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 |
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000-19319 |
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04-3039129 |
(State or other jurisdiction of incorporation) |
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(Commission File Number) |
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(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 |
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Description of Document |
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99.1 |
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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 |
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Kenneth S. Boger |
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Senior Vice President and General Counsel |
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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 |
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HCV RNA at Week 4 on TVR/P/R |
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N |
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<25 IU/mL |
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≥25 IU/mL |
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Week 4 NR |
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17 |
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12 (71) |
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5(a) (29) |
Week 12 NR |
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3 |
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2 (67) |
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1(b) (33) |
Week 24 detectable |
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7 |
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7 (100) |
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0 |
Week 20 Breakthrough |
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1 |
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1 (100) |
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0 |
Relapsers |
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4 |
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4 (100) |
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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.