SHENZHEN, China - Monday, March 24th 2014 [ME NewsWire]
(BUSINESS WIRE)-- Aeronautical Radio of Thailand Limited, a state enterprise under the Ministry of Transport and Communications of Thailand, recently announced that Hytera Communications Co., Ltd has won the contract to supply TETRA radios for Suvarnabhumi and Don Muang Airport in Bangkok, Thailand.
Aeronautical Radio of Thailand Limited (AEROTHAI), founded in 1948 by airlines with the consent of the Royal Thai Government, aims to provide air traffic control and aeronautical communication services for airline operations. AEROTHAI built an integrated TETRA system network covering Bangkok International Airports since 2007, and it was used by the ground crews and logistic company for daily operational communications.
Provided by AEROTHAI, Suvarnabhumi and Don Muang Airport in Bangkok, Thailand, among the top 15 busiest airports in the world, have been using Hytera TETRA radios since April 2013 for trial. The use of portable radios PT580H and mobile radios MT680 ensures more convenient and reliable communications for crews in airports. MT680 enables quick access to the TETRA network and roaming services, and the superior voice quality of PT580H is ideal for communications in the clamorous environment of airports. The outstanding performance of Hytera TETRA radios during the trial is critical for winning the contract of AEROTHAI. It is expected that more TETRA terminals from Hytera will be deployed in these two airports to facilitate their operation in 2014.
About Hytera
Founded in 1993 in Shenzhen, China, Hytera (SZ002583) is a key player in PMR (Professional Mobile Radio) communication industry with a large client base covering more than 80 countries and regions worldwide. Hytera values innovation and invests over 15% of its revenue in Research and Development, and is actively involved in developing global PMR standards. Hytera is one of the few radio communication providers that masters in all the three main stream digital standards, namely TETRA (Terrestrial Trunked Radio), DMR (Digital Mobile Radio) and PDT (Professional Digital Trunking).
Hytera’s global sales network includes 3 subsidiaries in the US, UK, and Germany, 14 branches and 8 offices. It responds to customers' needs immediately through the cooperation with over 600 partners across the world. Since its establishment, Hytera has set up over 1,000 professional wireless communication networks and provided solutions to more than 5 million clients.
Contacts
Hytera
Iris Wang, +86-755-26972999
iris.wang@hytera.com
www.hytera.com
Permalink: http://me-newswire.net/news/10424/en
Tuesday, March 25, 2014
Caledonian Bank Taps i2c for Debit Card Processing
i2c's global platform provides bank with advanced card processing and mobile capabilities
REDWOOD CITY, Calif - Tuesday, March 25th 2014 [ME NewsWire]
(BUSINESS WIRE)-- i2c, Inc., a provider of payment processing and emerging commerce solutions, today announced that Caledonian Bank Ltd., a division of Caledonian Global Financial Services Inc., is leveraging its global platform for next-generation card processing.
Founded in 1970, Caledonian provides high net worth individuals and corporations around the world with a full range of financial services, including banking, brokerage, wealth management and asset protection services. It was named Best Private Bank in 2013 by World Finance and Best Offshore Bank by Global Financial Review.
“Caledonian is guided by a set of core values – Integrity, Excellence and Leadership – which factored into our choice of payment processor. We chose i2c because they will be a partner in helping us uphold these values,” said Elljanna Dixon, Client Services Manager. “i2c's next-generation processing capabilities allow us to offer better features to our high-end client base, such as mobile apps, text alerts and more powerful cardholder websites.”
“Caledonian's discerning clientele rely on them to provide banking and financial services solutions of the highest quality. This means that their service delivery and product offerings need to be top notch,” said Miguel Cintron, vice president, Business Development, at i2c. “i2c's track record of 99.99% availability and robust processing capabilities will enable Caledonian to deliver the superior experience their clients expect.”
Caledonian is based in the Cayman Islands, with offices in Canada and the British Virgin Islands. i2c processes over $1.5 billion annually in the Latin America & Caribbean region.
About i2c, Inc.
From its Silicon Valley headquarters, i2c provides the infrastructure financial institutions, corporations, brands and governments around the world need to launch and profitably manage prepaid and next-generation commerce products. i2c's global, cloud-based platform supports virtually any prepaid, debit or credit program in plastic, virtual or mobile form. Clients on six continents use the i2c platform to build profitable, differentiated payment products and services that meet unique customer needs. For more information go to www.i2cinc.com.
Contacts
i2c, Inc.
Melissa Telli, +1 650-593-5400
Director of Marketing and Communications
marketing@i2cinc.com
REDWOOD CITY, Calif - Tuesday, March 25th 2014 [ME NewsWire]
(BUSINESS WIRE)-- i2c, Inc., a provider of payment processing and emerging commerce solutions, today announced that Caledonian Bank Ltd., a division of Caledonian Global Financial Services Inc., is leveraging its global platform for next-generation card processing.
Founded in 1970, Caledonian provides high net worth individuals and corporations around the world with a full range of financial services, including banking, brokerage, wealth management and asset protection services. It was named Best Private Bank in 2013 by World Finance and Best Offshore Bank by Global Financial Review.
“Caledonian is guided by a set of core values – Integrity, Excellence and Leadership – which factored into our choice of payment processor. We chose i2c because they will be a partner in helping us uphold these values,” said Elljanna Dixon, Client Services Manager. “i2c's next-generation processing capabilities allow us to offer better features to our high-end client base, such as mobile apps, text alerts and more powerful cardholder websites.”
“Caledonian's discerning clientele rely on them to provide banking and financial services solutions of the highest quality. This means that their service delivery and product offerings need to be top notch,” said Miguel Cintron, vice president, Business Development, at i2c. “i2c's track record of 99.99% availability and robust processing capabilities will enable Caledonian to deliver the superior experience their clients expect.”
Caledonian is based in the Cayman Islands, with offices in Canada and the British Virgin Islands. i2c processes over $1.5 billion annually in the Latin America & Caribbean region.
About i2c, Inc.
From its Silicon Valley headquarters, i2c provides the infrastructure financial institutions, corporations, brands and governments around the world need to launch and profitably manage prepaid and next-generation commerce products. i2c's global, cloud-based platform supports virtually any prepaid, debit or credit program in plastic, virtual or mobile form. Clients on six continents use the i2c platform to build profitable, differentiated payment products and services that meet unique customer needs. For more information go to www.i2cinc.com.
Contacts
i2c, Inc.
Melissa Telli, +1 650-593-5400
Director of Marketing and Communications
marketing@i2cinc.com
WASHINGTON - Monday, March 24th 2014 [ME NewsWire]
(BUSINESS WIRE)--- In a quarterly meeting March 20, the Overseas Private Investment Corporation’s (OPIC) Board of Directors approved two framework agreements that will align OPIC with Citi, the leading global bank, in sharing credit risk for development financing in overseas projects. The global risk-sharing frameworks cover both commercial lending and a new inclusive finance facility.
The two agreements provide OPIC’s guarantee of loans made by Citi to borrowers in OPIC-eligible countries around the world. Beginning in 2003, Citi and OPIC developed a Risk Sharing Program wherein OPIC provides a comprehensive partial guarantee for loans originated and extended by Citi in the emerging markets. During a decade-plus partnership, Citi and OPIC have executed 16 different frameworks totaling $2.8 billion in guarantee capacity.
Loans previously guaranteed by OPIC through Citibank have supported large-scale development projects in underserved regions to build the infrastructure necessary for growth as well as $290 million in funding to networks of microfinance lenders to foster the entrepreneurs who form the foundation of an emerging economy. These new framework agreements expand this successful partnership between OPIC and Citi with a $550 million global loan facility for eligible corporates and financial institutions and a $220 million loan facility for global inclusive finance.
“The cooperation we’re extending with Citi is one that has far-reaching effects in several aspects,” said Elizabeth Littlefield, OPIC’s President and CEO. “OPIC has a history of partnering with commercial lenders to enter emerging markets in places around the world. By putting OPIC’s guarantee behind Citi’s loans, borrowers in these markets will now have access to the crucial lending needed to propel societies and economies to the next level.”
