CHMP Recommends EU Approval of VIZAMYL™ (Flutemetamol F18 Injection) for PET Imaging of Beta Amyloid Plaque

PET Imaging Agent Receives Positive Opinion

ME NewsWire/Business Wire

CHALFONT ST. GILES, England. - Tuesday, July 1st 2014

GE Healthcare today announced the receipt of a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). This opinion recommends the granting of a marketing authorisation for VIZAMYL™ (Flutemetamol F18 injection), a radiopharmaceutical medicinal product indicated for Positron Emission Tomography (PET) imaging of beta amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive impairment. VIZAMYL™ is for diagnostic use only and should be used in conjunction with a clinical evaluation.

“The CHMP positive recommendation further strengthens GE Healthcare’s longstanding commitment to the early and accurate detection of AD pathology and to improving quality of life for patients and their caregivers,” said Kieran Murphy, President and CEO, Life Sciences, GE Healthcare. “When approved in the European Union, VIZAMYL will be an important tool to support assessments of patients with cognitive disorders, including AD.”

PET imaging with VIZAMYL detects the accumulation of beta amyloid in the brain, one of the pathological in-vivo markers of AD, and allows for visual interpretation of colour images. While VIZAMYL does not establish a diagnosis for AD or other cognitive disorders, it is a useful tool in conjunction with a clinical evaluation, and may have the potential to lead to earlier diagnosis and intervention in the future.

“AD is a major unmet medical need and the lack of diagnostic tools increases the potential for diagnostic uncertainty and the risk of mismanagement,” said Professor Philip Scheltens, Professor of Cognitive Neurology and Director of the Alzheimer Center at the VU University Medical Center, Amsterdam. “Once approved, VIZAMYL may help physicians to assess specific patients with suspected Alzheimer’s disease. This may help physicians determine appropriate treatment options, support patients and caregivers in planning for the future, and support clinical researchers in identifying patients for clinical trials.”

The CHMP positive opinion of VIZAMYL was based on review of pivotal and supportive data from a series of clinical trials, including several Phase III brain autopsy and biopsy studies which showed high sensitivity and specificity for visual interpretation of [18F]flutemetamol PET images, using beta amyloid pathology as the standard of truth.1,2 In October 2013, the U.S. Food and Drug Administration (FDA) approved VIZAMYL for PET imaging of the brain to estimate beta amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for AD or other causes of cognitive decline.

GE Healthcare has developed and validated an electronic reader training program (ETP) to instruct U.S.-based physicians in accurate interpretation of VIZAMYL images. Images should be interpreted only by readers who have completed the GE Healthcare electronic reader training program that will be made available free of charge to healthcare professionals who want to conduct and interpret VIZAMYL imaging. Upon VIZAMYL approval, online and in-person training will be available in the European Union.

GE’S COMMITMENT TO IMAGING RESEARCH

[18F]Flutemetamol is one component of a broad portfolio of investigational diagnostic solutions that GE Healthcare is currently developing in the neurology field. GE Healthcare is taking a comprehensive approach to understanding dementia and AD through its ongoing research to uncover the causes, risks, and physical effects of the disease. GE Healthcare offers a broad portfolio of imaging resources including cyclotrons and chemistry systems to manufacture PET imaging agents, PET and MR scanners to scan patients, and is developing image analysis software to provide quantification, optimized visualization and reporting tools.

Additionally, GE Healthcare is collaborating with the pharmaceutical industry to assist in their development of the next generation of therapies. To that end, we are working with potential partners in the industry to understand their strategic needs, and helping to provide imaging support for clinical trials of therapeutic agents.

ABOUT GE HEALTHCARE

GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE (NYSE: GE) works on things that matter - great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients.

