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 10, 2006

THERAVANCE, INC.

(Exact Name of Registrant as Specified in its Charter)

Delaware	000-30319	94-3265960
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(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 7.01 Regulation FD Disclosure.

The information contained in this Item 7.01 and in the accompanying exhibits shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.

Theravance, Inc. (the “Theravance”) today announced additional results from its ATLAS 1 and ATLAS 2 studies, as described in the press release attached hereto as Exhibit 99.1 and incorporated herein by reference. Dr. Ralph Corey of Duke Clinical Research Institute, the principal investigator in the ATLAS program, will discuss these results today at the Third International Symposium on Resistant Gram-Positive Infections. Copies of Dr. Corey’s presentation slides are attached hereto as Exhibit 99.2 and are incorporated herein by reference.

ITEM 9.01   Financial Statements and Exhibits.

(d)    Exhibits

Exhibit	Description
Exhibit 99.1	Press release dated October 10, 2006
Exhibit 99.2	Presentation slides

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 10, 2006	By:	/s/ Michael W. Aguiar
		Michael W. Aguiar
		Chief Financial Officer

EXHIBIT INDEX

Exhibit No.	Exhibit
99.1	Press release dated October 10, 2006
99.2	Presentation slides

EX-99.1

Exhibit 99.1

Theravance Announces Additional Results From Successful Phase 3
Telavancin Complicated Skin and Skin Structure Program

SOUTH SAN FRANCISCO, CA/October 10, 2006 — Theravance, Inc. (NASDAQ: THRX) today announced additional results from its ATLAS 1 and ATLAS 2 studies assessing the safety and efficacy of telavancin, a rapidly bactericidal injectable antibiotic with multiple mechanisms of action, in the treatment of complicated skin and skin structure infections (cSSSI) caused by Gram-positive bacteria.  The data will be presented today at the Third International Symposium on Resistant Gram-Positive Infections in Niagara-on-the-Lake, Ontario.

ATLAS 1 and ATLAS 2 were two large, multi-center, multinational, double-blind, randomized Phase 3 clinical studies that enrolled and treated 1,867 patients in total, 719 of whom were infected with methicillin-resistant Staphylococcus aureus (MRSA).

In the combined ATLAS 1 and ATLAS 2 studies, patients with cSSSI were randomized (1:1) to receive either telavancin 10 mg/kg IV once daily or vancomycin 1 gm IV q 12hr (dosages adjusted per site specific guidelines) for 7-14 days.  Evaluations of efficacy were performed at a follow-up visit that occurred 7-14 days following the end of treatment. Of the patients enrolled and treated, approximately 80% were clinically evaluable and approximately 70% were microbiologically evaluable. Mean age of the patients was approximately 49 years, 25% were diabetic, and 12% had moderate to severe renal insufficiency at baseline.  Approximately 80% of the patients had a major abscess or deep, extensive cellulitis.  Staphylococcus aureus was the most common baseline pathogen with the majority of the isolates being methicillin-resistant strains.

Key findings were as follows:

The primary efficacy endpoint of non-inferiority in the clinical cure rate at the follow-up visit, comparing telavancin to vancomycin, was achieved in both studies, and the rates of clinical cure, microbiological eradication, and overall therapeutic response for telavancin compared favorably to those for vancomycin.

In the combined data from both studies in patients with MRSA, clinical cure rates, microbiologic eradication rates and overall therapeutic response (combination of clinical cure + microbiologic eradication) favored telavancin over vancomycin:

	Telavancin		Vancomycin		95% confidence
	total	success	total	success	interval
Clinical Cure	278	90.6%	301	86.4%	(-1.1, 9.3)
Microbiologic Eradication	278	89.9%	301	85.4%	(-0.9, 9.8)
Overall Therapeutic Response	278	89.9%	301	84.7%	(-0.3, 10.5)

The most common adverse events reported in patients receiving telavancin were taste disturbance (telavancin 33% versus vancomycin 7%), nausea (telavancin 27% versus vancomycin 15%), and vomiting (telavancin 14% versus vancomycin 7%). Less than 1% of these events were judged to be severe.  Renal adverse events occurred in 2.5% of telavancin patients versus 0.5% of vancomycin patients.  In patients with a serious renal adverse event, which occurred in less than 1% of patients in both groups, the event had resolved, or was resolving, at the last visit.  Prolongation of the QTc interval from pre-treatment values by greater than 60 msec occurred in 1% of the telavancin group versus 0.5% of the vancomycin group.  QTc interval of greater than 500 msec occurred in one telavancin patient versus two vancomycin patients.  No cardiac events were attributable to QTc prolongation.

