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Last $133.20 USD
Change Today -2.62 / -1.93%
Volume 1.2M
VRTX On Other Exchanges
Symbol
Exchange
NASDAQ GS
Frankfurt
As of 8:10 PM 04/24/15 All times are local (Market data is delayed by at least 15 minutes).

vertex pharmaceuticals inc (VRTX) Snapshot

Open
$133.61
Previous Close
$135.82
Day High
$135.94
Day Low
$132.94
52 Week High
04/23/15 - $137.50
52 Week Low
05/9/14 - $62.41
Market Cap
32.4B
Average Volume 10 Days
1.4M
EPS TTM
$-2.76
Shares Outstanding
243.6M
EX-Date
--
P/E TM
--
Dividend
--
Dividend Yield
--
Current Stock Chart for VERTEX PHARMACEUTICALS INC (VRTX)

vertex pharmaceuticals inc (VRTX) Related Businessweek News

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vertex pharmaceuticals inc (VRTX) Details

Vertex Pharmaceuticals Incorporated engages in discovering, developing, manufacturing, and commercializing small molecule drugs for patients with serious diseases in specialty markets. The company focuses on developing and commercializing therapies for the treatment of cystic fibrosis (CF); and advancing its research and early-stage development programs. It markets KALYDECO (ivacaftor) to treat patients of six years of age and older with CF who have the mutations in their cystic fibrosis transmembrane conductance regulator (CFTR) gene in the United States, Australia, Canada, and the European Union. The company also provides INCIVEK for the treatment of adults with genotype 1 hepatitis C virus infection. In addition, it is developing CFTR correctors, including lumacaftor in combination with ivacaftor, which has completed Phase III development program; and VX-661 in combination with ivacaftor, which is in Phase III development program. Further, it identifies and develops next-generation CFTR corrector compounds; and is involved in the research and early-stage development programs, including programs in the areas of oncology and neurology. Vertex Pharmaceuticals Incorporated sells its products principally to specialty pharmacy providers and wholesalers in North America, as well as government-owned and supported customers in international markets. The company has collaboration agreements with Cystic Fibrosis Foundation Therapeutics Incorporated; BioAxone Biosciences, Inc.; and Janssen Pharmaceuticals, Inc. Vertex Pharmaceuticals Incorporated was founded in 1989 and is headquartered in Boston, Massachusetts.

1,830 Employees
Last Reported Date: 02/13/15
Founded in 1989

vertex pharmaceuticals inc (VRTX) Top Compensated Officers

Chairman, Chief Executive Officer and Preside...
Total Annual Compensation: $1.0M
Chief Financial Officer and Executive Vice Pr...
Total Annual Compensation: $583.0K
Chief Commercial Officer and Executive Vice P...
Total Annual Compensation: $553.8K
Special Counsel to the Chief Executive Office...
Total Annual Compensation: $465.0K
Compensation as of Fiscal Year 2013.

vertex pharmaceuticals inc (VRTX) Key Developments

Vertex Pharmaceuticals Incorporated Announces Data from 12-Week Phase 2 Study Evaluating VX-661 in Combination with Ivacaftor

Vertex Pharmaceuticals Incorporated announced data from a 12-week Phase 2 study evaluating VX-661 in combination with ivacaftor in 39 people with CF ages 18 and older who have two copies of the F508del mutation. The study evaluated two doses of VX-661 (100 mg once daily or 50 mg every 12 hours) in combination with ivacaftor (150 mg every 12 hours). The primary endpoint of the study was safety. The study showed that the combination regimen was generally well tolerated, and all patients completed 12 weeks of treatment. The most common adverse events were pulmonary exacerbation, which occurred in 38% of all patients who received VX-661 and 44% of those who received placebo, and cough, which occurred in 33% of all patients who received VX-661 and 39% of those who received placebo. Secondary endpoints evaluated the effect of the combination on lung function (percent predicted forced expiratory volume in one second; ppFEV1), and the mean within-group absolute improvement from baseline in ppFEV1 for those who received 100 mg of VX-661 in combination with ivacaftor (n=15) was 4.4 (p=0.009) and 3.0 (p=0.026) percentage points at week 4 and through 12 weeks of treatment, respectively. Consistent with prior Phase 2 studies that evaluated 4 weeks of treatment with VX-661 in combination with ivacaftor, this study showed a rapid improvement in lung function within four weeks of treatment, and after patients completed treatment, lung function returned to baseline.

