LONDON - Sunday, November 3rd 2013 [ME NewsWire]
The Year in Infrastructure 2013
(BUSINESS WIRE) Bentley Systems, Incorporated, the leading company dedicated to providing comprehensive software solutions for sustaining infrastructure, today announced the winners of the 2013 Be Inspired Awards. The awards honor the extraordinary work of Bentley users improving the world’s infrastructure. They were presented last night at a ceremony during The Year in Infrastructure 2013 Conference, held 29-31 October in London, United Kingdom. This global gathering of leading executives in the world of infrastructure design, construction, and operations featured presentations and interactive sessions exploring the intersection of technology and business drivers, and how they are shaping the future of infrastructure delivery and investment returns. It was also attended by more than 100 members of the media from leading publications around the globe.
Special guest keynoters included Sir John Armitt, chairman of the Olympic Delivery Authority for London 2012 and chairman of National Express; Andrew Wolstenholme, CEO of Crossrail Ltd.; Peter Hansford, chief construction advisor to the U.K. government; and Pedro Miranda, corporate VP, Siemens AG, and head of the Global Center of Competence Cities.
During the awards ceremony, 22 Be Inspired Awards winners and nine Be Inspired Special Recognition Awards winners were acknowledged. In addition, this year’s recipient of the Bentley Educator of the Year award, Dr. Francelina Neto of California State Polytechnic University Pomona, United States, was acknowledged, as was Captain Nicholas Sloane, the Salvage Master of the Costa Concordia Parbuckling Project, who was saluted as an Infrastructure Hero for his key role in this unprecedented engineering feat to safely right and remove the sunken Costa Concordia cruise ship.
Six independent panels of jurors, comprising accomplished Bentley users and distinguished industry experts, selected the Be Inspired Awards winners from 65 project finalists. These finalists had been previously chosen from submissions by more than 300 organizations in 43 countries.
Candidates for Bentley’s Be Inspired Special Recognition Awards were selected by the jurors from the top finalist projects as well as other exemplary nominations. This selection was based on the projects’ uniquely innovative and visionary achievements that transcend the narrower focus of the standing Be Inspired Awards categories. The nominees were then reviewed by a panel of Bentley executives, who evaluated them based on the criteria established for each award.
Bentley Systems CEO Greg Bentley said, “I attend many Bentley events throughout the year, and I certainly enjoy and value each and every one of them. But our Be Inspired Awards ceremony – now part of our broader and more compelling Year in Infrastructure Conference – is, indeed, one of my favorites. It reminds me why all of us in the field of sustaining infrastructure do what we do. Hearing about the remarkable projects that are delivered every year in service to enhanced quality of life is an inspiration like no other. I thank and congratulate this year’s award winners, along with all of our nominees, for their important contributions to sustaining our society, our environment, and global economic growth.”
Bentley Systems has posted highlights of this year’s winning projects on its website and will include detailed descriptions of all nominated projects in the print and digital versions of The Year in Infrastructure 2013, which will be published by year’s end. To review the last nine editions of this publication, which together feature more than 2,000 world-class projects recognized in the Be Inspired Awards program since 2004, visit www.bentley.com/yearininfrastructure.
The Be Inspired Special Recognition Awards winners for 2013 are as follows:
Sustaining Our Society
Henan Water & Power Engineering Consulting Co., Ltd – Shahe Aqueduct Project – (Pingdingshan, Henan, China)
Sustaining Our Environment
Kursk Power Station and JSC Neolant – Information Support System for Decommissioning Kursk Nuclear Power Plant – (Kurchatov, Kursk Region, Russia)
Sustaining the Professions
SNC-Lavalin – (Montreal, Quebec, Canada)
Attaining Return on Innovation
Kellogg Joint Venture Gorgon – Gorgon Project – (Barrow Island, Australia)
Infrastructure Hero of the Year
TECON S.r.l. – Costa Concordia Wreck Removal Project – (Isola del Giglio, Grosseto, Italy)
Initiative in Information Mobility
Imarati Engineers & Consultants – IEC BIM-based Program Management – (Abu Dhabi, United Arab Emirates)
Innovation in Comprehensive BIM
Morphosis Architects – Perot Museum of Nature and Science – (Dallas, Texas, United States)
Innovation in Comprehensive BIM
Consolidated Contractors Company on Behalf of TCAJV – Midfield Terminal Building - Abu Dhabi International Airport – (Abu Dhabi, United Arab Emirates)
Innovation in Comprehensive BIM
GS Engineering & Construction – Mokpo Cable-stayed Bridge – (Mokpo, South Korea)
The Be Inspired Awards winners for 2013 are as follows:
Innovation in Asset Lifecycle Information Management
Suncor Energy Inc. (Edmonton Refinery) – Information Plant – (Edmonton, Alberta, Canada)
Innovation in Asset Performance Management
ScottishPower – ScottishPower Strategy for Asset Management and Process Safety – (United Kingdom)
Innovation in Bridges
Bloom Companies, LLC – Rawson Avenue Interchange Reconstruction – (Milwaukee, Wisconsin, United States)
Innovation in Building
Rogers Stirk Harbour + Partners – Cancer Treatment Centre for Guy’s and St Thomas’ Hospitals – (London, United Kingdom)
Innovation in Collaboration Using i-models
CB&I Power – AP1000 Nuclear Power Plant i-models – (Jenkinsville, South Carolina and Waynesboro, Georgia, United States)
Innovation in Construction
Intelliwave Technologies Inc. – Alberta Oil Sands – (Alberta, Canada)
Innovation in Generative Design
LAB Architecture Studio with SIADR – Wujin Council Offices – (Changzhou, Jiangsu, China)
Innovation in Geospatial Networks
EPCOR Water Services Inc. – WALRUS - Water and Land Related Utility System – (Edmonton, Alberta, Canada)
Innovation in Government
Crossrail Ltd – Managing Complexity on Crossrail – (London, United Kingdom)
Innovation in Land Development, Engineering, and Management
Foth Infrastructure & Environment, LLC – Lower Fox River, Operable Unit 1 – (Neenah, Wisconsin, United States)
Innovation in Mining and Metals
Hatch Associates Pty Ltd – Qinghai Magnesium Smelter – Dehydration Facility – (Golmud, Qinghai, China)
Innovation in Offshore Engineering
TECON S.r.l. – Costa Concordia Wreck Removal Project – (Isola del Giglio, Grosseto, Italy)
Innovation in Point-cloud Processing and Management
J.L. Patterson & Associates, Inc. – Cascade Tunnel Study – (Stevens Pass, Washington, United States)
Innovation in Power Generation
Eskom Holdings (Pty) Ltd – Kusile Power Station - Virtual 3D Plant Simulator for O&M – (Witbank, Mpumalanga, South Africa)
Innovation in Process Manufacturing
Pall India Pvt. Ltd. – Jet-pulse Blowback Filtration System (Gas Solid Separation System-GSS) – (Panipat, Haryana, India)
Innovation in Rail and Transit
Ineco – HS2 Birmingham Delta Junction – (Birmingham, United Kingdom)
Innovation in Roads
URS Corporation – Stockholm Bypass, FSK06 Akalla - Häggvik Design Contract – (Stockholm, Sweden)
Innovation in Structural Engineering
Shibanee and Kamal Architects – Bhau Institute of Innovation, Entrepreneurship and Leadership – (Pune, Maharashtra, India)
Innovation in Transportation Asset Management
Utah Transit Authority – Transit Asset Management – (Salt Lake City, Utah, United States)
Innovation in Utility Transmission and Distribution Infrastructure
China Power Construction Corporation Jiangxi Electric Power Design Institute – Duxiling 220 Kilovolt Substation – (Pingxiang, Jiangxi, China)
Innovation in Water or Wastewater Treatment Plants
CH2M HILL – City of Las Vegas Wastewater Pollution Control Facility (WPCF) Infrastructure Replacement – (Las Vegas, Nevada, United States)
Innovation in Water, Wastewater, and Stormwater Network Modeling and Analysis
Maynilad Water Services, Inc. – Remote Leak Detection through Hydraulic Modeling – (Malabon City, Philippines)
For additional information about each of the 2013 Be Inspired Awards project winners, visit www.bentley.com/beinspired2013winners.
About Be Inspired Awards Program and The Year in Infrastructure 2013 Conference
Since 2004, the Be Inspired Awards competition has showcased excellence and innovation in the design, construction, and operations of architecture and engineering infrastructure projects around the world. The Be Inspired Awards is unique – the only competition of its kind that is global in scope and comprehensive in categories covered, encompassing all types of infrastructure projects. In the awards program, which is open to all users of Bentley software, independent panels of industry experts select finalists for each category. For additional information, visit www.bentley.com/BeInspired.
Bentley’s Year in Infrastructure Conference is a global gathering of leading executives in the world of infrastructure design, construction, and operations. The conference features a series of presentations and interactive workshops exploring the intersection of technology and business drivers, and how they are shaping the future of infrastructure delivery and investment returns.
The Year in Infrastructure 2013 Conference included:
The Innovations for Buildings Summit
The International Rail and Transit Summit
The Project Delivery Summit
The Power Delivery Summit
The Asset Performance Management Summit
The Be Inspired Awards
CIO Workshop – An invitation-only workshop for CIOs and business executives focused on the asset information management needs of infrastructure owner-operators
Media Day
On Oct. 28, more than 100 journalists from leading media outlets around the globe gathered at the Hilton London Metropole for Bentley’s annual Media Day briefing. These journalists also participated in The Year in Infrastructure 2013 Conference.
For additional information about The Year in Infrastructure 2013 Conference, click here.
About Bentley Systems, Incorporated
Bentley is the global leader dedicated to providing architects, engineers, geospatial professionals, constructors, and owner-operators with comprehensive software solutions for sustaining infrastructure. Bentley Systems applies information mobility to improve asset performance by leveraging information modeling through integrated projects for intelligent infrastructure. Its solutions encompass the MicroStation platform for infrastructure design and modeling, the ProjectWise platform for infrastructure project team collaboration and work sharing, and the AssetWise platform for infrastructure asset operations – all supporting a broad portfolio of interoperable applications and complemented by worldwide professional services. Founded in 1984, Bentley has more than 3,000 colleagues in 50 countries, more than $500 million in annual revenues, and since 2005 has invested more than $1 billion in research, development, and acquisitions.