“Staphylococcal infections, and in particular those caused by methicillin-resistant Staph. aureus bacteria, are becoming a more frequent and serious medical problem,” said Dr. G. Ralph Corey of Duke Clinical Research Institute, the principal investigator in the ATLAS program.  “Results demonstrated clinical, microbiological, and overall therapeutic response that consistently favored telavancin over vancomycin.  Importantly, telavancin has a safety profile that is compatible with treatment of serious infections due to resistant bacteria. These are important and encouraging findings in this area of increasing medical need.”

Conference Call and Webcast Information

As previously announced, the company has scheduled a conference call to discuss this announcement beginning tomorrow at 8:00 a.m. Eastern Daylight Time.  To participate in the live call, please dial 877-704-5384 from the U.S. and Canada, or 913-312-1297 for international callers. The live webcast and accompanying slides can be accessed from Theravance’s web site at www.theravance.com. Please go to the web site 15 minutes prior to its start to register, download, and install any necessary audio software.

A replay of the conference call and webcast will be available on the company’s web site for 30 days through November 10, 2006. An audio replay will also be available through 11:59 p.m. Eastern Standard Time on November 10, 2006 by dialing 888-203-1112 from the U.S., or 719-457-0820 for international callers, and entering confirmation code 5592554.

About Theravance

Theravance is a biopharmaceutical company with a pipeline of internally discovered product candidates. Theravance is focused on the discovery, development and commercialization of small molecule medicines across a number of therapeutic areas including respiratory disease, bacterial infections and gastrointestinal motility dysfunction. Of the five programs in development, two are in late stage — its telavancin program focusing on treating serious Gram-positive bacterial infections with Astellas Pharma Inc. and the Beyond Advair collaboration with GlaxoSmithKline. By leveraging its proprietary insight of multivalency to drug discovery focused on validated targets, Theravance is pursuing a next generation drug discovery strategy designed to discover superior medicines in large markets. For more information, please visit the company’s web site at www.theravance.com.

THERAVANCE®, the Theravance logo, and MEDICINES THAT MAKE A DIFFERENCE® are registered trademarks of Theravance, Inc.

This press release contains and the conference call will contain certain “forward-looking” statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives and future events. Theravance intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Exchange Act and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to the goals, timing and expected results of clinical studies, statements regarding the potential benefits and mechanisms of action of drug candidates, statements concerning the goals and timing of seeking regulatory approval of our product candidates, the enabling capabilities of Theravance’s approach to drug discovery and its proprietary insights, statements concerning expectations for product candidates through development and commercialization and projections of revenue and other financial items. These statements are based on the current estimates and assumptions of the management of Theravance today and as of the date of the conference call, and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance to be materially different from those reflected in its forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to delays or difficulties in commencing or completing clinical and preclinical studies, the potential that results of clinical or preclinical studies indicate product candidates are unsafe, ineffective, inferior or not superior, and delays or failure to achieve regulatory approvals, and risks of collaborating with third parties to develop and commercialize products. These and other risks are described in greater detail under the heading “Risk Factors” contained in Item 1A of Theravance’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 4, 2006 and the risks discussed in our other filings with the SEC. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Theravance assumes no obligation to update its forward-looking statements.

Contact Information:

Investors
Theravance, Inc.
Allison Parker, Director, Investor Relations
650-808-4100
investor.relations@theravance.com

Media
Theravance, Inc.
David Brinkley, Sr. Vice President, Commercial Development
650-808-3784
dbrinkley@theravance.com

EX-99.2

Exhibit 99.2

 

STUDIES OF TELAVANCIN IN cSSSI G. Ralph Corey, MD Duke Clinical Research Institute Niagara-on-the-Lake October 10, 2006

 

Disclosures Consultant / Research Support: Cubist Pharmaceuticals, Inc. Theravance, Inc.

 

Background

 

cSSSIs: A Worsening Medical Problem Staphylococcal skin and soft tissue infections - more frequent and serious medical problem for both outpatients and inpatients Until recently cellulitis, wound infections and abscesses managed using “traditional” antibiotics: β-lactams, macrolides, fluoroquinolones Recent epidemic of CA-MRSA has forced a significant change in standard patient care

 

CA-MRSA Now the most prevalent cause of outpatient SSSI in many parts of the country/world Spread by skin-to-skin contact/contaminated surfaces/shared items Staphylococcal Cassette Chromosome (SCC) mec type IV/V; Panton-Valentine Leukocidin (PVL) often present Resistant to b-lactams and often to macrolides, fluoroquinolones

 

CA-MRSA Skin Lesion

 

Telavancin Telavancin was specifically designed to outperform vancomycin in the treatment of S. aureus infections Telavancin is an intravenously administered lipoglycopeptide active against Gram-positive bacteria

 