Vertex Pharmaceuticals Incorporated Receives U.S. Food and Drug Administration Approval of Kalydeco® for Children with Cystic Fibrosis Ages 2 to 5 Who Have Specific Mutations in the CFTR Gene

Vertex Pharmaceuticals Incorporated announced that the U.S. Food and Drug Administration (FDA) approved KALYDECO® for use in children ages 2 to 5 with cystic fibrosis (CF) who have one of 10 mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene (G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R and R117H). Prior to today’s approval, KALYDECO was approved in the United States for people ages 6 and older with these mutations. There are approximately 300 children in the United States ages 2 to 5 who have one of these 10 mutations, including 150 who have the R117H mutation and 150 who have one of the other nine mutations that result in a gating defect in the CFTR protein. A new weight-based oral granule formulation of KALYDECO (50 mg and 75 mg) that can be mixed in soft foods or liquids was created to meet the needs of children in this age group who may be unable to swallow a tablet. The approval is based on previously announced results of an open-label Phase 3 24-week study that was designed to evaluate the safety and pharmacokinetics of weight-based dosing of ivacaftor (50 mg or 75 mg twice daily) in children ages 2 to 5. With today’s approval, more than 3,400 people are currently eligible for treatment with KALYDECO in the United States, Canada, Europe and Australia. Cystic fibrosis is caused by a defective or missing CFTR protein resulting from mutations in the CFTR gene. In Europe, an MAA line extension for ivacaftor in children ages 2 to 5 with specific mutations in the CFTR gene has been validated by the European Medicines Agency (EMA) and is currently under review by the Committee for Medicinal Products for Human Use (CHMP). Ivacaftor is a cystic fibrosis transmembrane conductance regulatory (CFTR) potentiator indicated for the treatment of cystic fibrosis (CF). In the U.S. (in patients age 2 years and older) and Europe (in patients age 6 years and older), ivacaftor is indicated for patients who have one of the following mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R. In Canada (in patients 6 years and older), ivacaftor is indicated for patients with these same mutations and also for patients with the G970R mutation. Additionally, in the U.S. (in patients age 2 years and older) and Canada (in patients age 18 years and older) ivacaftor is indicated for the treatment of CF in patients who have an R117H mutation in the CFTR gene. Ivacaftor is available as 150 mg tablets in countries where it is approved for patients age 6 years and older, and additionally in the U.S. as 50 mg and 75 mg oral granules for patients age 2 to less than 6 years. Ivacaftor is not effective in patients with CF with 2 copies of the F508del mutation (F508del/F508del) in the CFTR gene. The safety and efficacy of ivacaftor in children with CF younger than 2 years of age have not been studied. The use of ivacaftor in children under the age of 2 years is not recommended. High liver enzymes (transaminases; ALT and AST) have been reported in patients with CF receiving ivacaftor. Transaminase elevations were more common in patients with a history of transaminase elevations or in patients who had abnormal transaminases at baseline. It is recommended that ALT and AST be assessed prior to initiating ivacaftor, every 3 months during the first year of treatment, and annually thereafter. For patients with a history of transaminase elevations, more frequent monitoring of liver function tests should be considered. Patients who develop increased transaminase levels should be closely monitored until the abnormalities resolve. Dosing should be interrupted in patients with ALT or AST of greater than 5 times the upper limit of normal. Following resolution of transaminase elevations, consider the benefits and risks of resuming ivacaftor dosing. Use of ivacaftor with medicines that are strong CYP3A inducers, such as the antibiotics rifampin and rifabutin; seizure medications (phenobarbital, carbamazepine, or phenytoin); and the herbal supplement St. John's wort, substantially decreases exposure of ivacaftor and may diminish effectiveness. Therefore, co-administration is not recommended. The dose of ivacaftor must be adjusted when used concomitantly with strong and moderate CYP3A inhibitors or when used in patients with moderate or severe hepatic disease. Cases of non-congenital lens opacities/cataracts have been reported in pediatric patients treated with ivacaftor. Baseline and follow-up ophthalmological examinations are recommended in pediatric patients initiating ivacaftor treatment. Serious adverse reactions that occurred more frequently with ivacaftor included abdominal pain, increased liver enzymes, and low blood sugar (hypoglycemia). The most common side effects associated with ivacaftor include headache; upper respiratory tract infection (common cold), including sore throat, nasal or sinus congestion, and runny nose; stomach (abdominal) pain; diarrhea; rash; nausea; and dizziness. These are not all the possible side effects of ivacaftor. A list of the adverse reactions can be found in the product labeling for each country where ivacaftor is approved. Patients should tell their healthcare providers about any side effect that bothers them or does not go away.

