THERAVANCE INC

FORM 8-K(Current report filing)

Filed 03/19/08 for the Period Ending 03/19/08

Address 901 GATEWAY BLVD

SOUTH SAN FRANCISCO, CA 94080Telephone 6508086000

CIK 0001080014Symbol THRX

SIC Code 2834 - Pharmaceutical PreparationsIndustry Biotechnology & Drugs

Sector TechnologyFiscal Year 12/31

http://www.edgar-online.com© Copyright 2008, EDGAR Online, Inc. All Rights Reserved.

Distribution and use of this document restricted under EDGAR Online, Inc. Terms of Use.

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): March 19, 2008

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): � Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) � Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) � Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) � Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Delaware 000-30319

94-3265960 (State or Other Jurisdiction of

(Commission File Number) (I.R.S. Employer Identification Number)

Incorporation)

Item 7.01 Regulation FD Disclosure.

The information in this Current Report (including Exhibit 99.1) is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section. The information in this Current Report (including Exhibit 99.1) shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.

Today at the International Symposium on Intensive Care and Emergency Medicine in Brussels, Belgium, Professor Antoni Torres of the Hospital

Clinic de Barcelona will present data from Theravance’s ATLAS and ATTAIN programs. Those of Professor Torres’ slides containing information regarding telavancin have been excerpted and are attached hereto as Exhibit 99.1 and incorporated herein by reference. ITEM 9.01 Financial Statements and Exhibits.

2

(d) Exhibits

Exhibit Description

Exhibit 99.1

Excerpt of 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.

3

THERAVANCE, INC.

Date: March 19, 2008

By: /s/ Michael W. Aguiar

Michael W. Aguiar

Chief Financial Officer

EXHIBIT INDEX

4

Exhibit No. Exhibit

99.1 Excerpt of presentation slides

Exhibit 99.1

Te lavanc in • A novel rapi dl y bacte ric idal lipogl ycopeptide • Unique mult ifunc tional mechanism of ac tion – inhi bi tion of bacte ri al cell wall synthesis – depolar iza tion of the bacte ri al membrane • Ac tive aga inst clinically relevant Gram-posit ive pa thogens incl uding stra ins resistant t o ot he r G ram-posit ive agents • At least as efficac ious as vancomycin in pa tient s with complica ted skin and soft tissue infections caused by MRS A • Exceptional intrace llular and extrace llula r act ivity • Good penetrati on into pulmonary f luids and alveol ar macrophages

Te lavanc in spec trum of G ram-posit ive act ivity 0.12 0.03 <0.015–1 169 - Vir idans strep 0.03 0.015 <0.001–0.06 455 A ll† S. pneumoniae 0.06 0.06 <0.001–0.12 99 - S. agal act iae 0.06 0.03 0.015–0.12 122 - S. pyogenes 1 0.5 0.06–1 855 VSE E. faeca lis 0.25 0.12 <0.015–1 368 VSE E. faecium 0.25 0.25 0.06–1 1313 MRSA 0.5 0.25 0.03–1 1491 MSS A S. aureus MIC90 MIC50 Range Tota l Phenotype Organism Te lavanc in MIC (µ g/ ml ) † PS SP, PRSP , Macrolide-resistant VSE= vancomyci n susceptibl e enterococci MIC= minimum inhi bi tory concent ra tion 2004–2005 Telavanci n US and Europe Surve illance (Focus Bio-Inova). Da ta on file .

Compara tive act ivity of telavancin against MRS A Dapt omyc in Susceptibility of MR SA (N=1629) < 0.5 – >4 2 0.5 – 4 1 0.12 – > 1 1 0.06 – 1 0.5 Range 90% MIC (µ g/ mL) 0.03 0.06 0.12 0.25 0.5 1 2 4 8 0 20 40 60 80 100 Te lavanc in Vancomycin Linezolid MIC (µ g/ ml ) Cumul ative % at MIC 2005 Te lavanc in US and Europe Surve illance (Focus Bio-Inova). Da ta on file .