“Citi is excited to expand our partnership with OPIC to further achieve common objectives in economic development and financial inclusion. The $220 million Inclusive Growth agreement will promote business development, expansion and access to finance, supporting a wide range of institutions and strategies to expand market access, secure more sustainable and inclusive supply chains, offering diverse financial services to small producers, distributors and underserved communities around the world”, said Bob Annibale, Global head of Microfinance and Community Development at Citi.
“We are pleased to further strengthen the collaboration with OPIC and support its mission; with the new agreements, OPIC and Citi will be in a position to support new developmental investments of Citi’s clients in many emerging countries around the world,” said Valentino Gallo, Managing Director and Global Head of Export & Agency Finance at Citi.
“Partnering with a proven global institution like Citi allows OPIC to act nimbly. We serve U.S. foreign policy aims and address development challenges in places around the world where Citi already operates. And our risk-sharing agreements today with Citi means OPIC can move more swiftly to achieve our goals,” Littlefield added.
About OPIC
OPIC is the U.S. Government’s development finance institution. It mobilizes private capital to help solve critical development challenges and in doing so, advances U.S. foreign policy. Because OPIC works with the U.S. private sector, it helps U.S. businesses gain footholds in emerging markets, catalyzing revenues, jobs and growth opportunities both at home and abroad. OPIC achieves its mission by providing investors with financing, guarantees, political risk insurance, and support for private equity investment funds.
Established as an agency of the U.S. Government in 1971, OPIC operates on a self-sustaining basis at no net cost to American taxpayers. OPIC services are available for new and expanding business enterprises in more than 150 countries worldwide. To date, OPIC has supported more than $200 billion of investment in over 4,000 projects, generated an estimated $76 billion in U.S. exports and supported more than 278,000 American jobs.
About Citi
Citi, the leading global bank, has approximately 200 million customer accounts and does business in more than 160 countries and jurisdictions. Citi provides consumers, corporations, governments and institutions with a broad range of financial products and services, including consumer banking and credit, corporate and investment banking, securities brokerage, transaction services, and wealth management.
Additional information may be found at http://www.citigroup.com | Twitter: @Citi | YouTube: http://www.youtube.com/citi | Blog: http://new.citi.com | Facebook:http://www.facebook.com/citi | LinkedIn: www.linkedin.com/company/citi.
Contacts
OPIC:
Charles Stadtlander, 202-336-8514
charles.stadtlander@opic.gov
Citi:
Danielle Romero-Apsilos, 212-816-2264
danielle.romeroapsilos@citi.com
Permalink: http://me-newswire.net/news/10426/en
(BUSINESS WIRE)--- In a quarterly meeting March 20, the Overseas Private Investment Corporation’s (OPIC) Board of Directors approved two framework agreements that will align OPIC with Citi, the leading global bank, in sharing credit risk for development financing in overseas projects. The global risk-sharing frameworks cover both commercial lending and a new inclusive finance facility.
The two agreements provide OPIC’s guarantee of loans made by Citi to borrowers in OPIC-eligible countries around the world. Beginning in 2003, Citi and OPIC developed a Risk Sharing Program wherein OPIC provides a comprehensive partial guarantee for loans originated and extended by Citi in the emerging markets. During a decade-plus partnership, Citi and OPIC have executed 16 different frameworks totaling $2.8 billion in guarantee capacity.
Loans previously guaranteed by OPIC through Citibank have supported large-scale development projects in underserved regions to build the infrastructure necessary for growth as well as $290 million in funding to networks of microfinance lenders to foster the entrepreneurs who form the foundation of an emerging economy. These new framework agreements expand this successful partnership between OPIC and Citi with a $550 million global loan facility for eligible corporates and financial institutions and a $220 million loan facility for global inclusive finance.
“The cooperation we’re extending with Citi is one that has far-reaching effects in several aspects,” said Elizabeth Littlefield, OPIC’s President and CEO. “OPIC has a history of partnering with commercial lenders to enter emerging markets in places around the world. By putting OPIC’s guarantee behind Citi’s loans, borrowers in these markets will now have access to the crucial lending needed to propel societies and economies to the next level.”
“Citi is excited to expand our partnership with OPIC to further achieve common objectives in economic development and financial inclusion. The $220 million Inclusive Growth agreement will promote business development, expansion and access to finance, supporting a wide range of institutions and strategies to expand market access, secure more sustainable and inclusive supply chains, offering diverse financial services to small producers, distributors and underserved communities around the world”, said Bob Annibale, Global head of Microfinance and Community Development at Citi.
“We are pleased to further strengthen the collaboration with OPIC and support its mission; with the new agreements, OPIC and Citi will be in a position to support new developmental investments of Citi’s clients in many emerging countries around the world,” said Valentino Gallo, Managing Director and Global Head of Export & Agency Finance at Citi.
“Partnering with a proven global institution like Citi allows OPIC to act nimbly. We serve U.S. foreign policy aims and address development challenges in places around the world where Citi already operates. And our risk-sharing agreements today with Citi means OPIC can move more swiftly to achieve our goals,” Littlefield added.
About OPIC
OPIC is the U.S. Government’s development finance institution. It mobilizes private capital to help solve critical development challenges and in doing so, advances U.S. foreign policy. Because OPIC works with the U.S. private sector, it helps U.S. businesses gain footholds in emerging markets, catalyzing revenues, jobs and growth opportunities both at home and abroad. OPIC achieves its mission by providing investors with financing, guarantees, political risk insurance, and support for private equity investment funds.
Established as an agency of the U.S. Government in 1971, OPIC operates on a self-sustaining basis at no net cost to American taxpayers. OPIC services are available for new and expanding business enterprises in more than 150 countries worldwide. To date, OPIC has supported more than $200 billion of investment in over 4,000 projects, generated an estimated $76 billion in U.S. exports and supported more than 278,000 American jobs.
About Citi
Citi, the leading global bank, has approximately 200 million customer accounts and does business in more than 160 countries and jurisdictions. Citi provides consumers, corporations, governments and institutions with a broad range of financial products and services, including consumer banking and credit, corporate and investment banking, securities brokerage, transaction services, and wealth management.
Additional information may be found at http://www.citigroup.com | Twitter: @Citi | YouTube: http://www.youtube.com/citi | Blog: http://new.citi.com | Facebook:http://www.facebook.com/citi | LinkedIn: www.linkedin.com/company/citi.
Contacts
OPIC:
Charles Stadtlander, 202-336-8514
charles.stadtlander@opic.gov
Citi:
Danielle Romero-Apsilos, 212-816-2264
danielle.romeroapsilos@citi.com
Permalink: http://me-newswire.net/news/10426/en
Monday, March 24, 2014
New Pradaxa ® Data to be Presented During the American College of Cardiology 's 63rd Annual Scientific Session
INGELHEIM, Germany - Monday, March 24th 2014 [ME NewsWire]
(BUSINESS WIRE) For media outside of the US, the UK & Canada only
Boehringer Ingelheim has today announced that new findings from ongoing Pradaxa® (dabigatran etexilate) research will be presented during the American College of Cardiology’s 63rd Annual Scientific Session (ACC.14) in Washington, USA, 29 – 31 March 2014. The data form part of Boehringer Ingelheim’s ongoing commitment to scientific innovation and advancing patient care.
Data from three separate company-sponsored Pradaxa®-related studies will be announced during the congress. The presentations will cover subgroup results from the pivotal RE-LY® trial, evaluating the use of Pradaxa® compared to warfarin in patients with atrial fibrillation and valvular heart disease*.1 An oral presentation will highlight new data from pre-clinical research into an investigational antidote for Pradaxa®.2 Furthermore, first data from GLORIA™-AF, one of the largest worldwide atrial fibrillation registries will be announced.3 The GLORIA™-AF registry programme is expected to provide meaningful knowledge on the global role and use of antithrombotic treatments in protecting patients with atrial fibrillation against the devastating effects of stroke.4
“The American College of Cardiology’s 63rd Annual Scientific Session provides a key opportunity to share new data with physicians to increase understanding of the latest developments in the field of anticoagulation,” said Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim. “At Boehringer Ingelheim we are proud of our commitment to driving research and innovation in the cardiovascular area. We hope this new data will support ongoing efforts to improve patient outcomes, especially in the area of stroke prevention in atrial fibrillation.”
