<i>-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-</i>
<br />
<i>-62% of African Americans/Blacks in the ADVANCE study achieved a
viral cure with telaprevir-</i>
<br />
<i>-Low discontinuation rates of all drugs due to adverse events-</i>
<br />
- 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
New Data Suggest Vertex's Oral Hepatitis C Virus Protease Inhibitor VX-950 May Reduce Liver Injury; VX-950 Clinical Milestones on Track Montreal, Canada, October 3, 2005 - New data show that patients with genotype 1 hepatitis C virus (HCV) infection treated with VX-950, an investigational oral HCV
- 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
- 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
-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
BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the New England Journal of Medicine (NEJM) published data from the two Phase 3 studies of ORKAMBI TM (lumacaftor/ivacaftor), an investigational medicine designed to treat the underlying cause of
<i><b>-Addition of telaprevir to standard HCV therapies significantly
improved rates of sustained viral response in half the time of current
treatments-</b></i><i><b>-SVR rates in Phase 2b studies of up to 69% with 24 weeks of
telaprevir-based treatment-</b></i><i><b>-Phase 3 program ongoing in more than 2,200 patients-</b></i>
-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
<i><b>-51% and 53% SVR rates when telaprevir was dosed in combination
with pegylated-interferon and ribavirin in treatment-failure patients,
compared to 14% SVR rate with pegylated-interferon and ribavirin alone-</b></i>
<br />
<i><b>-Telaprevir Phase 3 SVR data expected in second quarter 2010 for
treatment-naïve patients and third quarter 2010 for treatment-failure
patients-</b></i>
<br />
<i><b>-New Drug Application submission planned for second half of 2010
in treatment-naïve and treatment-failure HCV patients-</b></i>
<br />
New Pharmacokinetic Data on Co-Administration of the PI LEXIVA/r With the NRTI Tenofovir Quebec City, April 29, 2005 --Today new study results announced by GlaxoSmithKline showed the pharmacokinetics (PK) of the HIV protease inhibitor (PI) LEXIVA(R) (fosamprenavir calcium) dosed in combination with
New Pharmacokinetic Data On Taking Lexiva Simultaneously With Nexium Quebec City, April 29, 2005 --Today GlaxoSmithKline (GSK) presented new pharmacokinetic (PK) data on taking the HIV protease inhibitor LEXIVA(R) (fosamprenavir calcium, FPV) Tablets with the proton pump inhibitor (PPI), Nexium(R)
<i>-Over 3 million Americans have chronic hepatitis C -</i>
-<i>Baby boomers account for 2 of every 3 cases of hepatitis C virus and
vast majority unaware they have this chronic disease </i>-
-<i>Cost burden of hepatitis C to Medicare projected to increase 500% as
baby boomers with HCV age into severe complications of liver disease-</i>
CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that a decision has been made by the National Health Service (NHS) in England to fund KALYDECO™ (ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis (CF), for people
-All doses of VX-509 showed statistically significant ACR20 and ACR50 responses compared to placebo and statistically significant improvement from baseline in DAS28 compared to placebo- -Three highest doses of VX-509: ACR20 of 58% to 68% versus 18% for placebo; statistically significant ACR70
Pharmaceuticals Announces Results of First Interim Safety and Antiviral Analysis of the PROVE 1 Clinical Trial of Investigational HCV Protease Inhibitor Telaprevir (VX-950) Cambridge, MA, December 13, 2006 –– Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced results from a planned
-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
-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
<i>-Viral cure rates of 92% and 88% with 24 and 48-week regimens,
respectively, in people who met certain response criteria-</i>
<br />
<i>-Safety and tolerability results were similar to those seen in the
Phase 3 ADVANCE study</i>-
<br />
- Both studies met primary and all key secondary endpoints demonstrating significant improvements in lung function and other measures of the disease - - Results of both studies to be presented today at the 33rd Annual North American Cystic Fibrosis Conference as part of six presentations from
- 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 -
<br><br>
- 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 -
- Data showed significant improvements in lung function (ppFEV 1 ) with a favorable safety profile across multiple patient groups - - Tezacaftor/ivacaftor currently under review by the FDA and EMA; FDA Priority Review action date of February 28, 2018 - BOSTON --(BUSINESS WIRE)-- Vertex
- 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.
