-Enrollment complete for TRAFFIC and TRANSPORT Phase 3 studies of lumacaftor (VX-809) in combination with ivacaftor for people with two copies of the F508del mutation (homozygous); data expected in mid-2014- -12-week Phase 2 study of VX-661 in combination with ivacaftor planned for people with two
-sNDA also includes long-term safety and efficacy data for KALYDECO from PERSIST open-label rollover study- -Marketing Authorization Application (MAA) variation in Europe planned for October 2013 - CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) today
CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will report its third quarter 2013 financial results on Tuesday, October 29, 2013 after the financial markets close. The company will host a conference call and webcast at 5:00 p.m. ET .
-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
-Second quarter 2013 total revenues of $311 million , including net product revenues of $99 million for KALYDECO in cystic fibrosis and $156 million for INCIVEK in hepatitis C; cash position of approximately $1.43 billion on June 30, 2013 - -Data from Phase 3 study of ivacaftor monotherapy support
-U.S. Study: FDA places partial clinical hold on ongoing Phase 2 U.S. study of VX-135, preventing evaluation of 200 mg dose following observation of elevated liver enzymes in patients receiving 400 mg of VX-135 in combination with ribavirin in Phase 2 study in Europe ; evaluation of 100 mg dose
-- Approximately 250 people in Australia have the G551D mutation in the CFTR gene -- CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the Therapeutic Goods Administration (TGA) of Australia has approved KALYDECO™ (ivacaftor) for people
CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it has completed its previously announced call for redemption of $400 million in aggregate principal amount of 3.35% Convertible Senior Subordinated Notes due 2015.
-2015 Notes convertible at a conversion price of approximately $48.83 per share- CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced that it has called for redemption of its outstanding $400.0 million in aggregate principal amount of 3.35% Convertible
-First quarter 2013 total revenues of $328 million , including net product revenues of $206 million for INCIVEK in hepatitis C and $62 million for KALYDECO in cystic fibrosis- -Cystic fibrosis: Enrollment ongoing in Phase 3 program for VX-809 in combination with ivacaftor for people with two copies
- Interim analysis of the Phase 3b CONCISE study showed SVR12 rates of 87 percent with 12 total weeks of treatment and 97 percent with 24 total weeks of treatment among people who achieved RVR and completed 12 weeks of treatment - AMSTERDAM --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated
- After seven days of once-daily dosing with 200 mg of ALS-2200, genotype 1 patients with cirrhosis had a median 4.08 log 10 reduction in HCV RNA; among people with genotypes 3 or 4, there was a median 4.65 log 10 reduction in HCV RNA - - Data are consistent with previously reported ALS-2200
-Treatment with combination of VX-661 and ivacaftor for 28 days in two highest dose groups resulted in mean relative increases in lung function (percent predicted FEV 1 ) of 9.0% (p=0.01) and 7.5% (p=0.02) versus placebo - -VX-661 was generally well-tolerated alone and in combination with
-Two Phase 2 studies to evaluate once-daily combination of Vertex's investigational nucleotide analogue VX-135 and BMS' investigational NS5A replication complex inhibitor daclatasvir- -Study in people with genotype 1 hepatitis C planned to begin in second quarter of 2013- -Study in people with
- Treatment with highest dosing regimen of VX-787 reduced viral shedding by 94 percent versus placebo; Duration of flu symptoms were reduced by nearly half - - VX-787 is an investigational new class of medicine designed to directly inhibit replication of the influenza virus - CAMBRIDGE, Mass.
-Global studies to evaluate two different doses of VX-809 in combination with ivacaftor- - 24-week safety and efficacy data and submission of New Drug Application expected in 2014- CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the initiation
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
-2013 investment focused on key development programs in cystic fibrosis, hepatitis C and autoimmune diseases- -Full-year 2012 revenues of $1.53 billion , including net product revenues of $1.16 billion for INCIVEK in hepatitis C and $171.6 million for KALYDECO in cystic fibrosis- -Company ends 2012
-2013 investment focused on key development programs in cystic fibrosis, hepatitis C and autoimmune diseases- -First two Breakthrough Therapy Designations from U.S. FDA granted to ivacaftor monotherapy and to the combination regimen of VX-809 and ivacaftor for the treatment of cystic fibrosis- SAN
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
- Revised label includes Boxed Warning detailing risk of serious skin reactions observed in the post-marketing setting that require treatment discontinuation - CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the INCIVEK ® (telaprevir)
-- Approximately 100 people in Canada have the G551D mutation in the CFTR gene -- -- First medicine resulting from 1989 co-discovery of CF gene by researchers in Canada and the U.S. -- CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that
- New Phase 2 data showed approximately 3 of 4 people co-infected with hepatitis C virus (HCV) and HIV achieved HCV viral cure (SVR24) with telaprevir combination treatment - BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that new data from a Phase 3
- 4.54 log 10 median reduction in HCV RNA after 7 days of dosing; ALS-2200 was well-tolerated with no serious adverse events and no discontinuations due to adverse events - - Vertex moving forward with multiple Phase 2 trials in early 2013 exploring all-oral combinations, including VX-135 with
-Third quarter 2012 total revenues of $336 million , including third quarter 2012 net product revenues of approximately $254 million for INCIVEK in hepatitis C and $49 million for KALYDECO in cystic fibrosis- -Cystic Fibrosis: Three ongoing Phase 3 label expansion studies for ivacaftor monotherapy;
-Companies to evaluate two-drug combination of Vertex's investigational nucleotide analogue VX-135 and Janssen's investigational protease inhibitor simeprevir (TMC435)- -Phase 2 proof-of-concept study to begin in early 2013 to evaluate safety, tolerability and viral cure rates of 12-week treatment
-Companies to evaluate two-drug combination of Vertex's investigational nucleotide analogue VX-135 and GSK's investigational NS5A inhibitor GSK2336805- -Phase 2 proof-of-concept study to begin in early 2013 to evaluate safety, tolerability and viral cure rates of 12-week treatment regimen-
CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will announce its third quarter 2012 financial results on Monday, October 29, 2012 after the financial markets close. The company will host a conference call at 5:00 p.m. EDT .