Details of the Pradaxa® abstracts to be presented during the American College of Cardiology’s 63rd Annual Scientific Session can be found within the Scientific Programme, available at:
http://accscientificsession.cardiosource.org/~/media/Files/2014/02/ACC14/Arrhythmias%20and%20Clinical%20EP_022114_F.ashx
Additional information about Pradaxa® will be available at the Boehringer Ingelheim booth #3227 at the American College of Cardiology’s 63rd Annual Scientific Session.
*Pradaxa® is contra-indicated for patients with prosthetic heart valves
~ENDS~
Please click on the link below for ‘Notes to Editors’ and ‘References’:
http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2014/24_march_2014_dabigatranetexilate.html
Contacts
Boehringer Ingelheim
Corporate Communications
Media + PR
Julia Meyer-Kleinmann
Phone: +49 6132 – 77 8271
Fax: +49 6132 – 77 6601
Email: press@boehringer-ingelheim.com
More information
www.boehringer-ingelheim.com
Permalink: http://me-newswire.net/news/10432/en
(BUSINESS WIRE) For media outside of the US, the UK & Canada only
Boehringer Ingelheim has today announced that new findings from ongoing Pradaxa® (dabigatran etexilate) research will be presented during the American College of Cardiology’s 63rd Annual Scientific Session (ACC.14) in Washington, USA, 29 – 31 March 2014. The data form part of Boehringer Ingelheim’s ongoing commitment to scientific innovation and advancing patient care.
Data from three separate company-sponsored Pradaxa®-related studies will be announced during the congress. The presentations will cover subgroup results from the pivotal RE-LY® trial, evaluating the use of Pradaxa® compared to warfarin in patients with atrial fibrillation and valvular heart disease*.1 An oral presentation will highlight new data from pre-clinical research into an investigational antidote for Pradaxa®.2 Furthermore, first data from GLORIA™-AF, one of the largest worldwide atrial fibrillation registries will be announced.3 The GLORIA™-AF registry programme is expected to provide meaningful knowledge on the global role and use of antithrombotic treatments in protecting patients with atrial fibrillation against the devastating effects of stroke.4
“The American College of Cardiology’s 63rd Annual Scientific Session provides a key opportunity to share new data with physicians to increase understanding of the latest developments in the field of anticoagulation,” said Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim. “At Boehringer Ingelheim we are proud of our commitment to driving research and innovation in the cardiovascular area. We hope this new data will support ongoing efforts to improve patient outcomes, especially in the area of stroke prevention in atrial fibrillation.”
Details of the Pradaxa® abstracts to be presented during the American College of Cardiology’s 63rd Annual Scientific Session can be found within the Scientific Programme, available at:
http://accscientificsession.cardiosource.org/~/media/Files/2014/02/ACC14/Arrhythmias%20and%20Clinical%20EP_022114_F.ashx
Additional information about Pradaxa® will be available at the Boehringer Ingelheim booth #3227 at the American College of Cardiology’s 63rd Annual Scientific Session.
*Pradaxa® is contra-indicated for patients with prosthetic heart valves
~ENDS~
Please click on the link below for ‘Notes to Editors’ and ‘References’:
http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2014/24_march_2014_dabigatranetexilate.html
Contacts
Boehringer Ingelheim
Corporate Communications
Media + PR
Julia Meyer-Kleinmann
Phone: +49 6132 – 77 8271
Fax: +49 6132 – 77 6601
Email: press@boehringer-ingelheim.com
More information
www.boehringer-ingelheim.com
Permalink: http://me-newswire.net/news/10432/en
Is This What Happiness Sounds Like? Coca-Cola Celebrates International Day of Happiness with Mash-up of Upbeat Songs from around the World
Happiness Remix created by Rock Mafia and featuring Music Dealers’ Artists Available for Free Download
ATLANTA - Saturday, March 22nd 2014 [ME NewsWire]
(BUSINESS WIRE) As the world recognizes International Day of Happiness, Coca-Cola is joining the celebration by releasing Happiness Remix, a brand new track designed to bring out the happy in all who hear it. The track can be downloaded for free on Coca-Cola Journey.
Produced by acclaimed pop music ‘super producers’ Rock Mafia, Happiness Remix is an infectiously upbeat pop song, which fuses beats, melodies and rhythms from 17 songs created by independent artists from around the globe.
To find the songs for Happiness Remix, Coca-Cola worked with music licensing agency Music Dealers to invite emerging artists from around the globe to create a track inspired by a place of happiness.
Tim James and Antonina Armato, the talented duo behind Rock Mafia have worked with global superstars Miley Cyrus, Selena Gomez, Aloe Blacc and Mariah Carey. Combining the science of making people happy with the art of creating a hit song, Rock Mafia consulted respected music psychologist Professor Adrian North - author of the report ‘How to Produce Happy Music’ - on the creation of the track.
“I found the science fascinating! For me as a musician, I approach music from the heart,” said Tim James. “I believe in channeling inspiration but we were blown away with how, psycho-acoustically, music affects people, and which note combinations have this profound effect. It was great to see how aligned we were on what great music is and what moves people.”
Armato continues, “I don’t think anyone has ever done something like this before. It definitely put a smile on everyone’s face.”
Professor North, a respected music psychologist based at Curtin University in Australia, described some of the theory behind making happy music. “Universally, music is one of the most powerful stimulators of happiness. Different things make people happy, but there are ways, through music, to help deliberately evoke happiness through the arrangement of beats and melodies.”
“The Coca-Cola brand mission is to refresh the world and inspire moments of happiness,” said Joe Belliotti, Head of Global Music Marketing, The Coca-Cola Company. “We’re celebrating International Day of Happiness by releasing a song that we hope will literally make people feel happy. It’s up to music fans to decide, but we hope everyone enjoys listening to Happiness Remix.”
The video for Happiness Remix is a montage of happy moments featuring the artists as well as footage from Coca-Cola ads from around the world. Happiness Remix is the latest addition to the Coca-Cola Open Happiness campaign which has launched in over 200 markets worldwide.
To learn more about the making of Happiness Remix and to get to know the artists involved, visit Coca-Cola Journey.
International Day of Happiness was established by the United Nations to further the idea that happiness is a fundamental human right and everyone deserves the chance at a happy, healthy life.
Notes to editors:
The full list of Music Dealers artists included in the track is as follows:
Abi F Jones - Treetops (Vocals) - UK
Alex Nackman - It Was True Love (Bass, Gtr, Piano) - USA
Anita Benner - Destapa La Felicidad (Vocals) - USA
Ashlee Keating - Ice Kingdom (Strings) - USA
Bocatabu - Loca Realidad (Vocals) - DOMINICAN REPUBLIC
Dot Dot Dot - Top of the World (Vocals) - USA
Emma Jayne - Individual (Ukelele and Vocals) - USA
Jonah Swilley - Backseat (Vocals) - USA
Julian Bell - Downtown (Vocals) - USA
Laura Steel - Into This World (Vocals) - UK
Living In Pretend - Keep On Movin' (Synth, Vocals) - USA
Melissa Mars - Beautiful (Vocals) - FRANCE
Newmaik - Entre Los Dos (Vocals) - SPAIN
Northrock 360 - Let Fun Take Control (Vocals) - USA
Novel Nature - Hearts On Fire (Guitar samples) - USA
Roz Bell - Back In Bellwoods Park (Glockenspiel, Mandolin, Vocals) - CANADA
Zyme - Weekend (Vocals) - USA
Professor Adrian North’s research on the psychology of music is available at: http://healthsciences.curtin.edu.au/teaching/psych_people.cfm/Adrian.North
About The Coca-Cola Company
The Coca-Cola Company (NYSE: KO) is the world's largest beverage company, refreshing consumers with more than 500 sparkling and still brands. Led by Coca-Cola, one of the world's most valuable and recognizable brands, our Company's portfolio features 17 billion-dollar brands including Diet Coke, Fanta, Sprite, Coca-Cola Zero, vitaminwater, Powerade, Minute Maid, Simply, Georgia and Del Valle. Globally, we are the No. 1 provider of sparkling beverages, ready-to-drink coffees, and juices and juice drinks. Through the world's largest beverage distribution system, consumers in more than 200 countries enjoy our beverages at a rate of 1.9 billion servings a day. With an enduring commitment to building sustainable communities, our Company is focused on initiatives that reduce our environmental footprint, support active, healthy living, create a safe, inclusive work environment for our associates, and enhance the economic development of the communities where we operate. Together with our bottling partners, we rank among the world's top 10 private employers with more than 700,000 system associates. For more information, visit Coca-Cola Journey at www.coca-colacompany.com, follow us on Twitter at twitter.com/CocaColaCo, visit our blog, Coca-Cola Unbottled, at www.coca-colablog.com or find us on LinkedIn at www.linkedin.com/company/the-coca-cola-company.
