Press Releases

- Advisory Committee for the Food and Drug Administration reviewing the telaprevir New Drug Application for the treatment of hepatitis C- CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) announced that NASDAQ today halted trading of the company's common stock.

-Expanded collaboration supports development of a second corrector, VX-661, and accelerated discovery and development of next-generation correctors- -Phase 2 study of VX-661 planned for 2011 in people with CF who have the F508del mutation- CAMBRIDGE, Mass.

- 90% of people with the ‘CC' variation of IL28B who were new to treatment and received a telaprevir-based regimen achieved a viral cure, 78% of them were eligible to stop all treatment at 24 weeks - - Nearly three-fold improvement in viral cure rates was observed among people with the ‘CT' and

- All major subgroups achieved significantly higher viral cure rates with telaprevir-based therapy compared to pegylated-interferon and ribavirin: 86% vs. 24% in prior relapsers, 57% vs. 15% in prior partial responders and 31% vs. 5% in prior null responders - - No clinical benefit was observed in

BERLIN--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced interim results from an ongoing Phase 2 study (ZENITH) designed to assess the safety and tolerability of 12-week response-guided treatment regimens with its polymerase inhibitor, VX-222, and its protease

-Mean relative improvement in lung function of 17.4% and mean absolute improvement of 12.5% from baseline compared to placebo in children treated with VX-770- - No discontinuations due to adverse events through 24 weeks - -Vertex on track to submit regulatory applications for the approval of VX-770

-Results support continued development of VX-765 in people with treatment-resistant epilepsy- CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced results from a recently completed Phase 2 study of VX-765 in 60 people with treatment-resistant

  - Complete results from pivotal Phase 3 REALIZE study of telaprevir in people who had not achieved a viral cure (SVR) with currently available medicines - - First presentation of data from ongoing Phase 2 study evaluating response-guided, 12- and 24-week regimens of telaprevir and VX-222 combined

Early results from ongoing study showed that the hepatitis C virus was undetectable by week 4 in 70% of people treated with telaprevir-based combination therapy

  - Relative mean improvement in lung function of approximately 17% from baseline compared to placebo achieved by people treated with VX-770; mean absolute improvement from baseline of approximately 10.5% compared to placebo; both measures through 24 and 48 weeks - - Significant improvements in all

  -Hepatitis C: Regulatory agencies in U.S., Europe and Canada to provide accelerated reviews of telaprevir applications- -Cystic Fibrosis: First Phase 3 registration data for VX-770 expected in first quarter 2011; potential regulatory submissions in the U.S. and E.U.

-Six-month review date of May 23, 2011 set by FDA- CAMBRIDGE, Mass., Jan 20, 2011 (BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the U.S. Food and Drug Administration ( FDA) has accepted the New Drug Application (NDA) for telaprevir and granted the

-Hepatitis C: Submission of New Drug Application complete for telaprevir- -Cystic Fibrosis: First Phase 3 data for VX-770 expected in first quarter 2011- -Additional ongoing trials in HCV, CF, epilepsy and rheumatoid arthritis- -Vertex enters 2011 with cash and cash equivalents position of more

-Two-drug treatment arm of telaprevir and VX-222 alone discontinued- -Study continues with three arms, including all-oral combination of Vertex's lead protease and polymerase inhibitors with ribavirin- -Both of the four-drug treatment arms are fully enrolled; the majority of patients in these arms

- Submission based on results from Phase 3 studies that showed high SVR (viral cure) rates with telaprevir-based combination therapy compared to approved medicines - - Six-Month Priority Review Requested - CAMBRIDGE, Mass., Nov 23, 2010 (BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq:

-Treatment with VX-770 resulted in improvements in lung function and markers of disease- -There were no discontinuations of treatment due to adverse events- -Late-stage Phase 3 clinical trials for VX-770 ongoing- CAMBRIDGE, Mass., Nov 17, 2010 (BUSINESS WIRE)-- In a study published in this week's

-New treatment arm to evaluate all oral, triple combination regimen of telaprevir, VX-222, and ribavirin- CAMBRIDGE, Mass., Nov 10, 2010 (BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced plans to enroll an additional treatment arm as part of its ongoing Phase 2

-75% of people treated in the Phase 3 ADVANCE study achieved a viral cure with telaprevir; majority of people treated for a total of 24 weeks-
-62% of African Americans/Blacks in the ADVANCE study achieved a viral cure with telaprevir-
-Low discontinuation rates of all drugs due to adverse events-

-Hepatitis C: New Drug Application submission for telaprevir on track for fourth quarter 2010-
-Cystic Fibrosis: Phase 3 registration program ongoing for VX-770-
-Pipeline: Ongoing proof-of-concept clinical trials in hepatitis C, cystic fibrosis, epilepsy and rheumatoid arthritis-
-Financial: Company ends third quarter with a cash position of $1.2 billion-

- First Phase 3 study to evaluate twice-daily (BID) dosing of a protease inhibitor for hepatitis C -
- All patients will receive telaprevir-based combination therapy -