Additional information about Bentley is available at www.bentley.com and in Bentley’s annual report. For Bentley news as it happens, subscribe to an RSS feed of Bentley press releases and news alerts. To view a searchable collection of innovative infrastructure projects from the annual Be Inspired Awards, access Bentley’s Year in Infrastructure publications. To access a professional networking site that enables members of the infrastructure community to connect, communicate, and learn from each other, visit Be Communities.
To download the Bentley Infrastructure 500 Top Owners ranking, a unique global compendium of the top public- and private-sector owners of infrastructure based on the value of their cumulative infrastructure investments, visit www.bentley.com/500.
Bentley, the “B” Bentley logo, Be, MicroStation, and ProjectWise are either registered or unregistered trademarks or service marks of Bentley Systems, Incorporated or one of its direct or indirect wholly owned subsidiaries. All other brands and product names are trademarks of their respective owners.
Contacts
Bentley Systems, Incorporated
Press Contact:
Ron Kuhfeld, +1 610-321-6493
ron.kuhfeld@bentley.com
Follow us on Twitter
@BentleySystems
#YII2013
Permalink: http://www.me-newswire.net/news/9046/en
Monday, November 4, 2013
NYSE Euronext and IntercontinentalExchange Announce Preliminary Results of Proration Calculations
ME Newswire / Business Wire
NEW YORK - Sunday, November 3rd 2013
IntercontinentalExchange (NYSE:ICE), a leading operator of global markets and clearing houses, and NYSE Euronext (NYSE: NYX), today announced the preliminary results of the proration calculations performed by Computershare Inc., the exchange agent for ICE’s pending acquisition of NYX.
As previously announced, under the terms of the Amended and Restated Agreement and Plan of Merger, dated as of March 19, 2013 (the “Merger Agreement”), by and among NYX, ICE, IntercontinentalExchange Group, Inc. (“ICE Group”), Braves Merger Sub, Inc., and NYSE Euronext Holdings LLC (f/k/a Baseball Merger Sub, LLC), subject to proration, allocation and certain limitations set forth in the Merger Agreement, shareholders of NYX had the option to elect to receive for each share of NYX common stock (except for excluded shares and dissenting shares as more particularly set forth in the Merger Agreement):
a number of validly issued, fully paid and non-assessable shares of common stock of ICE Group, par value $0.01 per share (each, an “ICE Group Share”) equal to 0.1703 and an amount of cash equal to $11.27, without interest (together, the “Standard Consideration”);
an amount in cash equal to $33.12, without interest (the “Cash Consideration”); or
a number of ICE Group Shares equal to 0.2581.
As previously announced, because the Stock Consideration option was substantially oversubscribed, the consideration to be received by the holders who elected the Stock Consideration will be prorated pursuant to the terms set forth in the Merger Agreement. Based on available information as of 5:00 p.m., New York City time, on November 1, 2013, and subject to final determination:
Stockholders of NYX who elected to receive the Standard Consideration and those that failed to make a valid election prior to 5:00 p.m., New York City time, on October 31, 2013, the election deadline, and therefore were deemed to have elected the Standard Consideration, will receive the Standard Consideration.
Stockholders of NYX who elected to receive the Cash Consideration will receive the Cash Consideration.
Stockholders of NYX who elected to receive the Stock Consideration will receive, for each share of NYX common stock (except for excluded shares and dissenting shares as more particularly set forth in the Merger Agreement), a number of validly issued, fully paid and non-assessable shares of common stock of ICE Group equal to 0.171200756 and an amount of cash equal $11.154424.
As previously announced, ICE and NYX expect to complete the pending acquisition within two business days after receipt of the final regulatory approvals, which ICE and NYX expect to receive in the coming days.
About IntercontinentalExchange
IntercontinentalExchange (NYSE: ICE) is a leading operator of regulated exchanges and clearing houses serving the risk management needs of global markets for agricultural, credit, currency, emissions, energy and equity index products. www.theice.com.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995 - Statements in this press release regarding IntercontinentalExchange’s business that are not historical facts are “forward-looking statements” that involve risks and uncertainties. For a discussion of additional risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see ICE’s Securities and Exchange Commission (SEC) filings, including, but not limited to, the risk factors in ICE’s Annual Report on Form 10-K for the year ended December 31, 2012, as filed with the SEC on February 6, 2013.
About NYSE Euronext
NYSE Euronext (NYX) is a leading global operator of financial markets and provider of innovative trading technologies. The company's exchanges in Europe and the United States trade equities, futures, options, fixed-income and exchange-traded products. With approximately 8,000 listed issues (excluding European Structured Products), NYSE Euronext's equities markets - the New York Stock Exchange, NYSE Euronext, NYSE MKT, NYSE Alternext and NYSE Arca - represent one-third of the world’s equities trading, the most liquidity of any global exchange group. NYSE Euronext also operates NYSE Liffe, one of the leading European derivatives businesses and the world's second-largest derivatives business by value of trading. The company offers comprehensive commercial technology, connectivity and market data products and services through NYSE Technologies. For more information, please visit: http://www.nyx.com.
CAUTIONARY STATEMENT REGARDING FORWARD LOOKING STATEMENTS
This written communication contains “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by words such as “may,” “hope,” “will,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “potential,” “continue,” “could,” “future” or the negative of those terms or other words of similar meaning. You should carefully read forward-looking statements, including statements that contain these words, because they discuss our future expectations or state other “forward-looking” information. Forward-looking statements are subject to numerous assumptions, risks and uncertainties which change over time. ICE Group, ICE and NYSE Euronext caution readers that any forward-looking statement is not a guarantee of future performance and that actual results could differ materially from those contained in the forward-looking statement.
Forward-looking statements include, but are not limited to, statements about the benefits of the proposed merger involving ICE Group, ICE and NYSE Euronext, including future financial results, ICE’s and NYSE Euronext’s plans, objectives, expectations and intentions, the expected timing of completion of the transaction and other statements that are not historical facts. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are set forth in ICE’s and NYSE Euronext’s filings with the U.S. Securities and Exchange Commission (the “SEC”). These risks and uncertainties include, without limitation, the following: the inability to close the merger in a timely manner; the failure to satisfy other conditions to completion of the merger, including receipt of required regulatory and other approvals; the failure of the proposed transaction to close for any other reason; the possibility that any of the anticipated benefits of the proposed transaction will not be realized; the risk that integration of NYSE Euronext’s operations with those of ICE will be materially delayed or will be more costly or difficult than expected; the challenges of integrating and retaining key employees; the effect of the announcement of the transaction on ICE’s, NYSE Euronext’s or the combined company’s respective business relationships, operating results and business generally; the possibility that the anticipated synergies and cost savings of the merger will not be realized, or will not be realized within the expected time period; the possibility that the merger may be more expensive to complete than anticipated, including as a result of unexpected factors or events; diversion of management’s attention from ongoing business operations and opportunities; general competitive, economic, political and market conditions and fluctuations; actions taken or conditions imposed by the United States and foreign governments or regulatory authorities; and adverse outcomes of pending or threatened litigation or government investigations. In addition, you should carefully consider the risks and uncertainties and other factors that may affect future results of the combined company, as are described in the section entitled “Risk Factors” in the joint proxy statement/prospectus filed by ICE Group with the SEC, and as described in ICE’s and NYSE Euronext’s respective filings with the SEC that are available on the SEC’s web site located at www.sec.gov, including the sections entitled “Risk Factors” in ICE’s Form 10-K for the fiscal year ended December 31, 2012, as filed with the SEC on February 6, 2013, and “Risk Factors” in NYSE Euronext’s Form 10-K for the fiscal year ended December 31, 2012, as filed with the SEC on February 26, 2013. You should not place undue reliance on forward-looking statements, which speak only as of the date of this written communication. Except for any obligations to disclose material information under the Federal securities laws, ICE Group, ICE and NYSE Euronext undertake no obligation to publicly update any forward-looking statements to reflect events or circumstances after the date of this written communication.
IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND WHERE TO FIND IT
This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval. In connection with the proposed transaction, ICE Group has filed with the SEC a registration statement on Form S-4, which the SEC has declared effective and which contains a joint proxy statement/prospectus with respect to the proposed acquisition of NYSE Euronext by ICE Group. The final joint proxy statement/prospectus has been delivered to the stockholders of ICE and NYSE Euronext. INVESTORS AND SECURITY HOLDERS OF BOTH ICE AND NYSE EURONEXT ARE URGED TO READ THE JOINT PROXY STATEMENT/PROSPECTUS REGARDING THE PROPOSED TRANSACTION CAREFULLY AND IN ITS ENTIRETY, INCLUDING ANY DOCUMENTS PREVIOUSLY FILED WITH THE SEC AND INCORPORATED BY REFERENCE INTO THE JOINT PROXY STATEMENT/PROSPECTUS, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THOSE DOCUMENTS, BECAUSE IT CONTAINS IMPORTANT INFORMATION REGARDING ICE, NYSE EURONEXT AND THE PROPOSED TRANSACTION. Investors and security holders may obtain a free copy of the joint proxy statement/prospectus, as well as other filings containing information about ICE and NYSE Euronext, without charge, at the SEC’s website at http://www.sec.gov. Investors may also obtain these documents, without charge, from ICE’s website at http://www.theice.com and from NYSE Euronext’s website at http://www.nyx.com.
Contacts
Media
Robert Rendine: 212-656-2180
rrendine@nyx.com
Eric Ryan: 212-656-2411
eryan@nyx.com
Caroline Tourrier: +33 (0)1 49 27 10 82
ctourrier@nyx.com
Investor Relations
Stephen Davidson: 212-656-2183
sdavidson@nyx.com
Permalink: http://me-newswire.net/news/9061/en
NEW YORK - Sunday, November 3rd 2013
IntercontinentalExchange (NYSE:ICE), a leading operator of global markets and clearing houses, and NYSE Euronext (NYSE: NYX), today announced the preliminary results of the proration calculations performed by Computershare Inc., the exchange agent for ICE’s pending acquisition of NYX.
As previously announced, under the terms of the Amended and Restated Agreement and Plan of Merger, dated as of March 19, 2013 (the “Merger Agreement”), by and among NYX, ICE, IntercontinentalExchange Group, Inc. (“ICE Group”), Braves Merger Sub, Inc., and NYSE Euronext Holdings LLC (f/k/a Baseball Merger Sub, LLC), subject to proration, allocation and certain limitations set forth in the Merger Agreement, shareholders of NYX had the option to elect to receive for each share of NYX common stock (except for excluded shares and dissenting shares as more particularly set forth in the Merger Agreement):
a number of validly issued, fully paid and non-assessable shares of common stock of ICE Group, par value $0.01 per share (each, an “ICE Group Share”) equal to 0.1703 and an amount of cash equal to $11.27, without interest (together, the “Standard Consideration”);
an amount in cash equal to $33.12, without interest (the “Cash Consideration”); or
a number of ICE Group Shares equal to 0.2581.
