Alliance Celebrates Decade of Global Standards Development and Certification for Connected Digital Living; Identifies Key Industry Challenges Ahead
PORTLAND, Ore - Tuesday, October 29th 2013 [ME NewsWire]
(BUSINESS WIRE) The Digital Living Network Alliance (DLNA®) is celebrating a decade of enabling consumers to connect and enjoy their music, videos and photos from any DLNA Certified® product. Hundreds of multi-industry companies from around the world have joined DLNA to support a shared vision of digital interoperability, where consumers can confidently choose compatible products and content sources from a range of service providers and manufacturers, today as well as in the future.
“DLNA is widely recognized as the standard for interoperability between networked home and mobile entertainment devices,” noted Nidhish Parikh, chairman and president of DLNA. “Alliance guidelines have been adopted by both the International Electrotechnical Commission (IEC) and the U.S. Federal Communications Commission (FCC) as standards for connectivity. We are well positioned to address upcoming industry challenges as consumers adopt new content storage and sharing habits that make interoperability across a wide range of devices, applications and services even more important.”
Growth of DLNA Certified® Products
New research from industry analyst firm Parks Associates highlights DLNA’s deep reach into consumers’ digital lifestyles. With two billion DLNA Certified® products already purchased by consumers, the firm projects a total of three billion products will be sold globally by 2014 with a further increase to five billion by 2016.
“DLNA continues to be an important industry standard for the connected home, and new additions to the guidelines are likely to increase DLNA’s influence in the future,” said Brett Sappington, director of research at Parks Associates. “Sales of DLNA Certified® products will see significant growth in upcoming years, exceeding the rate of growth of non-certified products in several categories.”
Additional Parks Associates’ findings in each of the fastest growing DLNA product categories include:
The projected compounded annual growth (CAGR) of global DLNA Certified® device shipments exceeds those of corresponding non-DLNA Certified® devices in almost all product categories. Unit volume is highest in smartphones, tablets, computers, and smart TVs.
Overall sales of DLNA Certified® devices across all categories will grow at an annual rate of 15 percent through 2018.
Driven by the increase in video consumption on mobile devices, smartphones are the highest volume global market for DLNA Certified® products, with 264 million DLNA Certified® smartphones sold during 2013.
Looking Forward to the Industry Challenges Ahead
DLNA has identified a number of key trends and industry challenges for 2014 and beyond that will require a continuing focus on specifications that meet an evolving connected lifestyle. These specifications will leverage the broadly adopted foundation DLNA has established over the past 10 years. Industry trends and challenges include:
New types of entertainment applications and services that will impact the sales, features and interoperability requirements of products including set-top boxes, gateways and televisions, as well as smartphones, computers and tablets.
The implications of the cloud for the connected lifestyle.
Emerging digital platforms including the connected car.
“DLNA continues to build on its guidelines to create greater consumer engagement across DLNA Certified® devices,” continued Parikh. “DLNA has already built the strong guidelines framework needed to address new and emerging industry trends. We will continue to advance DLNA to accommodate ongoing changes in the market. These efforts, combined with an ever-growing list of members committed to furthering the Alliance’s mission, are laying the groundwork for another successful decade of innovation and interoperability.”
To access the complete Parks Associates "DLNA Market Overview 2013" report, please visit: http://www.dlna.org/dlna-for-industry/newsroom/parks-associates-report-2013.
About DLNA
The Digital Living Network Alliance (DLNA) is a technology standards organization driven to build industry consensus to advance the interoperability of products in consumers’ connected homes. Founded in 2003 with a current membership of more than 250 companies, this unique multi-industry collaboration continues to implement an innovative set of guidelines utilized by service providers, electronics manufacturers, and software developers to provide consistent performance in a connected home environment. Consumers can share and enjoy personal and premium content, regardless of manufacturer, on a wide variety of products including mobile devices, PCs, set top boxes, AV receivers, game consoles, TVs and more. DLNA has also created a robust certification program which tests and verifies the interoperability of products built to its standards, ensuring consumers that devices branded with the DLNA Certified® mark will successfully connect and exchange content. Additional information about the Alliance is available at www.dlna.org. Find DLNA on Facebook at facebook.com/dlnacertified or on Twitter @DLNA.
DLNA's leading member companies include ACCESS, ARRIS, AT&T, AwoX, Broadcom, CableLabs, Cisco, Comcast, DIRECTV, Dolby Laboratories, DTS, Google, Huawei, Intel, LG, Microsoft, Nokia, Panasonic, Qualcomm, Samsung, Sony, Technicolor, Time Warner Cable and Verizon.
Contacts
Digital Living Network Alliance
Katie Gengler, 503-908-1121
Katie@global-dlna.org
Permalink: http://www.me-newswire.net/news/8964/en
Wednesday, October 30, 2013
Tuesday, October 29, 2013
EY: Cyber-Crime is greatest global threat to organizations' survival today
LONDON - Tuesday, October 29th 2013 [ME NewsWire]
Information security function fully meets needs in only 17% of organizations
Ninety-three per cent of companies maintained or increased security budget over last 12 months – yet budget constraints still biggest obstacle to delivering value
Organizations must be forward-looking and prepare for emerging technologies
Talent shortage hindering fight against cyber-attacks – especially in Europe
(BUSINESS WIRE) With information security functions not fully meeting the needs in 83% of organizations, 93% of companies globally are maintaining or increasing their investment in cyber-security to combat the ever increasing threat from cyber-attacks, according to a new survey released by EY today.
Under cyber-attack, EY's 16th annual Global Information Security Survey 2013 tracks the level of awareness and action by companies in response to cyber threats and canvases the opinion of over 1,900 senior executives globally. This year’s results show that as companies continue to invest heavily to protect themselves against cyber-attacks, the number of security breaches is on the rise and it is no longer of question of if, but when, a company will be the target of an attack.
Thirty-one percent of respondents report the number of security incidents within their organization has increased by at least 5% over the last 12 months. Many have realized the extent and depth of the threat posed to them; resulting in information security now being ‘owned’ at the highest level within 70% of the organizations surveyed.
Paul van Kessel, EY Global Risk Leader comments “This year’s survey shows that organizations are moving in the right direction, but more still needs to be done – urgently. There are promising signs that the issue is now gaining traction at the highest levels. In 2012, none of the information security professionals surveyed reported to senior executives – in 2013 this jumped to 35%.”
Ken Allan, EY Global Information Security Leader adds: “Cyber-crime is the greatest threat for organizations’ survival today. While budget allocations toward security innovation are inching their way up, enabling organizations to channel more resources toward innovating solutions that can protect them against the great unknown – the future – many information security professionals continue to feel that their budgets are insufficient to address mounting cyber risks.”
Information security departments are still feeling the pinch
Despite half of the respondents planning to increase their budget by 5% or more in the next 12 months, 65% cite an insufficient budget as their number one challenge to operating at the levels the business expects; and among organizations with revenues of US$10m or less this figure rises to 71%.
Of the budgets planned for the next 12 months, 14% is ear-marked for security innovation and emerging technologies. As current technologies become further entrenched in an organization’s network and culture, organizations need to be aware of how employees use the devices, both in the workplace and in their personal lives. This is especially true when it comes to social media, which respondents identified as an area where they continue to still feel unsure in their capability to address risks.