For our latest news, please visit http://newsroom.gehealthcare.com

1 Ikonomovic M, Buckley C, Smith A et al. [18F]Flutemetamol injection PET images reflect brain amyloid levels. Data presented at Alzheimer's Association® International Conference 2012 (AAIC 2012), Vancouver, BC, Canada. 2 Wolk D, Gamez J, Sadowsky C et. al. Brain autopsy and in vivo cortical brain biopsy trials show a strong concordance between [18F]Flutemetamol PET and amyloid-β pathology. Poster presented at: 64th Annual Meeting of the American Academy of Neurology, April 21-28, 2012; New Orleans, LA.

Contacts

GE Healthcare

Scott Lerman

+1 609 514 6346 (office)

+1 609 937 9253 (mobile)

scott.lerman@ge.com









Permalink: http://www.me-newswire.net/news/11494/en

airweave Supplies Mattress Toppers to Players of the Brazilian National Football Team During the Final Tournament in 2014

NUKATA, Japan - Tuesday, July 1st 2014 [ME NewsWire]

(BUSINESS WIRE)-- airweave, the top-selling brand for premium bedding toppers and pillows, has contributed to a higher quality sleep to the players of the Brazilian National Football team. airweave has supplied the entire team with its highly resilient portable mattress topper “airweave portable DUAL MODE” for use during the final tournament in 2014 in Brazil. The Brazilian team is the most successful national football team in the world by winning the world championship five times. A high quality sleep is important for everyone but is even more crucial for athletes, such as the Brazilian National Football players, who need effective rest to stay on top of their game. airweave is proud to be able to support these athletes.

About airweave

Founded in 2007, airweave, a premium bedding topper, has been offering comfortable support for the best possible quality sleep. The scientifically supported topper allows for more restful slumber through its ergonomic, breathable design, and high resilience which help users turn over more easily. airweave is enhancing the daily life and athletic performance of its users, which include:

    Several-National Olympic Delegations including the United States, Austria, France, Germany, Switzerland and Japan. Nearly 33% of the medaling athletes at the Sochi 2014 Olympic Winter Games were members of Olympic Teams to which airweave supplied bedding toppers;
    Top amateur and professional athletes around the globe, including two-time Masters Champion Bubba Watson, and LPGA Tour star Paula Creamer;
    All beds in the dormitory are furnished with airweave bedding toppers at the Paris Opera Ballet School, where airweave supports the sleep of its students;
    More than 500 students of IMG Academy whose residence hall features airweave bedding toppers. (Sleep research has been conducted at the academy to measure the effect of airweave bedding toppers on individual athletic performance.);
    First and business class passengers of Japan Air Lines international flights;
    Guests at high-end hotels, such as Four Seasons Hotel Tokyo at Marunouchi, The Ritz Carlton Shanghai Pudong, The Ritz-Carlton Beijing Financial Street and Park Hyatt Shanghai

For more information, visit airweave.com.

Key benefits of the airweave bedding topper

1. Highly resilient bedding material allows you to turn over more easily and maintain deeper sleep.

2. Excellent dispersion of body pressure prevents physical strain and minimizes peak pressure points.

3. Breathability of core material helps to dissipate heat and moisture generated by body during sleep.

4. Mattress cover and core material are easily washable with water.

Contacts

airweave inc.

Fumi Aramachi, +(81) 3 5511 2555

Global Marketing

global-marketing@airweave.jp

Seiko Instruments Launches New Automotive Voltage Detectors Capable of 125 Degree C Operation and 36V Input Voltage

- The S-19110x series enables direct detection of 12V lead–acid battery voltage, reducing Electronic Control Unit (ECU) current consumption -

CHIBA, Japan - Tuesday, July 1st 2014 [ME NewsWire]

(BUSINESS WIRE)-- Seiko Instruments Inc. (SII) launches new automotive voltage detectors, the S-19110 series, that are capable of 125 degree C operation and 36V input voltage while allowing for direct detection of 12V lead–acid battery voltage. Typical applications include ECUs for engines, transmissions and suspensions, Anti-lock Brake Systems, related Electric Vehicle equipment, and Hybrid Electric Vehicle and Plug-in Hybrid Electric Vehicle electronics.