As previously announced, because the Stock Consideration option was substantially oversubscribed, the consideration to be received by the holders who elected the Stock Consideration will be prorated pursuant to the terms set forth in the Merger Agreement. Based on available information as of 5:00 p.m., New York City time, on November 1, 2013, and subject to final determination:
Stockholders of NYX who elected to receive the Standard Consideration and those that failed to make a valid election prior to 5:00 p.m., New York City time, on October 31, 2013, the election deadline, and therefore were deemed to have elected the Standard Consideration, will receive the Standard Consideration.
Stockholders of NYX who elected to receive the Cash Consideration will receive the Cash Consideration.
Stockholders of NYX who elected to receive the Stock Consideration will receive, for each share of NYX common stock (except for excluded shares and dissenting shares as more particularly set forth in the Merger Agreement), a number of validly issued, fully paid and non-assessable shares of common stock of ICE Group equal to 0.171200756 and an amount of cash equal $11.154424.
As previously announced, ICE and NYX expect to complete the pending acquisition within two business days after receipt of the final regulatory approvals, which ICE and NYX expect to receive in the coming days.
About IntercontinentalExchange
IntercontinentalExchange (NYSE: ICE) is a leading operator of regulated exchanges and clearing houses serving the risk management needs of global markets for agricultural, credit, currency, emissions, energy and equity index products. www.theice.com.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995 - Statements in this press release regarding IntercontinentalExchange’s business that are not historical facts are “forward-looking statements” that involve risks and uncertainties. For a discussion of additional risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see ICE’s Securities and Exchange Commission (SEC) filings, including, but not limited to, the risk factors in ICE’s Annual Report on Form 10-K for the year ended December 31, 2012, as filed with the SEC on February 6, 2013.
About NYSE Euronext
NYSE Euronext (NYX) is a leading global operator of financial markets and provider of innovative trading technologies. The company's exchanges in Europe and the United States trade equities, futures, options, fixed-income and exchange-traded products. With approximately 8,000 listed issues (excluding European Structured Products), NYSE Euronext's equities markets - the New York Stock Exchange, NYSE Euronext, NYSE MKT, NYSE Alternext and NYSE Arca - represent one-third of the world’s equities trading, the most liquidity of any global exchange group. NYSE Euronext also operates NYSE Liffe, one of the leading European derivatives businesses and the world's second-largest derivatives business by value of trading. The company offers comprehensive commercial technology, connectivity and market data products and services through NYSE Technologies. For more information, please visit: http://www.nyx.com.
CAUTIONARY STATEMENT REGARDING FORWARD LOOKING STATEMENTS
This written communication contains “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by words such as “may,” “hope,” “will,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “potential,” “continue,” “could,” “future” or the negative of those terms or other words of similar meaning. You should carefully read forward-looking statements, including statements that contain these words, because they discuss our future expectations or state other “forward-looking” information. Forward-looking statements are subject to numerous assumptions, risks and uncertainties which change over time. ICE Group, ICE and NYSE Euronext caution readers that any forward-looking statement is not a guarantee of future performance and that actual results could differ materially from those contained in the forward-looking statement.
Forward-looking statements include, but are not limited to, statements about the benefits of the proposed merger involving ICE Group, ICE and NYSE Euronext, including future financial results, ICE’s and NYSE Euronext’s plans, objectives, expectations and intentions, the expected timing of completion of the transaction and other statements that are not historical facts. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are set forth in ICE’s and NYSE Euronext’s filings with the U.S. Securities and Exchange Commission (the “SEC”). These risks and uncertainties include, without limitation, the following: the inability to close the merger in a timely manner; the failure to satisfy other conditions to completion of the merger, including receipt of required regulatory and other approvals; the failure of the proposed transaction to close for any other reason; the possibility that any of the anticipated benefits of the proposed transaction will not be realized; the risk that integration of NYSE Euronext’s operations with those of ICE will be materially delayed or will be more costly or difficult than expected; the challenges of integrating and retaining key employees; the effect of the announcement of the transaction on ICE’s, NYSE Euronext’s or the combined company’s respective business relationships, operating results and business generally; the possibility that the anticipated synergies and cost savings of the merger will not be realized, or will not be realized within the expected time period; the possibility that the merger may be more expensive to complete than anticipated, including as a result of unexpected factors or events; diversion of management’s attention from ongoing business operations and opportunities; general competitive, economic, political and market conditions and fluctuations; actions taken or conditions imposed by the United States and foreign governments or regulatory authorities; and adverse outcomes of pending or threatened litigation or government investigations. In addition, you should carefully consider the risks and uncertainties and other factors that may affect future results of the combined company, as are described in the section entitled “Risk Factors” in the joint proxy statement/prospectus filed by ICE Group with the SEC, and as described in ICE’s and NYSE Euronext’s respective filings with the SEC that are available on the SEC’s web site located at www.sec.gov, including the sections entitled “Risk Factors” in ICE’s Form 10-K for the fiscal year ended December 31, 2012, as filed with the SEC on February 6, 2013, and “Risk Factors” in NYSE Euronext’s Form 10-K for the fiscal year ended December 31, 2012, as filed with the SEC on February 26, 2013. You should not place undue reliance on forward-looking statements, which speak only as of the date of this written communication. Except for any obligations to disclose material information under the Federal securities laws, ICE Group, ICE and NYSE Euronext undertake no obligation to publicly update any forward-looking statements to reflect events or circumstances after the date of this written communication.
IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND WHERE TO FIND IT
This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval. In connection with the proposed transaction, ICE Group has filed with the SEC a registration statement on Form S-4, which the SEC has declared effective and which contains a joint proxy statement/prospectus with respect to the proposed acquisition of NYSE Euronext by ICE Group. The final joint proxy statement/prospectus has been delivered to the stockholders of ICE and NYSE Euronext. INVESTORS AND SECURITY HOLDERS OF BOTH ICE AND NYSE EURONEXT ARE URGED TO READ THE JOINT PROXY STATEMENT/PROSPECTUS REGARDING THE PROPOSED TRANSACTION CAREFULLY AND IN ITS ENTIRETY, INCLUDING ANY DOCUMENTS PREVIOUSLY FILED WITH THE SEC AND INCORPORATED BY REFERENCE INTO THE JOINT PROXY STATEMENT/PROSPECTUS, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THOSE DOCUMENTS, BECAUSE IT CONTAINS IMPORTANT INFORMATION REGARDING ICE, NYSE EURONEXT AND THE PROPOSED TRANSACTION. Investors and security holders may obtain a free copy of the joint proxy statement/prospectus, as well as other filings containing information about ICE and NYSE Euronext, without charge, at the SEC’s website at http://www.sec.gov. Investors may also obtain these documents, without charge, from ICE’s website at http://www.theice.com and from NYSE Euronext’s website at http://www.nyx.com.
Contacts
Media
Robert Rendine: 212-656-2180
rrendine@nyx.com
Eric Ryan: 212-656-2411
eryan@nyx.com
Caroline Tourrier: +33 (0)1 49 27 10 82
ctourrier@nyx.com
Investor Relations
Stephen Davidson: 212-656-2183
sdavidson@nyx.com
Permalink: http://me-newswire.net/news/9061/en
Coca-Cola and (RED) Join Forces to Inspire People to Move for the Movement to Help Deliver an AIDS-Free Generation
Harry Shum, Jr., Jabbawockeez and Dancers from Around the World Invite People to Get Up and Dance to Help End Mother-To-Child Transmission of HIV
ME NewsWire / Business Wire
ATLANTA - Saturday, November 2nd 2013
Your favorite dance move could help save lives. Coca-Cola and (RED) have enlisted the help of Harry Shum, Jr. (Mike Chang, “Glee”) and the world-famous dance crew Jabbawockeez, as well as other notable dancers to harness the power of dance and inspire people to participate in a global dance movement with the goal of helping end mother-to-child transmission of HIV by 2015. Every day, 700 babies are born with HIV. By supporting programs that offer prevention, treatment, counseling, HIV testing and care services for pregnant women, that number can be near zero.
Being part of the movement couldn’t be easier. Step to the left, then step to the right or do whatever moves come naturally to you and then upload a video of the dance to YouTube or Instagram, using #CokeREDMoves in the title or as the hashtag. For the first 1,000 videos submitted, Coca-Cola will make a donation to buy life-saving medicine for someone living with HIV. This is in addition to the $1 million donation Coca-Cola made earlier this year to the Global Fund to help finance HIV/AIDS programs in Africa.
“We hold a fundamental belief that more movement brings more happiness, for everyone,” said Wendy Clark, SVP Sparkling Brand Center, The Coca-Cola Company. “Partnering with (RED) to connect people through the universal language of dance is a meaningful way to show our support.”
In collaboration with The DanceOn Network - the leading dance channel on YouTube – and Recreation Worldwide, Coca-Cola worked with Shum, Jabbawockeez, Nappy Tabs, Brian Puspos and Ian Eastwood, 8 Flavahz, Tyanna Padilla aka “Tiny Miney”, Jasmine Meakin from “Mega Jam” and Les Twins. The dancers came together to support the cause in the official music video for Celebrate (Tommy Trash Remix) by Empire of the Sun & Tommy Trash, which was created exclusively for (RED) and launched today on YouTube www.youtube.com/watch?v=9lWhVii3D24. The track will be featured on the upcoming DANCE (RED) SAVE LIVES2 compilation album.
To help inspire people to show their moves, Shum and the Jabawockeez developed an easy-to-follow dance that anyone can learn that is featured in the music video. Consumers can visit www.CokeREDMoves.com to download a free clip of the Celebrate remix, view a tutorial for the dance move and find instructions on how to upload a dance video and to learn more about how their moves could help support this important cause.
“This cause and this program really spoke to me,” said Shum. “Dancing is such a huge part of my life and I believe in its power to bring people from all walks of life together for a singular purpose. It’s inspiring to know that my generation has the power to help eliminate mother-to-child transmission of HIV. I’m excited to work with Coca-Cola and (RED) to help make that goal a reality.”