Vertex Receives U.S. Food and Drug Administration Approval of KALYDECO ® (Ivacaftor) for Children with Cystic Fibrosis Ages 2 to 5 Who Have Specific Mutations in the CFTR Gene

Vertex Pharmaceuticals Incorporated announced that the U.S. Food and Drug Administration (FDA) approved KALYDECO® for use in children ages 2 to 5 with cystic fibrosis (CF) who have one of 10 mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene (G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R and R117H). Prior to the approval, KALYDECO was approved in the United States for people ages 6 and older with these mutations. There are approximately 300 children in the United States a ges 2 to 5 who have one of these 10 mutations, including 150 who have the R117H mutation and 150 who have one of the other nine mutations that result in a gating defect in the CFTR protein. A new weight-based oral granule formulation of KALYDECO (50 mg and 75 mg) that can be mixed in soft foods or liquids was created to meet the needs of children in this age group who may be unable to swallow a tablet. The approval is based on previously announced results of an open-label Phase 3 24-week study that was designed to evaluate the safety and pharmacokinetics of weight-based dosing of ivacaftor (50 mg or 75 mg twice daily) in children ages 2 to 5. With the approval, more than 3,400 people are currently eligible for treatment with KALYDECO in the United States, Canada, Europe and Australia. Cystic fibrosis is caused by a defective or missing CFTR protein resulting from mutations in the CFTR gene. Ivacaftor is a cystic fibrosis transmembrane conductance regulatory (CFTR) potentiator indicated for the treatment of cystic fibrosis (CF). In the U.S. (in patients age 2 years and older) and Europe (in patients age 6 years and older), ivacaftor is indicated for patients who have one of the following mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R. In Canada (in patients 6 years and older), ivacaftor is indicated for patients with these same mutations and also for patients with the G970R mutation. Additionally, in the U.S. (in patients age 2 years and older) and Canada (in patients age 18 years and older) ivacaftor is indicated for the treatment of CF in patients who have an R117H mutation in the CFTR gene. Ivacaftor is available as 150 mg tablets in countries where it is approved for patients age 6 years and older, and additionally in the U.S. as 50 mg and 75 mg oral granules for patients age 2 to less than 6 years. Ivacaftor is not effective in patients with CF with 2 copies of the F508del mutation (F508del/F508del) in the CFTR gene. The safety and efficacy of ivacaftor in children with CF younger than 2 years of age have not been studied. The use of ivacaftor in children under the age of 2 years is not recommended. High liver enzymes (transaminases; ALT and AST) have been reported in patients with CF receiving ivacaftor. Transaminase elevations were more common in patients with a history of transaminase elevations or in patients who had abnormal transaminases at baseline. It is recommended that ALT and AST be assessed prior to initiating ivacaftor, every 3 months during the first year of treatment, and annually thereafter. For patients with a history of transaminase elevations, more frequent monitoring of liver function tests should be considered. Patients who develop increased transaminase levels should be closely monitored until the abnormalities resolve. Dosing should be interrupted in patients with ALT or AST of greater than 5 times the upper limit of normal. Following resolution of transaminase elevations, consider the benefits and risks of resuming ivacaftor dosing.

 

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