Automotive ECU power supplies use 12V lead–acid batteries, and the power supply must be monitored to prevent ECU malfunctions caused by voltage fluctuations from the 12V lead–acid batteries. The new S-19110 Series’ high withstand voltage feature of 36V input and maximum rating of 45V, allows for direct voltage detection from 12V lead–acid batteries, while other detectors typically require an external resistor voltage divider to accomplish this. The S-19110 Series also reduces the current consumption from approximately 100uA from an external divider to under 2uA (Figure 1). In addition, unlike other typical voltage detectors, the S-19110 series positioned the ground pin away from the power supply pin, to help prevent the possibility of a short circuit between adjacent pins (Figure 2).

The S-19110 series was specifically developed to meet the demanding high quality requirements for automotive use, and will be AEC-Q100 certified. The S-19110 series has a wide operating temperature range from -40 to 125 degrees C, low current consumption of 600nA, and a voltage detection range of 3.0V to 10.0V available in 0.05V steps which can be set internally and requires no external parts. Two types are available for voltage detection: a VDD detection type and a SENSE detection type. The SENSE detection type has a SENSE pin in addition to a VDD pin, and the added SENSE pin allows stable output even when the SENSE pin voltage drops to 0V. The S-19110 series is offered in the lead (Pb)-free/halogen-free SOT-23-6 package.

Detailed information: http://datasheet.sii-ic.com/en/voltage_detector/S19110xxxA_E.pdf http://datasheet.sii-ic.com/en/voltage_detector/S19110xxxH_E.pdf

Please visit: English: http://www.sii-ic.com/en/ Simplified Chinese: http://www.sii-ic.com/cn/

About Seiko Instruments Inc. (SII) http://www.sii.co.jp/en/

Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50893958&lang=en

Contacts
Seiko Instruments Inc.
Yasuko Arai, +81-43-211-1111 (Japanese inquiry only)
Corporate Communications Dept.
pr@sii.co.jp
Online Inquiry: https://krs.bz/sii/m/sii_inquiry_en









Permalink: http://me-newswire.net/news/11501/en

GSMA Announces mHealth Partnership Across Sub-Saharan Africa

Inter-Industry Partnership to Connect Mobile and Health Industries, With a Focus on Maternal and Child Health in a Region With Over 15 Million Pregnant Woman