-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
- 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
Phase III, 48-Week NEAT Study Results Comparing LEXIVA(TM) to Nelfinavir Published in the Journal of Acquired Immune Deficiency Syndrome (JAIDS) Cambridge, MA and Research Triangle Park, NC, January 20, 2004 -- The final 48-week results from the NEAT trial, an open-label, multi-center study
- 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
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
-Study met primary endpoint with a statistically significant improvement in absolute change in lung clearance index (LCI 2.5 ) through 8 weeks of tezacaftor/ivacaftor treatment- -Tezacaftor in combination with ivacaftor was generally well tolerated and safety data were consistent with previous
- Study met primary endpoint with a statistically significant improvement in absolute change in lung clearance index (LCI 2.5 ) compared to placebo through 24 weeks of treatment - - ORKAMBI was well tolerated with safety data that were similar to data from previous Phase 3 open-label safety study -
-Phase 3 study met primary endpoint and all secondary endpoints- -Study is a U.S. post-marketing commitment and will be submitted to FDA- -Data also will be submitted to the European Medicines Agency to support indication expansion of the EU label following triple combination approval- BOSTON
- Longer-term follow-up data demonstrate consistent and durable response to treatment - BOSTON --(BUSINESS WIRE)--Dec. 11, 2023-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced two oral presentations at the American Society of Hematology (ASH) Annual Meeting and Exposition from
- Both trials met the primary and key secondary endpoints at the pre-specified interim analysis - - Data continue to demonstrate transformative and durable benefit - - Safety profile consistent with busulfan conditioning and autologous hematopoietic stem cell transplant - BOSTON & ZUG,
-Data are consistent with in vitro observations in residual function mutations showing that ivacaftor improved CFTR activity- -8-week open-label period showed improvements in lung function- -Data support plans to initiate a Phase 3 study of ivacaftor in people with CF who have a residual function
CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the Health Service Executive (HSE) in the Republic of Ireland will fund KALYDECO™ (ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis (CF), for people ages 6 and
- 12 of 12 (100%) patients HCV RNA undetectable with no evidence of viral breakthrough at end of 28 days VX-950 dosing -<br />
- 92% (11 of 12) continued to have undetectable HCV RNA through 12 weeks of follow-on therapy -
- 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
-Mean absolute treatment difference in lung function (percent predicted FEV 1 ) between treatment with ivacaftor and placebo was 10.7% (p < 0.0001); mean relative treatment difference between treatment with ivacaftor and placebo was 14.2% (p < 0.0001)- -Statistically significant improvements
BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Sangeeta N. Bhatia , M.D., Ph.D., joined its board of directors as an independent director. Dr. Bhatia was elected to serve a three-year term ending in 2018. " Dr.
CAMBRIDGE, Mass., May 13, 2010 (BUSINESS WIRE) -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced results of the voting at its 2010 Annual Meeting of Shareholders. At the meeting, shareholders re-elected director nominees Dr. Joshua Boger, Dr. Charles A. Sanders and Elaine S.
Vertex receives exclusive options to license a number of Skyhawk’s product candidates directed at serious diseases Skyhawk receives $40 million upfront as well as potential milestones and royalty payments on future sales WALTHAM, Mass. & BOSTON --(BUSINESS WIRE)--Dec.
LONDON --(BUSINESS WIRE)--Oct. 21, 2019-- Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) today announced that the Spanish Government has approved terms for the national reimbursement of ORKAMBI ® (lumacaftor/ivacaftor) and SYMKEVI ® (tezacaftor/ivacaftor) in combination with KALYDECO ®
CAMBRIDGE, Mass., May 14, 2009 (BUSINESS WIRE) -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced results of the voting at its 2009 Annual Meeting of Stockholders. At the meeting, stockholders approved the amendment to Vertex's Amended and Restated 2006 Stock and Option Plan
CAMBRIDGE, Mass., May 15, 2008 (BUSINESS WIRE) -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced results of the voting at its 2008 Annual Meeting of Stockholders. At the meeting, stockholders approved the amendment to Vertex's Articles of Organization increasing the number of
