ILLUMENATE First-in-Human Clinical Trial Supports the Stellarex™ Balloon with EnduraCoat™ Technology in Treating Peripheral Arterial Disease
PARIS - Thursday, May 22nd 2014 [ME NewsWire]
(BUSINESS WIRE)-- Covidien’s Stellarex™ drug-coated angioplasty balloon (Stellarex DCB) continues to be shown as safe and effective for treatment of peripheral arterial disease (PAD), according to new 24-month data released today from the company’s ILLUMENATE First-in-Human (FIH) Study. The Stellarex DCB uses EnduraCoat™ technology, a durable, uniform balloon coating designed to prevent drug loss during transit and facilitate controlled, efficient drug delivery to the treatment site. The FIH study results were reported at the EuroPCR Scientific Congress in Paris, held May 20-23, 2014.
According to The Lancet, 40.5 million cases of PAD were reported in Europe in 20101. PAD is one of the most common vascular diseases and is associated with heart attack, stroke, amputation and death. It occurs when arteries in the legs become narrowed or blocked by plaque. These blockages can result in severe pain, limited physical mobility and non-healing leg ulcers.
The ILLUMENATE FIH study is a prospective, multi-center, single arm study designed to assess the safety and effectiveness of the Stellarex DCB. In the study, 58 superficial femoral and/or popliteal lesions in 50 patients were pre-dilated with an uncoated angioplasty balloon, followed by treatment with the Stellarex DCB. When used to treat lesions in leg arteries, the Stellarex DCB is intended to open narrowed or occluded vessels to restore blood flow and simultaneously deliver paclitaxel, the drug used in the balloon coating, to the vessel wall. This helps prevent restenosis, or the formation of new blockages within an artery, after the artery has been treated.
The study found the Stellarex DCB to be safe, with durable results to 24 months, including:
Primary patency (defined as the treated artery remaining open without further treatment required or renewed blockage detected by ultrasound scanning) was 82.3 percent at 24 months.
Freedom from clinically-driven target lesion revascularization at 24 months was 87.9 percent. This is the same rate observed at 12 months; no new events were reported demonstrating a sustained low rate of repeat treatment out to 24 months.
No amputations or cardiovascular deaths were reported.
“We are very pleased with the study’s promising results, as they support the use of an important emerging treatment for a painful and physically limiting condition that affects millions of people around the world,” said Dr. Henrik Schröder, MD, Radiologist, Vascular Center-Jewish Hospital, Berlin, Germany, and principal investigator, ILLUMENATE FIH Study. “Good patency after two years, which translated into the absence of new clinically-driven target lesion revascularizations after one year and through the second year patient follow up, demonstrates the durability of the Stellarex drug-coated angioplasty balloon.”
Covidien is conducting additional large clinical trials to further validate the FIH findings.
“ILLUMENATE’s long-term results represent some of the best 24-month patency and freedom from target lesion revascularization rates seen in first-in-human studies to date. “These encouraging, long-term findings suggest Stellarex may be uniquely effective compared with other paclitaxel-based DCBs,” said Dr. Mark A. Turco, MD, chief medical officer, Vascular, Covidien. “The ILLUMENATE trial series demonstrates Covidien’s ongoing commitment to develop innovative solutions for treating vascular diseases.”
About Covidien
Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien develops, manufactures and sells a diverse range of industry-leading medical device and supply products. With 2013 revenue of $10.2 billion, Covidien has more than 38,000 employees worldwide in more than 70 countries, and its products are sold in over 150 countries. Please visit www.covidien.com to learn more about our business.
1 Fowkes, et al. “Comparison of Global Estimates of Prevalence and Risk Factors for Peripheral Arterial Disease in 2010: A Systematic Review and Analysis.” Lancet 2013 October 19:382(9901):1329-40.
Contacts
Covidien
David T. Young, 508-452-1644
Manager, External Communications
Vascular Therapies
david.young@covidien.com
Cole Lannum, CFA, 508-452-4343
Vice President
Investor Relations
cole.lannum@covidien.com
Peter Lucht, 508-452-4168
Vice President, External Communications
Corporate Communications
peter.lucht@covidien.com
Todd Carpenter, 508-452-4363
Senior Director
Vascular Therapies
todd.carpenter@covidien.com
Permalink: http://www.me-newswire.net/news/11067/en
Monday, May 26, 2014
Covidien Releases Two-Year Study Results Demonstrating Sustained Effectiveness of Drug-Coated Angioplasty Balloon Technology
Posted by
Business Daily Africa
COPD: First Phase III Data Show Lung Function Benefits of Tiotropium + Olodaterol Fixed-Dose Combination go Beyond Tiotropium (Spiriva®) Alone
SAN DIEGO. - Thursday, May 22nd 2014 [ME NewsWire]
ATS 2014
Results from VIVACITO™ study showed significant improvement in lung function (FEV1*) using
fixed-dose combination of tiotropium and olodaterol (tiotropium + olodaterol FDC†) in patients with
COPD‡, compared to monotherapies or placebo1
VIVACITO™ is the first study presented from the >8,000 patient TOviTO™ Phase III clinical trial
programme for tiotropium + olodaterol FDC
Further tiotropium + olodaterol FDC data on patient outcomes such as quality of life are due to
report later this year
(BUSINESS WIRE) For media outside of the US, the UK & Canada only
Boehringer Ingelheim today announced the first Phase III data for the once-daily fixed-dose
combination of tiotropium and olodaterol. Results from the Phase III VIVACITO™ study show that
once-daily tiotropium + olodaterol FDC improved lung function (FEV1*) of COPD patients to levels
significantly above those achieved with tiotropium or olodaterol monotherapies, or with placebo.
The 6-week trial with an incomplete crossover design was conducted in patients with moderate to
severe COPD. The results were presented at the American Thoracic Society (ATS) 2014 International
Congress in San Diego. Further data from the Phase III programme for tiotropium + olodaterol FDC
are due to report later this year.
They are expected to further show the efficacy and safety of the tiotropium + olodaterol FDC and
how its benefits in lung function translate into meaningful benefits to patients in their daily lives.