JOHANNESBURG, South Africa. - Tuesday, July 1st 2014 [ME NewsWire]
(BUSINESS WIRE) The GSMA today announced that its Mobile for Development mHealth programme has launched a new cross-ecosystem partnership designed to provide a range of mHealth services to women and children, with a particular focus on nutrition, across Sub-Saharan Africa. Initial launch partners for the initiative include Gemalto, Hello Doctor, Lifesaver, Mobenzi, Mobilium, MTN, Omega Diagnostics and Samsung. This programme could have far-reaching impact; according to GSMA Intelligence, there is a total annual, addressable market of 15.5 million pregnant women and mothers with children under five years of age.
“This new mobile ecosystem partnership, developed by the GSMA, is committed to connecting the mobile and health industries to develop commercially sustainable mHealth services that meet public health needs,” said Tom Phillips, Chief Regulatory Officer, GSMA. “The companies in this partnership are working to deliver the objectives of the United Nations Every Women Every Child Global Strategy, as well as the Global Nutrition for Growth Compact, in the areas of nutrition and maternal and child health. We call on mobile ecosystem players, health providers, governments, NGOs, civil society and others to work with us to launch life-saving mobile health services.”
The partners will jointly launch services in seven countries - Côte d’Ivoire, Ghana, Nigeria, Rwanda, South Africa, Uganda and Zambia - from September 2014. Phase two, which commences in 2015, will incorporate additional partners and services and will address four more countries: Kenya, Malawi, Mozambique and Tanzania. Collectively, the partnership will reduce barriers to handset ownership and connectivity for consumers and health workers by committing to:
Offer discounted Samsung handsets and tablets to consumers and health workers across Africa;
Provide access to the Samsung ecosystem (e.g. music, video and other value-added services) to be used as an incentive to drive health usage;
Pre-embed a Smart Health application that provides a range of professional applications, information and services on 80 million Samsung handsets;
Leverage existing and new MTN SIMs to allow free access to health content, health registration and data collection via the Smart Health application;
Provide simplified access to MTN mobile money, advertising and billing capabilities; and
Make innovative diagnostics like the Omega Diagnostics Visitect HIV CD4 point of care solution more affordable and accessible via mobile integration.
Through these commitments, the partners aim to simplify the relationships between mobile and health stakeholders, while maximising the ubiquitous nature of mobile technology and its capabilities for health providers and, ultimately, for patients. Health content, patient registration, data collection and critical diagnostics will increase the access to health care for vulnerable women and children across Africa, while providing the delivery mechanism for mHealth services that are commercially sustainable and scalable.
“This partnership heralds a new era in the delivery of health care in Sub-Saharan Africa, where currently access to even the most basic of health services remains the worst in the world. MTN is therefore proud to be part of this collaborative effort, which will deliver solutions that harnesses the expertise of some of the leading companies in the world, to improve access to health care for many of our customers across the seven launch countries,” said MTN Group Chief Commercial Officer, Pieter Verkade.
“Current lab based static diagnostics tools are unable to meet growing patients’ needs as countries step up their HIV treatment programs in conjunction with the decentralisation of CD4 testing. Multi-layer partnerships for mHealth smartphone applications are poised to become an essential foundation in the bridge to augment the continuum of care to the neediest patients, whilst also providing management information and real time surveillance data,” said Andrew Shepherd, Founder and Managing Director, Omega Diagnostics Ltd.
“Healthcare in Africa has benefited greatly from advancements in mobile technology. Simultaneously, the healthcare industry is moving towards a delivery model that is more patient-centered, value-based and accessible in even remote environments. In this regard, Samsung is perfectly positioned to add value to this digital evolution in healthcare, as our devices are both at the cutting edge of innovation and available widely across the continent. These capabilities provide the much needed healthcare support in Africa, ensuring that we are aligned with the Millennium Development Goals as set by the United Nations,” said Thabiet Allie, Head of Content and Services at Samsung Electronics Africa.
For more information please visit www.gsma.com/mobilefordevelopment/programmes/mhealth
-ENDS-
About the GSMA
The GSMA represents the interests of mobile operators worldwide. Spanning more than 220 countries, the GSMA unites nearly 800 of the world’s mobile operators with more than 250 companies in the broader mobile ecosystem, including handset makers, software companies, equipment providers and Internet companies, as well as organisations in industry sectors such as financial services, healthcare, media, transport and utilities. The GSMA also produces industry-leading events such as the Mobile World Congress and Mobile Asia Expo.


Contacts
For the GSMA
Charlie Meredith-Hardy
+44 7917 298428
CMeredith-Hardy@webershandwick.com

Jill Hamilton
+27 826 588 831
jhamilton@webershandwick.com

GSMA Press Office
press@gsma.com


Permalink: http://me-newswire.net/news/11497/en

Toshiba and GDF SUEZ Complete NuGen Deal Europe's Largest New Nuclear Energy Project

LONDON. - Tuesday, July 1st 2014 [ME NewsWire]

    Toshiba and GDF SUEZ complete NuGen deal
    The first of three Westinghouse AP1000® reactors targeted for operation in 2024
    Project to provide nearly seven percent of U.K.’s projected electricity requirements
    Project is forecast to create between 14,000 and 21,000 UK jobs.

(BUSINESS WIRE) Toshiba Corporation (TOKYO:6502) and GDF SUEZ have completed a deal that will boost development of the Moorside new nuclear power project on the West Cumbria coast in northwest England – the largest, single proposed nuclear power plant construction project in Europe.

