ABU DHABI, United Arab Emirates - Sunday, January 25th 2015 [ME NewsWire]
The Law Respect Culture Bureau, at the General Secretariat of the Office of H.H Deputy Prime Minister and Minister of Interior, is organizing educational lectures addressed to the Ministry of Interior’s overseas scholarship students in order to raise their awareness regarding the law respect culture in the countries to which they were sent to study.
Lieutenant Colonel Dr. Salah Al Ghoul, Director of Law Respect Culture Bureau, said: “The students that have been sent abroad to study are basically ambassadors for the UAE, therefore it is just as important to educate this segment of society in regards to their country of study as it is to educate all of the other segments of society.”
In turn, Lieutenant Saleem Al Afari, the Administrative Official for the program at the Law Respect Culture Bureau, said: “These educational lectures are to equip students with all of the guidelines and legal issues that they need to know in order to avoid violating the laws of the countries where they are studying. The civilized principles of law respect culture are essential in the protection of individuals – hiding behind ignorance will not protect an individual from punishment.”
For more information about:
The Ministry of Interior, please click HERE
Abu Dhabi Police, please click HERE
Follow us and check our Social Media feeds on: YouTube, Facebook and Twitter
The Arabic-language text of this announcement is the official, authoritative version. Translations are provided as an accommodation only, and should be cross-referenced with the Arabic-language text, which is the only version of the text intended to have legal effect.
Contacts
The UAE Minister of Interior's General Secretariat, Tactical Affairs and Security Media Department
Abu Dhabi Police GHQ - Security Media
Chris Cron +971-(0)-50-987-1317
E-mail: cron.media@hotmail.com
Permalink: http://me-newswire.net/news/13470/en
Wednesday, January 28, 2015
Fox Animation Acquires Film Rights to Sanrio’s Mr. Men Little Miss Properties
LOS ANGELES. - Tuesday, January 27th 2015 [ME NewsWire]
Shawn Levy to Produce
(BUSINESS WIRE) Fox Animation has secured the motion pictures rights to the iconic Mr. Men Little Miss characters. The deal was announced today by Fox Animation President Vanessa Morrison and Janet Hsu, President and COO of Sanrio, Inc. Fox Animation is the studio behind the ICE AGE and RIO movie franchises. Sanrio Entertainment Division, based in North America, develops brand extensions and experiential initiatives for U.S. and global distribution.
“The Mr. Men and Little Miss characters have delighted readers from around the world for decades,” commented Morrison. “We are thrilled to work with Sanrio and 21 Laps on this beloved property.”
“Sanrio Entertainment Division aims to connect fans with our properties beyond the standard retail license model,” said Hsu. “Partnering with Fox Animation will bring the Mr. Men Little Miss characters to life and evolve the storytelling for their multi-generational global fan base.”
Shawn Levy - the producer and director of the blockbuster family franchise NIGHT AT THE MUSEUM, among others - will produce through his Fox-based 21 Laps Entertainment. There is no director or writer yet attached to the project. Fox Animation Production VP Ralph Millero is overseeing Mr. Men Little Miss for the studio. Will Rack and Emily Morris are overseeing for 21 Laps.
Commented Levy: "I loved reading these books as a kid, and now I love reading them to my own kids. Their humor, wit and uniquely specific tone make this a truly classic series. I can't wait to help shepherd them to the big screen.”
The Mr. Men Little Miss series of timeless characters originated in books created by Roger Hargreaves in 1971 in the U.K. Each of the 85 characters is named after his or her unique personality traits, giving them wide appeal as they synch seamlessly with the personalities of their fans. Mr. Men Little Miss is a classic, evergreen brand whose colorful characters are woven into the lives of millions of children and adults worldwide. A Mr. Men Little Miss book is sold every 2.5 seconds across the world.
“In addition to Sanrio’s ‘kawaii’ character family, the Mr. Men Little Miss characters are the perfect blend of self-expression, humor and nostalgia in a classic, contemporary brand. We are excited to take Roger Hargreaves’ creations to a new level for their loyal fans from around the world and continue to expand our global business with this portfolio,” said Ray Hatoyama, CEO of Mister Men Limited and Managing Director of Sanrio Co., Ltd.
About 20th Century Fox Film
One of the world’s largest producers and distributors of motion pictures, 20th Century Fox Film produces, acquires and distributes motion pictures throughout the world. These motion pictures are produced or acquired by the following units of 20th Century Fox Film: Twentieth Century Fox, Fox 2000 Pictures, Fox Searchlight Pictures, Fox International Productions and Twentieth Century Fox Animation.
About Sanrio
Sanrio is the global lifestyle brand best known for pop icon Hello Kitty, who recently celebrated her 40th Anniversary. Home to many endearing characters including Chococat, My Melody, Badtz-Maru and Keroppi, Sanrio was founded on the 'small gift, big smile' philosophy - that a small gift can bring happiness and friendship to people of all ages. Since 1960, this philosophy has served as the inspiration for the broad spectrum of unique products and experiences. Today, more than 50,000 Sanrio-branded items are available in over 70 countries and upwards of 15,000 U.S. retail locations including department, specialty, national chain stores and Sanrio boutiques. For more information please visit www.sanrio.com and www.facebook.com/hellokitty.
About 21 Laps
Founded in 2005 by director/producer Shawn Levy, 21 Laps Entertainment produced the billion-dollar Night at the Museum franchise. In the last year, Levy and 21 Laps produced the third Night at the Museum film starring Ben Stiller for Fox which has already made over $300 million and counting at the worldwide box office, Disney’s Alexander And The Terrible Horrible No Good Very Bad Day starring Steve Carell, and This Is Where I Leave You starring Jason Bateman and Tina Fey for Warner Brothers. The company is producing the upcoming Denis Villeneuve-directed sci-fi thriller Story Of Your Life, which stars Amy Adams and which Paramount acquired at Cannes in a record deal, and the Fox Searchlight wedding comedy Table 19 directed by Jeff Blitz and starring Anna Kendrick. Previously, 21 Laps produced the Levy-directed worldwide hits Real Steel starring Hugh Jackman and Date Night starring Steve Carell and Tina Fey, along with the Sundance award winner and critically acclaimed The Spectacular Now, directed by James Ponsoldt and starring Miles Teller and Shailene Woodley.
About Mr. Men Little Miss
Mr. Men Little Miss is an iconic lifestyle brand that features the beloved family of over 85 boldly illustrated characters with unique personalities. The characters, including Mr. Tickle, Mr. Happy, Mr. Bump, Little Miss Sunshine and Little Miss Princess, have multi-generational appeal and blend self-expression, humor and design in a classic, evergreen property. Created in 1971 by British Author Roger Hargreaves, the brand has evolved through books, TV series and a variety of consumer products released with worldwide distribution. Mr. Men Little Miss was acquired by Sanrio Co., Ltd. in 2011. For more information, please visit www.mrmen.com and www.facebook.com/mrmenlittlemiss.
Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=51026939&lang=en
Contacts
20th Century Fox Film
Chelsey Summey, 310-369-7930
chelsey.summey@fox.com
Permalink: http://me-newswire.net/news/13488/en
Shawn Levy to Produce
(BUSINESS WIRE) Fox Animation has secured the motion pictures rights to the iconic Mr. Men Little Miss characters. The deal was announced today by Fox Animation President Vanessa Morrison and Janet Hsu, President and COO of Sanrio, Inc. Fox Animation is the studio behind the ICE AGE and RIO movie franchises. Sanrio Entertainment Division, based in North America, develops brand extensions and experiential initiatives for U.S. and global distribution.
“The Mr. Men and Little Miss characters have delighted readers from around the world for decades,” commented Morrison. “We are thrilled to work with Sanrio and 21 Laps on this beloved property.”
“Sanrio Entertainment Division aims to connect fans with our properties beyond the standard retail license model,” said Hsu. “Partnering with Fox Animation will bring the Mr. Men Little Miss characters to life and evolve the storytelling for their multi-generational global fan base.”
Shawn Levy - the producer and director of the blockbuster family franchise NIGHT AT THE MUSEUM, among others - will produce through his Fox-based 21 Laps Entertainment. There is no director or writer yet attached to the project. Fox Animation Production VP Ralph Millero is overseeing Mr. Men Little Miss for the studio. Will Rack and Emily Morris are overseeing for 21 Laps.
Commented Levy: "I loved reading these books as a kid, and now I love reading them to my own kids. Their humor, wit and uniquely specific tone make this a truly classic series. I can't wait to help shepherd them to the big screen.”
