococcal penicillin was allowed for infections with methicillin-susceptible S. aureus.

·Concomitant treatment with aztreonam and/or metronidazole was permitted for polymicrobial infections.

·Baseline clinical assessments included medical history, physical examination, chest radiograph or chest computed tomography, arterial blood gas in patients on mechanical ventilation or with an arterial line, creatinine clearance calculation, and electrocardiogram.

·Components of the Acute Physiology and Chronic Health Evaluation (APACHE) II score were collected for all patients. Calculations were performed by imputing zeroes for missing components.

·Severity of illness was determined based on each of the following: APACHE II score >20, baseline Clinical Pulmonary Infection Score >6, presence or absence of acute lung injury (ALI) or acute respiratory distress syndrome (ARDS), presence or absence of bacteremia, and age >65 years.

·Safety assessments included vital signs, adverse events, electrocardiograms, and laboratory parameters.

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Analysis populations

·AT: Randomized patients who received >1 dose of study medication.

·Modified all-treated (MAT): AT patients with baseline pathogen.

·CE: Compliant AT patients with a clinical response of “cure” after receiving study medication >5 days and at least 80% of the intended dose, or “failure” following >3 days on study medication at test-of-cure (TOC) 7 to 14 days after last dose of study drug.

·Microbiologically evaluable (ME): CE patients with a Gram-positive pathogen recovered from baseline respiratory specimens or blood cultures.

Study end points

·Clinical response at TOC:

·Cure: Signs and symptoms of pneumonia resolved

·Failure: Persistence/progression of pneumonia or relapse after end of therapy, termination of study medication due to lack of efficacy, death after >3 days attributable to the primary infection

·Indeterminate: Inability to determine outcome.

Statistics

·Descriptive statistics were calculated for patient demographics and safety data.

·Two-sided, 95% confidence intervals were constructed on the difference in cure rates (telavancin minus vancomycin).

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RESULTS

Disposition and outcomes

·A total of 1532 individuals were randomized to receive study medication and 1503 received at least 1 dose of study medication (Figure 1).

·In the combined CE population of ATTAIN, the proportions of severely ill patients and older patients (>65 years) were mostly balanced between treatment groups, although more patients in the telavancin group had ALI or ARDS (Table 1).

·The cure rates obtained with telavancin were comparable to those achieved with conventional therapy across all severity subgroups. The cure rates were numerically higher in the APACHE II >20, ALI or ARDS, bacteremia, and age >65 years severity subgroups (Figure 2).

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Safety

·The incidence of treatment-emergent adverse events in patients meeting at least 1 of the criteria for more severe HAP or underlying illness were similar for both treatment groups (Table 2).

CONCLUSIONS

·Telavancin achieved numerically higher cure rates than vancomycin for treatment of HAP in severely ill and older patients.

·The comparable incidence of treatment-emergent adverse events between telavancin and vancomycin suggest that, if approved, telavancin may be an important option for the treatment of these vulnerable populations.

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REFERENCES

(1)Klevens RM et al. Public Health Rep 2007;122:160–166.

(2)Kollef MH et al. Chest 2005;128:3854–3862.

(3)Gonzalez C et al. Clin Infect Dis 1999;29:1171–1177.

(4)Attwood RJ, LaPlante KL. Am J Health Syst Pharm 2007;64:2335–2348.

(5)Stryjewski ME et al. Clin Infect Dis 2008;46:1683–1693.

(6)Rubinstein E et al. Clin Microbiol Infect 2008;14:S14.

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EX-99.2

Exhibit 99.2

Telavancin for Treatment of Hospital-Acquired

Pneumonia Caused by MRSA and MSSA: The

ATTAIN Studies

E Rubinstein,(1) GR Corey,(2) ME Stryjewski,(2),(3) JL Vincent,(4) JY Fagon,(5) MH Kollef,(6) MM Kitt,(7) HD Friedland(7); on behalf of the ATTAIN Study Group

(1)University of Manitoba, Winnipeg, Canada; (2)Duke Clinical Research Institute, Durham, NC, USA; (3)Centro de Educación Médica e Investigaciones Clínicas (CEMIC), Buenos Aires, Argentina; (4)Hôpital Erasme, Brussels, Belgium; (5)Hôpital Européen Georges Pompidou, Paris, France; (6)Washington University, St. Louis, MO, USA; (7)Theravance, Inc., South San Francisco, CA, USA

Presented at the 48th Annual ICAAC/IDSA 46th Annual Meeting, Washington, DC, October 25-28, 2008.