The agreement sees Toshiba acquiring a 60-percent stake and GDF SUEZ retaining a 40-percent holding in NuGeneration Ltd (NuGen), the U.K.-based nuclear energy company that plans to build three Westinghouse AP1000 reactors in West Cumbria. Each reactor will take approximately four years to build. When fully operational, the Moorside site is expected to deliver around seven percent of the U.K.’s future electricity requirements.

A deal has also been concluded with the Nuclear Decommissioning Authority (NDA) on the extension of a land option agreement for the Moorside site.

The Moorside plant is targeted to come online in 2024. When fully operational, it will have a combined capacity of 3.4GW, enough to deliver power to six million homes. The project supports the U.K. Government’s low-carbon and energy security objectives at a time when existing power plants are retiring and low-carbon generation is required to meet national and international commitments. The Westinghouse AP1000 reactor — a pressurised water reactor — is licensed by the U.S. Nuclear Regulatory Commission. Currently, eight AP1000 reactors are under construction globally.

Before the final investment decision which is forecast to be taken by the end of 2018, NuGen will be undertaking a broad range of preparatory works, including regulatory, permitting and commercial activities. The management team’s focus in 2014 will be on site investigations, preliminary studies for site layouts and stakeholder engagement and preparation for stakeholder consultations.

With 40 years of owner and operator expertise in nuclear energy, GDF SUEZ will provide solid and proven skills as a nuclear power plant operator in all the activities that are vital throughout the lifecycle of a nuclear plant. Tractebel Engineering, a subsidiary of GDF SUEZ, will act as the owner’s engineer of NuGen. Its role will be to provide a range of engineering services from feasibility studies through construction, operation, maintenance and decommissioning.

Westinghouse intends to utilise its Springfields facility, a UK-licensed fuel manufacturing facility near Preston to manufacture the fuel for AP1000 reactors built in the UK, thereby securing indigenous fuel supply. The facility currently manufactures fuel for the entire U.K. fleet of advanced gas-cooled reactors, and pressurised water reactor fuel for export.

The global expertise and commitment of Toshiba, GDF SUEZ’s pioneering expertise as a European nuclear operator, and Westinghouse’s world-leading technology are a powerful combination that will make a significant contribution to energy security and long-term employment in the UK.

Commenting on the deal finalisation, Mr. Hisao Tanaka, President and CEO, Toshiba Corporation, said: “We welcome the closing of the contract, which reconfirms Toshiba’s, GDF SUEZ’ and Westinghouse’s commitment to build three AP1000 reactors at Moorside. We are confident this project will support the U.K. in meeting the challenges of securing a stable, affordable future energy supply and cutting CO2 emissions.”

GDF SUEZ Chairman and CEO, Gérard Mestrallet, stated: “The industrial partnership with Toshiba and Westinghouse and the pursuit of the NuGen project reflects GDF SUEZ’ nuclear strategy and ambitions. GDF SUEZ has a solid track record in developing and managing substantial energy projects around the world, in-depth knowledge of diverse market models and broad experience of all types of power generation, including nuclear energy. We wish to mention and recognize the U.K.’s strong strategic vision and political consensus which have enabled the framework designed to ensure a secure, low-carbon electricity generation future – with nuclear energy as part of it, while remaining attractive to investors.”

Westinghouse President and CEO Danny Roderick recognised the momentous occasion by saying: “Westinghouse is delighted that Europe’s largest AP1000 nuclear plant project to date will be constructed in the U.K., which already is home to one of our largest global operations. The local economy will reap many benefits as a result of this project, including calling upon the local supply chain, and creating thousands of skilled jobs. We commend the U.K. on its decision to move forward with safe, clean and affordable nuclear energy that will benefit the region for decades to come.”