About Rock Mafia
Rock Mafia is best known for their breakout successes in writing, producing and launching huge artist careers which resulted in over 50 million albums sold, eleven multi-platinum # 1 hits, and seventeen top 5 records. Rock Mafia has worked with artists like Wyclef Jean, Aloe Blacc, Miley Cyrus, Green Day, Timbaland, and many others. Currently, Rock Mafia scored another number one success with their production of ‘Stars Dance’ for Selena Gomez, which went straight to #1 on the US Billboard charts, as well as # 1 on the world wide global album charts and is Gomez’s follow up to the Rock Mafia production "Love You Like A Love Song," which also has achieved numerous platinum awards all over the world, and was certified 4X platinum in the US alone.
About Music Dealers
Music Dealers™ is a global music technology company that provides clients in the advertising, television, film and gaming industries with the highest quality emerging music to enhance their work. Powered by a global artist community of the world’s top breakout artists, Music Dealers crowd-sources existing and original music, procures brand partnerships and offers the largest emerging artist music-licensing database in the world. In 2011, Music Dealers cemented a groundbreaking partnership with The Coca-Cola Company, which secured Music Dealers’ position as the organization's exclusive global music partner and earned Coca-Cola a minority stake in the company. Music Dealers is based in Chicago, with offices in Los Angeles, New York, Atlanta, London and Mexico City.
For more info, please visit: www.musicdealers.com.
Contacts
The Coca-Cola Company
Global Public Affairs & Communications Department:
Carrie Brown, 404-676-2683
carribrown@coca-cola.com
ATLANTA - Saturday, March 22nd 2014 [ME NewsWire]
(BUSINESS WIRE) As the world recognizes International Day of Happiness, Coca-Cola is joining the celebration by releasing Happiness Remix, a brand new track designed to bring out the happy in all who hear it. The track can be downloaded for free on Coca-Cola Journey.
Produced by acclaimed pop music ‘super producers’ Rock Mafia, Happiness Remix is an infectiously upbeat pop song, which fuses beats, melodies and rhythms from 17 songs created by independent artists from around the globe.
To find the songs for Happiness Remix, Coca-Cola worked with music licensing agency Music Dealers to invite emerging artists from around the globe to create a track inspired by a place of happiness.
Tim James and Antonina Armato, the talented duo behind Rock Mafia have worked with global superstars Miley Cyrus, Selena Gomez, Aloe Blacc and Mariah Carey. Combining the science of making people happy with the art of creating a hit song, Rock Mafia consulted respected music psychologist Professor Adrian North - author of the report ‘How to Produce Happy Music’ - on the creation of the track.
“I found the science fascinating! For me as a musician, I approach music from the heart,” said Tim James. “I believe in channeling inspiration but we were blown away with how, psycho-acoustically, music affects people, and which note combinations have this profound effect. It was great to see how aligned we were on what great music is and what moves people.”
Armato continues, “I don’t think anyone has ever done something like this before. It definitely put a smile on everyone’s face.”
Professor North, a respected music psychologist based at Curtin University in Australia, described some of the theory behind making happy music. “Universally, music is one of the most powerful stimulators of happiness. Different things make people happy, but there are ways, through music, to help deliberately evoke happiness through the arrangement of beats and melodies.”
“The Coca-Cola brand mission is to refresh the world and inspire moments of happiness,” said Joe Belliotti, Head of Global Music Marketing, The Coca-Cola Company. “We’re celebrating International Day of Happiness by releasing a song that we hope will literally make people feel happy. It’s up to music fans to decide, but we hope everyone enjoys listening to Happiness Remix.”
The video for Happiness Remix is a montage of happy moments featuring the artists as well as footage from Coca-Cola ads from around the world. Happiness Remix is the latest addition to the Coca-Cola Open Happiness campaign which has launched in over 200 markets worldwide.
To learn more about the making of Happiness Remix and to get to know the artists involved, visit Coca-Cola Journey.
International Day of Happiness was established by the United Nations to further the idea that happiness is a fundamental human right and everyone deserves the chance at a happy, healthy life.
Notes to editors:
The full list of Music Dealers artists included in the track is as follows:
Abi F Jones - Treetops (Vocals) - UK
Alex Nackman - It Was True Love (Bass, Gtr, Piano) - USA
Anita Benner - Destapa La Felicidad (Vocals) - USA
Ashlee Keating - Ice Kingdom (Strings) - USA
Bocatabu - Loca Realidad (Vocals) - DOMINICAN REPUBLIC
Dot Dot Dot - Top of the World (Vocals) - USA
Emma Jayne - Individual (Ukelele and Vocals) - USA
Jonah Swilley - Backseat (Vocals) - USA
Julian Bell - Downtown (Vocals) - USA
Laura Steel - Into This World (Vocals) - UK
Living In Pretend - Keep On Movin' (Synth, Vocals) - USA
Melissa Mars - Beautiful (Vocals) - FRANCE
Newmaik - Entre Los Dos (Vocals) - SPAIN
Northrock 360 - Let Fun Take Control (Vocals) - USA
Novel Nature - Hearts On Fire (Guitar samples) - USA
Roz Bell - Back In Bellwoods Park (Glockenspiel, Mandolin, Vocals) - CANADA
Zyme - Weekend (Vocals) - USA
Professor Adrian North’s research on the psychology of music is available at: http://healthsciences.curtin.edu.au/teaching/psych_people.cfm/Adrian.North
About The Coca-Cola Company
The Coca-Cola Company (NYSE: KO) is the world's largest beverage company, refreshing consumers with more than 500 sparkling and still brands. Led by Coca-Cola, one of the world's most valuable and recognizable brands, our Company's portfolio features 17 billion-dollar brands including Diet Coke, Fanta, Sprite, Coca-Cola Zero, vitaminwater, Powerade, Minute Maid, Simply, Georgia and Del Valle. Globally, we are the No. 1 provider of sparkling beverages, ready-to-drink coffees, and juices and juice drinks. Through the world's largest beverage distribution system, consumers in more than 200 countries enjoy our beverages at a rate of 1.9 billion servings a day. With an enduring commitment to building sustainable communities, our Company is focused on initiatives that reduce our environmental footprint, support active, healthy living, create a safe, inclusive work environment for our associates, and enhance the economic development of the communities where we operate. Together with our bottling partners, we rank among the world's top 10 private employers with more than 700,000 system associates. For more information, visit Coca-Cola Journey at www.coca-colacompany.com, follow us on Twitter at twitter.com/CocaColaCo, visit our blog, Coca-Cola Unbottled, at www.coca-colablog.com or find us on LinkedIn at www.linkedin.com/company/the-coca-cola-company.