1

ABSTRACT (REVISED)

Background. Vancomycin (VAN) is the standard of care for the treatment of methicillin- resistant S. aureus (MRSA) pneumonia but is felt to be less effective for infections with methicillin-susceptible (MSSA) strains. Telavancin (TLV) is an investigational, bactericidal lipoglycopeptide with potent activity against Gram-positive pathogens in vitro. We compared the efficacy of TLV and VAN for treatment of HAP caused by Gram-positive bacteria.

Methods. ATTAIN 1 and 2 were randomized, methodologically identical, double-blind, Phase 3, clinical studies. Patients (>18 years of age) with HAP suspected or documented to be due to Gram-positive pathogens were randomized to receive TLV 10 mg/kg IV q24 h or VAN 1 g IV q12 h for 7 to 21 days. Test-of-cure (TOC) visit was conducted 7 to 14 days after end of study treatment. The microbiologically evaluable (ME) population consisted of clinically evaluable patients with Gram-positive pathogen isolated at baseline.

Results. Pooled clinical cure rates at TOC for ME patients with monomicrobial infections are presented in the Table. Patients with mixed Gram+/Gram– infection are not included.

Conclusions. TLV achieved numerically higher clinical cure rates in ME patients with monomicrobial HAP caused by MRSA and MSSA.

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INTRODUCTION

·Staphylococcus aureus has emerged as a major pathogen in hospital-acquired pneumonia (HAP).(1)

·Methicillin-resistant S. aureus (MRSA) strains are now implicated in 20% to 40% of all cases of HAP.(2)

·Inadequate antimicrobial treatment of critically ill patients is associated with increased mortality, and this is most commonly due to inappropriate treatment of resistant organisms.(3)

·The empiric use of vancomycin has increased in response to the epidemic spread of MRSA.(4) However, vancomycin is less efficacious than b-lactam antibiotics for treatment of invasive infections with methicillin-susceptible (MSSA) strains.(5),(6)

·Telavancin is an investigational, rapidly bactericidal lipoglycopeptide with a multifunctional mechanism of action against clinically relevant pathogens, including MRSA.(7)

·In Phase 3 trials, telavancin has demonstrated noninferiority compared with conventional therapy for treatment of complicated skin and soft tissue infections(8) and HAP.(9)

·In this analysis, we compared telavancin and vancomycin for treatment of HAP in patients with a monomicrobial Gram-positive infection at baseline from the Assessment of Telavancin for Hospital-acquired Pneumonia (ATTAIN) studies.

METHODS

Patients

Major inclusion criteria

·Men and nonpregnant women >18 years of age.

·Clinical signs and symptoms consistent with pneumonia acquired after 48 hours in an inpatient acute- or chronic-care facility, or acquired within 7 days after being discharged following >3 days of hospital stay.

·Radiographic and laboratory findings consistent with bacterial pneumonia.

·Adequate respiratory specimen for Gram stain and culture.

3

Major exclusion criteria

·Receipt of potentially effective systemic antibiotic therapy for Gram-positive pneumonia for more than 24 hours immediately prior to randomization.

·Respiratory tract specimens with only Gram-negative bacteria seen on Gram stain or culture at enrollment.

·An infection due to organisms known to be resistant to either of the study medication regimens or suspected pulmonary disease that precluded evaluation of therapeutic response.

·Documented or suspected meningitis, endocarditis, or osteomyelitis and evidence for compromised host immune response.

Study design

·ATTAIN 1 and 2 were methodologically identical, randomized, double-blind, comparator-controlled, parallel-group Phase 3 studies conducted at 275 sites in 38 countries.

·Enrollment took place between January 2005 and June 2007.

·Patients were randomized (1:1) to receive telavancin 10 mg/kg intravenously (IV) every 24 hours or vancomycin 1 g IV every 12 hours for 7 to 21 consecutive days.

·Telavancin dose was adjusted in patients with creatinine clearance of <50 mL/min.

·Vancomycin dose was adjusted per site-specific guidelines maintaining study blinding.

·Switching to antistaphylococcal penicillin was allowed for MSSA infections.

·Baseline clinical assessments included medical history, physical examination, chest radiograph or chest computed tomography, arterial blood gas in patients on mechanical ventilation or with an arterial line, creatinine clearance calculation, and electrocardiogram.