Te lavanc in re tai ns potent ac tivity against S . aureus with reduced susceptibi lity to ot he r agents 1 1 1 2 1 1 1 1 1 1 2 1 1 MIC MIC µ g/ ml µ g/ ml VAN VAN NS > 4 S 0.5 0.12 S. aureus NS >4 S 0.5 0.12 S. aureus NS > 4 S 0.5 0.12 S. aureus NS >4 S 0.5 0.06 S. aureus S 1 NS > 1 0.25 S . aureus S 2 NS >1 0.5 S. aureus S 1 NS > 1 0.5 S . aureus >4 >4 > 4 >4 >4 1 MIC MIC µg/ ml µ g/ ml LZD LZD NS NS NS NS NS S CLS I* CLSI* S S S S S NS CLSI* CLS I* 0.5 0.5 0.5 0.5 0.5 >1 MIC MIC µg/ ml µ g/ ml DAP DAP 0.5 0.25 0.25 0.25 0.25 0.5 MIC MIC µg/ ml µ g/ ml TLV TLV S. aureus S. aureus S. aureus S. aureus S. aureus S. aureus Organism Organism Draghi DC, e t al. ICAAC 2006. Poste r E -0715. Activity of TLV vs S . aureus not susceptible to DAP or LZD *C LS I M100-S15 (2005) breakpoi nts ut ilized to interpre t isolates as susceptible (S), intermedia tely susceptibl e (I) , resistant (R), or nonsusceptible (NS).

60 -mi n IV infusion of 10 mg/ kg once da ily for 3 days • Te lavanc in was present in ELF at pharmacologically re levant concent ra tions for the enti re dosing interval (24 h) Te lavanc in concent ra tions in pl asma, a lveola r macrophages (AM) and epithe lial l ining fluid (ELF) 0 5 10 15 20 25 0.1 1 10 100 1000 Plasma AM ELF Time (h) Te lavanc in Concentrat ion (µg/ mL) MIC90 Cmax (ELF), 3.73 µg/ ml at 8 h Cmax (plasma), 116 µg/ ml at 1 h Cmax (AM), 45 µg/ ml at 12 h Gotfried M. ICAAC 2005. Poste r A -14.

Te lavanc in concent ra tion in alveola r macrophages (AM) and epithel ial li ni ng fluid (ELF) from BAL Samples Gotfried M. ICAAC 2005. Poster A -14. Mean Ratios of ELF and AM Concentrat ions t o MIC90 for Staphylococcus aureus at the 4 BAL Sampling Times ELF /MIC ELF/MIC90 90 AM/MIC AM/MIC90 90 0 25 50 75 100 4 8 12 24 Time (h) Concentrat ion Ratio 0 2 4 6 8 10 4 8 12 24 Time (h) Concentrat ion Ratio

Te lavanc in cli ni ca l programme • Indica tions studied: cSS TI and HAP – Two large, me thodologi ca lly identical, double-bl ind, multi cent re , mult inationa l, randomised, act ive controll ed studies t o evalua te the efficacy and safety of tel avanc in in each indica tion • La rge pa tient popula tions – No upper age limit – Incl uded modera te and severe rena l impa irment in contrast to other regi stra tional programs excl udi ng rena l impai rment • Focus on MRSA – Communit y- and hospita l-acquired MR SA – La rgest regi stra tional tr ia l experience of MR SA i nfections to da te

Corey R , e t al . IDSA 2006. Poster LB-17. ATLAS phase 3 cSS TI: conclusions • Te lavanc in was shown to be as effective as vancomycin for the trea tment of cSS TI • The telavancin sa fe ty profi le was compatible wi th treatment of ser ious Gram-posit ive infections due to resistant bacte ri a • These da ta support the efficacy and safety of once-da ily te lavanc in in t he treat ment of G ram-posit ive cSS TI