“Many COPD patients remain symptomatic despite current standard care and therefore are limited in
their daily activities, like meeting friends or doing outdoor activities. New, innovative treatments are
needed to help improve patients’ lung function and their quality of life," said Klaus F. Rabe,
Professor of Pulmonary Medicine at the University of Kiel and Director of the Department of
Pneumology at Clinic Grosshansdorf, Germany. “The increase of more than 200 ml in trough FEV1
seen in the VIVACITO™ study with tiotropium + olodaterol FDC compared to placebo is significant.
A few years ago we would simply not have thought this level of improvement would be possible.”
Once-daily tiotropium + olodaterol FDC is an investigational treatment that contains the well-
established once-daily LAMA§ tiotropium (Spiriva®) combined with olodaterol (Striverdi®), the
new once-daily and fast-acting LABA** delivered by the Respimat® SoftMist™ Inhaler. Respimat®
is an innovative inhaler delivering a unique slow-moving SoftMist™ that allows gentle inhalation –
making it easy for patients to take their therapy.
The VIVACITO™ data show that the tiotropium + olodaterol FDC demonstrated clear and consistent
improvements in lung function (FEV1*) over 24 hours compared with tiotropium or olodaterol
monotherapies, and placebo. In the study, tiotropium + olodaterol FDC was shown to have a safety
profile similar to tiotropium.
The results from VIVACITO™ are the first Phase III data for tiotropium + olodaterol FDC presented
from the TOviTO™ programme, one of the largest Phase III clinical trial programmes ever conducted
in COPD. In addition to evaluating the effects of the tiotropium + olodaterol FDC on lung function,
the TOviTO™ programme is also focused on the evaluation of other important clinical outcomes
related to the daily life of patients with COPD.
Results from the pivotal 52-week Phase III TONADO™ 1&2 trials, investigating the effect of
tiotropium + olodaterol FDC on lung function and quality of life in patients with COPD, are due to
report later in 2014.
These data will form a major part of Boehringer Ingelheim’s submission to regulatory authorities to
support the registration of tiotropium + olodaterol FDC in COPD.
* FEV1 is the maximum volume of air that can be forcibly expired in 1st second, following maximal
inspiration and is an important indicator of lung function
†Tiotropium + olodaterol FDC is an investigational treatment. It has not been approved for clinical
use. Its safety and efficacy have not yet been fully established
‡Chronic obstructive pulmonary disease
§Long-acting muscarinic antagonist
**Long-acting beta2-agonist
For more detailed information please follow the links below:
Tiotropium + olodaterol FDC backgrounder: click here
VIVACITO™ clinical trial backgrounder: click here
TOviTO™ clinical trial programme backgrounder: click here
Notes to editors and references: click here
Contacts
Boehringer Ingelheim
Corporate Communications
Media + PR
Kristin Jakobs
Phone: +49 (6132) 77-14 45 53
Fax: +49 (6132) 77-66 01
Email: kristin.jakobs@boehringer-ingelheim.com
More information
www.boehringer-ingelheim.com
Permalink: http://www.me-newswire.net/news/11064/en
ATS 2014
Results from VIVACITO™ study showed significant improvement in lung function (FEV1*) using
fixed-dose combination of tiotropium and olodaterol (tiotropium + olodaterol FDC†) in patients with
COPD‡, compared to monotherapies or placebo1
VIVACITO™ is the first study presented from the >8,000 patient TOviTO™ Phase III clinical trial
programme for tiotropium + olodaterol FDC
Further tiotropium + olodaterol FDC data on patient outcomes such as quality of life are due to
report later this year
(BUSINESS WIRE) For media outside of the US, the UK & Canada only
Boehringer Ingelheim today announced the first Phase III data for the once-daily fixed-dose
combination of tiotropium and olodaterol. Results from the Phase III VIVACITO™ study show that
once-daily tiotropium + olodaterol FDC improved lung function (FEV1*) of COPD patients to levels
significantly above those achieved with tiotropium or olodaterol monotherapies, or with placebo.
The 6-week trial with an incomplete crossover design was conducted in patients with moderate to
severe COPD. The results were presented at the American Thoracic Society (ATS) 2014 International
Congress in San Diego. Further data from the Phase III programme for tiotropium + olodaterol FDC
are due to report later this year.
They are expected to further show the efficacy and safety of the tiotropium + olodaterol FDC and
how its benefits in lung function translate into meaningful benefits to patients in their daily lives.
“Many COPD patients remain symptomatic despite current standard care and therefore are limited in
their daily activities, like meeting friends or doing outdoor activities. New, innovative treatments are
needed to help improve patients’ lung function and their quality of life," said Klaus F. Rabe,
Professor of Pulmonary Medicine at the University of Kiel and Director of the Department of
Pneumology at Clinic Grosshansdorf, Germany. “The increase of more than 200 ml in trough FEV1
seen in the VIVACITO™ study with tiotropium + olodaterol FDC compared to placebo is significant.
A few years ago we would simply not have thought this level of improvement would be possible.”
Once-daily tiotropium + olodaterol FDC is an investigational treatment that contains the well-
established once-daily LAMA§ tiotropium (Spiriva®) combined with olodaterol (Striverdi®), the
new once-daily and fast-acting LABA** delivered by the Respimat® SoftMist™ Inhaler. Respimat®
is an innovative inhaler delivering a unique slow-moving SoftMist™ that allows gentle inhalation –
making it easy for patients to take their therapy.
The VIVACITO™ data show that the tiotropium + olodaterol FDC demonstrated clear and consistent
improvements in lung function (FEV1*) over 24 hours compared with tiotropium or olodaterol
monotherapies, and placebo. In the study, tiotropium + olodaterol FDC was shown to have a safety
profile similar to tiotropium.
The results from VIVACITO™ are the first Phase III data for tiotropium + olodaterol FDC presented
from the TOviTO™ programme, one of the largest Phase III clinical trial programmes ever conducted
in COPD. In addition to evaluating the effects of the tiotropium + olodaterol FDC on lung function,
the TOviTO™ programme is also focused on the evaluation of other important clinical outcomes
related to the daily life of patients with COPD.