-- Additional KALYDECO™ (ivacaftor) and CF pipeline presentations highlight Vertex's commitment to advancing CF treatment by targeting the underlying cause of the disease -- ORLANDO, Fla. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that data from a Phase 2
CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that 11 abstracts from its hepatitis C research and development program will be presented at The Liver Meeting ® , the 63rd Annual Meeting of the American Association for the Study of Liver
CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that 10 abstracts from its cystic fibrosis (CF) research and development program will be presented at the 26th Annual North American Cystic Fibrosis Conference (NACFC) in Orlando, Fla.
- ALS-2158: Well-tolerated in a seven-day viral kinetic study; development discontinued due to lack of efficacy - - ALS-2200: Data from additional cohort of seven-day viral kinetic study with ALS-2200 (200 mg, QD) in combination with ribavirin show median 4.18 log 10 reduction in HCV RNA with 5 of
CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Yuchun Lee joined its board of directors as an independent director. Mr. Lee was appointed to the class of directors whose term expires in 2013.
CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) today announced the appointment of Stuart A. Arbuckle as Executive Vice President and Chief Commercial Officer. Mr. Arbuckle has more than 25 years of experience in leading global sales and marketing efforts at
-Second quarter 2012 total revenues of $418 million , including second quarter 2012 net product revenues of approximately $328 million for INCIVEK in hepatitis C and $46 million for KALYDECO in cystic fibrosis; company revises financial guidance for full-year 2012 INCIVEK net revenues- -Cystic
- 4.54 log 10 median reduction in HCV RNA observed in people with genotype 1 hepatitis C treated with a once-daily 200 mg dose of ALS-2200 for seven days; treatment was well-tolerated- - Phase 2 studies of 12-week all-oral regimens planned for this year - CAMBRIDGE, Mass.
- European Commission approval comes two months after positive CHMP opinion - GENEVA --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the European Commission has approved KALYDECO TM (ivacaftor) for people with cystic fibrosis (CF) ages 6 and older who
- Mean absolute improvement in lung function of 6.1 percentage points within group (p < 0.001) and 8.6 percentage points compared to placebo (p < 0.001) in homozygous patients receiving combination treatment (Day 28 to 56) with highest study dose of VX-809 (600mg) - - Adverse events were
- Vertex commits more than $1 million to support education for BPS students and to prepare teachers for new science education standards- -Company dedicates 3,000 square foot learning laboratory at new Fan Pier headquarters to local community- BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals
CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) today announced two changes to its executive leadership team. Following a comprehensive search, Vertex has appointed Kenneth Horton to the role of Chief Legal Officer, where he will take on the additional title
- Data from nine presentations at the European Cystic Fibrosis Society Conference underscore Vertex's ongoing commitment to change CF treatment by targeting the underlying cause of the disease - DUBLIN --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today new data
- Corrected Data: Responder analysis showed 35% of patients experienced an absolute improvement in lung function (FEV 1 ) of at least 5 percentage points and 19% had at least a 10 percentage-point improvement when treated with VX-809 and KALYDECO - - Additional Data: Patients treated with VX-809
- Global studies showed significant and sustained improvements in lung function and other measures of disease among people with a specific genetic mutation - CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the European Committee for
CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that David Altshuler , M.D., Ph.D., joined its board of directors as an independent director. Dr. Altshuler was appointed to the class of directors whose term expires in 2015.
-Unique collaboration between a biotech company, nonprofit organization and academic centres to focus on underlying biology of IBD-<br>
-Collaboration complements Vertex's ongoing IBD research efforts
at its Canadian research and development site-
- Interim analysis showed 46% of patients experienced at least 5% absolute improvement in lung function (FEV 1 ) from baseline; 30% of patients experienced at least 10% absolute improvement - - Vertex plans to start a pivotal study of VX-809 and KALYDECO to treat the underlying cause of CF in
-Approximately 600 people with cystic fibrosis have started treatment with KALYDECO since approval on January 31 - -Multiple ongoing clinical trials to generate data beginning in second quarter, including study of KALYDECO combined with VX-809 in cystic fibrosis and first data for Alios nucleotides
- Vertex working with other provincial funding agencies to make INCIVEK available to more people in Canada - LAVAL, Quebec --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the province of Quebec is now funding INCIVEK ™ (telaprevir) tablets for residents
- Subanalysis of Phase 2 data shows 12 weeks of INCIVEK combination treatment resulted in a viral cure (SVR) for 100% of people with hepatitis C who had the IL28B CC genotype; Phase 3 study enrolling - - Vertex's four direct-acting antivirals allow for the clinical exploration of multiple