Coca-Cola has made a commitment of more than $5 million USD from 2011 to 2015, and over the next two years the partnership with (RED) will raise awareness and money to help eliminate mother-to-child transmission of HIV. This money will help fund up to 7.5 million doses of antiretroviral treatment for people affected by HIV/AIDS in Africa.
“Raising awareness and heat around the AIDS fight is so critical to winning the battle against this disease,” said Deborah Dugan, Chief Executive Officer for (RED). “Coca-Cola has the unique ability to motivate and inspire young people around the world to get involved and show their support through great initiatives like this. We’re so excited to have such extraordinary support for this year’s DANCE (RED), SAVE LIVES campaign.”
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 16 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 more than 1.8 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 (RED)™
(RED) was founded in 2006 by Bono and Bobby Shriver to engage businesses and people in the fight against AIDS.
(RED) partners with the world’s most iconic brands who contribute up to 50% of profits from (RED) branded goods and services to the Global Fund. (RED) Proud Partners include: Apple, Starbucks, The Coca-Cola Company, Beats by Dr. Dre, Belvedere, Claro, SAP and Telcel. (RED) Special Edition partners include: Shazam, Girl Skateboards, Mophie, FEED, Nanda Home, Bottletop, Tourneau, Fatboy USA, Bed Bath & Beyond, HEAD. To date, (RED) has generated more than $215 million for the Global Fund to fight AIDS, Tuberculosis and Malaria, to support HIV/AIDS grants in Ghana, Lesotho, Rwanda, South Africa, Swaziland, Zambia, Kenya and Tanzania. 100 percent of that money goes to work on the ground – no overhead is taken. Global Fund grants that (RED) supports have impacted more than 14 million people with prevention, treatment, counseling, HIV testing and care services. (RED) is a division of The ONE Campaign. Learn more at www.red.org.
About The Global Fund to Fight AIDS, Tuberculosis and Malaria
The Global Fund is an international financing institution dedicated to attracting and disbursing resources to prevent and treat HIV and AIDS, TB and malaria. The Global Fund promotes partnerships between governments, civil society, the private sector and affected communities, the most effective way to help reach those in need. This innovative approach relies on country ownership and performance-based funding, meaning that people in countries implement their own programs based on their priorities and the Global Fund provides financing where verifiable results are achieved.
Since its creation in 2002, the Global Fund has approved funding of US$ 22.9 billion for in 140 countries. To date, programs supported by the Global Fund have provided AIDS treatment for 5.3 million people, anti-tuberculosis treatment for 11 million people and 340 million insecticide-treated nets for the prevention of malaria. The Global Fund works in close collaboration with other bilateral and multilateral organizations to supplement existing efforts in dealing with the three diseases.
NOTE TO EDITORS:
Visuals to accompany this release can be viewed at: http://www.coca-colacompany.com/press-center/
Contacts
The Coca-Cola Company
Kate Hartman, +01-404-676-2683
Permalink: http://www.me-newswire.net/news/9041/en
ME NewsWire / Business Wire
ATLANTA - Saturday, November 2nd 2013
Your favorite dance move could help save lives. Coca-Cola and (RED) have enlisted the help of Harry Shum, Jr. (Mike Chang, “Glee”) and the world-famous dance crew Jabbawockeez, as well as other notable dancers to harness the power of dance and inspire people to participate in a global dance movement with the goal of helping end mother-to-child transmission of HIV by 2015. Every day, 700 babies are born with HIV. By supporting programs that offer prevention, treatment, counseling, HIV testing and care services for pregnant women, that number can be near zero.
Being part of the movement couldn’t be easier. Step to the left, then step to the right or do whatever moves come naturally to you and then upload a video of the dance to YouTube or Instagram, using #CokeREDMoves in the title or as the hashtag. For the first 1,000 videos submitted, Coca-Cola will make a donation to buy life-saving medicine for someone living with HIV. This is in addition to the $1 million donation Coca-Cola made earlier this year to the Global Fund to help finance HIV/AIDS programs in Africa.
“We hold a fundamental belief that more movement brings more happiness, for everyone,” said Wendy Clark, SVP Sparkling Brand Center, The Coca-Cola Company. “Partnering with (RED) to connect people through the universal language of dance is a meaningful way to show our support.”
In collaboration with The DanceOn Network - the leading dance channel on YouTube – and Recreation Worldwide, Coca-Cola worked with Shum, Jabbawockeez, Nappy Tabs, Brian Puspos and Ian Eastwood, 8 Flavahz, Tyanna Padilla aka “Tiny Miney”, Jasmine Meakin from “Mega Jam” and Les Twins. The dancers came together to support the cause in the official music video for Celebrate (Tommy Trash Remix) by Empire of the Sun & Tommy Trash, which was created exclusively for (RED) and launched today on YouTube www.youtube.com/watch?v=9lWhVii3D24. The track will be featured on the upcoming DANCE (RED) SAVE LIVES2 compilation album.
To help inspire people to show their moves, Shum and the Jabawockeez developed an easy-to-follow dance that anyone can learn that is featured in the music video. Consumers can visit www.CokeREDMoves.com to download a free clip of the Celebrate remix, view a tutorial for the dance move and find instructions on how to upload a dance video and to learn more about how their moves could help support this important cause.
“This cause and this program really spoke to me,” said Shum. “Dancing is such a huge part of my life and I believe in its power to bring people from all walks of life together for a singular purpose. It’s inspiring to know that my generation has the power to help eliminate mother-to-child transmission of HIV. I’m excited to work with Coca-Cola and (RED) to help make that goal a reality.”
Coca-Cola has made a commitment of more than $5 million USD from 2011 to 2015, and over the next two years the partnership with (RED) will raise awareness and money to help eliminate mother-to-child transmission of HIV. This money will help fund up to 7.5 million doses of antiretroviral treatment for people affected by HIV/AIDS in Africa.
“Raising awareness and heat around the AIDS fight is so critical to winning the battle against this disease,” said Deborah Dugan, Chief Executive Officer for (RED). “Coca-Cola has the unique ability to motivate and inspire young people around the world to get involved and show their support through great initiatives like this. We’re so excited to have such extraordinary support for this year’s DANCE (RED), SAVE LIVES campaign.”
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 16 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 more than 1.8 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 (RED)™
(RED) was founded in 2006 by Bono and Bobby Shriver to engage businesses and people in the fight against AIDS.
(RED) partners with the world’s most iconic brands who contribute up to 50% of profits from (RED) branded goods and services to the Global Fund. (RED) Proud Partners include: Apple, Starbucks, The Coca-Cola Company, Beats by Dr. Dre, Belvedere, Claro, SAP and Telcel. (RED) Special Edition partners include: Shazam, Girl Skateboards, Mophie, FEED, Nanda Home, Bottletop, Tourneau, Fatboy USA, Bed Bath & Beyond, HEAD. To date, (RED) has generated more than $215 million for the Global Fund to fight AIDS, Tuberculosis and Malaria, to support HIV/AIDS grants in Ghana, Lesotho, Rwanda, South Africa, Swaziland, Zambia, Kenya and Tanzania. 100 percent of that money goes to work on the ground – no overhead is taken. Global Fund grants that (RED) supports have impacted more than 14 million people with prevention, treatment, counseling, HIV testing and care services. (RED) is a division of The ONE Campaign. Learn more at www.red.org.
About The Global Fund to Fight AIDS, Tuberculosis and Malaria
The Global Fund is an international financing institution dedicated to attracting and disbursing resources to prevent and treat HIV and AIDS, TB and malaria. The Global Fund promotes partnerships between governments, civil society, the private sector and affected communities, the most effective way to help reach those in need. This innovative approach relies on country ownership and performance-based funding, meaning that people in countries implement their own programs based on their priorities and the Global Fund provides financing where verifiable results are achieved.
Since its creation in 2002, the Global Fund has approved funding of US$ 22.9 billion for in 140 countries. To date, programs supported by the Global Fund have provided AIDS treatment for 5.3 million people, anti-tuberculosis treatment for 11 million people and 340 million insecticide-treated nets for the prevention of malaria. The Global Fund works in close collaboration with other bilateral and multilateral organizations to supplement existing efforts in dealing with the three diseases.
NOTE TO EDITORS:
Visuals to accompany this release can be viewed at: http://www.coca-colacompany.com/press-center/
Contacts
The Coca-Cola Company
Kate Hartman, +01-404-676-2683
Permalink: http://www.me-newswire.net/news/9041/en
Phase III data show Boehringer Ingelheim's faldaprevir* was highly effective in a broad range of patients with genotype-1 hepatitis C
INGELHEIM, Germany - Saturday, November 2nd 2013 [ME NewsWire]
Pivotal Phase III STARTVerso™ data show efficacy of faldaprevir* in difficult-to-cure patient populations such as those with HIV co-infection and advanced liver disease
84% of patients benefited from a shorter time on treatment and the majority went on to achieve viral cure, with no compromise on safety and tolerability (STARTVerso™1&2)1
Second-generation protease inhibitor faldaprevir* is being investigated in combinations both with and without interferon
(BUSINESS WIRE)-- For media outside of the U.S.A., UK and Canada only
Boehringer Ingelheim today announced new data from its Phase III clinical trial programme, STARTVerso™, which evaluates faldaprevir* in combination with pegylated interferon and ribavirin (PegIFN/RBV). Patients with genotype-1 (GT-1) hepatitis C (HCV) who have not received previous treatment (treatment-naĂŻve: STARTVerso™1&2),1 treatment-experienced patients (STARTVerso™3),2 and HIV co-infected patients (STARTVerso™4)3 participated in this study programme. The results from these and additional studies will be presented at the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), also known as The Liver Meeting®, taking place 1-5 November in Washington, D.C.
In STARTVerso™1&2, 84% of treatment-naĂŻve patients receiving faldaprevir* were able to shorten the total time on treatment from 48 to 24 weeks; 83% of these patients achieved viral cure (SVR12).1 Overall, 73% and 72% of patients achieved SVR12 with faldaprevir* 120mg and 240mg regimens, respectively. Interim results from STARTVerso™4 showed that 74% of patients with HCV/HIV co-infection treated with faldaprevir* had undetectable HCV 4 weeks after the conclusion of treatment (SVR4), a response rate similar to that seen with HCV mono-infection.3 Additionally, treatment of difficult-to-cure patients who have relapsed on previous HCV treatment (STARTVerso™3) demonstrated viral cure rates of 70% with faldaprevir*.2 In the same study, patients who partially responded and those who showed no response to previous treatment achieved viral cure rates of up to 58% and 33%, respectively.3 For the full STARTVerso™ results, see notes to editors.