Results from the pivotal 52-week Phase III TONADO™ 1&2 trials, investigating the effect of
tiotropium + olodaterol FDC on lung function and quality of life in patients with COPD, are due to
report later in 2014.
These data will form a major part of Boehringer Ingelheim’s submission to regulatory authorities to
support the registration of tiotropium + olodaterol FDC in COPD.
* FEV1 is the maximum volume of air that can be forcibly expired in 1st second, following maximal
inspiration and is an important indicator of lung function
†Tiotropium + olodaterol FDC is an investigational treatment. It has not been approved for clinical
use. Its safety and efficacy have not yet been fully established
‡Chronic obstructive pulmonary disease
§Long-acting muscarinic antagonist
**Long-acting beta2-agonist
For more detailed information please follow the links below:
Tiotropium + olodaterol FDC backgrounder: click here
VIVACITO™ clinical trial backgrounder: click here
TOviTO™ clinical trial programme backgrounder: click here
Notes to editors and references: click here
Contacts
Boehringer Ingelheim
Corporate Communications
Media + PR
Kristin Jakobs
Phone: +49 (6132) 77-14 45 53
Fax: +49 (6132) 77-66 01
Email: kristin.jakobs@boehringer-ingelheim.com
More information
www.boehringer-ingelheim.com
Permalink: http://www.me-newswire.net/news/11064/en
Posted by
Business Daily Africa
Data on Angiox (Bivalirudin Injection) in Heart Attack Patients Presented at EuroPCR and Published in European Heart Journal
PARIS. - Thursday, May 22nd 2014 [ME NewsWire]
(BUSINESS WIRE) During the Late Breaking Clinical Trial sessions at EuroPCR yesterday and published simultaneously in the European Heart Journal, Professor Uwe Zeymer of Klinikum Ludwigshafen, Ludwigshafen, Germany and others reported a paper entitled: “Bivalirudin is superior to heparins alone with bailout GP IIb/IIIa inhibitors in patients with ST-segment elevation myocardial infarction transported emergently for primary percutaneous coronary intervention: a pre-specified analysis from the EUROMAX trial”.
The EUROMAX trial studied 2,198 patients with heart attacks (STEMI) during their transport on the way to urgent heart procedures (PPCI) aimed at unblocking coronary arteries occluded by blood clots – the underlying cause of heart attacks. Treatment with bivalirudin (Angiox) was compared to heparin or low-molecular weight heparin (heparins) given with optional glycoprotein inhibitors (GPI). As reported in The New England Journal of Medicine last year, the trial met all of its pre-specified endpoints.
Lead author and presenter of the new analysis Dr Uwe Zeymer MD, of Klinikum Ludwigshafen, Ludwigshafen, Germany said, ‘’The results of this pre-specified subgroup analysis are consistent with the overall trial results. Bivalirudin resulted in significantly lower rates of the primary outcome and major bleeding regardless of routine or bailout only use of GPI.”
Principal investigator of the EUROMAX trial Professor P. Gabriel Steg, MD, of Hôpital Bichat in Paris said, "The results of this pre-specified subgroup analysis are in keeping with the overall trial results and provide evidence that the reductions in the primary endpoint and protocol major bleeding seen with bivalirudin over heparin are consistent regardless of the use of GPI. However, the 1% absolute increase in acute stent thrombosis observed in the overall EUROMAX trial was also seen in this pre-specified analysis.”
About Angiox/Angiomax
In the United States, bivalirudin is marketed under the trade name Angiomax® and is indicated in patients undergoing PCI with provisional use of GPI and in patients with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI. In addition, Angiomax is also indicated for use as an anticoagulant in patients with UA undergoing percutaneous transluminal coronary angioplasty (PTCA). Angiomax is intended for use with aspirin. Angiomax is not approved for use in patients with acute coronary syndromes (ACS) not undergoing PCI or PTCA. Please see full prescribing information for Angiomax, available at http://www.angiomax.com.
In Europe, bivalirudin is marketed under the trade name Angiox® and is indicated as an anticoagulant for adult patients undergoing PCI, including patients with STEMI undergoing primary PCI. Angiox is also indicated for the treatment of adult patients with unstable angina/non-ST segment elevation MI planned for urgent or early intervention. Please see full prescribing information available at http://www.angiox.com.
In clinical trials comparing Angiomax and heparin, the most common adverse reaction for Angiomax was bleeding (28%). Other common adverse reactions were headache, thrombocytopenia and fever. An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic event and cessation of Angiomax administration. Angiomax should be used with caution in patients with disease states associated with an increased risk of bleeding.
In gamma brachytherapy, an increased risk of thrombus formation, including fatal outcomes, has been associated with the use of Angiomax. Angiomax is contraindicated in patients with active major bleeding or hypersensitivity to Angiomax or its components.
About EUROMAX
EUROMAX (EUROpean aMbulance Acs angioX trial) was a 2,218 randomized, controlled, open label, international, multicenter study that compared early administration of bivalirudin, which is marketed as Angiox in the European Union, and Angiomax in the US, to heparins with or without glycoprotein inhibitors (GPI). Patients with ST-segment elevation myocardial infarction (STEMI) who were being transported for primary PCI received either bivalirudin or unfractionated or low-molecular-weight heparin with optional GPI (control group). At 30 days, the primary outcome was a composite of death or major bleeding not associated with coronary-artery bypass grafting (CABG), and the principal secondary outcome was a composite of death, reinfarction, or non-CABG major bleeding. Patients who were assigned to the bivalirudin group received a bolus of 0.75 mg per kilogram, followed by an infusion of 1.75 mg per kilogram per hour, which should be continued for at least 4 hours after PCI. The protocol also specified that the dose during the post-PCI interval should be 0.25 mg per kilogram per hour; however, continuation of the higher dose used during PCI was also permitted. Bailout use of a GPI was allowed in the event of giant thrombus or no-reflow.