The Mr. Men Little Miss series of timeless characters originated in books created by Roger Hargreaves in 1971 in the U.K. Each of the 85 characters is named after his or her unique personality traits, giving them wide appeal as they synch seamlessly with the personalities of their fans. Mr. Men Little Miss is a classic, evergreen brand whose colorful characters are woven into the lives of millions of children and adults worldwide. A Mr. Men Little Miss book is sold every 2.5 seconds across the world.
“In addition to Sanrio’s ‘kawaii’ character family, the Mr. Men Little Miss characters are the perfect blend of self-expression, humor and nostalgia in a classic, contemporary brand. We are excited to take Roger Hargreaves’ creations to a new level for their loyal fans from around the world and continue to expand our global business with this portfolio,” said Ray Hatoyama, CEO of Mister Men Limited and Managing Director of Sanrio Co., Ltd.
About 20th Century Fox Film
One of the world’s largest producers and distributors of motion pictures, 20th Century Fox Film produces, acquires and distributes motion pictures throughout the world. These motion pictures are produced or acquired by the following units of 20th Century Fox Film: Twentieth Century Fox, Fox 2000 Pictures, Fox Searchlight Pictures, Fox International Productions and Twentieth Century Fox Animation.
About Sanrio
Sanrio is the global lifestyle brand best known for pop icon Hello Kitty, who recently celebrated her 40th Anniversary. Home to many endearing characters including Chococat, My Melody, Badtz-Maru and Keroppi, Sanrio was founded on the 'small gift, big smile' philosophy - that a small gift can bring happiness and friendship to people of all ages. Since 1960, this philosophy has served as the inspiration for the broad spectrum of unique products and experiences. Today, more than 50,000 Sanrio-branded items are available in over 70 countries and upwards of 15,000 U.S. retail locations including department, specialty, national chain stores and Sanrio boutiques. For more information please visit www.sanrio.com and www.facebook.com/hellokitty.
About 21 Laps
Founded in 2005 by director/producer Shawn Levy, 21 Laps Entertainment produced the billion-dollar Night at the Museum franchise. In the last year, Levy and 21 Laps produced the third Night at the Museum film starring Ben Stiller for Fox which has already made over $300 million and counting at the worldwide box office, Disney’s Alexander And The Terrible Horrible No Good Very Bad Day starring Steve Carell, and This Is Where I Leave You starring Jason Bateman and Tina Fey for Warner Brothers. The company is producing the upcoming Denis Villeneuve-directed sci-fi thriller Story Of Your Life, which stars Amy Adams and which Paramount acquired at Cannes in a record deal, and the Fox Searchlight wedding comedy Table 19 directed by Jeff Blitz and starring Anna Kendrick. Previously, 21 Laps produced the Levy-directed worldwide hits Real Steel starring Hugh Jackman and Date Night starring Steve Carell and Tina Fey, along with the Sundance award winner and critically acclaimed The Spectacular Now, directed by James Ponsoldt and starring Miles Teller and Shailene Woodley.
About Mr. Men Little Miss
Mr. Men Little Miss is an iconic lifestyle brand that features the beloved family of over 85 boldly illustrated characters with unique personalities. The characters, including Mr. Tickle, Mr. Happy, Mr. Bump, Little Miss Sunshine and Little Miss Princess, have multi-generational appeal and blend self-expression, humor and design in a classic, evergreen property. Created in 1971 by British Author Roger Hargreaves, the brand has evolved through books, TV series and a variety of consumer products released with worldwide distribution. Mr. Men Little Miss was acquired by Sanrio Co., Ltd. in 2011. For more information, please visit www.mrmen.com and www.facebook.com/mrmenlittlemiss.
Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=51026939&lang=en
Contacts
20th Century Fox Film
Chelsey Summey, 310-369-7930
chelsey.summey@fox.com
Permalink: http://me-newswire.net/news/13488/en
Posted by
Business Daily Africa
Abu Dhabi Police Organizes the First Knowledge Exchange Forum for This Year
ABU DHABI, United Arab Emirates - Sunday, January 25th 2015 [ME NewsWire]
The Strategy and Performance Development Department at Abu Dhabi Police organized the first forum to exchange knowledge and innovative ideas for this year under the theme of ‘The Role and Benefits of Policies (Institutional and General) in the Development of Police Work’. The inauguration ceremony for the Forum was held in the Abu Dhabi Police General Headquarters (GHQ).
Major General Dr. Abdul Quddous Abdul Razzaq Al Obaidly, Deputy Commander-in-Chief of Dubai Police for the Quality and Excellence Affairs and Head of the Sheikh Khalifa Government Excellence Awards Teams at the Ministry of Interior; Brigadier Ismail Al Sirkal, Deputy Director General of Abu Dhabi Police Central Operations at Abu Dhabi Police; and a number of other officers and staff members of the Abu Dhabi Police attended the ceremony.
According to Colonel Mohammed Hamid bin Dalmouj Al Dhaheri, Strategy and Performance Development Director General at the Ministry of Interior: “The Forum, organized by the Knowledge Center in cooperation with the Policies Division at the Strategy and Performance Development Department, embodies the vision of the Abu Dhabi Police GHQ, which aims to ensure that the Emirate of Abu Dhabi remains a safe and secure society through the provision of high-quality police services for citizens, residents, and visitors.”
“Knowledge forums and workshops organized by the Knowledge Center aim to not only enhance the knowledge culture, but to also spread this culture and the knowledge gained across all sectors through the implementation of best practices. These forums represent the perfect opportunity to discuss and review the most distinguished experiences, and to ultimately further develop knowledge through this exchange,” he said.
For his part, Major Khaled Hussein Al Khoury, Director of the Knowledge Center, gave an overview of the Knowledge Center’s achievements and of the most important topics regarding the Center’s future plans for the year 2015. He also highlighted the importance of such knowledge-based initiatives in ensuring continued transfer of expertise between staff members; investing in performance development; and in enhancing knowledge management at the Abu Dhabi Police GHQ.
Expert John Alterman, Vice President of the Strategic and International Studies in Washington, USA, presented a paper at the forum entitled ‘The International Perspective for the Development of Strategic Policies’. He spoke about the external environment and its impact both locally and regionally; the challenges facing the collaboration between different authorities; the combination of security, openness and transparency; deterring negative behavior and promoting self-discipline; and handling events swiftly and efficiently when necessary.
Alterman explained that working policies regulate procedures and harmonize institutional efforts by integrating local and international bodies. They also help to re-focus and define which efforts are of the utmost priority. Several practical exercises were also carried out during the workshop, which provided an interactive and engaging experience for attendees.
Follow us and check our Social Media feeds on: YouTube, Facebook and Twitter
The Arabic-language text of this announcement is the official, authoritative version. Translations are provided as an accommodation only, and should be cross-referenced with the Arabic-language text, which is the only version of the text intended to have legal effect.
Contacts
The UAE Minister of Interior's General Secretariat, Tactical Affairs and Security Media Department
Abu Dhabi Police GHQ - Security Media
Chris Cron +971-(0)-50-987-1317
E-mail: cron.media@hotmail.com
Permalink: http://me-newswire.net/news/13469/en
The Strategy and Performance Development Department at Abu Dhabi Police organized the first forum to exchange knowledge and innovative ideas for this year under the theme of ‘The Role and Benefits of Policies (Institutional and General) in the Development of Police Work’. The inauguration ceremony for the Forum was held in the Abu Dhabi Police General Headquarters (GHQ).
Major General Dr. Abdul Quddous Abdul Razzaq Al Obaidly, Deputy Commander-in-Chief of Dubai Police for the Quality and Excellence Affairs and Head of the Sheikh Khalifa Government Excellence Awards Teams at the Ministry of Interior; Brigadier Ismail Al Sirkal, Deputy Director General of Abu Dhabi Police Central Operations at Abu Dhabi Police; and a number of other officers and staff members of the Abu Dhabi Police attended the ceremony.
According to Colonel Mohammed Hamid bin Dalmouj Al Dhaheri, Strategy and Performance Development Director General at the Ministry of Interior: “The Forum, organized by the Knowledge Center in cooperation with the Policies Division at the Strategy and Performance Development Department, embodies the vision of the Abu Dhabi Police GHQ, which aims to ensure that the Emirate of Abu Dhabi remains a safe and secure society through the provision of high-quality police services for citizens, residents, and visitors.”
“Knowledge forums and workshops organized by the Knowledge Center aim to not only enhance the knowledge culture, but to also spread this culture and the knowledge gained across all sectors through the implementation of best practices. These forums represent the perfect opportunity to discuss and review the most distinguished experiences, and to ultimately further develop knowledge through this exchange,” he said.
For his part, Major Khaled Hussein Al Khoury, Director of the Knowledge Center, gave an overview of the Knowledge Center’s achievements and of the most important topics regarding the Center’s future plans for the year 2015. He also highlighted the importance of such knowledge-based initiatives in ensuring continued transfer of expertise between staff members; investing in performance development; and in enhancing knowledge management at the Abu Dhabi Police GHQ.
