UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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 31, 2008
(Exact name of registrant as specified in its charter)
|
MASSACHUSETTS |
|
000-19319 |
|
04-3039129 |
|
(State or other jurisdiction of incorporation) |
|
(Commission File Number) |
|
(IRS Employer Identification No.) |
|
130 Waverly Street |
|
Cambridge, Massachusetts 02139 |
|
(Address of principal executive offices) (Zip Code) |
(617) 444-6100
(Registrants telephone number, including area code)
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
On March 31, 2008, an abstract entitled A Study of Telaprevir (TVR) with Peginterferon alfa-2A (P) and Ribavirin (R) in Subjects with Well-documented prior P/R Null Response, Non-Response or relapse: Preliminary Results for a poster to be presented at the 43rd Annual Meeting of the European Association for Study of the Liver, or EASL, was posted on the internet at http://www.easl.ch/liver-meeting/program/SessionIndex.asp by EASL. A copy of the abstract is attached to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
|
Exhibit |
|
Description of Document |
|
|
|
|
|
99.1 |
|
Abstract
entitled A Study of Telaprevir (TVR) with |
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.
|
VERTEX PHARMACEUTICALS INCORPORATED |
|
(Registrant) |
|
Date: March 31, 2008 |
/s/ Kenneth S. Boger |
|
|
Kenneth S. Boger |
|
|
Senior Vice President and General Counsel |
3
Exhibit 99.1
A STUDY OF TELAPREVIR (TVR) WITH PEGINTERFERON ALFA-2A (P) AND RIBAVIRIN (R) IN SUBJECTS WITH WELL-DOCUMENTED PRIOR P/R NULL RESPONSE, NON-RESPONSE OR RELAPSE: PRELIMINARY RESULTS
Fred Poordad, Mitchell Shiffman, Kenneth Sherman, Jill Smith, Min Yao, Shelley George, Nathalie Adda, John McHutchison for the VX06-950-107 Study Team
Background: VX06-950-107 is an ongoing open-label study of TVR/P/R in genotype 1 HCV subjects who failed to achieve SVR in the control arms (P/R) of the TVR Phase 2 studies. Study 107 provides a unique opportunity to correlate within individual subjects the anti-viral response to TVR/P/R with that of their original response to P/R. In this preliminary analysis we evaluated the anti-viral response to TVR/P/R at week 4 in non-responders to P/R.
Methods: Null-responders (NR) (<1 log10 decrease at week 4 or < 2 log10 decrease at week 12), non-responders at W24 (HCV RNA detectable) and relapsers from the P/R arms of PROVE studies were eligible. Study dosing consisted of 12 weeks TVR 750 mg q8 hour + P/R at standard doses, followed by 12 weeks P/R. In this study, subjects with HCV RNA >25IU/mL (Taqman assay; LOQ 25 IU/mL) at Week 4 met a stopping rule and discontinued.
Results: To date 54 subjects were enrolled, 52 were dosed and 32 completed Week 4 assessment: 24 male/8 female with median age of 51.5 years, 28 Caucasians, 3 Blacks, 1 Hispanic. Median baseline HCV RNA was 6.9 Log10IU/ml. 1 subject discontinued TVR and R due to fatigue. Results by prior virologic response to P/R regimen are summarized below:
|
Prior
P/R Virologic Responses |
|
HCV RNA at Week 4 on TVR/P/R |
||||
|
|
N |
|
<25 IU/mL |
|
≥25 IU/mL |
|
|
Week 4 NR |
|
17 |
|
12 (71) |
|
5(a) (29) |
|
Week 12 NR |
|
3 |
|
2 (67) |
|
1(b) (33) |
|
Week 24 detectable |
|
7 |
|
7 (100) |
|
0 |
|
Week 20 Breakthrough |
|
1 |
|
1 (100) |
|
0 |
|
Relapsers |
|
4 |
|
4 (100) |
|
0 |
(a) 1 with 33, 1 with 43, 3 with >100 IU/mL
(b) 1 with 28 IU/mL
Conclusions: With TVR/P/R, 70% (14/20) of null responder subjects, 100% (7/7) of Week 24 detectable and 100% (4/4) relapsers to P/R achieved < 25 IU/mL at week 4. Only one subject had a virologic breakthrough. These results are promising, however SVR rates are yet to be determined.