About Rock Mafia
Rock Mafia is best known for their breakout successes in writing, producing and launching huge artist careers which resulted in over 50 million albums sold, eleven multi-platinum # 1 hits, and seventeen top 5 records. Rock Mafia has worked with artists like Wyclef Jean, Aloe Blacc, Miley Cyrus, Green Day, Timbaland, and many others. Currently, Rock Mafia scored another number one success with their production of ‘Stars Dance’ for Selena Gomez, which went straight to #1 on the US Billboard charts, as well as # 1 on the world wide global album charts and is Gomez’s follow up to the Rock Mafia production "Love You Like A Love Song," which also has achieved numerous platinum awards all over the world, and was certified 4X platinum in the US alone.
About Music Dealers
Music Dealers™ is a global music technology company that provides clients in the advertising, television, film and gaming industries with the highest quality emerging music to enhance their work. Powered by a global artist community of the world’s top breakout artists, Music Dealers crowd-sources existing and original music, procures brand partnerships and offers the largest emerging artist music-licensing database in the world. In 2011, Music Dealers cemented a groundbreaking partnership with The Coca-Cola Company, which secured Music Dealers’ position as the organization's exclusive global music partner and earned Coca-Cola a minority stake in the company. Music Dealers is based in Chicago, with offices in Los Angeles, New York, Atlanta, London and Mexico City.
For more info, please visit: www.musicdealers.com.
Contacts
The Coca-Cola Company
Global Public Affairs & Communications Department:
Carrie Brown, 404-676-2683
carribrown@coca-cola.com
WHOLE WORLD Water Launches Give the #WholeWorldWater Campaign to Address Global Water Crisis
Campaign created by Hill Holliday unites an industry and enlists the world to help end the global water crisis
NEW YORK. - Saturday, March 22nd 2014 [ME NewsWire]
Special Yahoo logo animation will run for 24 hours
(BUSINESS WIRE) On World Water Day, March 22, 2014, WHOLE WORLD Water, a new social enterprise that unites the hospitality and tourism industry to collectively address one of our world’s most pressing issues, access to clean and safe water, will launch a global call to action: Give the #WholeWorldWater.
One of the most prominent creative elements is a custom animation of the Yahoo logo to represent the ebb and flow of water, which will run on March 22.
The Give the #WholeWorldWater campaign will focus on galvanizing consumers to get involved in simple yet powerful ways. To raise awareness of this new social enterprise and the issue it addresses, consumers around the world can simply share a bottle of WHOLE WORLD Water through Facebook and Twitter – sharing stats and facts about the global water crisis. If consumers want to get further involved, through a partnership with Foursquare, they can help recruit their favorite hotels and restaurants to join WHOLE WORLD Water. And finally, they can donate directly to the WHOLE WORLD Water Fund thru PayPal, where 100% of the money raised will be invested in clean and safe water initiatives globally. This digital media campaign was created by Hill Holliday, agency of record for WHOLE WORLD Water, and The Audience, social media agency of record out of London.
“We asked ourselves how we could get people’s attention in a crowded digital space for one day, to get them to think about the world’s water shortage. Then we thought: what if we remove H20 from websites? What if the H’s and O’s literally disappeared from the internet? And what site would allow us to do this and reach hundreds of millions of people to spread the word? The first partner who came to mind was Yahoo,” said Dave Banta, EVP, Executive Creative Director at Hill Holliday.
“World Water Day is a day we celebrate innovative solutions that are focused on ending the global water crisis. WHOLE WORLD Water is one of those solutions. This new business model helps our members reduce costs, increase revenue, reduce plastic waste, and significantly increases funding for clean and safe water initiatives. And now we’re providing consumers easy ways to help us spread the word,” said Jenifer Willig and Karena Albers, cofounders of WHOLE WORLD Water.
“Solving our world’s great challenges requires screwing business as usual,” said Sir Richard Branson, Founder of Virgin Group and advisor to WHOLE WORLD Water. “Through the cooperation of government, the private and social sectors, and campaigns such as WHOLE WORLD Water, we can develop better business approaches and humanitarian solutions. I hope you’ll join us on March 22, World Water Day, to make an impact.”
Sir Richard, along with campaign ambassadors and friends Tilda Swinton, Yves Behar, Gabriel Byrne, David de Rothschild, Edward Norton, Shekhar Kapur, Graham Hill, Waris Ahluwalia, Ryan McGinley, Stanley Johnson, Haider Ackermann, and Ben Elliott are working with WHOLE WORLD Water to help raise awareness and encourage others to follow.
“We believe that a company must have a purpose beyond purely enriching shareholders. Both our Guests and our Hosts (Soneva-speak for employees) love the example of WHOLE WORLD Water,” said Sonu Shivdasani, Chairman & CEO of Soneva Group and cofounder of WHOLE WORLD Water.
About the issue:
Today, more than one billion people are without access to clean and safe drinking water. This is more than a developing-world problem, water scarcity is a primary issue that we all face today, and must all support the solutions designed to address and eradicate it.
About WHOLE WORLD Water:
Developed to end the global water crisis, WHOLE WORLD Water works to unite the hospitality and tourism industry to filter, bottle, and sell its own water, and contribute 10% of the proceeds to the WHOLE WORLD Water Fund. 100% of the proceeds are invested in clean and safe drinking water issues worldwide. Founded in 2012 by ecopioneer and visionary Sonu Shivdasani, award-winning documentary filmmaker Karena Albers, and Jenifer Willig, former CEO of the (RED) campaign, WHOLE WORLD Water seeks to prove that social, environmental, and economic progress are not mutually exclusive. For more information, please visit www.wholeworldwater.co and join the conversation on Twitter @WHOLEWORLDWater.
About The WHOLE WORLD Water Fund:
The WHOLE WORLD Water Fund was established to radically increase resources to provide access to clean and safe water to communities around the world. Designed specifically for clean and safe water investments, the fund can be accessed by organizations, charities and social enterprises focused on clean and safe drinking water issues. Trustees of the fund include Sonu Shivdasani, Sir Jonathon Porritt, Fraser McColl, and Carrie Lee.
Photos/Multimedia Gallery Available: http://www.businesswire.com/multimedia/home/20140321005305/en/
Contacts
WHOLE WORLD Water
Jenifer Willig, 646-240-2123
Karena Albers, 917-623-5623
Permalink: http://me-newswire.net/news/10413/en
NEW YORK. - Saturday, March 22nd 2014 [ME NewsWire]
Special Yahoo logo animation will run for 24 hours
(BUSINESS WIRE) On World Water Day, March 22, 2014, WHOLE WORLD Water, a new social enterprise that unites the hospitality and tourism industry to collectively address one of our world’s most pressing issues, access to clean and safe water, will launch a global call to action: Give the #WholeWorldWater.
One of the most prominent creative elements is a custom animation of the Yahoo logo to represent the ebb and flow of water, which will run on March 22.
The Give the #WholeWorldWater campaign will focus on galvanizing consumers to get involved in simple yet powerful ways. To raise awareness of this new social enterprise and the issue it addresses, consumers around the world can simply share a bottle of WHOLE WORLD Water through Facebook and Twitter – sharing stats and facts about the global water crisis. If consumers want to get further involved, through a partnership with Foursquare, they can help recruit their favorite hotels and restaurants to join WHOLE WORLD Water. And finally, they can donate directly to the WHOLE WORLD Water Fund thru PayPal, where 100% of the money raised will be invested in clean and safe water initiatives globally. This digital media campaign was created by Hill Holliday, agency of record for WHOLE WORLD Water, and The Audience, social media agency of record out of London.
“We asked ourselves how we could get people’s attention in a crowded digital space for one day, to get them to think about the world’s water shortage. Then we thought: what if we remove H20 from websites? What if the H’s and O’s literally disappeared from the internet? And what site would allow us to do this and reach hundreds of millions of people to spread the word? The first partner who came to mind was Yahoo,” said Dave Banta, EVP, Executive Creative Director at Hill Holliday.