About Toshiba

Toshiba Corporation, a Fortune Global 500 company, channels world-class capabilities in advanced electronic and electrical product and systems into five strategic business domains: Energy & Infrastructure, Community Solutions, Healthcare Systems & Services, Electronic Devices & Components, and Lifestyles Products & Services. Guided by the principles of The Basic Commitment of the Toshiba Group, “Committed to People, Committed to the Future”, Toshiba promotes global operations towards securing “Growth Through Creativity and Innovation”, and is contributing to the achievement of a world in which people everywhere live in safe, secure and comfortable society.

Founded in Tokyo in 1875, today’s Toshiba is at the heart of a global network of over 590 consolidated companies employing over 200,000 people worldwide, with annual sales surpassing 6.5 trillion yen (US$63 billion).

To find out more about Toshiba, visit www.toshiba.co.jp/index.htm

About GDF SUEZ GDF SUEZ develops its businesses (power, natural gas, energy services) around a model based on responsible growth to take up today’s major energy and environmental challenges: meeting energy needs, ensuring the security of supply, fighting against climate change and maximizing the use of resources. The Group provides highly efficient and innovative solutions to individuals, cities and businesses by relying on diversified gas-supply sources, flexible and low-emission power generation as well as unique expertise in four key sectors: independent power production, liquefied natural gas, renewable energy and energy efficiency services. GDF SUEZ employs 147,200 people worldwide and achieved revenues of €81,3 billion in 2013. The Group is listed on the Paris, Brussels and Luxembourg stock exchanges and is represented in the main international indices: CAC 40, BEL 20, DJ Euro Stoxx 50, Euronext 100, FTSE Eurotop 100, MSCI Europe and Euronext Vigeo (World 120, Eurozone 120, Europe 120 and France 20).

About Westinghouse Westinghouse Electric Company, a group company of Toshiba Corporation (TOKYO:6502), is the world's pioneering nuclear energy company and is a leading supplier of nuclear plant products and technologies to utilities throughout the world. Westinghouse supplied the world's first pressurized water reactor in 1957 in Shippingport, Pa., U.S. Today, Westinghouse technology is the basis for approximately one-half of the world's operating nuclear plants, including more than 50 percent of those in Europe. AP1000 is a trademark of Westinghouse Electric Company LLC. All rights reserved.

About NuGen NuGen is a UK nuclear company owned by Toshiba and GDF SUEZ. NuGen’s Moorside project focuses on the development of a new generation nuclear power station on land in West Cumbria, in the North West of England.

Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50896583&lang=en

Contacts

Toshiba Corporation

Midori Hara/Naomi Furuya, +81-3-3457-2100

PR & IR Office

media.relations@toshiba.co.jp



GDF SUEZ Press contact:

Tel France : +33 (0)1 44 22 24 35

Tel Belgium : +32 2 510 76 70

E-Mail : gdfsuezpress@gdfsuez.com

@gdfsuez

GDF SUEZ Investors relations contact:

Tel : +33 (0)1 44 22 66 29

E-Mail : ir@gdfsuez.com



Westinghouse Press Contact:

Westinghouse Europe, Middle East and Africa

Hans Korteweg

Communications Manager

+32 (0)2 645-7162 (office)

+32 (0)479-75-13-60 (mobile)

kortewh@westinghouse.com

Quintiles’ Second Quarter 2014 Earnings Call Scheduled for Thursday, July 31st

RESEARCH TRIANGLE PARK, N.C. - Tuesday, July 1st 2014 [ME NewsWire]

(BUSINESS WIRE) Quintiles Transnational Holdings Inc. (NYSE: Q) will release its financial results for the second quarter of 2014 prior to its quarterly earnings call on Thursday, July 31, 2014, at 8:00 a.m. EDT.

The conference call will be accessible, live via webcast, on the Investor Relations section of the Quintiles website at www.quintiles.com/investors. To participate via telephone, please dial +1 (855) 484-7367 in the United States or +1 (631) 259-7541 outside the United States, approximately 15 minutes before the scheduled start of the call.

An archived edition of the conference call will be available online at www.quintiles.com/investors after 1:00 p.m. EDT on Thursday, July 31st.