Ken explains: “Organizations need to be more forward-looking. Moreover, if organizations are putting all their energy into addressing current technology issues, how will they protect themselves against technologies that are just around the corner or are about to appear on the horizon? If organizations still don’t have a high level of confidence after four years of mobile device use in the workplace, how will they face the challenge of managing and defending against personal and hosted clouds for example?”
Information security departments struggle with a lack of skilled resources
Although information security is focusing on the right priorities, in many instances, the function doesn’t have the skilled resources or executive awareness and support needed to address them.
In particular, the gap is widening between supply and demand, creating a sellers’ market, with 50% of respondents citing a lack of skilled resources as a barrier to value creation. Similarly, where only 20% of previous survey participants indicated a lack of executive awareness or support, 31% now cite it as an issue.
Ken comments: “A lack of skilled talent is a global issue. It is particularly acute in Europe, where governments and companies are fiercely competing to recruit the brightest talent to their teams from a very small pool. As a result, while organizations feel they are addressing the right priorities, many indicate that they do not have the skilled resources to support their needs.”
Looking ahead Paul concludes: “Organizations must undertake more proactive thinking, with tone-from-the-top support. Greater emphasis on improving employee awareness, increasing budgets and devoting more resources to innovating security solutions is needed. The pace of technology evolution will only accelerate – as will the cyber risks and by not considering risks until they arise gives cyber attackers the advantage, jeopardizing an organization’s survival.”
For further information and to download the 2013 report, visit www.ey.com/GISS
About EY
EY is a global leader in assurance, tax, transaction and advisory services. The insights and quality services we deliver help build trust and confidence in the capital markets and in economies the world over. We develop outstanding leaders who team to deliver on our promises to all of our stakeholders. In so doing, we play a critical role in building a better working world for our people, for our clients and for our communities.
EY refers to the global organization, and may refer to one or more, of the member firms of Ernst & Young Global Limited, each of which is a separate legal entity. Ernst & Young Global Limited, a UK company limited by guarantee, does not provide services to clients. For more information about our organization, please visit ey.com.
This news release has been issued by EYGM Limited, a member of the global EY organization that also does not provide any services to clients.
Contacts
EY Global Media Relations
Ann Burton
+44 (0)20 7980 0552
Ann.Burton@uk.ey.com
Information security function fully meets needs in only 17% of organizations
Ninety-three per cent of companies maintained or increased security budget over last 12 months – yet budget constraints still biggest obstacle to delivering value
Organizations must be forward-looking and prepare for emerging technologies
Talent shortage hindering fight against cyber-attacks – especially in Europe
(BUSINESS WIRE) With information security functions not fully meeting the needs in 83% of organizations, 93% of companies globally are maintaining or increasing their investment in cyber-security to combat the ever increasing threat from cyber-attacks, according to a new survey released by EY today.
Under cyber-attack, EY's 16th annual Global Information Security Survey 2013 tracks the level of awareness and action by companies in response to cyber threats and canvases the opinion of over 1,900 senior executives globally. This year’s results show that as companies continue to invest heavily to protect themselves against cyber-attacks, the number of security breaches is on the rise and it is no longer of question of if, but when, a company will be the target of an attack.
Thirty-one percent of respondents report the number of security incidents within their organization has increased by at least 5% over the last 12 months. Many have realized the extent and depth of the threat posed to them; resulting in information security now being ‘owned’ at the highest level within 70% of the organizations surveyed.
Paul van Kessel, EY Global Risk Leader comments “This year’s survey shows that organizations are moving in the right direction, but more still needs to be done – urgently. There are promising signs that the issue is now gaining traction at the highest levels. In 2012, none of the information security professionals surveyed reported to senior executives – in 2013 this jumped to 35%.”
Ken Allan, EY Global Information Security Leader adds: “Cyber-crime is the greatest threat for organizations’ survival today. While budget allocations toward security innovation are inching their way up, enabling organizations to channel more resources toward innovating solutions that can protect them against the great unknown – the future – many information security professionals continue to feel that their budgets are insufficient to address mounting cyber risks.”
Information security departments are still feeling the pinch
Despite half of the respondents planning to increase their budget by 5% or more in the next 12 months, 65% cite an insufficient budget as their number one challenge to operating at the levels the business expects; and among organizations with revenues of US$10m or less this figure rises to 71%.
Of the budgets planned for the next 12 months, 14% is ear-marked for security innovation and emerging technologies. As current technologies become further entrenched in an organization’s network and culture, organizations need to be aware of how employees use the devices, both in the workplace and in their personal lives. This is especially true when it comes to social media, which respondents identified as an area where they continue to still feel unsure in their capability to address risks.
Ken explains: “Organizations need to be more forward-looking. Moreover, if organizations are putting all their energy into addressing current technology issues, how will they protect themselves against technologies that are just around the corner or are about to appear on the horizon? If organizations still don’t have a high level of confidence after four years of mobile device use in the workplace, how will they face the challenge of managing and defending against personal and hosted clouds for example?”
Information security departments struggle with a lack of skilled resources
Although information security is focusing on the right priorities, in many instances, the function doesn’t have the skilled resources or executive awareness and support needed to address them.
In particular, the gap is widening between supply and demand, creating a sellers’ market, with 50% of respondents citing a lack of skilled resources as a barrier to value creation. Similarly, where only 20% of previous survey participants indicated a lack of executive awareness or support, 31% now cite it as an issue.
Ken comments: “A lack of skilled talent is a global issue. It is particularly acute in Europe, where governments and companies are fiercely competing to recruit the brightest talent to their teams from a very small pool. As a result, while organizations feel they are addressing the right priorities, many indicate that they do not have the skilled resources to support their needs.”
Looking ahead Paul concludes: “Organizations must undertake more proactive thinking, with tone-from-the-top support. Greater emphasis on improving employee awareness, increasing budgets and devoting more resources to innovating security solutions is needed. The pace of technology evolution will only accelerate – as will the cyber risks and by not considering risks until they arise gives cyber attackers the advantage, jeopardizing an organization’s survival.”
For further information and to download the 2013 report, visit www.ey.com/GISS
About EY
EY is a global leader in assurance, tax, transaction and advisory services. The insights and quality services we deliver help build trust and confidence in the capital markets and in economies the world over. We develop outstanding leaders who team to deliver on our promises to all of our stakeholders. In so doing, we play a critical role in building a better working world for our people, for our clients and for our communities.
EY refers to the global organization, and may refer to one or more, of the member firms of Ernst & Young Global Limited, each of which is a separate legal entity. Ernst & Young Global Limited, a UK company limited by guarantee, does not provide services to clients. For more information about our organization, please visit ey.com.
This news release has been issued by EYGM Limited, a member of the global EY organization that also does not provide any services to clients.
Contacts
EY Global Media Relations
Ann Burton
+44 (0)20 7980 0552
Ann.Burton@uk.ey.com
Procter & Gamble Brands Unite to Kick Off Sochi 2014 Olympic Winter Games ‘Thank You Mom’ Campaign by Launching a Series of 28 Raising an Olympian Films
Raising an Olympian series pays tribute to moms by showcasing the journey of world-class athletes as seen through eyes of their moms
CINCINNATI - Tuesday, October 29th 2013 [ME NewsWire]
(BUSINESS WIRE) Procter & Gamble (NYSE: PG), a Worldwide Olympic Partner, kicked off the company’s Thank You Mom campaign today with the Raising an Olympian series featuring Olay® athlete Lindsey Vonn (United States), Gillette® athletes Felix Neureuther (Germany) and Sven Kramer (Netherlands) and Pantene® athlete Elena Ilinykh (Russia).