“These data are encouraging and reinforce the potential benefits of faldaprevir* as an effective treatment for genotype-1 infected HCV patients,” said Ira Jacobson, M.D., Chief of the Division of Gastroenterology and Hepatology, Weill Cornell Medical College, New York. “The broad populations studied in STARTVerso™ and the fact that very few patients discontinued treatment due to adverse events provides physicians with confidence in faldaprevir* as an important potential addition to the available agents for the treatment of hepatitis C.”
More than 2,200 patients have been studied in the STARTVerso™ trial programme, including patients with difficult-to-cure types of HCV:
Over 300 patients in the programme have HCV/HIV co-infection;3 these patients have higher levels of HCV in their blood and can be more difficult to cure4
677 patients were treatment-experienced, meaning they had attempted previous HCV treatment but did not achieve viral cure2
40% of patients in STARTVerso™3 had advanced liver disease (≥F3 fibrosis)2
59% of patients in STARTVerso™1&2 had a non-CC IL28B genotype;1 in previous studies, these patients were less likely to achieve viral cure5
“The STARTVerso™ trial results are particularly promising given the inclusion of a broad range of patients and the similar success rates seen in both HCV mono and HCV/HIV co-infected patients. These data will form the basis of regulatory submissions and we look forward to the outcome,” said Professor Klaus Dugi, Senior Vice President Medicine at Boehringer Ingelheim. “Faldaprevir* may offer a simple and convenient option for patients, due to once-daily dosing and no food restrictions. Faldaprevir* is the foundation of our HCV pipeline and we look forward to presenting pivotal Phase III HCVerso® data for the treatment of HCV as part of an interferon-free regimen in 2014.”
Faldaprevir* as part of this interferon-based regimen is likely to offer advantages over first generation protease inhibitors with fewer skin reactions, gastrointestinal events and no additional anaemia. In the STARTVerso™ clinical trial programme, adverse events (AEs) were generally mild and well manageable. Most common AEs included jaundice due to transient bilirubin elevation (unconjugated hyperbilirubinemia), nausea, fatigue, diarrhoea, headache, anaemia and rash. 95% of patients completed faldaprevir* treatment.1,2,3 For full STARTVerso™ results, see notes to editors.
ADDITIONAL BOEHRINGER INGELHEIM DATA AT THE MEETING
Faldaprevir* in further clinical settings
Further studies adding to the robust portfolio of evidence for faldaprevir* will be presented at the meeting. These include studies exploring drug-drug interactions in patients who are taking oral birth control pills and common medication to treat drug dependence and studies evaluating faldaprevir* in patients who have renal impairment.
Faldaprevir* as part of an interferon-free regimen
Additional news from Boehringer Ingelheim was released today featuring data from the collaborative trial with Presidio Pharmaceuticals. The ongoing Phase II trial investigating the regimen of faldaprevir*, deleobuvir* and PPI-668 (with and without ribavirin) in genotype-1a infected patients was accepted as late breaker and will be presented on Monday.
* Faldaprevir and deleobuvir are investigational compounds and not yet approved. Their safety and efficacy have not yet been fully established.
^SVR12 = sustained viral response 12 weeks after treatment completion, also described as “viral cure”
# # #
NOTES TO EDITORS
Phase III STARTVerso™ results
STARTVerso™1&2 Treatment-naĂŻve patients were randomised 1:2:2 to receive 48 weeks of PegIFN/RBV plus: placebo (Arm 1); faldaprevir* 120mg once-daily for 12 or 24 weeks (Arm 2); or faldaprevir* 240mg once-daily for 12 weeks (Arm 3). SVR12 rates were:1
Arm 1: 50% (131/264)
Arm 2: 73% (382/521)
Arm 3: 72% (378/524)
Patients in arms 2 and 3 stopped all treatment at week 24 if HCV RNA <25IU/mL was detected or undetected at week 4 and undetected at week 8 of treatment. Results were:1
Arm 2: 84% (436/521) of which 83% (362/436) achieved SVR12
Arm 3: 84% (441/524) of which 83% (368/441) achieved SVR12
In the study, the most common AEs were gastrointestinal events and anaemia, occurring in 11%/18% and 14%/13% of patients treated with 120mg/240mg faldaprevir* regimens respectively. Hyperbilirubinemia occurred in 12% and 46% of patients, respectively.1
STARTVerso™3 The trial included 3 cohorts of treatment-experienced patients who had: prior relapse (cohort 1), prior partial response (cohort 2) and prior null response (cohort 3).2
Cohort 1 Patients were randomised 1:2:2 to receive 48 weeks of PegIFN/RBV plus: placebo (placebo); faldaprevir* 240mg once-daily for 12 weeks (FDV12W); or faldaprevir* 240mg once-daily for 24 weeks (FDV24W). SVR12 rates were:2
Placebo: 14% (7/49)
FDV12W: 70% (69/99)
FDV24W: 70% (71/102)
87% of patients stopped all treatment at week 24 of whom 75% achieved SVR12
Cohort 2 Patients were randomised 1:2:2 to receive 48 weeks of PegIFN/RBV plus: placebo (placebo); faldaprevir* 240mg once-daily for 12 weeks (FDV12W); or faldaprevir* 240mg once-daily for 24 weeks (FDV24W). SVR12 rates were:2
Placebo: 3% (1/29)
FDV12W: 58% (33/57)
FDV24W: 47% (26/55)
Cohort 3 Patients were randomised 1:1 to receive faldaprevir* 240mg once-daily for 12 weeks (FDV12W) or faldaprevir* 240mg once-daily for 24 weeks (FDV24W) with PegIFN/RBV for 48 weeks. SVR12 rates were:2
FDV12W: 33% (48/145)
FDV24W: 33% (46/141)
AEs of at least moderate intensity included gastrointestinal side effects, which occurred in 20% and 17% of patients in the 12- and 24-week faldaprevir* arms respectively. Also, anemia occurred in 10% of patients in both faldaprevir* arms.2
STARTVerso™4 The ongoing trial includes patients co-infected with HCV and HIV who are HCV treatment-naĂŻve or have relapsed after previous HCV therapy. Patients received 48 weeks of PegIFN/RBV plus either: faldaprevir* 120mg once-daily for 24 weeks (Arm A); or faldaprevir* 240mg once-daily for 12 or 24 weeks (dependent on randomisation at week 12) (Arm B). SVR4 rates were:3
Arm A: 72% (89/123)
Arm B, faldaprevir* 12 weeks: 79% (66/84)
Arm B, faldaprevir* 24 weeks: 84% (72/86)
Arm B, total: 76% (140/185a)
Total: 74% (229/308)
aincludes additional patients from 240mg treatment group who discontinued prior to week 12
Patients in whom HCV RNA <25IU/mL was detected or undetected at week 4 and undetected at week 8, were randomised 1:1 to stop treatment at week 24 or continue PegIFN/RBV to 48 weeks. Results were:3
Arm A: 77% (95/123) of which 89% (85/95) achieved SVR4
Arm B, total: 81% (150/185) of which 87% (131/150) achieved SVR4
Total: 80% (245/308) of which 88% (216/245) achieved SVR4
The most common AEs in the study were nausea, fatigue and diarrhoea , occurring in 28% and 44%; 32% and 35%; and 25% and 28% with the 120mg and 240mg faldaprevir* regimens respectively.3
The Boehringer Ingelheim NewsHome: An innovative resource for journalists
The Boehringer Ingelheim hepatitis C www.newshome.com is the one-stop-shop for clear, concise and easy to understand information about hepatitis C for media.
For the full ‘Notes to Editors’ and ‘References’ please visit:
https://www.boehringer-ingelheim.com/news/news_releases/press_releases/2013/02_novermber_2013_hepatitisc.html
Contacts
Boehringer Ingelheim
Corporate Communications
Media + PR
Reinhard Malin
Tel: +49 (6132) 77-90815
Fax: +49 (6132) 77-6601
Email: press@boehringer-ingelheim.com
More information
www.boehringer-ingelheim.com
Permalink: http://www.me-newswire.net/news/9057/en
Pivotal Phase III STARTVerso™ data show efficacy of faldaprevir* in difficult-to-cure patient populations such as those with HIV co-infection and advanced liver disease
84% of patients benefited from a shorter time on treatment and the majority went on to achieve viral cure, with no compromise on safety and tolerability (STARTVerso™1&2)1
Second-generation protease inhibitor faldaprevir* is being investigated in combinations both with and without interferon
(BUSINESS WIRE)-- For media outside of the U.S.A., UK and Canada only
Boehringer Ingelheim today announced new data from its Phase III clinical trial programme, STARTVerso™, which evaluates faldaprevir* in combination with pegylated interferon and ribavirin (PegIFN/RBV). Patients with genotype-1 (GT-1) hepatitis C (HCV) who have not received previous treatment (treatment-naĂŻve: STARTVerso™1&2),1 treatment-experienced patients (STARTVerso™3),2 and HIV co-infected patients (STARTVerso™4)3 participated in this study programme. The results from these and additional studies will be presented at the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), also known as The Liver Meeting®, taking place 1-5 November in Washington, D.C.
In STARTVerso™1&2, 84% of treatment-naĂŻve patients receiving faldaprevir* were able to shorten the total time on treatment from 48 to 24 weeks; 83% of these patients achieved viral cure (SVR12).1 Overall, 73% and 72% of patients achieved SVR12 with faldaprevir* 120mg and 240mg regimens, respectively. Interim results from STARTVerso™4 showed that 74% of patients with HCV/HIV co-infection treated with faldaprevir* had undetectable HCV 4 weeks after the conclusion of treatment (SVR4), a response rate similar to that seen with HCV mono-infection.3 Additionally, treatment of difficult-to-cure patients who have relapsed on previous HCV treatment (STARTVerso™3) demonstrated viral cure rates of 70% with faldaprevir*.2 In the same study, patients who partially responded and those who showed no response to previous treatment achieved viral cure rates of up to 58% and 33%, respectively.3 For the full STARTVerso™ results, see notes to editors.
“These data are encouraging and reinforce the potential benefits of faldaprevir* as an effective treatment for genotype-1 infected HCV patients,” said Ira Jacobson, M.D., Chief of the Division of Gastroenterology and Hepatology, Weill Cornell Medical College, New York. “The broad populations studied in STARTVerso™ and the fact that very few patients discontinued treatment due to adverse events provides physicians with confidence in faldaprevir* as an important potential addition to the available agents for the treatment of hepatitis C.”