Unique Multifunctional Mechanism of Action Membrane Cell Wall n Transpeptidation Cross-linked Peptidoglycan TG TP PBP Transglycosylation X Telavancin D-Ala-D-Ala-Tri Inhibition of cell wall synthesis AND disruption of plasma membrane barrier functions Telavancin ATP K+ H+ -PP D-Ala-D-Ala-Tri -PP -D-Ala-D-Ala-Tri Telavancin Cytoplasm -D-Ala-Tri D-Ala-Tri X Vancomycin TG TP PBP

 

Telavancin Disrupts Both Bacterial Cell Wall and Membrane Integrity

 

Telavancin: Summary of Microbiologic and Pharmacologic Characteristics Low MICs versus a broad spectrum of Gram-positive pathogens including drug-resistant pathogens Rapid bactericidal activity/Concentration-dependent killing Prolonged post antibiotic effect Intracellular and extra-cellular killing Good tissue penetration Superior efficacy in neutropenic animal models

 

Telavancin In Vitro Bactericidal Activity against MRSA All agents were tested at 8 x MIC. 0 4 8 12 16 20 24 0 1 2 3 4 5 6 7 8 9 10 Time (hr) Log (CFU/ml) Pace et al. (2003). AAC 47:3602 Growth Control 2 Linezolid 1 Vancomycin 0.5 Telavancin

 

Telavancin Plasma Concentrations vs. MIC90 for MRSA TLV MIC90 MRSA = 0.5mg/ml Steady State Concentrations in cSSSI Patients - TLV 10 mg/kg Stryjewski et al. (2006). AAC 50:862 0 10 20 1 10 100 Time (hr) TLV Plasma Concentration ( m g/mL)

 

Study Design – ATLAS 1 & 2 Identical double-blind, randomized (1:1), active-controlled, multinational studies Evaluation of efficacy / safety: Telavancin - 10 mg/kg IV q 24hr; or Vancomycin - 1 gm IV q 12 hr (adjusted per site SOP) Patients enrolled at 129 sites in 21 countries Pts with cSSSI due to GPC requiring intravenous treatment for ≥ 7 days 1,867 patients received at least 1 dose of study medication

 

Study Objectives Primary Endpoints Clinical cure rate in each study in the Clinically Evaluable population Clinical cure rate in combined MRSA population Secondary endpoints Overall response rate (combination of clinical & microbiologic) Cure rates by pathogen Microbiologic eradication rates Safety

 

Analysis Populations 527 (71%) † 745 (80%)* 680 (73%)* 928 (100%) Telavancin 1063 536 (72%)† Microbiologically Evaluable (ME) 1489 744 (79%)* Clinically Evaluable (CE) 1383 703 (75%)* Modified All-Treated (MAT) 1867 939 (100%) All-Treated (AT) TOTAL Vancomycin * Percent of AT † Percent of CE

 

Clinically Evaluable N=1489 Microbiologically Evaluable N=1063 Patient Populations – ATLAS 1 & 2 S. aureus N=929 MRSA N=579 MSSA N=357 62% 38%

 

CE Population Overall Therapeutic Response Clinical Response Microbiological Eradication Efficacy Endpoints

 

Baseline Demographic & Disease Characteristics 20% 14% 6% 22% 14% 5% Hispanic Black Asian 69 : 31 68 : 32 US: Non-US Race 12% 12% CrCl < 50 mL / min Renal Function 39% 25% 38% 25% Obese (BMI>30) Diabetic 85.3 kg 86.7 kg Mean Weight 60:40 56:44 Male: Female 19% 19% Age 65 yr or greater 48.7 yr 48.8 yr Mean Age Vancomycin Telavancin N = 928 N = 939

 

Distribution of Infection Types in ATLAS 1% (8) 2% (12) Infected Burn 4% (33) 5% (38) Infected Ulcer 14% (101) 15% (110) Wound Infection 39% (291) 36% (266) Deep / Extensive Cellulitis 42% (311) 43% (319) Major Abscesses VAN (N=744) TLV (N=745) ATLAS 1 + 2 42% 38% 14% 5% 1% CE Population Infected Burn Infected Ulcer Wound Infection Major Abscesses Deep/Extensive Cellulitis

 

MRSA Enrollment Underscores the Change in Incidence 2006 2004 2002 2000 Year of Study 14% 64 Daptomycin 2% 3* Linezolid 62% 579 Telavancin 21% 71 Tigecycline % MRSA Patients # MRSA Patients Number and Percent of S. aureus Patients Infected with MRSA in Phase 3 Double-Blind Registrational Studies for cSSSI * Linezolid registrational program included an additional open-label study of 116 MRSA patients (66 with cSSSI)

 