The ATTAIN programme: ATTAIN 1 & 2 • Two large, me thodologi ca lly identical, double-bl ind, multi cent re , mult inationa l, randomised, act ive controll ed studies t o evalua te the efficacy and safety of tel avanc in versus vancomycin for treatment of hospita l-acquired pneumonia due to Gram-posit ive bacte ri a • Pri mary endpoi nt – non-infe rior ity in clinical cure at test-of-cure (TOC) visi t in t he all -treated (AT) and c linica lly evaluable (CE) popula tions • Study popula tion – 1503 pa tient s treated in 38 countr ies – 464 with MRS A identif ied a t baseli ne culture

Key pa tient inclusion and exclusion c rite r ia Incl usi on: • Ma le and female pa tients > 18 years old • Clinica l signs and symptoms of pneumonia acquired a fte r > 48 hours of hospita lisa tion OR acquired < 7 days after discharge from > 3 days of hospita lisa tion • Diagnosi s of pneumonia by chest radiograph < 48 hours pr ior t o randomisa tion • Respiratory or sputum specimens for Gram -staining and culture avail able • Pati ents with rena l impa irment, including patients on hemodia lysis were not excluded Exc lusion: • > 24 hours pot entia lly ef fective antibiotic therapy – known infection w ith MS SA or S. pneumoniae AND required concomitant therapy for Gram -posit ives > 24 hours ac tive against e ither of these • Respiratory specimen wit h only G ram-negative bact er ia on Gram stai n or culture • Legione lla pneumophili a pneumonia , meningitis, infectious endocarditis or ost eomyelit is • Neut ropenia

Trea tment regimen • Randomisati on (1:1) to – Te lavanc in 10 mg/kg IV q24h – Vancomycin 1 g IV q12h ¦ dosing opti misation a llowed pe r individua l site guide lines ¦ switching to antistaphyl ococcal penicil lin allowed for MS SA infections • Study treatment for 7–21 days ¦ concomitant azt reonam and/or me troni dazole pe rmi tted for pa tient s with confirmed or suspected polymic robia l infections ¦ pi pe racil lin-tazobactam or imipenem may be administe red for Gram -negative coverage only if azt reonam is not appropriate due to resistance issues • Follow -up for test-of-cure 7–14 days after end of study treatment

Demographic and baseli ne charac ter istics 28% 29% VAP 46% 46% Vent ilated 14% / 3% 13% / 3% Obese / morbidly obese 71 kg 72 kg Mean we ight 22% 23% Diabetic 31% 31% Age 75 yr or grea ter 54% 53% Age 65 yr or grea ter 63 yr 62 yr Mean age 62 : 38 65 : 35 Male : Fema le 21 : 79 24 : 76 US : Non-US Vancomyc in n = 754 Te lavanc in n = 749

Clinica l response Clinica l cure a t TOC in CE popula tion and in subpopulat ions VAP 1.8 (–4.1, 7.7) 80.9% 82.7% Clinica lly evaluable 88.4% 75.5% 84.2% 67.6% 74.1% Vancomycin 1.9 (–5.4, 9.3) 90.3% Non -ICU pneumonia 13.2 (–1.8, 26.8) 80.3% Yes –0.8 ( –7.2, 5.6) 83.4% No 2.2 (–6.3, 10.7) 77.7 % ICU pneumonia IC U locat ion a t baseli ne 8.1%, (–3.3, 19.4) 82.0% MR SA pneumonia Dif fe rence ,% (95% CI) Te lavanc in

Overview of adverse events 8% 10% Rena l adverse events 7% 8% QTc > 60 ms prolongation 2% 2% QTc interval > 500 ms 9% 9% Constipat ion 11% 9% Anemi a 12% 11% Dia rrhea Most frequent treatment emergent adverse events 81% 82% At least 1 AE Vancomycin Te lavanc in

Conc lusions Te lavanc in in HAP Phase 3 programme • Study met pr imary endpoi nt – non -infe rior ity att ained in AT and CE popula tions in both studies, 95% CIs well within 10% margin • Numerical trends favouring telavancin in subpopulat ions of pa tient s with severe disease – VAP, MRSA • Safety profile compatible wi th treatment of ser ious Gram -posit ive infect ions