“World Water Day is a day we celebrate innovative solutions that are focused on ending the global water crisis. WHOLE WORLD Water is one of those solutions. This new business model helps our members reduce costs, increase revenue, reduce plastic waste, and significantly increases funding for clean and safe water initiatives. And now we’re providing consumers easy ways to help us spread the word,” said Jenifer Willig and Karena Albers, cofounders of WHOLE WORLD Water.
“Solving our world’s great challenges requires screwing business as usual,” said Sir Richard Branson, Founder of Virgin Group and advisor to WHOLE WORLD Water. “Through the cooperation of government, the private and social sectors, and campaigns such as WHOLE WORLD Water, we can develop better business approaches and humanitarian solutions. I hope you’ll join us on March 22, World Water Day, to make an impact.”
Sir Richard, along with campaign ambassadors and friends Tilda Swinton, Yves Behar, Gabriel Byrne, David de Rothschild, Edward Norton, Shekhar Kapur, Graham Hill, Waris Ahluwalia, Ryan McGinley, Stanley Johnson, Haider Ackermann, and Ben Elliott are working with WHOLE WORLD Water to help raise awareness and encourage others to follow.
“We believe that a company must have a purpose beyond purely enriching shareholders. Both our Guests and our Hosts (Soneva-speak for employees) love the example of WHOLE WORLD Water,” said Sonu Shivdasani, Chairman & CEO of Soneva Group and cofounder of WHOLE WORLD Water.
About the issue:
Today, more than one billion people are without access to clean and safe drinking water. This is more than a developing-world problem, water scarcity is a primary issue that we all face today, and must all support the solutions designed to address and eradicate it.
About WHOLE WORLD Water:
Developed to end the global water crisis, WHOLE WORLD Water works to unite the hospitality and tourism industry to filter, bottle, and sell its own water, and contribute 10% of the proceeds to the WHOLE WORLD Water Fund. 100% of the proceeds are invested in clean and safe drinking water issues worldwide. Founded in 2012 by ecopioneer and visionary Sonu Shivdasani, award-winning documentary filmmaker Karena Albers, and Jenifer Willig, former CEO of the (RED) campaign, WHOLE WORLD Water seeks to prove that social, environmental, and economic progress are not mutually exclusive. For more information, please visit www.wholeworldwater.co and join the conversation on Twitter @WHOLEWORLDWater.
About The WHOLE WORLD Water Fund:
The WHOLE WORLD Water Fund was established to radically increase resources to provide access to clean and safe water to communities around the world. Designed specifically for clean and safe water investments, the fund can be accessed by organizations, charities and social enterprises focused on clean and safe drinking water issues. Trustees of the fund include Sonu Shivdasani, Sir Jonathon Porritt, Fraser McColl, and Carrie Lee.
Photos/Multimedia Gallery Available: http://www.businesswire.com/multimedia/home/20140321005305/en/
Contacts
WHOLE WORLD Water
Jenifer Willig, 646-240-2123
Karena Albers, 917-623-5623
Permalink: http://me-newswire.net/news/10413/en
Sunday, March 23, 2014
OTEZLA (apremilast) - First Oral Therapy Approved by the U.S. Food and Drug Administration for the Treatment of Adults with Active Psoriatic Arthritis
SUMMIT, N.J. - Sunday, March 23rd 2014 [ME NewsWire]
In phase III studies, OTEZLA demonstrated clinically significant improvements across multiple manifestations of psoriatic arthritis and a consistent safety profile
Routine laboratory monitoring for patients taking OTEZLA is not required
OTEZLA is an oral therapy that modulates inflammation through intracellular inhibition of PDE4
(BUSINESS WIRE)-- Celgene Corporation (NASDAQ: CELG) today announced that the U.S. Food and Drug Administration (FDA) has approved OTEZLA® (apremilast), the Company’s oral, selective inhibitor of phosphodiesterase 4 (PDE4), for the treatment of adult patients with active psoriatic arthritis. A chronic disorder, psoriatic arthritis is characterized by pain, stiffness, swelling and tenderness of the joints, inflammation of specific ligaments and tendons, and a decrease in physical functioning. OTEZLA is the only FDA-approved oral treatment for psoriatic arthritis.
“The approval of oral OTEZLA is significant for patients living with psoriatic arthritis, which is a debilitating, painful disease that has a significant effect on a patient’s day-to-day activities,” said Dr. Alvin Wells, M.D., Ph.D., Director, Rheumatology and Immunotherapy Center, Franklin, WI, U.S. “OTEZLA offers physicians and patients a meaningful new treatment option, with the potential to benefit psoriatic arthritis patients irrespective of prior treatment.”
"OTEZLA works differently from other therapies approved for psoriatic arthritis through the intracellular inhibition of PDE4,” said Philip Mease, MD, Director of the Rheumatology Clinical Research Division of Swedish Medical Center and Clinical Professor, University of Washington. “The approval of an oral therapy with a novel mechanism of action for patients with psoriatic arthritis offers a different approach to patient care.”
The approval was based on safety and efficacy results from three multi-center, randomized, double-blind, placebo-controlled trials – PALACE 1, 2 and 3 – conducted in adult patients with active psoriatic arthritis who were inadequately controlled by disease-modifying anti-rheumatic drugs (DMARDs) and/or biologics. More than 75 percent of patients were previously treated with DMARDs only and 22 percent of patients were previously treated with biologics.
OTEZLA treatment with or without (±) concomitant DMARDs, compared with placebo ± concomitant DMARDs, resulted in greater improvement in the signs and symptoms of psoriatic arthritis, as demonstrated by the proportion of patients with an ACR 20 response at week 16. In PALACE-1, 38 percent of patients treated with OTEZLA® (apremilast) 30 mg twice daily achieved an ACR 20 response at week 16 versus 19 percent of patients on placebo. Consistent results were observed in PALACE-2 and PALACE-3. Improvement in ACR 50 and ACR 70 responses were observed at week 16 across the three studies.
A characteristic of psoriatic arthritis is tenderness and swelling in and around the joints. At week 16, patients treated with OTEZLA achieved a reduction in tender and swollen joint counts compared with placebo. OTEZLA treatment resulted in improvement for each of the seven ACR components measured, compared with placebo, at week 16. Improvements were also seen in disease-related physical functioning.
Treatment with OTEZLA resulted in improvement in dactylitis (inflammation of fingers and toes) and enthesitis (inflammation at sites where tendons or ligaments insert into bone) in patients with these pre-existing symptoms. Enthesitis and dactylitis are specific disease manifestations related to psoriatic arthritis.
In OTEZLA clinical trials, the majority of the most common adverse reactions occurred within the first two weeks of treatment and tended to resolve over time with continued dosing. Adverse reactions reported in at least two percent of patients on OTEZLA 30 mg twice daily and at least one percent greater than that observed in patients on placebo for up to 16 weeks were diarrhea, nausea, headache, upper respiratory tract infection, vomiting, nasopharyngitis, and upper abdominal pain. The proportion of patients who discontinued treatment due to any adverse reaction was 4.6 percent for patients taking OTEZLA 30 mg twice daily and 1.2 percent for patients taking placebo. The most common adverse reactions leading to discontinuation among patients treated up to 16 weeks with OTEZLA 30 mg twice daily were nausea (1.8 percent), diarrhea (1.8 percent) and headache (1.2 percent).
OTEZLA is contraindicated for use in patients with a known severe allergic reaction to OTEZLA or other components in OTEZLA. Across the three PALACE studies, 1.0 percent (10/998) of patients treated with OTEZLA reported depression or depressed mood compared with 0.8 percent (4/495) treated with placebo; 0.3 percent (4/1441) of patients treated with OTEZLA discontinued treatment due to depression or depressed mood compared with none among placebo-treated patients. In the PALACE studies, 10 percent of patients taking OTEZLA, compared with 3.3 percent of patients taking placebo, reported weight loss of five to ten percent. It is recommended that patients taking OTEZLA have their weight checked regularly.
During the placebo-controlled phase of the clinical trials, the rate of major adverse cardiac events, serious infections, including opportunistic infections, and malignancies, was comparable between placebo and OTEZLA groups. The product labeling does not require routine laboratory monitoring for patients taking OTEZLA.