The launch of the Thank You Mom campaign marks 100 days to go until the start of the Sochi 2014 Olympic Winter Games and is supported by more than fifteen P&G brands around the globe such as Pampers®, Head & Shoulders® and COVERGIRL®.
“P&G brands look at Olympic sponsorship through a special lens,” said Marc Pritchard P&G Global Brand Building Officer. “Our brands don’t just live at the finish line; they’re about the everyday journey athletes take to get to the Games, a journey they started in childhood with their moms. That’s why if a P&G brand sponsors an athlete, we also celebrate the mom who helped get them there.”
The P&G Sochi 2014 campaign will come to life through P&G’s iconic brands and their inspiring campaigns:
P&G Beauty will inspire women to ‘Look Winter Wonderful’ this season, and the Olay campaign in particular will feature LINDSEY VONN (U.S. Olympic Gold Medalist, Alpine Skiing)
Gillette is encouraging men everywhere to ‘Reveal their Inner Steel’ featuring ALEXANDER OVECHKIN (Russian Olympian, Ice Hockey), as well as SVEN KRAMER (Dutch Olympic Gold Medalist, Speed Skating)
Pantene and ELENA ILINYKH (Russian Olympic Hopeful, Figure Skating), are proving that hair can pass the winter torture test to ‘Win Over Winter and Shine!’
Head & Shoulders is washing out flakes, washing in Inner Confidence with EVGENI MALKIN (Russian Olympian, Ice Hockey)
Bounty® recognizes that if you’re raising an aspiring athlete, then it helps to be uninhibited by messes with the ‘Let the Spills Begin’ campaign featuring JULIE CHU (U.S. Olympic Medalist and National Team Forward, Women's Ice Hockey)
Blend-a-Med® and Crest® campaigns, featuring ALENA LEONOVA (Russian Olympic Hopeful, Figure Skating) and EVAN LYSACEK (U.S. Olympic Gold Medalist, Figure Skating) highlight that when you want to get noticed you need to “Be Prepared for Your Spotlight Moment”.
“I would never be the athlete I am today without my mom,” said Dutch speed skating Gold Medalist Sven Kramer. “So I’m proud to be a Gillette athlete not just because Gillette stands for the highest standard of performance, but because of the way they’ve treated my mom.”
U.S. Olympic Gold Medalist, Lindsey Vonn also comments, “I am so excited to be part of P&G’s Thank You Mom program and be in the company of some of the greatest athletes in the world, sponsored by P&G and some of the greatest brands in the world. In our training and competitions, we combat all the elements. As a skier, my skin undergoes the most extreme winter conditions. That’s why I trust Olay to keep my skin as healthy as possible.”
Through the Raising an Olympian series P&G is paying homage to moms of athletes from across the globe, bringing to life the daily lessons all moms teach. From their kid’s first steps to their first failures, the series highlights the unconditional love moms give their kids no matter what. Additional athletes featured in the Raising an Olympian series include Tessa Virtue and Scott Moir (Canadian Olympic Gold Medalists, Figure Skating) sponsored by P&G Beauty products like Pantene and Olay, USA’s Julie Chu who is sponsored by Bounty and Ekaterina Bobrova (Russian Ice Dancer) sponsored by Venus®.
“From Pampers to Crest and Ariel, our brands exist to serve moms and their families,” said Pritchard. “So when we look at the determination, commitment and grit that gets an athlete to the Olympic Games, we see the mom who helped teach those things. That’s why our brands are dedicated to not only our athletes, but also supporting their moms.”
The first half of the Raising an Olympian films can be viewed at: P&G Raising an Olympian
As part of P&G’s dedication to bringing the best to moms around the world, the Thank You Mom campaign will come to life through a variety of media channels and in store. Two million retailers throughout the world will feature P&G Olympic Games themed athlete packaging, end caps and displays.
To view photos, videos and additional information related to the P&G Thank You Mom campaign, visit www.image.net/pgolympicgames.
About P&G
P&G serves approximately 4.8 billion people around the world with its brands. The Company has one of the strongest portfolios of trusted, quality, leadership brands, including Ace®, Always®, Ambi Pur®, Ariel®, Bounty®, Charmin®, Crest®, Dawn®, Downy®, Duracell®, Fairy®, Febreze®, Fusion®, Gain®, Gillette®, Head & Shoulders®, Iams®, Lenor®, Mach3®, Olay®, Oral-B®, Pampers®, Pantene®, Prestobarba®, SK-II®, Tide®, Vicks®, Wella®, and Whisper®. The P&G community includes operations in approximately 70 countries worldwide. Please visit http://www.pg.com for the latest news and in-depth information about P&G and its brands.
Contacts
P&G
Jeannie Tharrington, +1-513-698-4607
tharrington.jm@pg.com
MMK
Tamara Jacobs, +1-770-971-0677
tamara.jacobs@ketchum.com
Permalink: http://www.me-newswire.net/news/9001/en
CINCINNATI - Tuesday, October 29th 2013 [ME NewsWire]
(BUSINESS WIRE) Procter & Gamble (NYSE: PG), a Worldwide Olympic Partner, kicked off the company’s Thank You Mom campaign today with the Raising an Olympian series featuring Olay® athlete Lindsey Vonn (United States), Gillette® athletes Felix Neureuther (Germany) and Sven Kramer (Netherlands) and Pantene® athlete Elena Ilinykh (Russia).
The launch of the Thank You Mom campaign marks 100 days to go until the start of the Sochi 2014 Olympic Winter Games and is supported by more than fifteen P&G brands around the globe such as Pampers®, Head & Shoulders® and COVERGIRL®.
“P&G brands look at Olympic sponsorship through a special lens,” said Marc Pritchard P&G Global Brand Building Officer. “Our brands don’t just live at the finish line; they’re about the everyday journey athletes take to get to the Games, a journey they started in childhood with their moms. That’s why if a P&G brand sponsors an athlete, we also celebrate the mom who helped get them there.”
The P&G Sochi 2014 campaign will come to life through P&G’s iconic brands and their inspiring campaigns:
P&G Beauty will inspire women to ‘Look Winter Wonderful’ this season, and the Olay campaign in particular will feature LINDSEY VONN (U.S. Olympic Gold Medalist, Alpine Skiing)
Gillette is encouraging men everywhere to ‘Reveal their Inner Steel’ featuring ALEXANDER OVECHKIN (Russian Olympian, Ice Hockey), as well as SVEN KRAMER (Dutch Olympic Gold Medalist, Speed Skating)
Pantene and ELENA ILINYKH (Russian Olympic Hopeful, Figure Skating), are proving that hair can pass the winter torture test to ‘Win Over Winter and Shine!’