Expert John Alterman, Vice President of the Strategic and International Studies in Washington, USA, presented a paper at the forum entitled ‘The International Perspective for the Development of Strategic Policies’. He spoke about the external environment and its impact both locally and regionally; the challenges facing the collaboration between different authorities; the combination of security, openness and transparency; deterring negative behavior and promoting self-discipline; and handling events swiftly and efficiently when necessary.
Alterman explained that working policies regulate procedures and harmonize institutional efforts by integrating local and international bodies. They also help to re-focus and define which efforts are of the utmost priority. Several practical exercises were also carried out during the workshop, which provided an interactive and engaging experience for attendees.
Follow us and check our Social Media feeds on: YouTube, Facebook and Twitter
The Arabic-language text of this announcement is the official, authoritative version. Translations are provided as an accommodation only, and should be cross-referenced with the Arabic-language text, which is the only version of the text intended to have legal effect.
Contacts
The UAE Minister of Interior's General Secretariat, Tactical Affairs and Security Media Department
Abu Dhabi Police GHQ - Security Media
Chris Cron +971-(0)-50-987-1317
E-mail: cron.media@hotmail.com
Permalink: http://me-newswire.net/news/13469/en
Posted by
Business Daily Africa
Woman Falls to Death in Vehicle from Sixth Floor
ABU DHABI, United Arab Emirates - Sunday, January 25th 2015 [ME NewsWire]
A European woman, aged 54, fell from the 6th floor while reversing her vehicle in a multi-story parking garage on Khalifa Street in Abu Dhabi, according to preliminary investigations.
Major Saeed Al Dhaheri, Director of Al Madina Police Station of the Capital Police Directorate at Abu Dhabi Police General Headquarters, who supervised the investigations of the accident said: “The operation room received a call around 8:00 am on Sunday regarding a vehicle that had fallen from a parking garage in Abu Dhabi.”
“The comprehensive police patrols, ambulances, and specialized police teams rushed to the scene and quickly addressed the situation. According to the reports, the car had been backing out before falling out of the parking garage, which led to the death of the woman. Additional physical damage had also been sustained during the accident,” he said.
Major Al Dhaheri said: “The investigations are underway and we are working towards understanding the events that have led up to this accident.”
For more information about:
The Ministry of Interior, please click HERE
Abu Dhabi Police, please click HERE
Follow us and check our Social Media feeds on: YouTube, Facebook and Twitter
The Arabic-language text of this announcement is the official, authoritative version. Translations are provided as an accommodation only, and should be cross-referenced with the Arabic-language text, which is the only version of the text intended to have legal effect
Contacts
The UAE Minister of Interior's General Secretariat, Tactical Affairs and Security Media Department
Abu Dhabi Police GHQ - Security Media
Chris Cron +971-(0)-50-987-1317
E-mail: cron.media@hotmail.com
Permalink: http://me-newswire.net/news/13472/en
A European woman, aged 54, fell from the 6th floor while reversing her vehicle in a multi-story parking garage on Khalifa Street in Abu Dhabi, according to preliminary investigations.
Major Saeed Al Dhaheri, Director of Al Madina Police Station of the Capital Police Directorate at Abu Dhabi Police General Headquarters, who supervised the investigations of the accident said: “The operation room received a call around 8:00 am on Sunday regarding a vehicle that had fallen from a parking garage in Abu Dhabi.”
“The comprehensive police patrols, ambulances, and specialized police teams rushed to the scene and quickly addressed the situation. According to the reports, the car had been backing out before falling out of the parking garage, which led to the death of the woman. Additional physical damage had also been sustained during the accident,” he said.
Major Al Dhaheri said: “The investigations are underway and we are working towards understanding the events that have led up to this accident.”
For more information about:
The Ministry of Interior, please click HERE
Abu Dhabi Police, please click HERE
Follow us and check our Social Media feeds on: YouTube, Facebook and Twitter
The Arabic-language text of this announcement is the official, authoritative version. Translations are provided as an accommodation only, and should be cross-referenced with the Arabic-language text, which is the only version of the text intended to have legal effect
Contacts
The UAE Minister of Interior's General Secretariat, Tactical Affairs and Security Media Department
Abu Dhabi Police GHQ - Security Media
Chris Cron +971-(0)-50-987-1317
E-mail: cron.media@hotmail.com
Permalink: http://me-newswire.net/news/13472/en
Posted by
Business Daily Africa
Murex Positioned as a Leader in Gartner’s 2014 “Magic Quadrant for Trading Platforms”
PARIS - Tuesday, January 27th 2015 [ME NewsWire]
(BUSINESS WIRE) Murex, the prime provider of cross-asset trading, risk management and processing solutions, is proud to announce that it has been named as a Leader, positioned furthest for Completeness of Vision and Ability to Execute in the 2014 Gartner Magic Quadrant for Trading Platforms (D.Furlonger, F.Chesini, 22 December 2014).
“We are delighted with this new recognition. We consider our position in the Leaders Quadrant as a confirmation of our role as transformation enabler, providing sell-side and buy-side institutions with timely and relevant solutions that help them adapt to the fundamental changes of the post-crisis era.” said Maroun EDDE, CEO of Murex.
Murex has been continuously adapting functionality and technology to new regulatory and market practices, providing flexibility and scalability at a controlled cost thanks to its investment in cutting-edge technology, such as memory data grids or GPU-based analytics. The MX.3 platform delivers the framework to rationalize in-house businesses and to build utility models.
Through the MX.3 platform, Murex hosts a range of “best-of-breed” Front-to-Back-to-Risk business solutions. In 2014, a complete overhaul of the collateral management delivered a state-of-the art enterprise solution that embeds best risk management practices into an advanced collateral operation framework. MX.3 for Collateral Management supports bilateral BCBS/IOSCO initial margin for uncleared and cleared OTC, as well as repo and securities lending, and exchange-traded derivative products.
Thanks to the breadth of its financial products, the front-to-risk consistency of its analytics and its ability to deliver real-time complex simulations, Murex plays a leading role in helping financial institutions to successfully adapt to next regulatory challenges of Basel 3 and Fundamental Review of Trading Book (“FRTB”).
“At a time when the finance industry needs simplification to drive cost rationalization, we strive to make our technology and business solutions a value creator for our clients” added Maroun EDDE.
To access the report, click on the following link (or copy and paste the URL into your browser): https://www.murex.com/node/575?fid=8397
About Murex (www.murex.com) Since its creation in 1986, Murex has played a key role in proposing effective technology as a catalyst for growth and innovation in capital markets, through the design and implementation of integrated trading, risk management, processing and post-trade platforms. Driven by innovation, Murex’s MX.3 Front-to-Back-to-Risk platform leverages the firm’s collective experience and expertise, accumulated through its strategic client partnerships, to offer an unrivalled asset class coverage and best-of-breed business solutions at every step of the financial trade lifecycle. Clients worldwide benefit from the MX.3 platform’s modular set of business solutions, specifically designed to solve the multi-faceted challenges of a transforming financial industry, while relying on the strength of 2,000 dedicated specialists.
Gartner does not endorse any vendor, product or service depicted in its research publications, and does not advise technology users to select only those vendors with the highest ratings or other designation. Gartner research publications consist of the opinions of Gartner's research organization and should not be construed as statements of fact. Gartner disclaims all warranties, expressed or implied, with respect to this research, including any warranties of merchantability or fitness for a particular purpose.
Contacts
Murex
Mireille Adebiyi,
+33144053200
Global Marketing Communications Manager
(BUSINESS WIRE) Murex, the prime provider of cross-asset trading, risk management and processing solutions, is proud to announce that it has been named as a Leader, positioned furthest for Completeness of Vision and Ability to Execute in the 2014 Gartner Magic Quadrant for Trading Platforms (D.Furlonger, F.Chesini, 22 December 2014).
“We are delighted with this new recognition. We consider our position in the Leaders Quadrant as a confirmation of our role as transformation enabler, providing sell-side and buy-side institutions with timely and relevant solutions that help them adapt to the fundamental changes of the post-crisis era.” said Maroun EDDE, CEO of Murex.
Murex has been continuously adapting functionality and technology to new regulatory and market practices, providing flexibility and scalability at a controlled cost thanks to its investment in cutting-edge technology, such as memory data grids or GPU-based analytics. The MX.3 platform delivers the framework to rationalize in-house businesses and to build utility models.