More than 2,200 patients have been studied in the STARTVerso™ trial programme, including patients with difficult-to-cure types of HCV:
Over 300 patients in the programme have HCV/HIV co-infection;3 these patients have higher levels of HCV in their blood and can be more difficult to cure4
677 patients were treatment-experienced, meaning they had attempted previous HCV treatment but did not achieve viral cure2
40% of patients in STARTVerso™3 had advanced liver disease (≥F3 fibrosis)2
59% of patients in STARTVerso™1&2 had a non-CC IL28B genotype;1 in previous studies, these patients were less likely to achieve viral cure5
“The STARTVerso™ trial results are particularly promising given the inclusion of a broad range of patients and the similar success rates seen in both HCV mono and HCV/HIV co-infected patients. These data will form the basis of regulatory submissions and we look forward to the outcome,” said Professor Klaus Dugi, Senior Vice President Medicine at Boehringer Ingelheim. “Faldaprevir* may offer a simple and convenient option for patients, due to once-daily dosing and no food restrictions. Faldaprevir* is the foundation of our HCV pipeline and we look forward to presenting pivotal Phase III HCVerso® data for the treatment of HCV as part of an interferon-free regimen in 2014.”
Faldaprevir* as part of this interferon-based regimen is likely to offer advantages over first generation protease inhibitors with fewer skin reactions, gastrointestinal events and no additional anaemia. In the STARTVerso™ clinical trial programme, adverse events (AEs) were generally mild and well manageable. Most common AEs included jaundice due to transient bilirubin elevation (unconjugated hyperbilirubinemia), nausea, fatigue, diarrhoea, headache, anaemia and rash. 95% of patients completed faldaprevir* treatment.1,2,3 For full STARTVerso™ results, see notes to editors.
ADDITIONAL BOEHRINGER INGELHEIM DATA AT THE MEETING
Faldaprevir* in further clinical settings
Further studies adding to the robust portfolio of evidence for faldaprevir* will be presented at the meeting. These include studies exploring drug-drug interactions in patients who are taking oral birth control pills and common medication to treat drug dependence and studies evaluating faldaprevir* in patients who have renal impairment.
Faldaprevir* as part of an interferon-free regimen
Additional news from Boehringer Ingelheim was released today featuring data from the collaborative trial with Presidio Pharmaceuticals. The ongoing Phase II trial investigating the regimen of faldaprevir*, deleobuvir* and PPI-668 (with and without ribavirin) in genotype-1a infected patients was accepted as late breaker and will be presented on Monday.
* Faldaprevir and deleobuvir are investigational compounds and not yet approved. Their safety and efficacy have not yet been fully established.
^SVR12 = sustained viral response 12 weeks after treatment completion, also described as “viral cure”
# # #
NOTES TO EDITORS
Phase III STARTVerso™ results
STARTVerso™1&2 Treatment-naĂŻve patients were randomised 1:2:2 to receive 48 weeks of PegIFN/RBV plus: placebo (Arm 1); faldaprevir* 120mg once-daily for 12 or 24 weeks (Arm 2); or faldaprevir* 240mg once-daily for 12 weeks (Arm 3). SVR12 rates were:1
Arm 1: 50% (131/264)
Arm 2: 73% (382/521)
Arm 3: 72% (378/524)
Patients in arms 2 and 3 stopped all treatment at week 24 if HCV RNA <25IU/mL was detected or undetected at week 4 and undetected at week 8 of treatment. Results were:1
Arm 2: 84% (436/521) of which 83% (362/436) achieved SVR12
Arm 3: 84% (441/524) of which 83% (368/441) achieved SVR12
In the study, the most common AEs were gastrointestinal events and anaemia, occurring in 11%/18% and 14%/13% of patients treated with 120mg/240mg faldaprevir* regimens respectively. Hyperbilirubinemia occurred in 12% and 46% of patients, respectively.1
STARTVerso™3 The trial included 3 cohorts of treatment-experienced patients who had: prior relapse (cohort 1), prior partial response (cohort 2) and prior null response (cohort 3).2
Cohort 1 Patients were randomised 1:2:2 to receive 48 weeks of PegIFN/RBV plus: placebo (placebo); faldaprevir* 240mg once-daily for 12 weeks (FDV12W); or faldaprevir* 240mg once-daily for 24 weeks (FDV24W). SVR12 rates were:2
Placebo: 14% (7/49)
FDV12W: 70% (69/99)
FDV24W: 70% (71/102)
87% of patients stopped all treatment at week 24 of whom 75% achieved SVR12
Cohort 2 Patients were randomised 1:2:2 to receive 48 weeks of PegIFN/RBV plus: placebo (placebo); faldaprevir* 240mg once-daily for 12 weeks (FDV12W); or faldaprevir* 240mg once-daily for 24 weeks (FDV24W). SVR12 rates were:2
Placebo: 3% (1/29)
FDV12W: 58% (33/57)
FDV24W: 47% (26/55)
Cohort 3 Patients were randomised 1:1 to receive faldaprevir* 240mg once-daily for 12 weeks (FDV12W) or faldaprevir* 240mg once-daily for 24 weeks (FDV24W) with PegIFN/RBV for 48 weeks. SVR12 rates were:2
FDV12W: 33% (48/145)
FDV24W: 33% (46/141)
AEs of at least moderate intensity included gastrointestinal side effects, which occurred in 20% and 17% of patients in the 12- and 24-week faldaprevir* arms respectively. Also, anemia occurred in 10% of patients in both faldaprevir* arms.2
STARTVerso™4 The ongoing trial includes patients co-infected with HCV and HIV who are HCV treatment-naĂŻve or have relapsed after previous HCV therapy. Patients received 48 weeks of PegIFN/RBV plus either: faldaprevir* 120mg once-daily for 24 weeks (Arm A); or faldaprevir* 240mg once-daily for 12 or 24 weeks (dependent on randomisation at week 12) (Arm B). SVR4 rates were:3
Arm A: 72% (89/123)
Arm B, faldaprevir* 12 weeks: 79% (66/84)
Arm B, faldaprevir* 24 weeks: 84% (72/86)
Arm B, total: 76% (140/185a)
Total: 74% (229/308)
aincludes additional patients from 240mg treatment group who discontinued prior to week 12
Patients in whom HCV RNA <25IU/mL was detected or undetected at week 4 and undetected at week 8, were randomised 1:1 to stop treatment at week 24 or continue PegIFN/RBV to 48 weeks. Results were:3
Arm A: 77% (95/123) of which 89% (85/95) achieved SVR4
Arm B, total: 81% (150/185) of which 87% (131/150) achieved SVR4
Total: 80% (245/308) of which 88% (216/245) achieved SVR4
The most common AEs in the study were nausea, fatigue and diarrhoea , occurring in 28% and 44%; 32% and 35%; and 25% and 28% with the 120mg and 240mg faldaprevir* regimens respectively.3
The Boehringer Ingelheim NewsHome: An innovative resource for journalists
The Boehringer Ingelheim hepatitis C www.newshome.com is the one-stop-shop for clear, concise and easy to understand information about hepatitis C for media.
For the full ‘Notes to Editors’ and ‘References’ please visit:
https://www.boehringer-ingelheim.com/news/news_releases/press_releases/2013/02_novermber_2013_hepatitisc.html
Contacts
Boehringer Ingelheim
Corporate Communications
Media + PR
Reinhard Malin
Tel: +49 (6132) 77-90815
Fax: +49 (6132) 77-6601
Email: press@boehringer-ingelheim.com
More information
www.boehringer-ingelheim.com
Permalink: http://www.me-newswire.net/news/9057/en
Boehringer Ingelheim's interferon-free hepatitis C treatment portfolio strengthened by promising Phase II data
INGELHEIM, Germany - Saturday, November 2nd 2013 [ME NewsWire]
High rate of virologic response in Phase II hepatitis C trial of a 12 week all-oral combination of Boehringer Ingelheim’s faldaprevir* and deleobuvir* and Presidio’s PPI-668* with and without ribavirin1
All patients (17/17) who have completed treatment achieved undetectable levels of hepatitis C virus at the end of treatment1
13 of these patients have reached their 4-week post-treatment follow-up and all have undetectable hepatitis C virus (SVR4)1
(BUSINESS WIRE)-- For media outside of the U.S.A., UK and Canada only
Interim data presented today show that all patients (13/13) who reached their 4-week post-treatment follow-up have undetectable levels of hepatitis C virus (SVR4) after completing a 12-week regimen of faldaprevir*, deleobuvir*, PPI-668* and ribavirin.1 These data from Boehringer Ingelheim’s ongoing Phase II collaborative trial with Presidio Pharmaceuticals will be presented on Monday during the ‘Late-Breaking Posters’ session at the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), taking place in Washington, D.C. Additional data from the trial show 100% of patients (12/12) treated with a ribavirin-free regimen had hepatitis C virus (HCV) levels below the lower level of quantification at 4 weeks.1 Safety and tolerability appears to be better in this ribavirin-free treatment arm compared to those with ribavirin.1
“These interim results add to the growing body of evidence for faldaprevir* as an effective treatment for a broad range of genotype-1 infected hepatitis C patients, including the more difficult-to-cure. The trial is still in the early stages but the initial results look promising,” said Professor Klaus Dugi, Senior Vice President of Medicine at Boehringer Ingelheim. “These data further demonstrate the future potential of faldaprevir* as the foundation of interferon-free treatment regimens. Our pivotal HCVerso® studies which investigate the interferon-free regimen of faldaprevir*, deleobuvir* and ribavirin are currently in Phase III development. We look forward to the final results from both trials in Q2 next year.”
The ongoing Phase II trial features the 12-week regimen both with and without ribavirin in 36 genotype-1a infected patients, one of the more difficult-to-cure types of hepatitis C virus. In addition, more than half the patients in the study (20/36) had pre-existing HCV mutations. This includes the Q80K variant which is common in genotype-1a infected patients2 and has been associated with reduced responses to some HCV protease inhibitors3. Notably, all 12 patients in the study with pre-existing Q80K mutations are responding well to treatment with the faldaprevir*-based interferon-free regimen.1
To date, all patients in the study have received at least 4 weeks of treatment and 97% (35/36) achieved HCV levels below the lower limit of quantification at week 4. One patient had an initial virologic response but then exhibited viral breakthrough and was discontinued after 5 weeks of treatment. Overall, adverse events in the study have been mild to moderate, with the incidence and severity of skin rashes and gastrointestinal side effects similar to those observed in previous trials studying faldaprevir* and deleobuvir*. For further results see notes to editors.