Head & Shoulders is washing out flakes, washing in Inner Confidence with EVGENI MALKIN (Russian Olympian, Ice Hockey)
Bounty® recognizes that if you’re raising an aspiring athlete, then it helps to be uninhibited by messes with the ‘Let the Spills Begin’ campaign featuring JULIE CHU (U.S. Olympic Medalist and National Team Forward, Women's Ice Hockey)
Blend-a-Med® and Crest® campaigns, featuring ALENA LEONOVA (Russian Olympic Hopeful, Figure Skating) and EVAN LYSACEK (U.S. Olympic Gold Medalist, Figure Skating) highlight that when you want to get noticed you need to “Be Prepared for Your Spotlight Moment”.
“I would never be the athlete I am today without my mom,” said Dutch speed skating Gold Medalist Sven Kramer. “So I’m proud to be a Gillette athlete not just because Gillette stands for the highest standard of performance, but because of the way they’ve treated my mom.”
U.S. Olympic Gold Medalist, Lindsey Vonn also comments, “I am so excited to be part of P&G’s Thank You Mom program and be in the company of some of the greatest athletes in the world, sponsored by P&G and some of the greatest brands in the world. In our training and competitions, we combat all the elements. As a skier, my skin undergoes the most extreme winter conditions. That’s why I trust Olay to keep my skin as healthy as possible.”
Through the Raising an Olympian series P&G is paying homage to moms of athletes from across the globe, bringing to life the daily lessons all moms teach. From their kid’s first steps to their first failures, the series highlights the unconditional love moms give their kids no matter what. Additional athletes featured in the Raising an Olympian series include Tessa Virtue and Scott Moir (Canadian Olympic Gold Medalists, Figure Skating) sponsored by P&G Beauty products like Pantene and Olay, USA’s Julie Chu who is sponsored by Bounty and Ekaterina Bobrova (Russian Ice Dancer) sponsored by Venus®.
“From Pampers to Crest and Ariel, our brands exist to serve moms and their families,” said Pritchard. “So when we look at the determination, commitment and grit that gets an athlete to the Olympic Games, we see the mom who helped teach those things. That’s why our brands are dedicated to not only our athletes, but also supporting their moms.”
The first half of the Raising an Olympian films can be viewed at: P&G Raising an Olympian
As part of P&G’s dedication to bringing the best to moms around the world, the Thank You Mom campaign will come to life through a variety of media channels and in store. Two million retailers throughout the world will feature P&G Olympic Games themed athlete packaging, end caps and displays.
To view photos, videos and additional information related to the P&G Thank You Mom campaign, visit www.image.net/pgolympicgames.
About P&G
P&G serves approximately 4.8 billion people around the world with its brands. The Company has one of the strongest portfolios of trusted, quality, leadership brands, including Ace®, Always®, Ambi Pur®, Ariel®, Bounty®, Charmin®, Crest®, Dawn®, Downy®, Duracell®, Fairy®, Febreze®, Fusion®, Gain®, Gillette®, Head & Shoulders®, Iams®, Lenor®, Mach3®, Olay®, Oral-B®, Pampers®, Pantene®, Prestobarba®, SK-II®, Tide®, Vicks®, Wella®, and Whisper®. The P&G community includes operations in approximately 70 countries worldwide. Please visit http://www.pg.com for the latest news and in-depth information about P&G and its brands.
Contacts
P&G
Jeannie Tharrington, +1-513-698-4607
tharrington.jm@pg.com
MMK
Tamara Jacobs, +1-770-971-0677
tamara.jacobs@ketchum.com
Permalink: http://www.me-newswire.net/news/9001/en
KCI Completes Acquisition of Systagenix
Peter Huntley Appointed Senior Vice President and Leader of Systagenix
SAN ANTONIO - Monday, October 28th 2013 [ME NewsWire]
(BUSINESS WIRE)-- Kinetic Concepts, Inc. (KCI) announced today that it has completed its acquisition of Systagenix, an established provider of advanced wound care products based in the United Kingdom. The acquisition of Systagenix enhances KCI’s position as a leading provider of transformational healing solutions with a diverse product portfolio dedicated to advancing the practice of medicine and improving patient lives around the world. The purchase price was $485 million.
As previously announced, KCI, Systagenix and LifeCell Corporation now form one company, a global leader in medical technology with more than $2 billion in revenue, poised for future success as a geographically diversified company with world-class wound care and biologics franchises.
“The successful completion of the Systagenix acquisition marks an important milestone in the advancement of our long-term strategy as the global leader in transformational healing solutions,” said Joe Woody, president & CEO. “Together, KCI, Systagenix and LifeCell will deliver customer-focused innovations and realize new possibilities beyond that which we could have achieved as a stand-alone organization.”
In connection with the acquisition, KCI announced that Peter Huntley has been appointed as senior vice president and leader of Systagenix going forward, reporting to KCI President & CEO Joe Woody. Huntley has more than 15 years of experience in the healthcare industry and was most recently CEO of Corin Group plc, where he successfully returned its orthopedics business to growth. Prior to Corin, Peter was a member of the executive committee at Smith & Nephew for 10 years, holding several roles including Group Director, Strategy and Business Development and later Group Director, Indirect Markets, where he was responsible for sales and marketing of the orthopedic reconstruction, orthopedic trauma, endoscopy and wound management portfolios. Ernest Waaser, departing CEO of Systagenix, will remain with the company for the next few months to support the integration efforts.
“I am pleased to welcome Peter Huntley as the new leader of Systagenix. He has extensive global leadership experience and a long track record of commercial success in the industry, which will add tremendous value as we combine KCI, Systagenix and LifeCell into a single company,” Woody continued. “I would also like to thank Ernest Waaser for his outstanding leadership of Systagenix that has brought us to this exciting milestone. The KCI family of companies and employees wishes him the best in his future endeavors.”
“This is an incredible opportunity and I am excited to lead the Systagenix team and to continue to build on the franchise’s compelling brand and product offerings,” said Peter Huntley, senior vice president, Systagenix. “I also look forward to collaborating with my new colleagues to drive growth and customer value across the combined company.”
Goldman, Sachs & Co. (lead advisor), BofA Merrill Lynch and Morgan Stanley provided financial advice to KCI. Debt financing for the transaction was provided by BofA Merrill Lynch, Morgan Stanley and Goldman, Sachs & Co. Simpson Thacher & Bartlett LLP and Kirkland & Ellis LLP acted as legal advisors to KCI. Jones Day acted as legal advisor to Systagenix.
About KCI
KCI is a leading global medical technology company devoted to understanding, developing and commercializing innovative, high-technology transformational healing solutions for customers and patients in more than 65 countries around the world. Headquartered in San Antonio, Texas, KCI is committed to advancing the science of healing and positively impacting patient care by developing customer-driven innovations to meet the evolving needs of healthcare professionals. Proprietary KCI negative pressure technologies have revolutionized the way in which caregivers treat a wide variety of wound types. The V.A.C.® Therapy System has been used on more than 7 million wounds worldwide. Additional information about KCI and its products is available at www.KCI1.com.
About LifeCell
LifeCell, based in Bridgewater, NJ, is a leader in regenerative medicine, develops and markets innovative tissue repair products for the reconstructive, orthopedic and urogynecologic biosurgery markets. LifeCell™ products include Strattice™ Reconstructive Tissue Matrix and AlloDerm® regenerative Tissue Matrix for plastic, reconstructive, and general surgical applications; Cymetra® Regenerative Tissue Matrix, a particulate form of AlloDerm® Tissue Matrix suitable for injection; Repliform® Regenerative Tissue Matrix for urogynecologic surgical procedures; Graftjacket® and Conexa™ for orthopedic surgical procedures; and the SPY® Elite System for the visualization and evaluation of tissue perfusion. Additional information about LifeCell and its products is available at www.LifeCell.com.