·Test-of-cure (TOC) visit 7 to 14 days after last dose of study drug.

Analysis populations

·All-treated (AT): Randomized patients who received >1 dose of study medication.

·Modified all-treated (MAT): AT patients with baseline pathogen.

·Clinically evaluable (CE): Compliant AT patients with a TOC clinical response of “cure” after receiving study medication >5 days and at least 80% of the intended dose,

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or “failure” following >3 days on study medication at TOC 7 to 14 days after last dose of study drug.

·Microbiologically evaluable (ME): CE patients with a Gram-positive pathogen recovered from baseline respiratory specimens or blood cultures.

Study end points

·Clinical response at TOC:

·Cure: Signs and symptoms of pneumonia resolved and no progression of radiological signs

·Failure: Persistence/progression of pneumonia or relapse after end of therapy, termination of study medication due to lack of efficacy, or death after >3 days attributable to the primary infection

·Indeterminate: Inability to determine outcome.

Microbiological evaluations

·Respiratory samples were obtained at baseline for Gram stain and culture. A sputum or endotracheal suction sample was considered adequate if it had >25 polymorphonuclear leukocytes and <10 squamous epithelial cells per high power field.

·In patients on mechanical ventilation, acceptable respiratory specimens included endotracheal suction, bronchoalveolar lavage (BAL), blind bronchial suctioning, protected specimen brush, or mini-BAL.

·Two blood culture specimens were also obtained at baseline.

·All isolated pathogens were submitted to a central laboratory for identification to ensure consistency of results.

·Susceptibility testing was performed in accordance with Clinical and Laboratory Standards Institute (CLSI) guidelines.(10)

Statistics

·Analysis was conducted on ME patients with monomicrobial infection.

·Descriptive statistics were calculated for subject demographics and safety data.

·Two-sided, 95% confidence intervals (CIs) were constructed on the difference in cure rates (telavancin minus vancomycin).

5

RESULTS

Disposition, baseline, and demographic characteristics

·In the combined population of ATTAIN, 1532 individuals were randomized to receive telavancin or vancomycin and 1503 received at least 1 dose of study medication (Figure 1).

·In total, 329 ME patients had a single Gram-positive pathogen isolated at baseline (telavancin, n=164; vancomycin, n=165). Baseline characteristics of patients in each treatment group were comparable (Table 1).

·Among ME patients with monomicrobial Gram-positive infection at baseline, the most common isolated pathogens were S. aureus and Streptococcus pneumoniae (Table 2).

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·Compared with the vancomycin group, a higher proportion of S. aureus isolates from patients in the telavancin group were MSSA (Table 2).

Outcomes

·The rate of clinical cure in ME patients with monomicrobial S. aureus infection at baseline was significantly greater for telavancin compared with VAN (Figure 2).

·Numerical differences favoring telavancin were also observed for patients from whom either MRSA or MSSA were identified as the baseline pathogen (Figure 2).

Safety

·The incidence of treatment-emergent adverse events were similar for both treatment groups (Table 3).

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CONCLUSIONS

·S. aureus was the pathogen most commonly associated with HAP in this collection of patients.

·Compared with vancomycin, telavancin achieved a significantly higher rate of cure for monomicrobial S. aureus infection and numerically higher cure rates for both MRSA and MSSA pneumonia groups.

·If approved, telavancin may be an important option for empirical treatment of HAP when a Gram-positive infection is suspected.

REFERENCES

(1)Kollef MH et al. Chest 2005;128:3854–3862.

(2)Rubinstein E et al. Clin Infect Dis 2008;46:S378–S385.

(3)Kollef MH et al. Chest 1999;115:462–474.

(4)Klevens RM et al; Active Bacterial Core surveillance (ABCs) MRSA Investigators. JAMA 2007;298:1763–1771.

(5)Bodi M et al. Crit Care Med 2001;29:N82–N86.

(6)Small PM et al. Antimicrob Agents Chemother 1990;34:1227–1231.

(7)Leonard SN et al. Pharmacotherapy 2008;28:458–468.

(8)Stryjewski ME et al. Clin Infect Dis 2008;46:1683–1693.

(9)Rubinstein E et al. Clin Microbiol and Infect 2008;14:S14.

(10)Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution of Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard M7-A7. Wayne, PA: CLSI; 2006.

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