About The Medicines Company
The Medicines Company's purpose is to save lives, alleviate suffering and contribute to the economics of healthcare by focusing on 3000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: acute cardiovascular care, surgery and perioperative care, and serious infection disease care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, NJ, USA and Zurich, Switzerland.
Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates" and "expects" and similar expressions, are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include whether physicians, patients and other key decision makers will accept clinical trial results and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Quarterly Report on Form 10-Q filed with the SEC on May 12, 2014, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
Contacts
The Medicines Company
Neera Dahiya Ravindran, MD, +1-973-290-6044
Vice President, Investor Relations & Strategic Planning
neera.ravindran@themedco.com
Permalink: http://me-newswire.net/news/11066/en
(BUSINESS WIRE) During the Late Breaking Clinical Trial sessions at EuroPCR yesterday and published simultaneously in the European Heart Journal, Professor Uwe Zeymer of Klinikum Ludwigshafen, Ludwigshafen, Germany and others reported a paper entitled: “Bivalirudin is superior to heparins alone with bailout GP IIb/IIIa inhibitors in patients with ST-segment elevation myocardial infarction transported emergently for primary percutaneous coronary intervention: a pre-specified analysis from the EUROMAX trial”.
The EUROMAX trial studied 2,198 patients with heart attacks (STEMI) during their transport on the way to urgent heart procedures (PPCI) aimed at unblocking coronary arteries occluded by blood clots – the underlying cause of heart attacks. Treatment with bivalirudin (Angiox) was compared to heparin or low-molecular weight heparin (heparins) given with optional glycoprotein inhibitors (GPI). As reported in The New England Journal of Medicine last year, the trial met all of its pre-specified endpoints.
Lead author and presenter of the new analysis Dr Uwe Zeymer MD, of Klinikum Ludwigshafen, Ludwigshafen, Germany said, ‘’The results of this pre-specified subgroup analysis are consistent with the overall trial results. Bivalirudin resulted in significantly lower rates of the primary outcome and major bleeding regardless of routine or bailout only use of GPI.”
Principal investigator of the EUROMAX trial Professor P. Gabriel Steg, MD, of Hôpital Bichat in Paris said, "The results of this pre-specified subgroup analysis are in keeping with the overall trial results and provide evidence that the reductions in the primary endpoint and protocol major bleeding seen with bivalirudin over heparin are consistent regardless of the use of GPI. However, the 1% absolute increase in acute stent thrombosis observed in the overall EUROMAX trial was also seen in this pre-specified analysis.”
About Angiox/Angiomax
In the United States, bivalirudin is marketed under the trade name Angiomax® and is indicated in patients undergoing PCI with provisional use of GPI and in patients with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI. In addition, Angiomax is also indicated for use as an anticoagulant in patients with UA undergoing percutaneous transluminal coronary angioplasty (PTCA). Angiomax is intended for use with aspirin. Angiomax is not approved for use in patients with acute coronary syndromes (ACS) not undergoing PCI or PTCA. Please see full prescribing information for Angiomax, available at http://www.angiomax.com.
In Europe, bivalirudin is marketed under the trade name Angiox® and is indicated as an anticoagulant for adult patients undergoing PCI, including patients with STEMI undergoing primary PCI. Angiox is also indicated for the treatment of adult patients with unstable angina/non-ST segment elevation MI planned for urgent or early intervention. Please see full prescribing information available at http://www.angiox.com.
In clinical trials comparing Angiomax and heparin, the most common adverse reaction for Angiomax was bleeding (28%). Other common adverse reactions were headache, thrombocytopenia and fever. An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic event and cessation of Angiomax administration. Angiomax should be used with caution in patients with disease states associated with an increased risk of bleeding.
In gamma brachytherapy, an increased risk of thrombus formation, including fatal outcomes, has been associated with the use of Angiomax. Angiomax is contraindicated in patients with active major bleeding or hypersensitivity to Angiomax or its components.
About EUROMAX
EUROMAX (EUROpean aMbulance Acs angioX trial) was a 2,218 randomized, controlled, open label, international, multicenter study that compared early administration of bivalirudin, which is marketed as Angiox in the European Union, and Angiomax in the US, to heparins with or without glycoprotein inhibitors (GPI). Patients with ST-segment elevation myocardial infarction (STEMI) who were being transported for primary PCI received either bivalirudin or unfractionated or low-molecular-weight heparin with optional GPI (control group). At 30 days, the primary outcome was a composite of death or major bleeding not associated with coronary-artery bypass grafting (CABG), and the principal secondary outcome was a composite of death, reinfarction, or non-CABG major bleeding. Patients who were assigned to the bivalirudin group received a bolus of 0.75 mg per kilogram, followed by an infusion of 1.75 mg per kilogram per hour, which should be continued for at least 4 hours after PCI. The protocol also specified that the dose during the post-PCI interval should be 0.25 mg per kilogram per hour; however, continuation of the higher dose used during PCI was also permitted. Bailout use of a GPI was allowed in the event of giant thrombus or no-reflow.
About The Medicines Company
The Medicines Company's purpose is to save lives, alleviate suffering and contribute to the economics of healthcare by focusing on 3000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: acute cardiovascular care, surgery and perioperative care, and serious infection disease care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, NJ, USA and Zurich, Switzerland.
Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates" and "expects" and similar expressions, are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include whether physicians, patients and other key decision makers will accept clinical trial results and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Quarterly Report on Form 10-Q filed with the SEC on May 12, 2014, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
Contacts
The Medicines Company
Neera Dahiya Ravindran, MD, +1-973-290-6044
Vice President, Investor Relations & Strategic Planning
neera.ravindran@themedco.com
Permalink: http://me-newswire.net/news/11066/en
Posted by
Business Daily Africa
ASQ Recognizes Companies for Creative and Innovative Solutions That Save Money, Improve Quality
MILWAUKEE. - Friday, May 23rd 2014 [ME NewsWire]
(BUSINESS WIRE) United Arab Emirates’ Dubai Aluminium and Argentina’s Tgestiona were awarded gold-level status at ASQ’s International Team Excellence Awards for increasing quality and financial savings for their organizations.