Overview of Boehringer Ingelheim’s HCV trial programme
Boehringer Ingelheim’s hepatitis C clinical trial programme includes a broad range of genotype-1 infected patients. The programme features three treatment regimens, with faldaprevir* as the foundation:
Study
Regimen
Population
Status
STARTVerso™
Faldaprevir* pegylated interferon, ribavirin
GT-1 , TN, TE, HCV/HIV co-infection, advanced liver disease
Regulatory submissions pending
For results see the STARTVerso press release here
HCVerso®
Faldaprevir*, deleobuvir*, ribavirin
GT-1b, TN, TE, advanced liver disease
Phase III results expected Q2 2014
Presidio collaboration
Faldaprevir*, deleobuvir*, PPI-668* +/- ribavirin
GT-1a, TN, non-cc IL28B
Phase II final results expected Q2 2014
An individualised approach to hepatitis C
The breadth of patients studied in Boehringer Ingelheim’s hepatitis C trial programme reflects a population that physicians see in the clinic, including those with difficult types of hepatitis C virus to cure.
“The huge diversity between hepatitis C patients, due to differing personal factors and variations in the virus, highlight the importance of an individualised approach to treatment,” said Graham Foster, Professor of Hepatology, Queen Mary’s, London. “The difference between HCV genotypes is substantial. For example, genotype-1a and 1b share only around 70% of the same genetic material which is more distant than the genetic similarity between humans and some other animals and patients have differing degrees of liver damage that may require changes to the therapeutic approach. Given the diversity of the disease and the virus it is likely that each patient will need to be assessed on an individual basis and the best treatment assigned accordingly.”
For more information on the importance of an individualised approach to hepatitis C, view the video here
*Faldaprevir, deleobuvir and PPI668 are investigational compounds and not yet approved. Their safety and efficacy have not yet been fully established.
# # #
NOTES TO EDITORS
Phase IIa Presidio collaboration trial results
The trial includes 36 treatment-naĂŻve patients with genotype-1a HCV treated for 12 weeks with an all-oral regimen, with 24 weeks of post-treatment follow-up. The primary endpoint is viral cure 12 weeks after treatment completion (SVR12). There are three cohorts in this study:1
Cohort 1: faldaprevir* 120 mg once-daily (QD), PPI-668 200mg QD and deleobuvir* 600mg twice-daily (BID) with ribavirin (n=12)
Cohort 2: faldaprevir* 120 mg QD, PPI-668 200mg QD and deleobuvir* 400mg BID with ribavirin (n=12)
Cohort 3: faldaprevir* 120mg QD, PPI-668 200mg QD and deleobuvir* 600 mg BID, without ribavirin (n=12)
Thirty-six patients in this study have reached week 4 of treatment, 17 patients have reached the end of treatment (12 weeks) and 13 patients have reached their 4 week post-treatment follow-up. Interim results show:1
97% of patients (35/36) achieved HCV levels below the lower limit of quantification at week 4
100% of patients (17/17) that completed the full course of treatment had undetectable hepatitis C virus at the conclusion of treatment
100% of patients (13/13) that completed the full course of treatment achieved SVR4
To date there has been just one treatment failure due to viral breakthrough. One patient had an initial virologic response but then exhibited viral breakthrough and was discontinued after 5 weeks of treatment. Only one AE was rated as ‘severe’ and attributable to study drugs; one patient reported severe fatigue in week 11 and the event was resolved with no change in treatment.1
NewsHome
The Boehringer Ingelheim NewsHome: An innovative resource for journalists
The Boehringer Ingelheim hepatitis C www.newshome.com is the one-stop-shop for clear, concise and easy to understand information about hepatitis C for the media.
About STARTVerso™ and HCVerso®
For information on the interferon-free Phase III HCVerso® trials please refer to the Clinical Trials backgrounder, available on NewsHome.
For the full ‘Notes to Editors’ and ‘References’ please visit:
https://www.boehringer-ingelheim.com/news/news_releases/press_releases/2013/02_novermber_2013_hepatitisc1.html
Contacts
Boehringer Ingelheim
Corporate Communications
Media + PR
Reinhard Malin
Tel: +49 (6132) 77-90815
Fax: +49 (6132) 77-6601
Email: press@boehringer-ingelheim.com
Permalink: http://me-newswire.net/news/9058/en
High rate of virologic response in Phase II hepatitis C trial of a 12 week all-oral combination of Boehringer Ingelheim’s faldaprevir* and deleobuvir* and Presidio’s PPI-668* with and without ribavirin1
All patients (17/17) who have completed treatment achieved undetectable levels of hepatitis C virus at the end of treatment1
13 of these patients have reached their 4-week post-treatment follow-up and all have undetectable hepatitis C virus (SVR4)1
(BUSINESS WIRE)-- For media outside of the U.S.A., UK and Canada only
Interim data presented today show that all patients (13/13) who reached their 4-week post-treatment follow-up have undetectable levels of hepatitis C virus (SVR4) after completing a 12-week regimen of faldaprevir*, deleobuvir*, PPI-668* and ribavirin.1 These data from Boehringer Ingelheim’s ongoing Phase II collaborative trial with Presidio Pharmaceuticals will be presented on Monday during the ‘Late-Breaking Posters’ session at the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), taking place in Washington, D.C. Additional data from the trial show 100% of patients (12/12) treated with a ribavirin-free regimen had hepatitis C virus (HCV) levels below the lower level of quantification at 4 weeks.1 Safety and tolerability appears to be better in this ribavirin-free treatment arm compared to those with ribavirin.1
“These interim results add to the growing body of evidence for faldaprevir* as an effective treatment for a broad range of genotype-1 infected hepatitis C patients, including the more difficult-to-cure. The trial is still in the early stages but the initial results look promising,” said Professor Klaus Dugi, Senior Vice President of Medicine at Boehringer Ingelheim. “These data further demonstrate the future potential of faldaprevir* as the foundation of interferon-free treatment regimens. Our pivotal HCVerso® studies which investigate the interferon-free regimen of faldaprevir*, deleobuvir* and ribavirin are currently in Phase III development. We look forward to the final results from both trials in Q2 next year.”
The ongoing Phase II trial features the 12-week regimen both with and without ribavirin in 36 genotype-1a infected patients, one of the more difficult-to-cure types of hepatitis C virus. In addition, more than half the patients in the study (20/36) had pre-existing HCV mutations. This includes the Q80K variant which is common in genotype-1a infected patients2 and has been associated with reduced responses to some HCV protease inhibitors3. Notably, all 12 patients in the study with pre-existing Q80K mutations are responding well to treatment with the faldaprevir*-based interferon-free regimen.1
To date, all patients in the study have received at least 4 weeks of treatment and 97% (35/36) achieved HCV levels below the lower limit of quantification at week 4. One patient had an initial virologic response but then exhibited viral breakthrough and was discontinued after 5 weeks of treatment. Overall, adverse events in the study have been mild to moderate, with the incidence and severity of skin rashes and gastrointestinal side effects similar to those observed in previous trials studying faldaprevir* and deleobuvir*. For further results see notes to editors.
Overview of Boehringer Ingelheim’s HCV trial programme
Boehringer Ingelheim’s hepatitis C clinical trial programme includes a broad range of genotype-1 infected patients. The programme features three treatment regimens, with faldaprevir* as the foundation:
Study
Regimen
Population
Status
STARTVerso™
Faldaprevir* pegylated interferon, ribavirin
GT-1 , TN, TE, HCV/HIV co-infection, advanced liver disease
Regulatory submissions pending
For results see the STARTVerso press release here
HCVerso®
Faldaprevir*, deleobuvir*, ribavirin
GT-1b, TN, TE, advanced liver disease
Phase III results expected Q2 2014
Presidio collaboration
Faldaprevir*, deleobuvir*, PPI-668* +/- ribavirin
GT-1a, TN, non-cc IL28B
Phase II final results expected Q2 2014
An individualised approach to hepatitis C
The breadth of patients studied in Boehringer Ingelheim’s hepatitis C trial programme reflects a population that physicians see in the clinic, including those with difficult types of hepatitis C virus to cure.
“The huge diversity between hepatitis C patients, due to differing personal factors and variations in the virus, highlight the importance of an individualised approach to treatment,” said Graham Foster, Professor of Hepatology, Queen Mary’s, London. “The difference between HCV genotypes is substantial. For example, genotype-1a and 1b share only around 70% of the same genetic material which is more distant than the genetic similarity between humans and some other animals and patients have differing degrees of liver damage that may require changes to the therapeutic approach. Given the diversity of the disease and the virus it is likely that each patient will need to be assessed on an individual basis and the best treatment assigned accordingly.”
For more information on the importance of an individualised approach to hepatitis C, view the video here
*Faldaprevir, deleobuvir and PPI668 are investigational compounds and not yet approved. Their safety and efficacy have not yet been fully established.
# # #
NOTES TO EDITORS
Phase IIa Presidio collaboration trial results
The trial includes 36 treatment-naĂŻve patients with genotype-1a HCV treated for 12 weeks with an all-oral regimen, with 24 weeks of post-treatment follow-up. The primary endpoint is viral cure 12 weeks after treatment completion (SVR12). There are three cohorts in this study:1
Cohort 1: faldaprevir* 120 mg once-daily (QD), PPI-668 200mg QD and deleobuvir* 600mg twice-daily (BID) with ribavirin (n=12)
Cohort 2: faldaprevir* 120 mg QD, PPI-668 200mg QD and deleobuvir* 400mg BID with ribavirin (n=12)
Cohort 3: faldaprevir* 120mg QD, PPI-668 200mg QD and deleobuvir* 600 mg BID, without ribavirin (n=12)
Thirty-six patients in this study have reached week 4 of treatment, 17 patients have reached the end of treatment (12 weeks) and 13 patients have reached their 4 week post-treatment follow-up. Interim results show:1
97% of patients (35/36) achieved HCV levels below the lower limit of quantification at week 4
100% of patients (17/17) that completed the full course of treatment had undetectable hepatitis C virus at the conclusion of treatment
100% of patients (13/13) that completed the full course of treatment achieved SVR4
To date there has been just one treatment failure due to viral breakthrough. One patient had an initial virologic response but then exhibited viral breakthrough and was discontinued after 5 weeks of treatment. Only one AE was rated as ‘severe’ and attributable to study drugs; one patient reported severe fatigue in week 11 and the event was resolved with no change in treatment.1
NewsHome
The Boehringer Ingelheim NewsHome: An innovative resource for journalists
The Boehringer Ingelheim hepatitis C www.newshome.com is the one-stop-shop for clear, concise and easy to understand information about hepatitis C for the media.
