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 17, 2007
THERAVANCE, INC.
(Exact Name of Registrant as Specified in its Charter)
|
Delaware |
|
000-30319 |
|
94-3265960 |
|
(State or Other Jurisdiction of |
|
(Commission File Number) |
|
(I.R.S. Employer Identification Number) |
|
Incorporation) |
|
|
|
|
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 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.
Today at the American College of Gastroenterology 2007 Annual Scientific Meeting in Philadelphia, Pennsylvania, Dr. Michael Goldberg, Vice President, Clinical Pharmacology of Theravance, Inc. (“Theravance”) will present data from Theravance’s ACCORD Phase 2 clinical study in chronic constipation with TD-5108, Theravance’s investigational compound for the treatment of chronic constipation and other disorders related to reduced gastrointestinal motility. A copy of Dr. Goldberg’s presentation slides are attached hereto as Exhibit 99.1 and are incorporated herein by reference.
2
ITEM 9.01 Financial Statements and Exhibits.
(d) Exhibits
|
Exhibit |
|
Description |
|
|
|
|
|
Exhibit 99.1 |
|
Presentation slides |
3
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 17, 2007 |
|
By: |
/s/ Michael W. Aguiar |
|
|
|
|
|
|
|
|
|
|
|
Michael W. Aguiar |
|
|
|
|
|
Chief Financial Officer |
|
4
EXHIBIT INDEX
|
Exhibit No. |
|
Exhibit |
|
99.1 |
|
Presentation slides |
5
Exhibit 99.1
|
|
Michael Goldberg, Yu-Ping Li, Brage Garofalo, Allan Valmonte, John Johanson*, Allen Mangel**, Michael Kitt In patients with chronic constipation, TD-5108, a selective 5-HT4 agonist with high intrinsic activity, increases bowel movement frequency and the proportion of patients with adequate relief Theravance, Inc. University of Illinois College of Medicine* RTI-Health Solutions** |
|
|
Goal: Highly Selective Full Agonist at 5-HT4 Receptors Pre-clinical >500-fold selective for 5-HT4 over other 5-HT receptor types High intrinsic activity in multiple assays Potent prokinetic activity in the GI tract Phase 1: Prokinetic activity confirmed Time to first BM, numbers of BMs & Bristol score Half-life consistent with once-a-day dosing Generally well tolerated at 50 mg/day for 2 weeks |
|
|
The ACCORD Study: TD-5108 in Chronic Constipation TD-5108 15, 30, and 50 mg/day PO versus placebo Double-blind, parallel group, United States only Four-week treatment period 401 patients randomized Chronic constipation by Rome III criteria <3 SBM* per week during 2-week baseline Daily stool diary by IVRS Primary endpoint: Change from baseline in average weekly SBM frequency over 4 weeks *Spontaneous Bowel Movements |
|
|
Treatment Groups: Balanced for Demographics and Constipation Severity (CSBM = SBM associated with a sensation of complete evacuation) Placebo (n=107) 15 mg (n=101) 30 mg (n= 96) 50 mg (n= 97) Average Age 44 44 46 46 % Female 92% 93% 91% 93% % White 65% 66% 71% 73% % Black 31% 32% 27% 24% Baseline Average (SD) SBM per Week 1.3 (0.9) 1.2 (0.8) 1.1 (0.8) 1.2 (0.8) Baseline Average (S D) C SBM per Week 0.2 (0.4) 0.3 (0.5) 0.2 (0.5) 0.3 (0.5) |
|
|
Significant Increase From Baseline in SBM Frequency Primary Endpoint All p<0.05 vs Placebo 1.4 1.4 1.5 1.6 1.3 3.6 4.2 3.2 3.4 3.5 3.3 4.7 3.1 3.0 2.5 3.5 4.3 3.3 3.3 2.9 0.0 1.0 2.0 3.0 4.0 5.0 6.0 Average Weeks 1-4 Week 1 Week 2 Week 3 Week 4 SBM / Week (Mean Change +SEM) Placebo 15 mg 30 mg 50 mg |
|
|
Significant Increase from Baseline in Complete SBM Frequency All p<0.05 vs Placebo 0.6 0.4 0.6 2.3 2.5 2.3 1.8 2.5 1.4 2.3 2.6 2.0 0.0 0.5 1.0 1.5 2.0 2.5 3.0 Average Weeks 1-4 Week 1 Week 4 CSBM / Week (Mean Change +SEM) Placebo 15 mg 30 mg 50 mg |
|
|
Responder Analysis: Significant Increase in Percentage with >3 SBM per Week All p<0.05 vs Placebo 49% 41% 22% 79% 78% 60% 78% 60% 42% 73% 72% 61% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Week 1 Week 4 All 4 Weeks Placebo 15 mg 30 mg 50 mg Percent ? 3 SBM / Week |
|
|
Responder Analysis: Significant Increase in Percentage with >3 CSBM per Week All p<0.05 vs Placebo 6% 9% 5% 46% 48% 27% 42% 27% 19% 44% 37% 21% 0% 10% 20% 30% 40% 50% Week 1 Week 4 All 4 Weeks Placebo 15 mg 30 mg 50 mg Percent ? 3 CSBM / Week |
|
|
Week 4 percentage with adequate relief: Significantly greater activity compared to placebo: % with at >3 SBM/week and an increase of >1 % with at >3 CSBM/week and an increase of >1 Time to bowel movement after first dose Average Bristol score Use of rescue laxative and time to first rescue Straining score Percentage with bloating Secondary Endpoints: Significantly Greater Percentage with Adequate Relief 54% p=0.0003 36% p=0.14 62% p<0.0001 26% 50 mg 30 mg 15 mg Placebo |
|
|
Adverse Events as Expected: Primarily GI and Headache *At least 10 events across all treatment groups Adverse Event* Placebo (n=107) 15 mg (n=101) 30 mg (n= 96) 50 mg (n= 97) Gastrointestinal Diarrhea 1 (1%) 12 (12%) 11 (11%) 15 (15%) Nausea 3 (3%) 5 (5%) 4 (4%) 15 (15%) Vomiting 1 (1%) 4 (4%) 2 (2%) 7 (7%) Flatulence 3 (3%) 3 (3%) 5 (5%) 2 (2%) Abdominal Pain 1 (1%) 4 (4%) 4 (4%) 3 (3%) Abdominal Pain Upper 1 (1%) 3 (3%) 5 (5%) 3 (3%) Headache 6 (6%) 6 (6%) 10 (10%) 20 (21%) Discontinuation due to AEs 1 (1%) 4 (4%) 3 (3%) 11 (11%) |
|
|
Conclusion: TD-5108 Demonstrated Clinically Significant Activity in Chronic Constipation 15, 30, and 50 mg/day were all clinically active doses Significant increases in SBM and CSBM frequency Positive effects on multiple secondary endpoints Adequate relief reported by significantly more patients Straining, bloating and rescue laxative use Generally well tolerated Development advancing into Phase 3 |