About Quintiles

Quintiles (NYSE: Q), a Fortune 500 company, is the world’s largest provider of biopharmaceutical development and commercial outsourcing services. With a network of more than 29,000 employees conducting business in approximately 100 countries, we helped develop or commercialize all of 2013’s top-100 best-selling drugs on the market. Quintiles applies the breadth and depth of our service offerings along with extensive therapeutic, scientific and analytics expertise to help our customers navigate an increasingly complex healthcare environment as they seek to improve efficiency and effectiveness in the delivery of better healthcare outcomes. To learn more about Quintiles, please visit www.quintiles.com

Click here to subscribe to Mobile Alerts for Quintiles.

Contacts

Quintiles

Phil Bridges, Media Relations (phil.bridges@quintiles.com)

+ 1-919-998-1653 (office) +1-919-457-6347 (mobile)



Karl Deonanan, Investor Relations (InvestorRelations@quintiles.com)

+1-919-998-2789







Permalink: http://www.me-newswire.net/news/11500/en

U.S. FDA Grants Breakthrough Therapy Designation to Pradaxa (dabigatran etexilate) Specific Investigational Antidote

INGELHEIM, Germany. - Monday, June 30th 2014 [ME NewsWire]

    Idarucizumab rapidly reverses anticoagulation induced with Pradaxa® and may broaden existing range of reversal options available to physicians in emergency situations1,2
   
    Previous results from study in healthy volunteers show antidote to be well-tolerated with immediate, complete and sustained effect1

(BUSINESS WIRE) For media outside of the U.S., the UK & Canada only

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to the investigational antidote idarucizumab* (a humanized antibody fragment), currently being studied as a specific antidote for the oral anticoagulant Pradaxa® (dabigatran etexilate).3

“In light of Boehringer Ingelheim’s core mission to provide value through innovation, we are pleased that the FDA has granted Breakthrough Therapy Designation to idarucizumab to help expedite its development,” said Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim. “It’s important to note that the positive efficacy and safety profile for Pradaxa® is well-documented in both clinical trials and real-world evaluations, which were all conducted in the absence of an antidote. The specific investigational antidote for Pradaxa®, which our scientists at Boehringer Ingelheim are developing, would give physicians an additional and highly targeted option beyond the already existing measures for treatment in case of certain emergency situations.”

The FDA established the Breakthrough Therapy Designation as a means to accelerate the development and review of drugs for serious or life-threatening conditions if preliminary clinical evidence indicates the therapy may demonstrate a substantial improvement over existing therapies on one or more clinically significant endpoints.4

Prior clinical research of the antidote in a healthy volunteer study with 145 participants has already demonstrated the potential of the antidote for immediate, complete and sustained reversal of the anticoagulant effect of dabigatran.1 In the placebo-controlled study, the antidote was well tolerated and did not cause any clinically relevant side effects.1 These aspects are especially valuable in clinical situations where rapid reversal of dabigatran-induced anticoagulation may be beneficial for patients taking Pradaxa®.

REVERSE-AD, a global patient study, is now underway to investigate the potential antidote in the clinical setting in patients taking Pradaxa® who have uncontrolled bleeding or require emergency procedures.3 The study will be open to eligible patients in more than 35 countries and at over 500 sites.3 This is the first time that an antidote under development for a novel oral anticoagulant is investigated in a study in patients.3

The antidote is still under investigation and has not yet been approved for clinical use.

* Idarucizumab is the recommended International Nonproprietary Name (INN).

~ENDS~

Please click on the link below for ‘Notes to Editors’ and ‘References’:

http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2014/30_june_2014_dabigatranetexilate.html

Contacts

Boehringer Ingelheim GmbH

Friederike Middeke

Phone: +49 6132 – 77 141575

Fax: +49 6132 – 77 6601

Email: press@boehringer-ingelheim.com

Twitter: http://twitter.com/Boehringer



More information

www.boehringer-ingelheim.com







Permalink: http://me-newswire.net/news/11498/en