About STARTVerso™ and HCVerso®
For information on the interferon-free Phase III HCVerso® trials please refer to the Clinical Trials backgrounder, available on NewsHome.
For the full ‘Notes to Editors’ and ‘References’ please visit:
https://www.boehringer-ingelheim.com/news/news_releases/press_releases/2013/02_novermber_2013_hepatitisc1.html
Contacts
Boehringer Ingelheim
Corporate Communications
Media + PR
Reinhard Malin
Tel: +49 (6132) 77-90815
Fax: +49 (6132) 77-6601
Email: press@boehringer-ingelheim.com
Permalink: http://me-newswire.net/news/9058/en
Sunday, November 3, 2013
Chicago-Based Performance Trust Investment Advisors, LLC (PTIA) Changes Name To Performance Trust Asset Management, LLC (PTAM)
CHICAGO - Saturday, November 2nd 2013 [ME NewsWire]
(BUSINESS WIRE)-- Chicago-based Performance Trust Investment Advisors, LLC (PTIA) is changing its name to Performance Trust Asset Management, LLC (PTAM).
Firm president Doug Rothschild explains, “The new name better reflects our primary focus on being an asset manager for institutional investors.” PTAM launched its first hedge fund in 2008, capturing opportunity for investors in the then-severely distressed residential mortgage-backed securities market. Since then, the firm has grown rapidly in terms of both assets and products.
Today, PTAM is an institutional-class platform employing a team of industry veterans with a broad scope of fixed income and credit expertise, including the recent hiring of Ethan Youderian, well known in industry circles for his time as Senior Portfolio Manager and Managing Director at Citadel Investment Group. Youderian is now leading the development of PTAM’s newest product, a fixed income-focused hedge fund vehicle expected to launch in the first quarter of 2014.
Performance Trust Asset Management, LLC is a Chicago-based alternative investment firm specializing in the credit and fixed income markets. PTAM seeks attractive investment returns by operating in complex markets where inefficiencies create unique drivers of return. The firm currently manages approximately $1 billion (as of September 30, 2013) of institutional and individual assets across multiple pooled investment vehicles, mutual funds, and separately managed accounts.
The ticker symbols for PTAM’s two mutual fund products will remain unchanged.
For more information, go to www.PTAM.com.
Contacts
Performance Trust Asset Management, LLC
Rick Sterioti, 312-521-1406
(BUSINESS WIRE)-- Chicago-based Performance Trust Investment Advisors, LLC (PTIA) is changing its name to Performance Trust Asset Management, LLC (PTAM).
Firm president Doug Rothschild explains, “The new name better reflects our primary focus on being an asset manager for institutional investors.” PTAM launched its first hedge fund in 2008, capturing opportunity for investors in the then-severely distressed residential mortgage-backed securities market. Since then, the firm has grown rapidly in terms of both assets and products.
Today, PTAM is an institutional-class platform employing a team of industry veterans with a broad scope of fixed income and credit expertise, including the recent hiring of Ethan Youderian, well known in industry circles for his time as Senior Portfolio Manager and Managing Director at Citadel Investment Group. Youderian is now leading the development of PTAM’s newest product, a fixed income-focused hedge fund vehicle expected to launch in the first quarter of 2014.
Performance Trust Asset Management, LLC is a Chicago-based alternative investment firm specializing in the credit and fixed income markets. PTAM seeks attractive investment returns by operating in complex markets where inefficiencies create unique drivers of return. The firm currently manages approximately $1 billion (as of September 30, 2013) of institutional and individual assets across multiple pooled investment vehicles, mutual funds, and separately managed accounts.
The ticker symbols for PTAM’s two mutual fund products will remain unchanged.
For more information, go to www.PTAM.com.
Contacts
Performance Trust Asset Management, LLC
Rick Sterioti, 312-521-1406
PerkinElmer’s DairyGuard™ is the First Analyzer to Add Screening for Unknown Adulterants in Milk Powder
Suppliers and manufacturers can screen faster for more known and unknown risks
WALTHAM, Mass - Friday, November 1st 2013 [ME NewsWire]
(BUSINESS WIRE) PerkinElmer, Inc., a global leader in improving the health and safety of people and the environment, today introduced the DairyGuard™ milk powder analyzer, a near infrared (NIR) spectrometer specifically developed for food suppliers and manufacturers. DairyGuard is the only system available that tests for unknown adulterants as well as known compounds, such as protein, moisture and fat content. Combined with faster preparation and sampling times that yield real-time results, DairyGuard provides heightened protection from supply chain risks to the safety and quality of milk powder.
With growing supply chain complexities and liability for potential recalls, food manufacturers are in need of a turnkey solution to accurately and cost-effectively screen both known and unknown contaminants in milk powder supplies. The DairyGuard analyzer’s preconfigured mathematical models of specific analytical profiles for milk powder – similar to a fingerprint – eliminates the need for upfront instrument configuration. In less than a minute, DairyGuard accurately tells whether a batch is safe to continue into manufacturing or if further analysis is required.
“Milk powder has been identified by many agencies as an ingredient with high risk for adulteration, creating a greater need for all food manufacturers to employ a reliable screening method,” said Sharon Palmer, food director, PerkinElmer. “To avoid food safety issues, such as the melamine incident in 2008, food manufacturers have to screen for not only known contaminants like pesticides and drug residues, but also unknown contaminants that might be unsafe substitutions. DairyGuard will give food suppliers greater confidence in their ingredients and help to ensure a safe end product for the consumer.”
“Infrared technologies have become a critical tool in our work to detect clandestine and economic adulteration in dietary supplements,” said James Neal-Kababick, director, Flora Research Labs. “The speed of analysis is unmatched by any other method we use and the ability to do non-destructive testing is essential in our phytoforensic work, especially when very limited sample is available. I consider having an infrared system in the laboratory as fundamental as having a balance. I could not imagine being without one. PerkinElmer technologies, like the infrared system in DairyGuard, have helped us solve some of the most complex cases of food and supplement contamination we have encountered.”
According to a 2010 A.T. Kearney study conducted for the Grocery Manufacturers Association (GMA), the cost of one adulteration incident averages between 2 and 15 percent of a company’s yearly revenues. Investments in the people and technology to ensure streamlined screening protocols are enabling processors and manufacturers to avoid the threats that contamination poses to customers and company reputations.
For more information on dairy analysis and other food safety solutions visit www.perkinelmer.com/food or stop by our booth at Dairy International, Chicago, Booth #341.
About PerkinElmer, Inc.
PerkinElmer, Inc. is a global leader focused on improving the health and safety of people and the environment. The company reported revenue of approximately $2.1 billion in 2012, has about 7,500 employees serving customers in more than 150 countries, and is a component of the S&P 500 Index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com. Join the conversation and follow us on twitter at www.twitter.com/perkinelmernews.
Contacts
Edelman (On behalf of PerkinElmer, Inc.)
Brittney Haynes, 404-460-9664
Brittney.haynes@edelman.com
WALTHAM, Mass - Friday, November 1st 2013 [ME NewsWire]
(BUSINESS WIRE) PerkinElmer, Inc., a global leader in improving the health and safety of people and the environment, today introduced the DairyGuard™ milk powder analyzer, a near infrared (NIR) spectrometer specifically developed for food suppliers and manufacturers. DairyGuard is the only system available that tests for unknown adulterants as well as known compounds, such as protein, moisture and fat content. Combined with faster preparation and sampling times that yield real-time results, DairyGuard provides heightened protection from supply chain risks to the safety and quality of milk powder.
With growing supply chain complexities and liability for potential recalls, food manufacturers are in need of a turnkey solution to accurately and cost-effectively screen both known and unknown contaminants in milk powder supplies. The DairyGuard analyzer’s preconfigured mathematical models of specific analytical profiles for milk powder – similar to a fingerprint – eliminates the need for upfront instrument configuration. In less than a minute, DairyGuard accurately tells whether a batch is safe to continue into manufacturing or if further analysis is required.
“Milk powder has been identified by many agencies as an ingredient with high risk for adulteration, creating a greater need for all food manufacturers to employ a reliable screening method,” said Sharon Palmer, food director, PerkinElmer. “To avoid food safety issues, such as the melamine incident in 2008, food manufacturers have to screen for not only known contaminants like pesticides and drug residues, but also unknown contaminants that might be unsafe substitutions. DairyGuard will give food suppliers greater confidence in their ingredients and help to ensure a safe end product for the consumer.”
“Infrared technologies have become a critical tool in our work to detect clandestine and economic adulteration in dietary supplements,” said James Neal-Kababick, director, Flora Research Labs. “The speed of analysis is unmatched by any other method we use and the ability to do non-destructive testing is essential in our phytoforensic work, especially when very limited sample is available. I consider having an infrared system in the laboratory as fundamental as having a balance. I could not imagine being without one. PerkinElmer technologies, like the infrared system in DairyGuard, have helped us solve some of the most complex cases of food and supplement contamination we have encountered.”
According to a 2010 A.T. Kearney study conducted for the Grocery Manufacturers Association (GMA), the cost of one adulteration incident averages between 2 and 15 percent of a company’s yearly revenues. Investments in the people and technology to ensure streamlined screening protocols are enabling processors and manufacturers to avoid the threats that contamination poses to customers and company reputations.
For more information on dairy analysis and other food safety solutions visit www.perkinelmer.com/food or stop by our booth at Dairy International, Chicago, Booth #341.
About PerkinElmer, Inc.
PerkinElmer, Inc. is a global leader focused on improving the health and safety of people and the environment. The company reported revenue of approximately $2.1 billion in 2012, has about 7,500 employees serving customers in more than 150 countries, and is a component of the S&P 500 Index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com. Join the conversation and follow us on twitter at www.twitter.com/perkinelmernews.
Contacts
Edelman (On behalf of PerkinElmer, Inc.)
Brittney Haynes, 404-460-9664
Brittney.haynes@edelman.com
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