ASQ recently announced the gold-level winners — along with silver-level and bronze-level winners — at its World Conference on Quality and Improvement in Dallas, Texas, USA. In its 29th year, 38 finalist teams from 14 countries competed for gold, silver and bronze status.
The ITEA process is the only one of its kind that recognizes organizations worldwide for successfully deploying quality team-based process improvement. The ITEA criteria provide a framework to enable teams to efficiently contribute to overall organizational improvement efforts.
Since 1985, more than 1,050 organizations of all sizes have showcased proven results with long-term implications, resulting in cost savings of millions of dollars.
Gold, silver and bronze awards are presented to teams that achieve minimum scores in each awards level. Teams are judged during Quality Impact Sessions at ASQ’s WCQI, where teams demonstrate real-life applications and success of quality processes.
Dubai Aluminium’s Stub Repair Reduction Team used quality tools and methodologies to decrease repair costs by reducing product damage, resulting in an annual savings of US$1.3 million.
Tgestiona’s Matter of Time Team, based in Buenos Aires, used Six Sigma to address the process for handling customer access to the company’s systems. The results included reducing the error rate from 10 percent to 0.05 percent, and reducing processing time from 26 days to less than three.
Other teams recognized included:
Silver-Level:
Khazanah Nasional Berhad, Team Blitz, Kuala Lumpur, Malaysia
Bronze-level:
Genpact, Transforming Order to Cash Process, Johannesburg, South Africa
Max Life Insurance Co. Ltd., Proactive Retention Team, Gurgaon, Haryana, India
Shanghai Johnson Controls Yanfeng Seating Mechanisms Co., Ltd., JCYM Continuous Improvement Team, Shanghai, China
Volkswagen Argentina — Córdoba Plant, Contact Zone, Córdoba, Argentina
To learn more about the teams’ award-winning projects, visit http://ow.ly/x717l.
To aid organizations in achieving performance excellence, ASQ will be offering a training and coaching program designed around the ITEA criteria. The training program will help organizations worldwide develop and sustain high performing teams. For more information on this unique training and coaching opportunity, e-mail Kevin Braley at kbraley@asq.org.
For information on how to participate in the 2014–2015 ITEA process, of which intent to submit forms are due July 1, visit wcqi.asq.org or e-mail gbalagopal@asq.org.
About ASQ
ASQ is a global community of people dedicated to quality who share the ideas and tools that make our world work better. ASQ has the reputation and reach to bring together the diverse quality champions who are transforming the world’s corporations, organizations and communities to meet tomorrow’s critical challenges. ASQ is headquartered in Milwaukee, Wis., with national service centers in China, India, Mexico and a regional service center in the United Arab Emirates. Learn more about ASQ’s members, mission, technologies and training at asq.org.
Contacts
ASQ
Kevin Braley
414-272-8575 Ext.7587
800-248-1946
kbraley@asq.org
Permalink: http://www.me-newswire.net/news/11074/en
(BUSINESS WIRE) United Arab Emirates’ Dubai Aluminium and Argentina’s Tgestiona were awarded gold-level status at ASQ’s International Team Excellence Awards for increasing quality and financial savings for their organizations.
ASQ recently announced the gold-level winners — along with silver-level and bronze-level winners — at its World Conference on Quality and Improvement in Dallas, Texas, USA. In its 29th year, 38 finalist teams from 14 countries competed for gold, silver and bronze status.
The ITEA process is the only one of its kind that recognizes organizations worldwide for successfully deploying quality team-based process improvement. The ITEA criteria provide a framework to enable teams to efficiently contribute to overall organizational improvement efforts.
Since 1985, more than 1,050 organizations of all sizes have showcased proven results with long-term implications, resulting in cost savings of millions of dollars.
Gold, silver and bronze awards are presented to teams that achieve minimum scores in each awards level. Teams are judged during Quality Impact Sessions at ASQ’s WCQI, where teams demonstrate real-life applications and success of quality processes.
Dubai Aluminium’s Stub Repair Reduction Team used quality tools and methodologies to decrease repair costs by reducing product damage, resulting in an annual savings of US$1.3 million.
Tgestiona’s Matter of Time Team, based in Buenos Aires, used Six Sigma to address the process for handling customer access to the company’s systems. The results included reducing the error rate from 10 percent to 0.05 percent, and reducing processing time from 26 days to less than three.
Other teams recognized included:
Silver-Level:
Khazanah Nasional Berhad, Team Blitz, Kuala Lumpur, Malaysia
Bronze-level:
Genpact, Transforming Order to Cash Process, Johannesburg, South Africa
Max Life Insurance Co. Ltd., Proactive Retention Team, Gurgaon, Haryana, India
Shanghai Johnson Controls Yanfeng Seating Mechanisms Co., Ltd., JCYM Continuous Improvement Team, Shanghai, China
Volkswagen Argentina — Córdoba Plant, Contact Zone, Córdoba, Argentina
To learn more about the teams’ award-winning projects, visit http://ow.ly/x717l.
To aid organizations in achieving performance excellence, ASQ will be offering a training and coaching program designed around the ITEA criteria. The training program will help organizations worldwide develop and sustain high performing teams. For more information on this unique training and coaching opportunity, e-mail Kevin Braley at kbraley@asq.org.
For information on how to participate in the 2014–2015 ITEA process, of which intent to submit forms are due July 1, visit wcqi.asq.org or e-mail gbalagopal@asq.org.
About ASQ
ASQ is a global community of people dedicated to quality who share the ideas and tools that make our world work better. ASQ has the reputation and reach to bring together the diverse quality champions who are transforming the world’s corporations, organizations and communities to meet tomorrow’s critical challenges. ASQ is headquartered in Milwaukee, Wis., with national service centers in China, India, Mexico and a regional service center in the United Arab Emirates. Learn more about ASQ’s members, mission, technologies and training at asq.org.