Clinical Response in Clinically Evaluable Patients 87.1% (744) 88.3% (745) ATLAS 1+2 87.6% (395) 88.7% (399) ATLAS 2 86.5% (349) 87.9% (346) ATLAS 1 VAN % Success (N) TLV % Success (N) -15 -10 -5 0 5 10 15 Favors Vancomycin Favors Telavancin -3.6 6.3 1.3 -3.4 1.1 5.6 -2.1 4.6 1.2 Difference in Success Rates (TLV - VAN, %) with 95% Confidence Interval

 

Clinical Response in S. aureus (ATLAS 1+2) 87.5% (176) 88.4% (181) MSSA 86.4% (301) 90.6% (278) MRSA 86.9% (473) 89.9% (456) SA (all) VAN% Success (N) TLV% Success (N) -15 -10 -5 0 5 10 15 Favors Vancomycin Favors Telavancin 3.0 -1.1 4.1 9.3 -5.8 7.7 0.9 7.3 -1.3 Difference in Success Rates (TLV - VAN, %) with 95% Confidence Interval

 

Clinical Response in MRSA 86.4% (301) 90.6% (278) ATLAS 1+2 87.1% (163) 93.2% (162) ATLAS 2 85.5% (138) 87.1% (116) ATLAS 1 VAN% Success (N) TLV % Success (N) -15 -10 -5 0 5 10 15 Favors Vancomycin Favors Telavancin -6.9 10.0 1.6 -0.3 6.1 12.5 -1.1 9.3 4.1 Difference in Success Rates (TLV - VAN, %) with 95% Confidence Interval

 

Microbiologic Eradication in MRSA 85.4% (301) 89.9% (278) ATLAS 1+2 85.9% (163) 92.0% (162) ATLAS 2 84.8% (138) 87.1% (116) ATLAS 1 VAN % Success (N) TLV % Success (N) -15 -10 -5 0 5 10 15 Favors Vancomycin Favors Telavancin -6.3 10.8 2.3 -0.7 6.1 12.9 -0.9 9.8 4.4 Difference in Success Rates (TLV - VAN, %) with 95% Confidence Interval

 

Overall Therapeutic Response in MRSA 84.7% (301) 89.9% (278) ATLAS 1+2 84.7% (163) 92.0% (162) ATLAS 2 84.8% (138) 87.1% (116) ATLAS 1 VAN % Success (N) TLV % Success (N) -15 -10 -5 0 5 10 15 Favors Vancomycin Favors Telavancin -6.3 10.8 2.3 0.4 7.3 14.2 -0.3 10.5 5.1 Difference in Success Rates (TLV - VAN, %) with 95% Confidence Interval

 

Summary of Clinical, Microbiologic and Overall Therapeutic Responses 86.4% (301) 90.6% (278) Clinical Response in MRSA 84.7% (301) 89.9% (278) Overall Therapeutic Response in MRSA 85.4% (301) 89.9% (278) Microbiological Eradication in MRSA 86.2% (536) 88.6% (527) Overall Therapeutic Response in ME Patients 87.1% (744) 88.3 % (745) Clinical Response in CE Patients VAN % Success (N) TLV % Success (N) -15 -10 -5 0 5 10 15 Favors Vancomycin Favors Telavancin 1.2 -1.1 4.1 9.3 -0.3 10.5 5.1 4.6 -2.1 -1.6 2.4 6.4 -0.9 4.4 9.8 Difference in Success Rates (TLV - VAN, %) with 95% Confidence Interval

 

Common Adverse Events and Side Effects 3% 13% Foamy Urine 7% 33% Altered / Metallic Taste 13% 14% Headache 9% 10% Insomnia 7% 10% Constipation 8% 7% Diarrhea 13% 6% Pruritus 6% 6% Dizziness 7% 0% 14% <1% Vomiting Severe 15% <1% 27% <1% Nausea Severe Vancomycin Telavancin Adverse Event / Side Effect

 

Safety Profile <1% <1% Deaths 6% 1% 8% 2% D/C due to AE’s D/C due to SAE’s 4% 7% Serious Adverse Events Vancomycin Telavancin

 

Safety Renal Renal adverse events (TLV: 2.5%; VAN: 0.5%) In patients with a serious renal adverse event (<1%), the event had resolved, or was resolving, at last visit. Electrocardiogram Prolonged QTc interval by >60 msec: 1% in TLV vs. 0.5% in VAN QTc >500 msec: 1 TLV patient vs. 2 VAN patients No cardiac events attributable to QT prolongation

 

Conclusions Telavancin was shown to be as effective as vancomycin for the treatment of cSSSI. Rates of clinical response, microbiologic eradication and overall response consistently favored telavancin. Safety profile compatible with treatment of serious infections due to resistant bacteria.