Through the MX.3 platform, Murex hosts a range of “best-of-breed” Front-to-Back-to-Risk business solutions. In 2014, a complete overhaul of the collateral management delivered a state-of-the art enterprise solution that embeds best risk management practices into an advanced collateral operation framework. MX.3 for Collateral Management supports bilateral BCBS/IOSCO initial margin for uncleared and cleared OTC, as well as repo and securities lending, and exchange-traded derivative products.
Thanks to the breadth of its financial products, the front-to-risk consistency of its analytics and its ability to deliver real-time complex simulations, Murex plays a leading role in helping financial institutions to successfully adapt to next regulatory challenges of Basel 3 and Fundamental Review of Trading Book (“FRTB”).
“At a time when the finance industry needs simplification to drive cost rationalization, we strive to make our technology and business solutions a value creator for our clients” added Maroun EDDE.
To access the report, click on the following link (or copy and paste the URL into your browser): https://www.murex.com/node/575?fid=8397
About Murex (www.murex.com) Since its creation in 1986, Murex has played a key role in proposing effective technology as a catalyst for growth and innovation in capital markets, through the design and implementation of integrated trading, risk management, processing and post-trade platforms. Driven by innovation, Murex’s MX.3 Front-to-Back-to-Risk platform leverages the firm’s collective experience and expertise, accumulated through its strategic client partnerships, to offer an unrivalled asset class coverage and best-of-breed business solutions at every step of the financial trade lifecycle. Clients worldwide benefit from the MX.3 platform’s modular set of business solutions, specifically designed to solve the multi-faceted challenges of a transforming financial industry, while relying on the strength of 2,000 dedicated specialists.
Gartner does not endorse any vendor, product or service depicted in its research publications, and does not advise technology users to select only those vendors with the highest ratings or other designation. Gartner research publications consist of the opinions of Gartner's research organization and should not be construed as statements of fact. Gartner disclaims all warranties, expressed or implied, with respect to this research, including any warranties of merchantability or fitness for a particular purpose.
Contacts
Murex
Mireille Adebiyi,
+33144053200
Global Marketing Communications Manager
Posted by
Business Daily Africa
ADP urge workers to use bridges, underpasses or dedicated zebra crossings
ABU DHABI, United Arab Emirates - Saturday, January 24th 2015 [ME NewsWire]
The Traffic and Patrols Directorate at Abu Dhabi Police recently organized a traffic safety awareness exhibition at Emirates Steel Industries in the Abu Dhabi emirate. The exhibition falls in line with the unremitting efforts to enhance awareness of workers and encourage them to cross the road safely by using pedestrian bridges, underpasses or dedicated crossings – zebra crossings.
Colonel Jamal Salem Al Ameri, Chief of Public Relations Section at the Traffic and Patrols Directorate, explained that the awareness exhibition marks the “Safety and Environment Day” initiative. “The initiative is part of the comprehensive traffic awareness plan that was launched earlier this year. It aims at reinforcing partnership with civil society organizations, in a bid to boost traffic safety culture among all society segments,” he noted.
Adding further, Colonel Al Ameri said: “As a part of the exhibition, workers watched an awareness-raising documentary film, warning them against the major causes of traffic accidents, and received brochures about pedestrian crossing rules and safe passage.” Workers interacted with the traffic safety awareness guidance offered by the mobile traffic education patrol, which would ultimately contribute to reducing the key causes of run-over accidents.
In the same context, Colonel Al Ameri called upon drivers to reduce speed when approaching places designed for pedestrian crossing and to give pedestrians right of way. He also urged pedestrians to use pedestrian bridges, underpass walkways or safe passageways.
For more information about:
The Ministry of Interior, please click HERE
Abu Dhabi Police, please click HERE
Follow us and check our Social Media feeds on: YouTube, Facebook and Twitter
The Arabic-language text of this announcement is the official, authoritative version. Translations are provided as an accommodation only, and should be cross-referenced with the Arabic-language text, which is the only version of the text intended to have legal effect.
Contacts
The UAE Minister of Interior's General Secretariat, Tactical Affairs and Security Media Department
Abu Dhabi Police GHQ - Security Media
Chris Cron +971-(0)-50-987-1317
E-mail: cron.media@hotmail.com
Permalink: http://me-newswire.net/news/13455/en
The Traffic and Patrols Directorate at Abu Dhabi Police recently organized a traffic safety awareness exhibition at Emirates Steel Industries in the Abu Dhabi emirate. The exhibition falls in line with the unremitting efforts to enhance awareness of workers and encourage them to cross the road safely by using pedestrian bridges, underpasses or dedicated crossings – zebra crossings.
Colonel Jamal Salem Al Ameri, Chief of Public Relations Section at the Traffic and Patrols Directorate, explained that the awareness exhibition marks the “Safety and Environment Day” initiative. “The initiative is part of the comprehensive traffic awareness plan that was launched earlier this year. It aims at reinforcing partnership with civil society organizations, in a bid to boost traffic safety culture among all society segments,” he noted.
Adding further, Colonel Al Ameri said: “As a part of the exhibition, workers watched an awareness-raising documentary film, warning them against the major causes of traffic accidents, and received brochures about pedestrian crossing rules and safe passage.” Workers interacted with the traffic safety awareness guidance offered by the mobile traffic education patrol, which would ultimately contribute to reducing the key causes of run-over accidents.
In the same context, Colonel Al Ameri called upon drivers to reduce speed when approaching places designed for pedestrian crossing and to give pedestrians right of way. He also urged pedestrians to use pedestrian bridges, underpass walkways or safe passageways.
For more information about:
The Ministry of Interior, please click HERE
Abu Dhabi Police, please click HERE
Follow us and check our Social Media feeds on: YouTube, Facebook and Twitter
The Arabic-language text of this announcement is the official, authoritative version. Translations are provided as an accommodation only, and should be cross-referenced with the Arabic-language text, which is the only version of the text intended to have legal effect.
Contacts
The UAE Minister of Interior's General Secretariat, Tactical Affairs and Security Media Department
Abu Dhabi Police GHQ - Security Media
Chris Cron +971-(0)-50-987-1317
E-mail: cron.media@hotmail.com
Permalink: http://me-newswire.net/news/13455/en
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Celgene Receives Positive CHMP Opinion for ABRAXANE® for First-Line Treatment of Patients with Non-Small Cell Lung Cancer
In Europe, Lung Cancer is the 4th most commonly diagnosed cancer and the leading cause of cancer-related mortality
BOUDRY, Switzerland - Tuesday, January 27th 2015 [ME NewsWire]
(BUSINESS WIRE)-- Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for ABRAXANE® (paclitaxel formulated as albumin-bound nanoparticles, or nab-paclitaxel) in combination with carboplatin for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.
Lung cancer is the fourth most commonly diagnosed cancer in both men and women, however it is the leading cause of cancer-related mortality in Europe. Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, accounting for 85 to 90% of all cases. The predominant cause of lung cancer is cigarette smoking, although environmental and occupational factors also can cause the cancer. Treatment options generally include systemic chemotherapy or protein kinase inhibitors. In the most advanced cases, only the symptoms of the disease can be managed; there is a clear need for innovative new medicines for the treatment of lung cancer.
“Progress in lung cancer will come first from early diagnosis with patients presenting promptly with symptoms and second, with new drugs that are well tolerated and improve on current therapies. Incremental steps can lead to a meaningful impact on patients and society, given the frequency and aggressiveness of lung cancer,” says Dr. Mary O’Brien, Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, UK. “The positive CHMP opinion for ABRAXANE in combination with carboplatin for the treatment of adult patients with NSCLC is a significant step toward bringing a new treatment option to patients in Europe. The clinical data show patients had a significant positive response rate to the treatment, combined with an established safety profile. The therapy has also shown a significant response benefit for a subset of patients with squamous cell lung cancer, where there have been limited treatment advances in recent years.”
The positive CHMP opinion was based on the results of a multicenter, randomized, open-label study including 1,052 chemotherapy-naive patients with Stage IIIb/IV non-small cell lung cancer. The study compared ABRAXANE in combination with carboplatin versus solvent-based paclitaxel in combination with carboplatin as first-line treatment in patients with advanced non-small cell lung cancer. The primary efficacy endpoint, overall response rate, was significantly higher for patients in the ABRAXANE/carboplatin arm at 33%, compared with patients in the control arm, at 25%. The most common adverse reactions
(≥ 20%) of ABRAXANE in combination with carboplatin for NSCLC were anaemia, neutropenia, thrombocytopenia, peripheral neuropathy, nausea, and fatigue.
Tuomo Pätsi, President of Celgene in Europe, the Middle East and Africa (EMEA), said, “The positive CHMP opinion is the first opportunity for Celgene to play a role in helping patients with NSCLC have access to an important treatment option in Europe. The anticipated European Commission decision would be the third approved indication for ABRAXANE, underscoring the value of this medicine. We are committed to ensuring that patients who need ABRAXANE will gain access to it once approved by the European Commission.”