Contacts
ASQ
Kevin Braley
414-272-8575 Ext.7587
800-248-1946
kbraley@asq.org
Permalink: http://www.me-newswire.net/news/11074/en
Posted by
Business Daily Africa
eBay Inc. To Ask eBay Users To Change Passwords
ME Newswire / Businesswire
SAN JOSE, Calif. - Thursday, May 22nd 2014
eBay Inc. (Nasdaq: EBAY) said beginning later today it will be asking eBay users to change their passwords because of a cyberattack that compromised a database containing encrypted passwords and other non-financial data. After conducting extensive tests on its networks, the company said it has no evidence of the compromise resulting in unauthorized activity for eBay users, and no evidence of any unauthorized access to financial or credit card information, which is stored separately in encrypted formats. However, changing passwords is a best practice and will help enhance security for eBay users.
Information security and customer data protection are of paramount importance to eBay Inc., and eBay regrets any inconvenience or concern that this password reset may cause our customers. We know our customers trust us with their information, and we take seriously our commitment to maintaining a safe, secure and trusted global marketplace.
Cyberattackers compromised a small number of employee log-in credentials, allowing unauthorized access to eBay's corporate network, the company said. Working with law enforcement and leading security experts, the company is aggressively investigating the matter and applying the best forensics tools and practices to protect customers.
The database, which was compromised between late February and early March, included eBay customers’ name, encrypted password, email address, physical address, phone number and date of birth. However, the database did not contain financial information or other confidential personal information. The company said that the compromised employee log-in credentials were first detected about two weeks ago. Extensive forensics subsequently identified the compromised eBay database, resulting in the company’s announcement today.
The company said it has seen no indication of increased fraudulent account activity on eBay. The company also said it has no evidence of unauthorized access or compromises to personal or financial information for PayPal users. PayPal data is stored separately on a secure network, and all PayPal financial information is encrypted.
Beginning later today, eBay users will be notified via email, site communications and other marketing channels to change their password. In addition to asking users to change their eBay password, the company said it also is encouraging any eBay user who utilized the same password on other sites to change those passwords, too. The same password should never be used across multiple sites or accounts.
About eBay Inc.
eBay Inc. (NASDAQ: EBAY) is a global commerce and payments leader, providing a robust platform where merchants of all sizes can compete and win. Founded in 1995 in San Jose, Calif., eBay Inc. connects millions of buyers and sellers and enabled $205 billion* of commerce volume in 2013. We do so through eBay, one of the world's largest online marketplaces, which allows users to buy and sell in nearly every country on earth; through PayPal, which enables individuals and businesses to securely, easily and quickly send and receive digital payments; and through eBay Enterprise, which enables omnichannel commerce, multichannel retailing and digital marketing for global enterprises in the U.S. and internationally. We also reach millions through specialized marketplaces such as StubHub, the world's largest ticket marketplace, and eBay classifieds sites, which together have a presence in more than 1,000 cities around the world. For more information about the company and its global portfolio of online brands, visit www.ebayinc.com.
* This adjusted number reflects decision to remove vehicles and real estate GMV from ongoing total GMV and ECV metrics (previously stated ECV for 2013 was $212 billion, incorporating vehicles and real estate GMV).
Contacts
eBay Inc.
Investor Relations Contact:
Tracey Ford
tford@ebay.com
Tom Hudson
thhudson@ebay.com
Media Relations Contact:
Amanda Miller
press@ebay.com
Investor Information Request:
408-376-7493
Company News:
http://www.ebayinc.com/news
Investor Relations website:
http://investor.ebayinc.com
Permalink: http://me-newswire.net/news/11063/en
SAN JOSE, Calif. - Thursday, May 22nd 2014
eBay Inc. (Nasdaq: EBAY) said beginning later today it will be asking eBay users to change their passwords because of a cyberattack that compromised a database containing encrypted passwords and other non-financial data. After conducting extensive tests on its networks, the company said it has no evidence of the compromise resulting in unauthorized activity for eBay users, and no evidence of any unauthorized access to financial or credit card information, which is stored separately in encrypted formats. However, changing passwords is a best practice and will help enhance security for eBay users.
Information security and customer data protection are of paramount importance to eBay Inc., and eBay regrets any inconvenience or concern that this password reset may cause our customers. We know our customers trust us with their information, and we take seriously our commitment to maintaining a safe, secure and trusted global marketplace.
Cyberattackers compromised a small number of employee log-in credentials, allowing unauthorized access to eBay's corporate network, the company said. Working with law enforcement and leading security experts, the company is aggressively investigating the matter and applying the best forensics tools and practices to protect customers.
The database, which was compromised between late February and early March, included eBay customers’ name, encrypted password, email address, physical address, phone number and date of birth. However, the database did not contain financial information or other confidential personal information. The company said that the compromised employee log-in credentials were first detected about two weeks ago. Extensive forensics subsequently identified the compromised eBay database, resulting in the company’s announcement today.
The company said it has seen no indication of increased fraudulent account activity on eBay. The company also said it has no evidence of unauthorized access or compromises to personal or financial information for PayPal users. PayPal data is stored separately on a secure network, and all PayPal financial information is encrypted.
Beginning later today, eBay users will be notified via email, site communications and other marketing channels to change their password. In addition to asking users to change their eBay password, the company said it also is encouraging any eBay user who utilized the same password on other sites to change those passwords, too. The same password should never be used across multiple sites or accounts.
About eBay Inc.
eBay Inc. (NASDAQ: EBAY) is a global commerce and payments leader, providing a robust platform where merchants of all sizes can compete and win. Founded in 1995 in San Jose, Calif., eBay Inc. connects millions of buyers and sellers and enabled $205 billion* of commerce volume in 2013. We do so through eBay, one of the world's largest online marketplaces, which allows users to buy and sell in nearly every country on earth; through PayPal, which enables individuals and businesses to securely, easily and quickly send and receive digital payments; and through eBay Enterprise, which enables omnichannel commerce, multichannel retailing and digital marketing for global enterprises in the U.S. and internationally. We also reach millions through specialized marketplaces such as StubHub, the world's largest ticket marketplace, and eBay classifieds sites, which together have a presence in more than 1,000 cities around the world. For more information about the company and its global portfolio of online brands, visit www.ebayinc.com.