About Systagenix
Systagenix is a global leader in innovative wound care established in 2008 following the acquisition of Johnson & Johnson’s professional wound care business by One Equity Partners. Systagenix is 100% dedicated to wound care, developing and marketing advanced wound diagnostic and therapeutic solutions and supplying over 20 million advanced wound dressings per month globally. Systagenix’ longstanding commitment to skin and wound care began with innovative wound care treatments developed by the experienced team of R&D Scientists at the Gargrave Centre of Excellence for Wound Healing in North Yorkshire, England. With approximately 800 employees worldwide, Systagenix distributes products and services to more than 75 countries.
Contacts
For more information:
KCI Corporate Communications
Mike Barger, +1-210-255-6824
mike.barger@kci1.com
KCI Investor Relations
Nathan Speicher, +1-210-255-6027
nathan.speicher@kci1.com
Permalink: http://me-newswire.net/news/8963/en
SAN ANTONIO - Monday, October 28th 2013 [ME NewsWire]
(BUSINESS WIRE)-- Kinetic Concepts, Inc. (KCI) announced today that it has completed its acquisition of Systagenix, an established provider of advanced wound care products based in the United Kingdom. The acquisition of Systagenix enhances KCI’s position as a leading provider of transformational healing solutions with a diverse product portfolio dedicated to advancing the practice of medicine and improving patient lives around the world. The purchase price was $485 million.
As previously announced, KCI, Systagenix and LifeCell Corporation now form one company, a global leader in medical technology with more than $2 billion in revenue, poised for future success as a geographically diversified company with world-class wound care and biologics franchises.
“The successful completion of the Systagenix acquisition marks an important milestone in the advancement of our long-term strategy as the global leader in transformational healing solutions,” said Joe Woody, president & CEO. “Together, KCI, Systagenix and LifeCell will deliver customer-focused innovations and realize new possibilities beyond that which we could have achieved as a stand-alone organization.”
In connection with the acquisition, KCI announced that Peter Huntley has been appointed as senior vice president and leader of Systagenix going forward, reporting to KCI President & CEO Joe Woody. Huntley has more than 15 years of experience in the healthcare industry and was most recently CEO of Corin Group plc, where he successfully returned its orthopedics business to growth. Prior to Corin, Peter was a member of the executive committee at Smith & Nephew for 10 years, holding several roles including Group Director, Strategy and Business Development and later Group Director, Indirect Markets, where he was responsible for sales and marketing of the orthopedic reconstruction, orthopedic trauma, endoscopy and wound management portfolios. Ernest Waaser, departing CEO of Systagenix, will remain with the company for the next few months to support the integration efforts.
“I am pleased to welcome Peter Huntley as the new leader of Systagenix. He has extensive global leadership experience and a long track record of commercial success in the industry, which will add tremendous value as we combine KCI, Systagenix and LifeCell into a single company,” Woody continued. “I would also like to thank Ernest Waaser for his outstanding leadership of Systagenix that has brought us to this exciting milestone. The KCI family of companies and employees wishes him the best in his future endeavors.”
“This is an incredible opportunity and I am excited to lead the Systagenix team and to continue to build on the franchise’s compelling brand and product offerings,” said Peter Huntley, senior vice president, Systagenix. “I also look forward to collaborating with my new colleagues to drive growth and customer value across the combined company.”
Goldman, Sachs & Co. (lead advisor), BofA Merrill Lynch and Morgan Stanley provided financial advice to KCI. Debt financing for the transaction was provided by BofA Merrill Lynch, Morgan Stanley and Goldman, Sachs & Co. Simpson Thacher & Bartlett LLP and Kirkland & Ellis LLP acted as legal advisors to KCI. Jones Day acted as legal advisor to Systagenix.
About KCI
KCI is a leading global medical technology company devoted to understanding, developing and commercializing innovative, high-technology transformational healing solutions for customers and patients in more than 65 countries around the world. Headquartered in San Antonio, Texas, KCI is committed to advancing the science of healing and positively impacting patient care by developing customer-driven innovations to meet the evolving needs of healthcare professionals. Proprietary KCI negative pressure technologies have revolutionized the way in which caregivers treat a wide variety of wound types. The V.A.C.® Therapy System has been used on more than 7 million wounds worldwide. Additional information about KCI and its products is available at www.KCI1.com.
About LifeCell
LifeCell, based in Bridgewater, NJ, is a leader in regenerative medicine, develops and markets innovative tissue repair products for the reconstructive, orthopedic and urogynecologic biosurgery markets. LifeCell™ products include Strattice™ Reconstructive Tissue Matrix and AlloDerm® regenerative Tissue Matrix for plastic, reconstructive, and general surgical applications; Cymetra® Regenerative Tissue Matrix, a particulate form of AlloDerm® Tissue Matrix suitable for injection; Repliform® Regenerative Tissue Matrix for urogynecologic surgical procedures; Graftjacket® and Conexa™ for orthopedic surgical procedures; and the SPY® Elite System for the visualization and evaluation of tissue perfusion. Additional information about LifeCell and its products is available at www.LifeCell.com.
About Systagenix
Systagenix is a global leader in innovative wound care established in 2008 following the acquisition of Johnson & Johnson’s professional wound care business by One Equity Partners. Systagenix is 100% dedicated to wound care, developing and marketing advanced wound diagnostic and therapeutic solutions and supplying over 20 million advanced wound dressings per month globally. Systagenix’ longstanding commitment to skin and wound care began with innovative wound care treatments developed by the experienced team of R&D Scientists at the Gargrave Centre of Excellence for Wound Healing in North Yorkshire, England. With approximately 800 employees worldwide, Systagenix distributes products and services to more than 75 countries.
Contacts
For more information:
KCI Corporate Communications
Mike Barger, +1-210-255-6824
mike.barger@kci1.com
KCI Investor Relations
Nathan Speicher, +1-210-255-6027
nathan.speicher@kci1.com
Permalink: http://me-newswire.net/news/8963/en
Oral Apremilast Demonstrated Rapid, Clinically Significant Improvements in Oral Ulcers in Patients with Behçet’s Disease in a Phase II Trial
BOUDRY, Switzerland - Monday, October 28th 2013 [ME NewsWire]
71% of patients achieved complete response at week 12 in clearing of ulcers
Apremilast also improved quality of life measures and pain associated with active oral ulcers, the cardinal manifestation of Behçet’s disease
Limited therapies currently available in U.S. or Europe for this orphan chronic inflammatory disorder
(BUSINESS WIRE)-- Celgene International Sà rl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ:CELG), today presented phase II trial (BCT-001) results of apremilast, the Company’s first-in-class, oral, targeted inhibitor of phosphodiesterase 4 (PDE4), in patients with Behçet’s disease. The findings were presented at the 2013 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) annual meeting in San Diego. These results have been featured as part of the official ACR press program, which highlights data considered representative of the highest quality and most meaningful research presented at the ACR annual meeting.