The CHMP reviews applications for all 28 member states in the European Union (EU), as well as Norway, Liechtenstein and Iceland. The European Commission, which generally follows the recommendation of the CHMP, is expected to make its final decision within approximately two months. If approval is granted, detailed conditions for the use of this product will be described in the Summary of Product Characteristics (SmPC), which will be published in the revised European Public Assessment Report (EPAR).
ABRAXANE is not currently indicated for the treatment of metastatic NSCLC in the European Union.
About ABRAXANE
ABRAXANE® is an albumin-bound form of paclitaxel that is manufactured using patented nab® technology. ABRAXANE is formulated with albumin, a human protein, and is free of solvents.
ABRAXANE was first approved in January 2005 by the U.S. Food and Drug Administration (FDA) for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. In Europe, ABRAXANE was approved in January 2008 as monotherapy for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated. ABRAXANE is now approved in more than 50 countries for the treatment of metastatic breast cancer.
In October 2012, ABRAXANE was approved by the FDA for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC), in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. ABRAXANE is also approved for the treatment of NSCLC in Argentina, Australia, Chile, Ecuador, Guatemala, Hong Kong, Japan, New Zealand and Singapore.
In September 2013, the FDA approved ABRAXANE as first–line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine. In December 2013, ABRAXANE in combination with gemcitabine was approved for first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas in Europe. ABRAXANE is also approved for the treatment of metastatic pancreatic cancer in more than 40 countries.
U.S. Regulatory Information for ABRAXANE
WARNING - NEUTROPENIA
Do not administer ABRAXANE therapy to patients who have baseline neutrophil counts of less than 1500 cells/mm3. In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection, it is recommended that frequent peripheral blood cell counts be performed on all patients receiving ABRAXANE
Note: An albumin form of paclitaxel may substantially affect a drug’s functional properties relative to those of drug in solution. DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS
CONTRAINDICATIONS
Neutrophil Counts
ABRAXANE should not be used in patients who have baseline neutrophil counts of <1500 cells/mm3
Hypersensitivity
Patients who experience a severe hypersensitivity reaction to ABRAXANE should not be rechallenged with the drug
WARNINGS AND PRECAUTIONS
Hematologic Effects
Bone marrow suppression (primarily neutropenia) is dose-dependent and a dose-limiting toxicity of ABRAXANE. In clinical studies, Grade 3-4 neutropenia occurred in 34% of patients with metastatic breast cancer (MBC), 47% of patients with non–small cell lung cancer (NSCLC), and 38% of patients with pancreatic cancer
Monitor for myelotoxicity by performing complete blood cell counts frequently, including prior to dosing on Day 1 (for MBC) and Days 1, 8, and 15 (for NSCLC and for pancreatic cancer)
Do not administer ABRAXANE to patients with baseline absolute neutrophil counts (ANC) of less than 1500 cells/mm3
In the case of severe neutropenia (<500 cells/mm3 for 7 days or more) during a course of ABRAXANE therapy, reduce the dose of ABRAXANE in subsequent courses in patients with either MBC or NSCLC
In patients with MBC, resume treatment with every-3-week cycles of ABRAXANE after ANC recovers to a level >1500 cells/mm3 and platelets recover to a level >100,000 cells/mm3
In patients with NSCLC, resume treatment if recommended at permanently reduced doses for both weekly ABRAXANE and every-3-week carboplatin after ANC recovers to at least 1500 cells/mm3 and platelet count of at least 100,000 cells/mm3 on Day 1 or to an ANC of at least 500 cells/mm3 and platelet count of at least 50,000 cells/mm3 on Days 8 or 15 of the cycle
In patients with adenocarcinoma of the pancreas, withhold ABRAXANE and gemcitabine if the ANC is less than 500 cells/mm3 or platelets are less than 50,000 cells/mm3 and delay initiation of the next cycle if the ANC is less than 1500 cells/mm3 or platelet count is less than 100,000 cells/mm3 on Day 1 of the cycle. Resume treatment with appropriate dose reduction if recommended
Nervous System
Sensory neuropathy is dose- and schedule-dependent
The occurrence of Grade 1 or 2 sensory neuropathy does not generally require dose modification
If ≥ Grade 3 sensory neuropathy develops, withhold ABRAXANE treatment until resolution to Grade 1 or 2 for MBC or until resolution to ≤ Grade 1 for NSCLC and pancreatic cancer followed by a dose reduction for all subsequent courses of ABRAXANE
Sepsis
Sepsis occurred in 5% of patients with or without neutropenia who received ABRAXANE in combination with gemcitabine
Biliary obstruction or presence of biliary stent were risk factors for severe or fatal sepsis
If a patient becomes febrile (regardless of ANC), initiate treatment with broad-spectrum antibiotics
For febrile neutropenia, interrupt ABRAXANE and gemcitabine until fever resolves and ANC ≥1500 cells/mm3, then resume treatment at reduced dose levels
Pneumonitis
Pneumonitis, including some cases that were fatal, occurred in 4% of patients receiving ABRAXANE in combination with gemcitabine
Monitor patients for signs and symptoms and interrupt ABRAXANE and gemcitabine during evaluation of suspected pneumonitis
Permanently discontinue treatment with ABRAXANE and gemcitabine upon making a diagnosis of pneumonitis
Hypersensitivity
Severe and sometimes fatal hypersensitivity reactions, including anaphylactic reactions, have been reported
Patients who experience a severe hypersensitivity reaction to ABRAXANE should not be rechallenged with this drug
Hepatic Impairment
Because the exposure and toxicity of paclitaxel can be increased with hepatic impairment, administration of ABRAXANE in patients with hepatic impairment should be performed with caution
Patients with hepatic impairment may be at an increased risk of toxicity, particularly from myelosuppression, and should be monitored for development of profound myelosuppression
For MBC and NSCLC, the starting dose should be reduced for patients with moderate or severe hepatic impairment
For pancreatic adenocarcinoma, ABRAXANE is not recommended for patients with moderate to severe hepatic impairment (total bilirubin >1.5 x ULN and AST ≤10 x ULN)
Albumin (Human)
ABRAXANE contains albumin (human), a derivative of human blood
Use in Pregnancy: Pregnancy Category D
ABRAXANE can cause fetal harm when administered to a pregnant woman
If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus
Women of childbearing potential should be advised to avoid becoming pregnant while receiving ABRAXANE
Use in Men
Men should be advised not to father a child while receiving ABRAXANE
ADVERSE REACTIONS
Randomized Metastatic Breast Cancer (MBC) Study
The most common adverse reactions (≥20%) with single-agent use of ABRAXANE vs paclitaxel injection in the MBC study are alopecia (90%, 94%), neutropenia (all cases 80%, 82%; severe 9%, 22%), sensory neuropathy (any symptoms 71%, 56%; severe 10%, 2%), abnormal ECG (all patients 60%, 52%; patients with normal baseline 35%, 30%), fatigue/asthenia (any 47%, 39%; severe 8%, 3%), myalgia/arthralgia (any 44%, 49%; severe 8%, 4%), AST elevation (any 39%, 32%), alkaline phosphatase elevation (any 36%, 31%), anemia (any 33%, 25%; severe 1%, <1%), nausea (any 30%, 22%; severe 3%, <1%), diarrhea (any 27%, 15%; severe <1%, 1%) and infections (24%, 20%), respectively
Sensory neuropathy was the cause of ABRAXANE discontinuation in 7/229 (3%) patients
Other adverse reactions of note with the use of ABRAXANE vs paclitaxel injection included vomiting (any 18%, 10%; severe 4%, 1%), fluid retention (any 10%, 8%; severe 0%, <1%), mucositis (any 7%, 6%; severe <1%, 0%), hepatic dysfunction (elevations in bilirubin 7%, 7%), hypersensitivity reactions (any 4%, 12%; severe 0%, 2%), thrombocytopenia (any 2%, 3%; severe <1%, <1%), neutropenic sepsis (<1%, <1%), and injection site reactions (<1%, 1%), respectively. Dehydration and pyrexia were also reported
Renal dysfunction (any 11%, severe 1%) was reported in patients treated with ABRAXANE (n=229)
In all ABRAXANE-treated patients (n=366), ocular/visual disturbances were reported (any 13%; severe 1%)
Severe cardiovascular events possibly related to single-agent ABRAXANE occurred in approximately 3% of patients and included cardiac ischemia/infarction, chest pain, cardiac arrest, supraventricular tachycardia, edema, thrombosis, pulmonary thromboembolism, pulmonary emboli, and hypertension
Cases of cerebrovascular attacks (strokes) and transient ischemic attacks have been reported
Non–Small Cell Lung Cancer (NSCLC) Study
The most common adverse reactions (≥20%) of ABRAXANE in combination with carboplatin are anemia, neutropenia, thrombocytopenia, alopecia, peripheral neuropathy, nausea, and fatigue