* This adjusted number reflects decision to remove vehicles and real estate GMV from ongoing total GMV and ECV metrics (previously stated ECV for 2013 was $212 billion, incorporating vehicles and real estate GMV).
Contacts
eBay Inc.
Investor Relations Contact:
Tracey Ford
tford@ebay.com
Tom Hudson
thhudson@ebay.com
Media Relations Contact:
Amanda Miller
press@ebay.com
Investor Information Request:
408-376-7493
Company News:
http://www.ebayinc.com/news
Investor Relations website:
http://investor.ebayinc.com
Permalink: http://me-newswire.net/news/11063/en
Posted by
Business Daily Africa
Turkish Airlines’ Innovative Partnership with BNP Paribas Group Recognized as “Tax Lease Deal of the Year 2013”
ME NewsWire/Business Wire
ISTANBUL - Friday, May 23rd 2014
Turkish Airlines, recently voted Europe’s best airline for the third consecutive year, has successfully completed another outstanding and innovative deal with one of its major business partners, BNP Paribas Group. The international carrier, which flies to 250 destinations worldwide, in more countries than any other airline, has been globally awarded for “Tax Lease Deal of the Year 2013” by Airfinance Journal –distributed in New York on May 22, 2014.
Turkish Airlines’ award-winning deal included two Airbus A330 aircrafts which have been financed by Development Bank of Japan (DBJ), and was arranged by BNP Paribas under Japanese Operating Lease with a Call Option. The deal is also combined with the European Export Credit Agencies’ (EECA) guaranteed bank debt (ECA JOLCO) structure.
Turkish Airlines had mandated BNP Paribas as lead arranger and lender of an ECA JOLCO financing structure for two Airbus A330 aircrafts delivered on November 20 and December 3, 2013, respectively. This transaction features a unique combination through a 12 year, 11 month Japanese Equity and a bank debt guaranteed by EECA, fronted by Euler Hermes, the German Export Credit Agency.
Turkish Airlines and BNP arranged a deal for the first time in 2011 that included a single A319 aircraft, and then in 2013, expanded the partnership to consist of two widebody A330 aircrafts. Together, along with the other JOLCOs, including commercial bank debt, three B737-800 aircrafts were negotiated again in 2013 by BNP Paribas. This deal stands as one of the largest JOLCO deals ever arranged and is ultimately a landmark transaction in terms of volume and ability to source a large number of Japanese equity providers, and also lenders with very attractive pricings on both sides. While not all airlines are eligible to enter to the JOLCO market, this is a 100 percent financing unlike any other alternative in the current aircraft financing market.
Another characteristic of the deal is the cash flow structure being arranged in Japanese Yen (JPY) currency. This allows Turkish Airlines to naturally hedge its currency risk by matching its excess JPY revenues by JPY lease payments without using any other derivative instrument.
Turkish Airlines has been awarded aircraft debt deals of the year in Europe several times in the past, by Jane’s Transport Finance, Global Transport Finance and Airfinance Journal in 2006, 2008, 2011 and 2012.
About Turkish Airlines:
Established in 1933 with a fleet of five aircraft, Star Alliance member Turkish Airlines is a 4-star airline today with a fleet of 250 (passenger and cargo) aircraft flying to 250 destinations worldwide with 207 international and 43 domestic. According to Skytrax survey of 2013, Turkish Airlines was chosen "Europe's Best Airline" for the third and "Best Airline in Southern Europe" for the fourth consecutive time. Having won in 2010 the world's "Best Economy Catering Service" award, Turkish Airlines was this year awarded the world's "Best Business Catering Service" prize in the Skytrax survey. More information about Turkish Airlines can be found on their website: www.turkishairlines.com.
About Star Alliance:
Turkish Airlines is a member of the airline alliance, Star Alliance which was established in 1997 as the first truly global airline alliance to offer worldwide reach, recognition and seamless service to the international traveller. Its acceptance by the market has been recognized by numerous awards, including the Air Transport World Market Leadership Award and Best Airline Alliance by both Business Traveller Magazine and Skytrax. The member airlines are: Adria Airways, Aegean Airlines, Air Canada, Air China, Air New Zealand, ANA, Asiana Airlines, Austrian, Avianca, Brussels Airlines, Copa Airlines, Croatia Airlines, EGYPTAIR, Ethiopian Airlines, EVA Air, LOT Polish Airlines, Lufthansa, Scandinavian Airlines, Shenzhen Airlines, Singapore Airlines, South African Airways, SWISS, TAP Portugal, THAI and United. Air India has been announced as a future member airline with Avianca Brazil to join under the existing Avianca membership. Overall, the Star Alliance network offers more than 18,000 daily flights to 1,269 airports in 193 countries.
Contacts
For Turkish Airlines
Audrey Sahl, 646-561-8508
Audrey@alpaytac.com
Permalink: http://www.me-newswire.net/news/11075/en
ISTANBUL - Friday, May 23rd 2014
Turkish Airlines, recently voted Europe’s best airline for the third consecutive year, has successfully completed another outstanding and innovative deal with one of its major business partners, BNP Paribas Group. The international carrier, which flies to 250 destinations worldwide, in more countries than any other airline, has been globally awarded for “Tax Lease Deal of the Year 2013” by Airfinance Journal –distributed in New York on May 22, 2014.
Turkish Airlines’ award-winning deal included two Airbus A330 aircrafts which have been financed by Development Bank of Japan (DBJ), and was arranged by BNP Paribas under Japanese Operating Lease with a Call Option. The deal is also combined with the European Export Credit Agencies’ (EECA) guaranteed bank debt (ECA JOLCO) structure.
Turkish Airlines had mandated BNP Paribas as lead arranger and lender of an ECA JOLCO financing structure for two Airbus A330 aircrafts delivered on November 20 and December 3, 2013, respectively. This transaction features a unique combination through a 12 year, 11 month Japanese Equity and a bank debt guaranteed by EECA, fronted by Euler Hermes, the German Export Credit Agency.