Behçet’s disease is a rare and chronic inflammatory disorder characterized by recurrent oral and genital ulcers, skin and eye lesions (which may cause blindness) and joint inflammation. Inflammation may also affect the brain and gastrointestinal tract.
These data, which were also presented at the European League Against Rheumatism (EULAR) annual meeting this year in June, showed that significantly more patients on apremilast achieved a complete response (were free from active oral ulcers) at week 12 compared with those on placebo (apremilast, 71%; placebo, 29%; p<0.0001). Among patients with genital ulcers at baseline (n=16), 100% of those receiving apremilast had a complete response at week 12 compared with 50% of those receiving placebo (p=0.036).
“Behçet’s disease can have a severe negative impact on patients’ quality of life, and there are limited therapies available, so there is a clear need for a new therapy to help this patient population,” said Gulen Hatemi, M.D., Associate Professor, Cerrahpasa Medical School, Istanbul, Turkey. “We are encouraged by the rapid response seen in this important phase II study and by apremilast’s potential to treat oral ulcers in this orphan disease.”
The beneficial effect of apremilast on oral ulcers reached a stable effect within two weeks and was sustained while patients remained on treatment.
At week 12, apremilast also improved several patient-reported outcome scores, including the Behçet’s disease current activity form (BDCAF), Behçet’s syndrome activity score (BSAS) and Behçet’s disease quality of life (QoL) instrument. Improvement in oral ulcer pain was also significantly higher with apremilast than with placebo (apremilast, -44.7 ± 24.30; placebo, -16.0 ± 32.54; p<0.0001).
The type and severity of adverse events (AEs) were comparable to the known apremilast safety profile. In BCT-001, treatment-emergent adverse events (TEAE), including severe and serious adverse events (SAEs) and withdrawal due to adverse events, were comparable between 30 mg twice daily (BID) and placebo. None of the SAEs in the apremilast group were reported more than once. Out of the five most common TEAEs in the 30 mg BID group, two (headache and Behçet’s syndrome/flare) were comparable to placebo, while nausea, diarrhea and vomiting were reported more frequently with APR 30 mg BID.
Limited therapies are available to treat this rare, chronic inflammatory disorder of unknown cause. The treatment options depend largely on the manifestations of the different organ systems involved. Treatment options recommended by physicians are largely aimed at alleviating specific patient symptoms and may include non-steroidal anti-inflammatory drug (NSAIDS), immunosuppressive medications and disease-modifying antirheumatic drugs (DMARDS) approved for other indications.
These results are from investigational studies. Apremilast is not an approved product for any indication.
The New Drug Application (NDA) and the New Drug Submission (NDS), based on the combined data from PALACE 1, 2 & 3 for psoriatic arthritis, were submitted to health authorities in the US and Canada in Q1 2013 and Q2 2013, respectively. An NDA to the U.S. Food and Drug Administration for psoriasis, in addition to a combined psoriatic arthritis/psoriasis Marketing Authorization Application (MAA) in Europe, is on-track for the fourth quarter of 2013. The Company is currently exploring opportunities to submit for an indication in Behçet’s disease in a number of countries.
About BCT-001
BCT-001 is a phase 2, multi-center, randomized, placebo-controlled, double-blind, parallel-group study with two treatment arms (apremilast 30 mg BID and placebo) in Behçet’s disease. The study consisted of a 90-day pre-randomization phase, a 12-week treatment phase, a 12-week extension phase and a four-week post-treatment observational follow-up phase. A total of 111 subjects with active Behçet’s disease were randomized 1:1 to receive either apremilast 30 mg BID or identically appearing placebo, stratified by gender. The primary endpoint of the study was the number of oral ulcers at day 85 (12 weeks). Because virtually all patients with Behçet’s disease have painful oral ulcers, this manifestation was chosen as the primary efficacy measure. Less common manifestations of Behçet’s disease, including genital ulcers, skin lesions, inflammatory eye disease, involvement of the gastrointestinal, vascular and central nervous systems, and pain from oral and genital ulcers, were chosen as secondary/exploratory efficacy variables or safety measures.
About Apremilast
Apremilast, an oral, targeted inhibitor of phosphodiesterase 4 (PDE4), intracellularly modulates the expression of a network of pro-inflammatory and anti-inflammatory cytokines. PDE4 is a cyclic adenosine monophosphate (cAMP)-specific PDE and the dominant PDE in inflammatory cells. PDE4 inhibition elevates intracellular cAMP levels, which in turn down-regulates the inflammatory response by modulating the expression of TNF-α, IL-23, and other inflammatory cytokines. Elevation of cAMP also increases anti-inflammatory cytokines such as IL-10.
About Behçet’s Disease
Behçet’s disease is a chronic inflammatory vasculitis of unknown cause characterized by recurrent oral and genital ulcers, multiple skin lesions ranging from acne to vasculitic ulcerations, vascular involvement, including venous thrombosis and aneurysms which may be life threatening, and inflammatory disease of the eye manifesting as uveitis (may lead to blindness), neurologic involvement and gastrointestinal involvement. Prevalence of Behçet’s disease is highest in the Middle East, Asia and Japan, but it is classified as a rare or “orphan” disease by the NIH in the United States. At this time, there are limited therapies for this orphan indication in the United States or throughout Europe. In some cases, uncontrolled inflammation may lead to blindness, intestinal perforations, stroke, and even aneurismal bleeding which can be fatal. Although the root cause of Behçet’s disease is unknown, the disease is associated with abnormalities of the immune system. To learn more about the role of PDE4 in inflammatory diseases, visit www.discoverpde4.com.
About Celgene
Celgene International SÃ rl, located in Boudry, Switzerland, is a wholly-owned subsidiary and international headquarters of Celgene Corporation. Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit www.celgene.com.
Forward-Looking Statements
This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in Celgene Corporation’s Annual Report on Form 10-K and other reports filed with the Securities and Exchange Commission.
Contacts
Celgene International SÃ rl
Investors:
+41 32 729 8303 ir@celgene.com
Media:
+41 32 729 8304 media@celgene.com
Permalink: http://www.me-newswire.net/news/8977/en
71% of patients achieved complete response at week 12 in clearing of ulcers
Apremilast also improved quality of life measures and pain associated with active oral ulcers, the cardinal manifestation of Behçet’s disease
Limited therapies currently available in U.S. or Europe for this orphan chronic inflammatory disorder
(BUSINESS WIRE)-- Celgene International Sà rl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ:CELG), today presented phase II trial (BCT-001) results of apremilast, the Company’s first-in-class, oral, targeted inhibitor of phosphodiesterase 4 (PDE4), in patients with Behçet’s disease. The findings were presented at the 2013 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) annual meeting in San Diego. These results have been featured as part of the official ACR press program, which highlights data considered representative of the highest quality and most meaningful research presented at the ACR annual meeting.
Behçet’s disease is a rare and chronic inflammatory disorder characterized by recurrent oral and genital ulcers, skin and eye lesions (which may cause blindness) and joint inflammation. Inflammation may also affect the brain and gastrointestinal tract.
These data, which were also presented at the European League Against Rheumatism (EULAR) annual meeting this year in June, showed that significantly more patients on apremilast achieved a complete response (were free from active oral ulcers) at week 12 compared with those on placebo (apremilast, 71%; placebo, 29%; p<0.0001). Among patients with genital ulcers at baseline (n=16), 100% of those receiving apremilast had a complete response at week 12 compared with 50% of those receiving placebo (p=0.036).