“Patients and physicians have expressed their desire for a safe and effective therapy for psoriatic arthritis that has the potential to simplify patient management. Celgene is excited to be expanding our transformational science into the therapeutic realm of Inflammation and Immunology, with a new approach for patients with psoriatic arthritis,” said Scott Smith, Global Head, Inflammation and Immunology, Celgene Corporation. “The FDA approval of OTEZLA is good news for patients and healthcare professionals who are looking for a different way to manage this disease.”
OTEZLA® (apremilast) is expected to be available in the U.S. in March 2014 and will be dispensed through a comprehensive network of specialty pharmacies. For more information about OTEZLA distribution and the exclusive treatment support services (including reimbursement assistance and 24/7 nurse support), doctors and patients can contact Otezla SupportPlus™ at 1-844-4OTEZLA (1-844-468-3952) or visit www.OTEZLA.com for more information.
About PALACE Program
PALACE 1, 2 and 3 are the pivotal phase III multi-center, double-blind, placebo-controlled, parallel-group studies with two active-treatment groups. Across these studies, approximately 1,500 patients were randomized 1:1:1 to receive either OTEZLA 20 mg twice daily, OTEZLA 30 mg twice daily, or identically-appearing placebo, for 16 weeks. At week 16, some placebo-treated patients were randomized to one of the two OTEZLA groups, while others remained on placebo through week 24. After week 24, patients began a subsequent long term, open-label, active treatment phase. The PALACE 1, 2 and 3 studies included a wide spectrum of patients with active psoriatic arthritis, including those who had been previously treated with oral DMARDs, and/or biologics, with some patients who had previously failed a tumor necrosis factor (TNF) blocker.
The primary endpoint of the PALACE 1, 2 and 3 studies was the modified American College of Rheumatology criteria for 20 percent improvement (ACR20) at week 16. Secondary endpoints included other measures of signs and symptoms of psoriatic arthritis, physical functioning, and patient-reported outcomes.
Taken together, the PALACE program is the largest psoriatic arthritis program to date intended for regulatory submission.
About OTEZLA
OTEZLA is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels.
Important Safety Information
Contraindications
OTEZLA® (apremilast) is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation.
Warnings and Precautions
Depression
Treatment with OTEZLA is associated with an increase in adverse reactions of depression. During clinical trials, 1.0% (10/998) of patients treated with OTEZLA reported depression or depressed mood compared to 0.8% (4/495) treated with placebo and 0.3% (4/1441) of patients treated with OTEZLA discontinued treatment due to depression or depressed mood compared with none in placebo treated patients (0/495). Depression was reported as serious in 0.2% (3/1441) of patients exposed to OTEZLA, compared to none in placebo treated patients (0/495). Suicidal ideation and behavior were observed in 0.2% (3/1441) of patients on OTEZLA, compared to none on placebo (0/495). Two patients who received placebo committed suicide compared to none on OTEZLA.
Carefully weigh the risks and benefits of treatment with OTEZLA for patients with a history of depression and/or suicidal thoughts/behavior, and of continued treatment with OTEZLA for patients with these symptoms. Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and they should contact their healthcare provider.
Weight Decrease
Body weight loss of 5-10% was reported in 10% of patients taking OTEZLA and in 3.3% of patients taking placebo. Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of OTEZLA.
Drug Interactions
Apremilast exposure is decreased when OTEZLA is co-administered with strong CYP450 inducers, such as rifampin, which may result in loss of efficacy of OTEZLA. Concomitant use of OTEZLA with CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended.
Adverse Reactions
Adverse reactions reported in at least 2% of patients taking OTEZLA, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 16 weeks (after the initial 5-day titration), were (OTEZLA%, placebo%): diarrhea (7.7, 1.6); nausea (8.9, 3.1); headache (5.9, 2.2); upper respiratory tract infection (3.9, 1.8); vomiting (3.2, 0.4); nasopharyngitis (2.6, 1.6); upper abdominal pain (2.0, 0.2).
Use in Specific Populations
Pregnancy and Nursing Mothers
OTEZLA is Pregnancy Category C; it has not been studied in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether apremilast or its metabolites are present in human milk. Caution should be exercised when OTEZLA is administered to a nursing woman.
Renal Impairment
OTEZLA dosage should be reduced in patients with severe renal impairment (creatinine clearance less than 30 mL/min); for details, see Dosage and Administration, Section 2, in the Full Prescribing Information
Please click here for Full Prescribing Information.
About Psoriatic Arthritis
Psoriatic arthritis is a painful, chronic inflammatory disease characterized by pain, stiffness, swelling and tenderness of the joints, inflammation of specific ligaments and tendons, and decrease in physical functioning. It is estimated that nearly 38 million people worldwide have psoriatic arthritis. Psoriatic arthritis can impact day-to-day activities and has been reported to increase work disability. Common signs and symptoms of psoriatic arthritis include pain, stiffness, and swelling in joints. To learn more about psoriatic arthritis, go to www.discoverpsa.com. To learn more about the role of PDE4 in inflammatory diseases, go to www.discoverpde4.com.
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit www.celgene.com.
Forward-Looking Statements
This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates,” “plans,” “will,” “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in our Annual Report on Form 10-K and other reports filed with the Securities and Exchange Commission.
Contacts
Investors:
Patrick E. Flanigan III, 908-673-9969
Vice President, Investor Relations
Media:
Catherine Cantone, 732-564-3592
Director, Corporate Communications
Permalink: http://www.me-newswire.net/news/10418/en
In phase III studies, OTEZLA demonstrated clinically significant improvements across multiple manifestations of psoriatic arthritis and a consistent safety profile
Routine laboratory monitoring for patients taking OTEZLA is not required
OTEZLA is an oral therapy that modulates inflammation through intracellular inhibition of PDE4
(BUSINESS WIRE)-- Celgene Corporation (NASDAQ: CELG) today announced that the U.S. Food and Drug Administration (FDA) has approved OTEZLA® (apremilast), the Company’s oral, selective inhibitor of phosphodiesterase 4 (PDE4), for the treatment of adult patients with active psoriatic arthritis. A chronic disorder, psoriatic arthritis is characterized by pain, stiffness, swelling and tenderness of the joints, inflammation of specific ligaments and tendons, and a decrease in physical functioning. OTEZLA is the only FDA-approved oral treatment for psoriatic arthritis.
“The approval of oral OTEZLA is significant for patients living with psoriatic arthritis, which is a debilitating, painful disease that has a significant effect on a patient’s day-to-day activities,” said Dr. Alvin Wells, M.D., Ph.D., Director, Rheumatology and Immunotherapy Center, Franklin, WI, U.S. “OTEZLA offers physicians and patients a meaningful new treatment option, with the potential to benefit psoriatic arthritis patients irrespective of prior treatment.”
"OTEZLA works differently from other therapies approved for psoriatic arthritis through the intracellular inhibition of PDE4,” said Philip Mease, MD, Director of the Rheumatology Clinical Research Division of Swedish Medical Center and Clinical Professor, University of Washington. “The approval of an oral therapy with a novel mechanism of action for patients with psoriatic arthritis offers a different approach to patient care.”
The approval was based on safety and efficacy results from three multi-center, randomized, double-blind, placebo-controlled trials – PALACE 1, 2 and 3 – conducted in adult patients with active psoriatic arthritis who were inadequately controlled by disease-modifying anti-rheumatic drugs (DMARDs) and/or biologics. More than 75 percent of patients were previously treated with DMARDs only and 22 percent of patients were previously treated with biologics.
OTEZLA treatment with or without (±) concomitant DMARDs, compared with placebo ± concomitant DMARDs, resulted in greater improvement in the signs and symptoms of psoriatic arthritis, as demonstrated by the proportion of patients with an ACR 20 response at week 16. In PALACE-1, 38 percent of patients treated with OTEZLA® (apremilast) 30 mg twice daily achieved an ACR 20 response at week 16 versus 19 percent of patients on placebo. Consistent results were observed in PALACE-2 and PALACE-3. Improvement in ACR 50 and ACR 70 responses were observed at week 16 across the three studies.