The most common serious adverse reactions of ABRAXANE in combination with carboplatin for NSCLC are anemia (4%) and pneumonia (3%)
The most common adverse reactions resulting in permanent discontinuation of ABRAXANE are neutropenia (3%), thrombocytopenia (3%), and peripheral neuropathy (1%)
The most common adverse reactions resulting in dose reduction of ABRAXANE are neutropenia (24%), thrombocytopenia (13%), and anemia (6%)
The most common adverse reactions leading to withholding or delay in ABRAXANE dosing are neutropenia (41%), thrombocytopenia (30%), and anemia (16%)
The following common (≥10% incidence) adverse reactions were observed at a similar incidence in ABRAXANE plus carboplatin–treated and paclitaxel injection plus carboplatin–treated patients: alopecia (56%), nausea (27%), fatigue (25%), decreased appetite (17%), asthenia (16%), constipation (16%), diarrhea (15%), vomiting (12%), dyspnea (12%), and rash (10%); incidence rates are for the ABRAXANE plus carboplatin treatment group
Adverse reactions with a difference of ≥2%, Grade 3 or higher, with combination use of ABRAXANE and carboplatin vs combination use of paclitaxel injection and carboplatin in NSCLC are anemia (28%, 7%), neutropenia (47%, 58%), thrombocytopenia (18%, 9%), and peripheral neuropathy (3%, 12%), respectively
Adverse reactions with a difference of ≥5%, Grades 1-4, with combination use of ABRAXANE and carboplatin vs combination use of paclitaxel injection and carboplatin in NSCLC are anemia (98%, 91%), thrombocytopenia (68%, 55%), peripheral neuropathy (48%, 64%), edema peripheral (10%, 4%), epistaxis (7%, 2%), arthralgia (13%, 25%), and myalgia (10%, 19%), respectively
Neutropenia (all grades) was reported in 85% of patients who received ABRAXANE and carboplatin vs 83% of patients who received paclitaxel injection and carboplatin
Pancreatic Adenocarcinoma Study
Among the most common (≥20%) adverse reactions in the phase III study, those with a ≥5% higher incidence in the ABRAXANE/gemcitabine group compared with the gemcitabine group are neutropenia (73%, 58%), fatigue (59%, 46%), peripheral neuropathy (54%, 13%), nausea (54%, 48%), alopecia (50%, 5%), peripheral edema (46%, 30%), diarrhea (44%, 24%), pyrexia (41%, 28%), vomiting (36%, 28%), decreased appetite (36%, 26%), rash (30%, 11%), and dehydration (21%, 11%)
Of these most common adverse reactions, those with a ≥2% higher incidence of Grade 3-4 toxicity in the ABRAXANE/gemcitabine group compared with the gemcitabine group, respectively, are neutropenia (38%, 27%), fatigue (18%, 9%), peripheral neuropathy (17%, 1%), nausea (6%, 3%), diarrhea (6%, 1%), pyrexia (3%, 1%), vomiting (6%, 4%), decreased appetite (5%, 2%), and dehydration (7%, 2%)
Thrombocytopenia (all grades) was reported in 74% of patients in the ABRAXANE/gemcitabine group vs 70% of patients in the gemcitabine group
The most common serious adverse reactions of ABRAXANE (with a ≥1% higher incidence) are pyrexia (6%), dehydration (5%), pneumonia (4%), and vomiting (4%)
The most common adverse reactions resulting in permanent discontinuation of ABRAXANE were peripheral neuropathy (8%), fatigue (4%), and thrombocytopenia (2%)
The most common adverse reactions resulting in dose reduction of ABRAXANE are neutropenia (10%) and peripheral neuropathy (6%)
The most common adverse reactions leading to withholding or delay in ABRAXANE dosing are neutropenia (16%), thrombocytopenia (12%), fatigue (8%), peripheral neuropathy (15%), anemia (5%), and diarrhea (5%)
Other selected adverse reactions with a ≥5% higher incidence for all-grade toxicity in the ABRAXANE/gemcitabine group compared to the gemcitabine group, respectively, are asthenia (19%, 13%), mucositis (10%, 4%), dysgeusia (16%, 8%), headache (14%, 9%), hypokalemia (12%, 7%), cough (17%, 7%), epistaxis (15%, 3%), urinary tract infection (11%, 5%), pain in extremity (11%, 6%), arthralgia (11%, 3%), myalgia (10%, 4%), and depression (12%, 6%)
Other selected adverse reactions with a ≥2% higher incidence for Grade 3-4 toxicity in the ABRAXANE/gemcitabine group compared to the gemcitabine group are thrombocytopenia (13%, 9%), asthenia (7%, 4%), and hypokalemia (4%, 1%)
Postmarketing Experience With ABRAXANE and Other Paclitaxel Formulations
Severe and sometimes fatal hypersensitivity reactions have been reported with ABRAXANE. The use of ABRAXANE in patients previously exhibiting hypersensitivity to paclitaxel injection or human albumin has not been studied
There have been reports of congestive heart failure, left ventricular dysfunction, and atrioventricular block with ABRAXANE, primarily among individuals with underlying cardiac history or prior exposure to cardiotoxic drugs
There have been reports of extravasation of ABRAXANE. Given the possibility of extravasation, it is advisable to monitor closely the ABRAXANE infusion site for possible infiltration during drug administration
DRUG INTERACTIONS
Caution should be exercised when administering ABRAXANE concomitantly with medicines known to inhibit or induce either CYP2C8 or CYP3A4
USE IN SPECIFIC POPULATIONS
Nursing Mothers
It is not known whether paclitaxel is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother
Pediatric
The safety and effectiveness of ABRAXANE in pediatric patients have not been evaluated
Geriatric
No toxicities occurred notably more frequently among patients ≥65 years of age who received ABRAXANE for MBC
Myelosuppression, peripheral neuropathy, and arthralgia were more frequent in patients ≥65 years of age treated with ABRAXANE and carboplatin in NSCLC
Diarrhea, decreased appetite, dehydration, and epistaxis were more frequent in patients 65 years or older compared with patients younger than 65 years old who received ABRAXANE and gemcitabine in adenocarcinoma of the pancreas
Renal Impairment
There are insufficient data to permit dosage recommendations in patients with severe renal impairment or end stage renal disease (estimated creatinine clearance <30 mL/min)
DOSAGE AND ADMINISTRATION
Do not administer ABRAXANE to any patient with total bilirubin greater than 5 x ULN or AST greater than 10 x ULN
For MBC and NSCLC, reduce starting dose in patients with moderate to severe hepatic impairment
For adenocarcinoma of the pancreas, do not administer ABRAXANE to patients who have moderate to severe hepatic impairment
Dose reductions or discontinuation may be needed based on severe hematologic, neurologic, cutaneous, or gastrointestinal toxicity
Monitor patients closely
Please see full Prescribing Information, including Boxed WARNING.
About Celgene
Celgene International Sàrl, located in Boudry, in the Canton of Neuchâtel, Switzerland, is a wholly-owned subsidiary and International Headquarters of Celgene Corporation. Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical 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 the Company's website at www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn and YouTube.
# # #
Contacts
Investors:
+41 32 729 8303 ir@celgene.com
Media: +41 32 729 8304 media@celgene.com
Permalink: http://me-newswire.net/news/13497/en
BOUDRY, Switzerland - Tuesday, January 27th 2015 [ME NewsWire]
(BUSINESS WIRE)-- Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for ABRAXANE® (paclitaxel formulated as albumin-bound nanoparticles, or nab-paclitaxel) in combination with carboplatin for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.
Lung cancer is the fourth most commonly diagnosed cancer in both men and women, however it is the leading cause of cancer-related mortality in Europe. Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, accounting for 85 to 90% of all cases. The predominant cause of lung cancer is cigarette smoking, although environmental and occupational factors also can cause the cancer. Treatment options generally include systemic chemotherapy or protein kinase inhibitors. In the most advanced cases, only the symptoms of the disease can be managed; there is a clear need for innovative new medicines for the treatment of lung cancer.
“Progress in lung cancer will come first from early diagnosis with patients presenting promptly with symptoms and second, with new drugs that are well tolerated and improve on current therapies. Incremental steps can lead to a meaningful impact on patients and society, given the frequency and aggressiveness of lung cancer,” says Dr. Mary O’Brien, Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, UK. “The positive CHMP opinion for ABRAXANE in combination with carboplatin for the treatment of adult patients with NSCLC is a significant step toward bringing a new treatment option to patients in Europe. The clinical data show patients had a significant positive response rate to the treatment, combined with an established safety profile. The therapy has also shown a significant response benefit for a subset of patients with squamous cell lung cancer, where there have been limited treatment advances in recent years.”