“Behçet’s disease can have a severe negative impact on patients’ quality of life, and there are limited therapies available, so there is a clear need for a new therapy to help this patient population,” said Gulen Hatemi, M.D., Associate Professor, Cerrahpasa Medical School, Istanbul, Turkey. “We are encouraged by the rapid response seen in this important phase II study and by apremilast’s potential to treat oral ulcers in this orphan disease.”
The beneficial effect of apremilast on oral ulcers reached a stable effect within two weeks and was sustained while patients remained on treatment.
At week 12, apremilast also improved several patient-reported outcome scores, including the Behçet’s disease current activity form (BDCAF), Behçet’s syndrome activity score (BSAS) and Behçet’s disease quality of life (QoL) instrument. Improvement in oral ulcer pain was also significantly higher with apremilast than with placebo (apremilast, -44.7 ± 24.30; placebo, -16.0 ± 32.54; p<0.0001).
The type and severity of adverse events (AEs) were comparable to the known apremilast safety profile. In BCT-001, treatment-emergent adverse events (TEAE), including severe and serious adverse events (SAEs) and withdrawal due to adverse events, were comparable between 30 mg twice daily (BID) and placebo. None of the SAEs in the apremilast group were reported more than once. Out of the five most common TEAEs in the 30 mg BID group, two (headache and Behçet’s syndrome/flare) were comparable to placebo, while nausea, diarrhea and vomiting were reported more frequently with APR 30 mg BID.
Limited therapies are available to treat this rare, chronic inflammatory disorder of unknown cause. The treatment options depend largely on the manifestations of the different organ systems involved. Treatment options recommended by physicians are largely aimed at alleviating specific patient symptoms and may include non-steroidal anti-inflammatory drug (NSAIDS), immunosuppressive medications and disease-modifying antirheumatic drugs (DMARDS) approved for other indications.
These results are from investigational studies. Apremilast is not an approved product for any indication.
The New Drug Application (NDA) and the New Drug Submission (NDS), based on the combined data from PALACE 1, 2 & 3 for psoriatic arthritis, were submitted to health authorities in the US and Canada in Q1 2013 and Q2 2013, respectively. An NDA to the U.S. Food and Drug Administration for psoriasis, in addition to a combined psoriatic arthritis/psoriasis Marketing Authorization Application (MAA) in Europe, is on-track for the fourth quarter of 2013. The Company is currently exploring opportunities to submit for an indication in Behçet’s disease in a number of countries.
About BCT-001
BCT-001 is a phase 2, multi-center, randomized, placebo-controlled, double-blind, parallel-group study with two treatment arms (apremilast 30 mg BID and placebo) in Behçet’s disease. The study consisted of a 90-day pre-randomization phase, a 12-week treatment phase, a 12-week extension phase and a four-week post-treatment observational follow-up phase. A total of 111 subjects with active Behçet’s disease were randomized 1:1 to receive either apremilast 30 mg BID or identically appearing placebo, stratified by gender. The primary endpoint of the study was the number of oral ulcers at day 85 (12 weeks). Because virtually all patients with Behçet’s disease have painful oral ulcers, this manifestation was chosen as the primary efficacy measure. Less common manifestations of Behçet’s disease, including genital ulcers, skin lesions, inflammatory eye disease, involvement of the gastrointestinal, vascular and central nervous systems, and pain from oral and genital ulcers, were chosen as secondary/exploratory efficacy variables or safety measures.
About Apremilast
Apremilast, an oral, targeted inhibitor of phosphodiesterase 4 (PDE4), intracellularly modulates the expression of a network of pro-inflammatory and anti-inflammatory cytokines. PDE4 is a cyclic adenosine monophosphate (cAMP)-specific PDE and the dominant PDE in inflammatory cells. PDE4 inhibition elevates intracellular cAMP levels, which in turn down-regulates the inflammatory response by modulating the expression of TNF-α, IL-23, and other inflammatory cytokines. Elevation of cAMP also increases anti-inflammatory cytokines such as IL-10.
About Behçet’s Disease
Behçet’s disease is a chronic inflammatory vasculitis of unknown cause characterized by recurrent oral and genital ulcers, multiple skin lesions ranging from acne to vasculitic ulcerations, vascular involvement, including venous thrombosis and aneurysms which may be life threatening, and inflammatory disease of the eye manifesting as uveitis (may lead to blindness), neurologic involvement and gastrointestinal involvement. Prevalence of Behçet’s disease is highest in the Middle East, Asia and Japan, but it is classified as a rare or “orphan” disease by the NIH in the United States. At this time, there are limited therapies for this orphan indication in the United States or throughout Europe. In some cases, uncontrolled inflammation may lead to blindness, intestinal perforations, stroke, and even aneurismal bleeding which can be fatal. Although the root cause of Behçet’s disease is unknown, the disease is associated with abnormalities of the immune system. To learn more about the role of PDE4 in inflammatory diseases, visit www.discoverpde4.com.
About Celgene
Celgene International SÃ rl, located in Boudry, Switzerland, is a wholly-owned subsidiary and international headquarters of Celgene Corporation. Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit www.celgene.com.
Forward-Looking Statements
This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in Celgene Corporation’s Annual Report on Form 10-K and other reports filed with the Securities and Exchange Commission.
Contacts
Celgene International SÃ rl
Investors:
+41 32 729 8303 ir@celgene.com
Media:
+41 32 729 8304 media@celgene.com
Permalink: http://www.me-newswire.net/news/8977/en
Moor Park Capital sells entire Banco Sabadell bank branch Portfolio to Mexican Investor Group backed by Moises El-Mann
ME Newswire / Businesswire
LONDON - Monday, October 28th 2013
Moor Park Capital LLP ("Moor Park Capital"), the London based specialists in European corporate finance led net lease real estate transactions for institutional and retail investors today announced that a group of Mexican investors led by Moisés El-Mann (the "Investors"), through the Mexican investment vehicle Branch Management, S.A.P.I. de C.V. ("Branch Management"), have acquired 100% of the share capital of the Spanish company ISC Fresh Water Investment, S.L.U. ("ISC Fresh Water"), owner of 253 bank branches in Spain, for a consideration of approx. EUR 290 million.
These bank branches, located throughout Spain with particular presence in Madrid and Barcelona, are let to Banco de Sabadell S.A. ("Banco Sabadell"), and represent one of the largest investments in the Spanish real estate market ever conducted by Mexican investors.
The bank branches have the benefit of a long term lease agreement with Banco Sabadell for an initial term of 25 years, put in place at the time the initial acquisition was closed by Moor Park Capital in April 2010, when 378 bank branches were acquired from Banco Sabadell. Since that time 125 bank branches have been successfully sold by Moor Park Capital to individual investors and the sale of the shares in ISC Freshwater completes the disposal process. Moor Park Capital have been retained by Branch Management as exclusive asset managers for the acquired bank branch portfolio. Clifford Chance (real estate and corporate/M&A), Garrigues (tax) and CBRE Spain advised Moor Park Capital on the sale and Banco Santander acted as financial advisors to the Investors and UrÃa Menéndez advised the Investors in relation to taxation and legal issues.