A characteristic of psoriatic arthritis is tenderness and swelling in and around the joints. At week 16, patients treated with OTEZLA achieved a reduction in tender and swollen joint counts compared with placebo. OTEZLA treatment resulted in improvement for each of the seven ACR components measured, compared with placebo, at week 16. Improvements were also seen in disease-related physical functioning.
Treatment with OTEZLA resulted in improvement in dactylitis (inflammation of fingers and toes) and enthesitis (inflammation at sites where tendons or ligaments insert into bone) in patients with these pre-existing symptoms. Enthesitis and dactylitis are specific disease manifestations related to psoriatic arthritis.
In OTEZLA clinical trials, the majority of the most common adverse reactions occurred within the first two weeks of treatment and tended to resolve over time with continued dosing. Adverse reactions reported in at least two percent of patients on OTEZLA 30 mg twice daily and at least one percent greater than that observed in patients on placebo for up to 16 weeks were diarrhea, nausea, headache, upper respiratory tract infection, vomiting, nasopharyngitis, and upper abdominal pain. The proportion of patients who discontinued treatment due to any adverse reaction was 4.6 percent for patients taking OTEZLA 30 mg twice daily and 1.2 percent for patients taking placebo. The most common adverse reactions leading to discontinuation among patients treated up to 16 weeks with OTEZLA 30 mg twice daily were nausea (1.8 percent), diarrhea (1.8 percent) and headache (1.2 percent).
OTEZLA is contraindicated for use in patients with a known severe allergic reaction to OTEZLA or other components in OTEZLA. Across the three PALACE studies, 1.0 percent (10/998) of patients treated with OTEZLA reported depression or depressed mood compared with 0.8 percent (4/495) treated with placebo; 0.3 percent (4/1441) of patients treated with OTEZLA discontinued treatment due to depression or depressed mood compared with none among placebo-treated patients. In the PALACE studies, 10 percent of patients taking OTEZLA, compared with 3.3 percent of patients taking placebo, reported weight loss of five to ten percent. It is recommended that patients taking OTEZLA have their weight checked regularly.
During the placebo-controlled phase of the clinical trials, the rate of major adverse cardiac events, serious infections, including opportunistic infections, and malignancies, was comparable between placebo and OTEZLA groups. The product labeling does not require routine laboratory monitoring for patients taking OTEZLA.
“Patients and physicians have expressed their desire for a safe and effective therapy for psoriatic arthritis that has the potential to simplify patient management. Celgene is excited to be expanding our transformational science into the therapeutic realm of Inflammation and Immunology, with a new approach for patients with psoriatic arthritis,” said Scott Smith, Global Head, Inflammation and Immunology, Celgene Corporation. “The FDA approval of OTEZLA is good news for patients and healthcare professionals who are looking for a different way to manage this disease.”
OTEZLA® (apremilast) is expected to be available in the U.S. in March 2014 and will be dispensed through a comprehensive network of specialty pharmacies. For more information about OTEZLA distribution and the exclusive treatment support services (including reimbursement assistance and 24/7 nurse support), doctors and patients can contact Otezla SupportPlus™ at 1-844-4OTEZLA (1-844-468-3952) or visit www.OTEZLA.com for more information.
About PALACE Program
PALACE 1, 2 and 3 are the pivotal phase III multi-center, double-blind, placebo-controlled, parallel-group studies with two active-treatment groups. Across these studies, approximately 1,500 patients were randomized 1:1:1 to receive either OTEZLA 20 mg twice daily, OTEZLA 30 mg twice daily, or identically-appearing placebo, for 16 weeks. At week 16, some placebo-treated patients were randomized to one of the two OTEZLA groups, while others remained on placebo through week 24. After week 24, patients began a subsequent long term, open-label, active treatment phase. The PALACE 1, 2 and 3 studies included a wide spectrum of patients with active psoriatic arthritis, including those who had been previously treated with oral DMARDs, and/or biologics, with some patients who had previously failed a tumor necrosis factor (TNF) blocker.
The primary endpoint of the PALACE 1, 2 and 3 studies was the modified American College of Rheumatology criteria for 20 percent improvement (ACR20) at week 16. Secondary endpoints included other measures of signs and symptoms of psoriatic arthritis, physical functioning, and patient-reported outcomes.
Taken together, the PALACE program is the largest psoriatic arthritis program to date intended for regulatory submission.
About OTEZLA
OTEZLA is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels.
Important Safety Information
Contraindications
OTEZLA® (apremilast) is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation.
Warnings and Precautions
Depression
Treatment with OTEZLA is associated with an increase in adverse reactions of depression. During clinical trials, 1.0% (10/998) of patients treated with OTEZLA reported depression or depressed mood compared to 0.8% (4/495) treated with placebo and 0.3% (4/1441) of patients treated with OTEZLA discontinued treatment due to depression or depressed mood compared with none in placebo treated patients (0/495). Depression was reported as serious in 0.2% (3/1441) of patients exposed to OTEZLA, compared to none in placebo treated patients (0/495). Suicidal ideation and behavior were observed in 0.2% (3/1441) of patients on OTEZLA, compared to none on placebo (0/495). Two patients who received placebo committed suicide compared to none on OTEZLA.
Carefully weigh the risks and benefits of treatment with OTEZLA for patients with a history of depression and/or suicidal thoughts/behavior, and of continued treatment with OTEZLA for patients with these symptoms. Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and they should contact their healthcare provider.
Weight Decrease
Body weight loss of 5-10% was reported in 10% of patients taking OTEZLA and in 3.3% of patients taking placebo. Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of OTEZLA.
Drug Interactions
Apremilast exposure is decreased when OTEZLA is co-administered with strong CYP450 inducers, such as rifampin, which may result in loss of efficacy of OTEZLA. Concomitant use of OTEZLA with CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended.
Adverse Reactions
Adverse reactions reported in at least 2% of patients taking OTEZLA, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 16 weeks (after the initial 5-day titration), were (OTEZLA%, placebo%): diarrhea (7.7, 1.6); nausea (8.9, 3.1); headache (5.9, 2.2); upper respiratory tract infection (3.9, 1.8); vomiting (3.2, 0.4); nasopharyngitis (2.6, 1.6); upper abdominal pain (2.0, 0.2).
Use in Specific Populations
Pregnancy and Nursing Mothers
OTEZLA is Pregnancy Category C; it has not been studied in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether apremilast or its metabolites are present in human milk. Caution should be exercised when OTEZLA is administered to a nursing woman.
Renal Impairment
OTEZLA dosage should be reduced in patients with severe renal impairment (creatinine clearance less than 30 mL/min); for details, see Dosage and Administration, Section 2, in the Full Prescribing Information
Please click here for Full Prescribing Information.
About Psoriatic Arthritis
Psoriatic arthritis is a painful, chronic inflammatory disease characterized by pain, stiffness, swelling and tenderness of the joints, inflammation of specific ligaments and tendons, and decrease in physical functioning. It is estimated that nearly 38 million people worldwide have psoriatic arthritis. Psoriatic arthritis can impact day-to-day activities and has been reported to increase work disability. Common signs and symptoms of psoriatic arthritis include pain, stiffness, and swelling in joints. To learn more about psoriatic arthritis, go to www.discoverpsa.com. To learn more about the role of PDE4 in inflammatory diseases, go to www.discoverpde4.com.
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit www.celgene.com.
Forward-Looking Statements
This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates,” “plans,” “will,” “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in our Annual Report on Form 10-K and other reports filed with the Securities and Exchange Commission.
Contacts
Investors:
Patrick E. Flanigan III, 908-673-9969
Vice President, Investor Relations
Media:
Catherine Cantone, 732-564-3592
Director, Corporate Communications
Permalink: http://www.me-newswire.net/news/10418/en
Subscribe to:
Posts (Atom)