The positive CHMP opinion was based on the results of a multicenter, randomized, open-label study including 1,052 chemotherapy-naive patients with Stage IIIb/IV non-small cell lung cancer. The study compared ABRAXANE in combination with carboplatin versus solvent-based paclitaxel in combination with carboplatin as first-line treatment in patients with advanced non-small cell lung cancer. The primary efficacy endpoint, overall response rate, was significantly higher for patients in the ABRAXANE/carboplatin arm at 33%, compared with patients in the control arm, at 25%. The most common adverse reactions
(≥ 20%) of ABRAXANE in combination with carboplatin for NSCLC were anaemia, neutropenia, thrombocytopenia, peripheral neuropathy, nausea, and fatigue.
Tuomo Pätsi, President of Celgene in Europe, the Middle East and Africa (EMEA), said, “The positive CHMP opinion is the first opportunity for Celgene to play a role in helping patients with NSCLC have access to an important treatment option in Europe. The anticipated European Commission decision would be the third approved indication for ABRAXANE, underscoring the value of this medicine. We are committed to ensuring that patients who need ABRAXANE will gain access to it once approved by the European Commission.”
The CHMP reviews applications for all 28 member states in the European Union (EU), as well as Norway, Liechtenstein and Iceland. The European Commission, which generally follows the recommendation of the CHMP, is expected to make its final decision within approximately two months. If approval is granted, detailed conditions for the use of this product will be described in the Summary of Product Characteristics (SmPC), which will be published in the revised European Public Assessment Report (EPAR).
ABRAXANE is not currently indicated for the treatment of metastatic NSCLC in the European Union.
About ABRAXANE
ABRAXANE® is an albumin-bound form of paclitaxel that is manufactured using patented nab® technology. ABRAXANE is formulated with albumin, a human protein, and is free of solvents.
ABRAXANE was first approved in January 2005 by the U.S. Food and Drug Administration (FDA) for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. In Europe, ABRAXANE was approved in January 2008 as monotherapy for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated. ABRAXANE is now approved in more than 50 countries for the treatment of metastatic breast cancer.
In October 2012, ABRAXANE was approved by the FDA for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC), in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. ABRAXANE is also approved for the treatment of NSCLC in Argentina, Australia, Chile, Ecuador, Guatemala, Hong Kong, Japan, New Zealand and Singapore.
In September 2013, the FDA approved ABRAXANE as first–line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine. In December 2013, ABRAXANE in combination with gemcitabine was approved for first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas in Europe. ABRAXANE is also approved for the treatment of metastatic pancreatic cancer in more than 40 countries.
U.S. Regulatory Information for ABRAXANE
WARNING - NEUTROPENIA
Do not administer ABRAXANE therapy to patients who have baseline neutrophil counts of less than 1500 cells/mm3. In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection, it is recommended that frequent peripheral blood cell counts be performed on all patients receiving ABRAXANE
Note: An albumin form of paclitaxel may substantially affect a drug’s functional properties relative to those of drug in solution. DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS
CONTRAINDICATIONS
Neutrophil Counts
ABRAXANE should not be used in patients who have baseline neutrophil counts of <1500 cells/mm3
Hypersensitivity
Patients who experience a severe hypersensitivity reaction to ABRAXANE should not be rechallenged with the drug
WARNINGS AND PRECAUTIONS
Hematologic Effects
Bone marrow suppression (primarily neutropenia) is dose-dependent and a dose-limiting toxicity of ABRAXANE. In clinical studies, Grade 3-4 neutropenia occurred in 34% of patients with metastatic breast cancer (MBC), 47% of patients with non–small cell lung cancer (NSCLC), and 38% of patients with pancreatic cancer
Monitor for myelotoxicity by performing complete blood cell counts frequently, including prior to dosing on Day 1 (for MBC) and Days 1, 8, and 15 (for NSCLC and for pancreatic cancer)
Do not administer ABRAXANE to patients with baseline absolute neutrophil counts (ANC) of less than 1500 cells/mm3
In the case of severe neutropenia (<500 cells/mm3 for 7 days or more) during a course of ABRAXANE therapy, reduce the dose of ABRAXANE in subsequent courses in patients with either MBC or NSCLC
In patients with MBC, resume treatment with every-3-week cycles of ABRAXANE after ANC recovers to a level >1500 cells/mm3 and platelets recover to a level >100,000 cells/mm3
In patients with NSCLC, resume treatment if recommended at permanently reduced doses for both weekly ABRAXANE and every-3-week carboplatin after ANC recovers to at least 1500 cells/mm3 and platelet count of at least 100,000 cells/mm3 on Day 1 or to an ANC of at least 500 cells/mm3 and platelet count of at least 50,000 cells/mm3 on Days 8 or 15 of the cycle
In patients with adenocarcinoma of the pancreas, withhold ABRAXANE and gemcitabine if the ANC is less than 500 cells/mm3 or platelets are less than 50,000 cells/mm3 and delay initiation of the next cycle if the ANC is less than 1500 cells/mm3 or platelet count is less than 100,000 cells/mm3 on Day 1 of the cycle. Resume treatment with appropriate dose reduction if recommended
Nervous System
Sensory neuropathy is dose- and schedule-dependent
The occurrence of Grade 1 or 2 sensory neuropathy does not generally require dose modification
If ≥ Grade 3 sensory neuropathy develops, withhold ABRAXANE treatment until resolution to Grade 1 or 2 for MBC or until resolution to ≤ Grade 1 for NSCLC and pancreatic cancer followed by a dose reduction for all subsequent courses of ABRAXANE
Sepsis
Sepsis occurred in 5% of patients with or without neutropenia who received ABRAXANE in combination with gemcitabine
Biliary obstruction or presence of biliary stent were risk factors for severe or fatal sepsis
If a patient becomes febrile (regardless of ANC), initiate treatment with broad-spectrum antibiotics
For febrile neutropenia, interrupt ABRAXANE and gemcitabine until fever resolves and ANC ≥1500 cells/mm3, then resume treatment at reduced dose levels
Pneumonitis
Pneumonitis, including some cases that were fatal, occurred in 4% of patients receiving ABRAXANE in combination with gemcitabine
Monitor patients for signs and symptoms and interrupt ABRAXANE and gemcitabine during evaluation of suspected pneumonitis
Permanently discontinue treatment with ABRAXANE and gemcitabine upon making a diagnosis of pneumonitis
Hypersensitivity
Severe and sometimes fatal hypersensitivity reactions, including anaphylactic reactions, have been reported
Patients who experience a severe hypersensitivity reaction to ABRAXANE should not be rechallenged with this drug
Hepatic Impairment
Because the exposure and toxicity of paclitaxel can be increased with hepatic impairment, administration of ABRAXANE in patients with hepatic impairment should be performed with caution
Patients with hepatic impairment may be at an increased risk of toxicity, particularly from myelosuppression, and should be monitored for development of profound myelosuppression
For MBC and NSCLC, the starting dose should be reduced for patients with moderate or severe hepatic impairment
For pancreatic adenocarcinoma, ABRAXANE is not recommended for patients with moderate to severe hepatic impairment (total bilirubin >1.5 x ULN and AST ≤10 x ULN)
Albumin (Human)
ABRAXANE contains albumin (human), a derivative of human blood
Use in Pregnancy: Pregnancy Category D
ABRAXANE can cause fetal harm when administered to a pregnant woman
If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus
Women of childbearing potential should be advised to avoid becoming pregnant while receiving ABRAXANE
Use in Men
Men should be advised not to father a child while receiving ABRAXANE
ADVERSE REACTIONS
Randomized Metastatic Breast Cancer (MBC) Study
The most common adverse reactions (≥20%) with single-agent use of ABRAXANE vs paclitaxel injection in the MBC study are alopecia (90%, 94%), neutropenia (all cases 80%, 82%; severe 9%, 22%), sensory neuropathy (any symptoms 71%, 56%; severe 10%, 2%), abnormal ECG (all patients 60%, 52%; patients with normal baseline 35%, 30%), fatigue/asthenia (any 47%, 39%; severe 8%, 3%), myalgia/arthralgia (any 44%, 49%; severe 8%, 4%), AST elevation (any 39%, 32%), alkaline phosphatase elevation (any 36%, 31%), anemia (any 33%, 25%; severe 1%, <1%), nausea (any 30%, 22%; severe 3%, <1%), diarrhea (any 27%, 15%; severe <1%, 1%) and infections (24%, 20%), respectively