Turkish Airlines and BNP arranged a deal for the first time in 2011 that included a single A319 aircraft, and then in 2013, expanded the partnership to consist of two widebody A330 aircrafts. Together, along with the other JOLCOs, including commercial bank debt, three B737-800 aircrafts were negotiated again in 2013 by BNP Paribas. This deal stands as one of the largest JOLCO deals ever arranged and is ultimately a landmark transaction in terms of volume and ability to source a large number of Japanese equity providers, and also lenders with very attractive pricings on both sides. While not all airlines are eligible to enter to the JOLCO market, this is a 100 percent financing unlike any other alternative in the current aircraft financing market.
Another characteristic of the deal is the cash flow structure being arranged in Japanese Yen (JPY) currency. This allows Turkish Airlines to naturally hedge its currency risk by matching its excess JPY revenues by JPY lease payments without using any other derivative instrument.
Turkish Airlines has been awarded aircraft debt deals of the year in Europe several times in the past, by Jane’s Transport Finance, Global Transport Finance and Airfinance Journal in 2006, 2008, 2011 and 2012.
About Turkish Airlines:
Established in 1933 with a fleet of five aircraft, Star Alliance member Turkish Airlines is a 4-star airline today with a fleet of 250 (passenger and cargo) aircraft flying to 250 destinations worldwide with 207 international and 43 domestic. According to Skytrax survey of 2013, Turkish Airlines was chosen "Europe's Best Airline" for the third and "Best Airline in Southern Europe" for the fourth consecutive time. Having won in 2010 the world's "Best Economy Catering Service" award, Turkish Airlines was this year awarded the world's "Best Business Catering Service" prize in the Skytrax survey. More information about Turkish Airlines can be found on their website: www.turkishairlines.com.
About Star Alliance:
Turkish Airlines is a member of the airline alliance, Star Alliance which was established in 1997 as the first truly global airline alliance to offer worldwide reach, recognition and seamless service to the international traveller. Its acceptance by the market has been recognized by numerous awards, including the Air Transport World Market Leadership Award and Best Airline Alliance by both Business Traveller Magazine and Skytrax. The member airlines are: Adria Airways, Aegean Airlines, Air Canada, Air China, Air New Zealand, ANA, Asiana Airlines, Austrian, Avianca, Brussels Airlines, Copa Airlines, Croatia Airlines, EGYPTAIR, Ethiopian Airlines, EVA Air, LOT Polish Airlines, Lufthansa, Scandinavian Airlines, Shenzhen Airlines, Singapore Airlines, South African Airways, SWISS, TAP Portugal, THAI and United. Air India has been announced as a future member airline with Avianca Brazil to join under the existing Avianca membership. Overall, the Star Alliance network offers more than 18,000 daily flights to 1,269 airports in 193 countries.
Contacts
For Turkish Airlines
Audrey Sahl, 646-561-8508
Audrey@alpaytac.com
Permalink: http://www.me-newswire.net/news/11075/en
Posted by
Business Daily Africa
Sunday, May 25, 2014
Panasonic Brings Together Power Semiconductor Tech in Europe
OSAKA, Japan - Friday, May 23rd 2014 [ME NewsWire]
(BUSINESS WIRE)-- From May 20 to 22, 2014, the industry's international key players were meeting at PCIM, Power Conversion Intelligent Motion in Nuremberg, Germany. The PCIM is Europe's leading meeting point for specialists in Power Electronics and its appliances in Intelligent Motion, Renewable Energy and Energy Management. Panasonic exhibits its advanced Power Devices and solutions and is challenging to expand and further develop its sales channels in Europe.
With increasing environmental issues and a rapid decrease in non-renewable energy resources such as oil - energy saving became a worldwide priority. The role of power supplies for electrical systems in energy conservation is becoming a major part of the solution. Power devices used in electrical energy conversion and control systems that consume tremendous amounts of power during operations are especially regarded as the key devices to "save energy". It is therefore important to optimize the efficiency of these devices to minimize the energy loss during their operation.
>> Watch a video report
As from October 2014, Panasonic will start a new organization: Automotive & Industrial Systems Europe. In the European Market Panasonic contributes to the progress of home appliances, automotive solutions as well as house and town management systems. Don't miss Panasonic with its forward-looking industrial device technologies and solutions.
Related Links:
Panasonic's Industrial Devices & Solutions Panasonic PCIM 2014 Booth info Videos: Electronic Devices - Channel Panasonic Automotive & Industrial Systems Company Panasonic News Portal
Contacts
Panasonic Corporation
Global Communication Group
Public Relations Office
+81-3-3574-5729
presscontact@ml.jp.panasonic.com
Permalink: http://me-newswire.net/news/11073/en
(BUSINESS WIRE)-- From May 20 to 22, 2014, the industry's international key players were meeting at PCIM, Power Conversion Intelligent Motion in Nuremberg, Germany. The PCIM is Europe's leading meeting point for specialists in Power Electronics and its appliances in Intelligent Motion, Renewable Energy and Energy Management. Panasonic exhibits its advanced Power Devices and solutions and is challenging to expand and further develop its sales channels in Europe.
With increasing environmental issues and a rapid decrease in non-renewable energy resources such as oil - energy saving became a worldwide priority. The role of power supplies for electrical systems in energy conservation is becoming a major part of the solution. Power devices used in electrical energy conversion and control systems that consume tremendous amounts of power during operations are especially regarded as the key devices to "save energy". It is therefore important to optimize the efficiency of these devices to minimize the energy loss during their operation.
>> Watch a video report
As from October 2014, Panasonic will start a new organization: Automotive & Industrial Systems Europe. In the European Market Panasonic contributes to the progress of home appliances, automotive solutions as well as house and town management systems. Don't miss Panasonic with its forward-looking industrial device technologies and solutions.
Related Links:
Panasonic's Industrial Devices & Solutions Panasonic PCIM 2014 Booth info Videos: Electronic Devices - Channel Panasonic Automotive & Industrial Systems Company Panasonic News Portal
Contacts
Panasonic Corporation
Global Communication Group
Public Relations Office
+81-3-3574-5729
presscontact@ml.jp.panasonic.com
Permalink: http://me-newswire.net/news/11073/en
Posted by
Business Daily Africa
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