- INCIVEK was well tolerated with commonly used Atripla- and Reyataz-based HIV treatment regimens, and no patients experienced HIV breakthrough - - Enrollment is ongoing in Phase 3 study evaluating 24- and 48-week treatment durations in people who are co-infected - SEATTLE --(BUSINESS WIRE)--
- Company plans to start Phase 2b study in Q3 2012 to evaluate this interferon-free combination regimen in a total treatment duration as short as 12 weeks - - Vertex also announces the advancement of its broad portfolio of direct acting antivirals, including its two structurally-distinct nucleotide
-Successful launch of INCIVEK (telaprevir) for hepatitis C and recent approval of KALYDECO (ivacaftor) for cystic fibrosis position Vertex for continued growth, earnings and cashflow- CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today reported consolidated
- FDA approval received 3 months after submission of New Drug Application - - KALYDECO approved to treat people with CF who have a specific genetic mutation - - Vertex launches a comprehensive financial assistance and patient support program - CAMBRIDGE, Mass.
-More than 25,000 people have started treatment for hepatitis C with INCIVEK ® , positioning Vertex for continued growth, earnings and cashflow in 2012- -Preparations for approval and launch of KALYDECO TM ongoing; additional studies of KALYDECO planned for mid-2012- -Nine new medicines in
-- Six-month review date of April 18, 2012 set by FDA -- -- European Medicines Agency accepts KALYDECO regulatory submission for accelerated assessment -- CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the U.S.
- Jeffrey Leiden , M.D., Ph.D., to become CEO in February 2012 - - Matthew Emmens elects to retire in May; will remain director for Vertex Board- CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that its Board of Directors has appointed Jeffrey
-Studies to evaluate safety and effects on viral kinetics in people with chronic genotype-1 hepatitis C- -Data expected in second quarter of 2012 could enable initiation of interferon-free, nucleotide-based combination studies in the second half of 2012- CAMBRIDGE, Mass.
-Data to be presented at American College of Rheumatology Annual Meeting next week- -Phase 2b study evaluating longer treatment duration for VX-509 planned for early 2012- CHICAGO --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the final results from a Phase
- Vertex announces it intends to start a Phase 3 study to evaluate a 12-week regimen in treatment naive and relapser patients with genotype 1 hepatitis C - SAN FRANCISCO --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today interim results from ZENITH, an ongoing
- Data showed 74% of people had undetectable hepatitis C virus 24 weeks after starting INCIVEK combination treatment - - Vertex to initiate Phase 3 study to evaluate 24- and 48-week treatment durations in people who are co-infected - SAN FRANCISCO --(BUSINESS WIRE)-- Vertex Pharmaceuticals
- Hep-C Circle of Care grants will fund new and existing programs with the potential to enhance patient care - CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it has awarded 16 grants totaling approximately $1.5 million to a variety of
- Additional presentations at the North American CF Conference include data from PERSIST that showed sustained safety and efficacy of KALYDECO through 60 weeks of treatment among adolescents and adults treated in the Phase 3 STRIVE study - ANAHEIM, Calif.
- New data at North American CF Conference showed a reduction in sweat chloride when KALYDECO was added to VX-809 in people with the F508del mutation — - Part 2 of study now enrolling patients - ANAHEIM, Calif. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced
- Study shows that treating CF by targeting the underlying cause of the disease leads to significant clinical benefits among people with the G551D mutation - CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) today announced that the New England Journal of
- $420 million in net product revenues for INCIVEK for the first full quarter since launch- -Continued strength in launch of INCIVEK for hepatitis C; submissions of KALYDECO TM (VX-770, ivacaftor) approval applications complete- CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals
-Final data to be presented from Phase 2 study in rheumatoid arthritis- CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that two abstracts related to its investigational oral JAK3 inhibitor, VX-509, will be presented at the 2011 Annual Meeting
— CONCISE study will evaluate twice-daily INCIVEK in combination with pegylated-interferon and ribavirin among patients new to treatment and prior relapsers who have the ‘CC' variation near the IL28B gene — CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX)
-- Accelerated assessment of KALYDECO granted by the European Medicines Agency ; MAA submission planned in EU by the end of October -- -- Phase 3 registration studies of KALYDECO showed significant improvements in lung function and other measures of disease among a subset of people with CF --
CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that nine abstracts from its cystic fibrosis (CF) research program, which is aimed at discovering and developing medicines that target the underlying cause of CF, will be presented at the 25th
-Vertex hiring for 150 jobs across the company to support global growth; Company plans to add more than 500 jobs through 2015- CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Science has ranked the company #1 in the magazine's annual list
- High viral cure rate achieved with a 24-week INCIVEK combination regimen - CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the New England Journal of Medicine (NEJM) published data from a Phase 3 study of INCIVEK™ (telaprevir) tablets
-12-week data support initiation of Phase 2b study to evaluate longer treatment duration for VX-509- CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that treatment with the investigational selective oral JAK3 inhibitor VX-509 in a Phase 2a
- Nearly 4 out of 5 people treated for the first time cleared the virus with INCIVEK combination treatment - CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Health Canada has approved INCIVEK™ (telaprevir) tablets for a broad group of
-Quarter highlighted by approval and launch of INCIVEK TM for hepatitis C and completion of VX-770 Phase 3 program in cystic fibrosis- -Continued progress in advancing new combinations of medicines for the future treatment of hepatitis C and cystic fibrosis- CAMBRIDGE, Mass.
-First data to show potential for viral cure in many patients with a 12-week combination regimen of multiple direct-acting antivirals- CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced interim results from ZENITH, an ongoing Phase 2 study
-INCIVEK was recently approved by the FDA and is now available for people with the most common form of chronic hepatitis C who are new to treatment and those who were treated before but not cured- CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced
-Vertex gains worldwide rights to two distinct nucleotide analogues, ALS-2200 and ALS-2158, that act on hepatitis C polymerase- -Collaboration provides multiple opportunities to develop new "all-oral" combination regimens- CAMBRIDGE, Mass. , & SOUTH SAN FRANCISCO, Calif.
- Complete data presented at ECFS showed improvements in lung function and reductions in sweat chloride observed at week two of treatment were sustained through 48 weeks -
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- Vertex also announces that 48-week data from the ENVISION study of VX-770 among children ages 6 to 11 years are consistent with previously announced 24-week results -
-13.17 mmol/L reduction in sweat chloride in one arm supports further evaluation of a combination approach to treating the root cause of cystic fibrosis- CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced interim results from the first part of a
-79% of people treated for the first time achieved a SVR (viral cure) with INCIVEK combination treatment- -Vertex launches a comprehensive financial assistance and patient support program- -Conference call today at 11:00 a.m. ET to provide more information on the commercialization of INCIVEK-
CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Terrence C. Kearney has joined its board of directors. The addition of Mr. Kearney brings the number of Vertex board members to nine. Mr. Kearney was appointed to the class of directors
CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced results of the voting at its 2011 Annual Meeting of Shareholders. At the meeting, shareholders re-elected director nominees Matthew W. Emmens and Wayne J. Riley , M.D.
-Hepatitis C: FDA decision on NDA for INCIVEK TM (telaprevir) expected this month- -Cystic Fibrosis: Phase 3 program for VX-770 supports applications for approval in U.S. and E.U., with NDA and MAA planned for second half of 2011- -Financial: Vertex enters second quarter with more than $820 million
CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the Antiviral Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) voted unanimously to recommend FDA approval of telaprevir for people with genotype 1 chronic hepatitis
- 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