Sensory neuropathy was the cause of ABRAXANE discontinuation in 7/229 (3%) patients
Other adverse reactions of note with the use of ABRAXANE vs paclitaxel injection included vomiting (any 18%, 10%; severe 4%, 1%), fluid retention (any 10%, 8%; severe 0%, <1%), mucositis (any 7%, 6%; severe <1%, 0%), hepatic dysfunction (elevations in bilirubin 7%, 7%), hypersensitivity reactions (any 4%, 12%; severe 0%, 2%), thrombocytopenia (any 2%, 3%; severe <1%, <1%), neutropenic sepsis (<1%, <1%), and injection site reactions (<1%, 1%), respectively. Dehydration and pyrexia were also reported
Renal dysfunction (any 11%, severe 1%) was reported in patients treated with ABRAXANE (n=229)
In all ABRAXANE-treated patients (n=366), ocular/visual disturbances were reported (any 13%; severe 1%)
Severe cardiovascular events possibly related to single-agent ABRAXANE occurred in approximately 3% of patients and included cardiac ischemia/infarction, chest pain, cardiac arrest, supraventricular tachycardia, edema, thrombosis, pulmonary thromboembolism, pulmonary emboli, and hypertension
Cases of cerebrovascular attacks (strokes) and transient ischemic attacks have been reported
Non–Small Cell Lung Cancer (NSCLC) Study
The most common adverse reactions (≥20%) of ABRAXANE in combination with carboplatin are anemia, neutropenia, thrombocytopenia, alopecia, peripheral neuropathy, nausea, and fatigue
The most common serious adverse reactions of ABRAXANE in combination with carboplatin for NSCLC are anemia (4%) and pneumonia (3%)
The most common adverse reactions resulting in permanent discontinuation of ABRAXANE are neutropenia (3%), thrombocytopenia (3%), and peripheral neuropathy (1%)
The most common adverse reactions resulting in dose reduction of ABRAXANE are neutropenia (24%), thrombocytopenia (13%), and anemia (6%)
The most common adverse reactions leading to withholding or delay in ABRAXANE dosing are neutropenia (41%), thrombocytopenia (30%), and anemia (16%)
The following common (≥10% incidence) adverse reactions were observed at a similar incidence in ABRAXANE plus carboplatin–treated and paclitaxel injection plus carboplatin–treated patients: alopecia (56%), nausea (27%), fatigue (25%), decreased appetite (17%), asthenia (16%), constipation (16%), diarrhea (15%), vomiting (12%), dyspnea (12%), and rash (10%); incidence rates are for the ABRAXANE plus carboplatin treatment group
Adverse reactions with a difference of ≥2%, Grade 3 or higher, with combination use of ABRAXANE and carboplatin vs combination use of paclitaxel injection and carboplatin in NSCLC are anemia (28%, 7%), neutropenia (47%, 58%), thrombocytopenia (18%, 9%), and peripheral neuropathy (3%, 12%), respectively
Adverse reactions with a difference of ≥5%, Grades 1-4, with combination use of ABRAXANE and carboplatin vs combination use of paclitaxel injection and carboplatin in NSCLC are anemia (98%, 91%), thrombocytopenia (68%, 55%), peripheral neuropathy (48%, 64%), edema peripheral (10%, 4%), epistaxis (7%, 2%), arthralgia (13%, 25%), and myalgia (10%, 19%), respectively
Neutropenia (all grades) was reported in 85% of patients who received ABRAXANE and carboplatin vs 83% of patients who received paclitaxel injection and carboplatin
Pancreatic Adenocarcinoma Study
Among the most common (≥20%) adverse reactions in the phase III study, those with a ≥5% higher incidence in the ABRAXANE/gemcitabine group compared with the gemcitabine group are neutropenia (73%, 58%), fatigue (59%, 46%), peripheral neuropathy (54%, 13%), nausea (54%, 48%), alopecia (50%, 5%), peripheral edema (46%, 30%), diarrhea (44%, 24%), pyrexia (41%, 28%), vomiting (36%, 28%), decreased appetite (36%, 26%), rash (30%, 11%), and dehydration (21%, 11%)
Of these most common adverse reactions, those with a ≥2% higher incidence of Grade 3-4 toxicity in the ABRAXANE/gemcitabine group compared with the gemcitabine group, respectively, are neutropenia (38%, 27%), fatigue (18%, 9%), peripheral neuropathy (17%, 1%), nausea (6%, 3%), diarrhea (6%, 1%), pyrexia (3%, 1%), vomiting (6%, 4%), decreased appetite (5%, 2%), and dehydration (7%, 2%)
Thrombocytopenia (all grades) was reported in 74% of patients in the ABRAXANE/gemcitabine group vs 70% of patients in the gemcitabine group
The most common serious adverse reactions of ABRAXANE (with a ≥1% higher incidence) are pyrexia (6%), dehydration (5%), pneumonia (4%), and vomiting (4%)
The most common adverse reactions resulting in permanent discontinuation of ABRAXANE were peripheral neuropathy (8%), fatigue (4%), and thrombocytopenia (2%)
The most common adverse reactions resulting in dose reduction of ABRAXANE are neutropenia (10%) and peripheral neuropathy (6%)
The most common adverse reactions leading to withholding or delay in ABRAXANE dosing are neutropenia (16%), thrombocytopenia (12%), fatigue (8%), peripheral neuropathy (15%), anemia (5%), and diarrhea (5%)
Other selected adverse reactions with a ≥5% higher incidence for all-grade toxicity in the ABRAXANE/gemcitabine group compared to the gemcitabine group, respectively, are asthenia (19%, 13%), mucositis (10%, 4%), dysgeusia (16%, 8%), headache (14%, 9%), hypokalemia (12%, 7%), cough (17%, 7%), epistaxis (15%, 3%), urinary tract infection (11%, 5%), pain in extremity (11%, 6%), arthralgia (11%, 3%), myalgia (10%, 4%), and depression (12%, 6%)
Other selected adverse reactions with a ≥2% higher incidence for Grade 3-4 toxicity in the ABRAXANE/gemcitabine group compared to the gemcitabine group are thrombocytopenia (13%, 9%), asthenia (7%, 4%), and hypokalemia (4%, 1%)
Postmarketing Experience With ABRAXANE and Other Paclitaxel Formulations
Severe and sometimes fatal hypersensitivity reactions have been reported with ABRAXANE. The use of ABRAXANE in patients previously exhibiting hypersensitivity to paclitaxel injection or human albumin has not been studied
There have been reports of congestive heart failure, left ventricular dysfunction, and atrioventricular block with ABRAXANE, primarily among individuals with underlying cardiac history or prior exposure to cardiotoxic drugs
There have been reports of extravasation of ABRAXANE. Given the possibility of extravasation, it is advisable to monitor closely the ABRAXANE infusion site for possible infiltration during drug administration
DRUG INTERACTIONS
Caution should be exercised when administering ABRAXANE concomitantly with medicines known to inhibit or induce either CYP2C8 or CYP3A4
USE IN SPECIFIC POPULATIONS
Nursing Mothers
It is not known whether paclitaxel is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother
Pediatric
The safety and effectiveness of ABRAXANE in pediatric patients have not been evaluated
Geriatric
No toxicities occurred notably more frequently among patients ≥65 years of age who received ABRAXANE for MBC
Myelosuppression, peripheral neuropathy, and arthralgia were more frequent in patients ≥65 years of age treated with ABRAXANE and carboplatin in NSCLC
Diarrhea, decreased appetite, dehydration, and epistaxis were more frequent in patients 65 years or older compared with patients younger than 65 years old who received ABRAXANE and gemcitabine in adenocarcinoma of the pancreas
Renal Impairment
There are insufficient data to permit dosage recommendations in patients with severe renal impairment or end stage renal disease (estimated creatinine clearance <30 mL/min)
DOSAGE AND ADMINISTRATION
Do not administer ABRAXANE to any patient with total bilirubin greater than 5 x ULN or AST greater than 10 x ULN
For MBC and NSCLC, reduce starting dose in patients with moderate to severe hepatic impairment
For adenocarcinoma of the pancreas, do not administer ABRAXANE to patients who have moderate to severe hepatic impairment
Dose reductions or discontinuation may be needed based on severe hematologic, neurologic, cutaneous, or gastrointestinal toxicity
Monitor patients closely
Please see full Prescribing Information, including Boxed WARNING.
About Celgene
Celgene International Sàrl, located in Boudry, in the Canton of Neuchâtel, Switzerland, is a wholly-owned subsidiary and International Headquarters of Celgene Corporation. Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical 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 the Company's website at www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn and YouTube.
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Contacts
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