This transaction represents the first investment of a major acquisition plan for real estate investments to be undertaken by the Investors in Europe.
The Investors plan to continue their real estate investments in Spain and Europe to convert Branch Management into a SOCIMI, the Spanish legal entity equivalent to a REIT (Real Estate Investment Trust) in the near future.
About Moor Park Capital Partners:
Moor Park Capital Partners, led by its founding partners, Gary Wilder, Shemeel Khan and Jagdeep Kapoor specialises in strategically driven, corporate finance led, real estate monetization transactions including sale and leaseback transactions for corporates, governments, financial institutions and municipalities with single tenants and multiple high quality assets in Europe. Moor Park Capital acts on a discretionary and non-discretionary basis on behalf of a pool of investors - both retail and institutional, including Sovereign Wealth Funds - seeking asset-backed, secured fixed income style, inflation protected returns. It originates, structures and manages bespoke investments for its investors. The Moor Park Capital team has extensive European real estate experience and has undertaken or advised on c£20bn of transactions.
www.moorparkcapital.com
Contacts
Moor Park Capital LLP
Shemeel Khan/Javier Paz Valbuena, +442030111572
shemeel.khan@moorparkcapital.com
javier.paz@moorparkcapital.com
Permalink: http://www.me-newswire.net/news/8993/en
LONDON - Monday, October 28th 2013
Moor Park Capital LLP ("Moor Park Capital"), the London based specialists in European corporate finance led net lease real estate transactions for institutional and retail investors today announced that a group of Mexican investors led by Moisés El-Mann (the "Investors"), through the Mexican investment vehicle Branch Management, S.A.P.I. de C.V. ("Branch Management"), have acquired 100% of the share capital of the Spanish company ISC Fresh Water Investment, S.L.U. ("ISC Fresh Water"), owner of 253 bank branches in Spain, for a consideration of approx. EUR 290 million.
These bank branches, located throughout Spain with particular presence in Madrid and Barcelona, are let to Banco de Sabadell S.A. ("Banco Sabadell"), and represent one of the largest investments in the Spanish real estate market ever conducted by Mexican investors.
The bank branches have the benefit of a long term lease agreement with Banco Sabadell for an initial term of 25 years, put in place at the time the initial acquisition was closed by Moor Park Capital in April 2010, when 378 bank branches were acquired from Banco Sabadell. Since that time 125 bank branches have been successfully sold by Moor Park Capital to individual investors and the sale of the shares in ISC Freshwater completes the disposal process. Moor Park Capital have been retained by Branch Management as exclusive asset managers for the acquired bank branch portfolio. Clifford Chance (real estate and corporate/M&A), Garrigues (tax) and CBRE Spain advised Moor Park Capital on the sale and Banco Santander acted as financial advisors to the Investors and UrÃa Menéndez advised the Investors in relation to taxation and legal issues.
This transaction represents the first investment of a major acquisition plan for real estate investments to be undertaken by the Investors in Europe.
The Investors plan to continue their real estate investments in Spain and Europe to convert Branch Management into a SOCIMI, the Spanish legal entity equivalent to a REIT (Real Estate Investment Trust) in the near future.
About Moor Park Capital Partners:
Moor Park Capital Partners, led by its founding partners, Gary Wilder, Shemeel Khan and Jagdeep Kapoor specialises in strategically driven, corporate finance led, real estate monetization transactions including sale and leaseback transactions for corporates, governments, financial institutions and municipalities with single tenants and multiple high quality assets in Europe. Moor Park Capital acts on a discretionary and non-discretionary basis on behalf of a pool of investors - both retail and institutional, including Sovereign Wealth Funds - seeking asset-backed, secured fixed income style, inflation protected returns. It originates, structures and manages bespoke investments for its investors. The Moor Park Capital team has extensive European real estate experience and has undertaken or advised on c£20bn of transactions.
www.moorparkcapital.com
Contacts
Moor Park Capital LLP
Shemeel Khan/Javier Paz Valbuena, +442030111572
shemeel.khan@moorparkcapital.com
javier.paz@moorparkcapital.com
Permalink: http://www.me-newswire.net/news/8993/en
Oral Apremilast Demonstrated Clinically Meaningful and Statistically Significant Improvements in Enthesitis and Dactylitis
ME NewsWire / Business Wire
BOUDRY, Switzerland - Monday, October 28th 2013
At week 52, median percent improvement in swollen joint counts reached up to an 87.5% reduction and median percent improvement in tender joint count reached up to a 70.0% reduction
Significant and clinically meaningful improvements were shown in physical function at weeks 16 and 24 and were sustained over 52 weeks
Celgene International SÃ rl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced research findings on apremilast, the Company’s first-in-class, oral, targeted inhibitor of phosphodiesterase 4 (PDE4), based on pooled data analyses from three randomized, controlled, phase III trials in psoriatic arthritis—PALACE 1, 2 and 3—at the 2013 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) annual meeting in San Diego.
Pre-specified analyses from PALACE 1, 2 and 3 pooled data demonstrated that treatment with apremilast in patients with pre-existing enthesitis or dactylitis, two key manifestations of psoriatic disease, resulted in statistically significant and clinically meaningful improvements in enthesitis and dactylitis scores. At week 24, mean change from baseline in the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) reached statistical significance for apremilast 30 mg twice daily (BID; -1.4 vs. -0.8 for placebo; p=0.0159), but not for apremilast 20 mg BID (-1.2; P=NS). At week 24, mean changes from baseline in dactylitis count (a count of fingers and toes with dactylitis) were -1.5 (P=NS) for apremilast 20 mg BID and -1.8 (P=0.0121) for apremilast 30 mg BID, versus -1.2 for placebo.
For those patients randomized to apremilast and completing 52 weeks of the study, the median percent change from baseline in MASES and dactylitis count were -66.7% and -100% for both apremilast treatment arms, respectively.
“Psoriatic arthritis is a serious, painful arthritic condition with signs and symptoms that can make day-to-day activities difficult and impede quality of life for many patients,” said Dafna Gladman, M.D., FRCPC, Professor of Medicine, University of Toronto. “Data from these pooled phase III trials showed that apremilast treatment significantly controlled multiple manifestations of psoriatic arthritis and suggest apremilast may provide patients who are living with painful, persistent signs and symptoms of the disease with a new long-term treatment option.”
Patients treated with apremilast achieved significant reduction in number of swollen and tender joints after 16 weeks, which was maintained over 52 weeks.
A characteristic of psoriatic arthritis is tenderness and swelling in and around the joints and places where tendons and ligaments connect to bone, which can be potentially disabling if untreated. Results from all three of the PALACE studies (PALACE 1, 2 and 3) demonstrated that the number of swollen joints and the number of tender joints were both significantly reduced in patients with psoriatic arthritis who were treated with apremilast for 16 weeks compared with placebo.
These improvements were sustained over 52 weeks of treatment. Across all three studies, for those patients randomized to apremilast and completing 52 weeks of the study, the median percent reduction in swollen joint counts reached up to 87.5% and the median percent reduction in tender joint count reached up to 70.0%.
Statistically significant and clinically meaningful improvements in physical function were demonstrated after 16 and 24 weeks of treatment with apremilast 30 mg BID and were sustained over 52 weeks.
The results of physical function analyses from the PALACE 1, 2 and 3 studies demonstrated that 16 or 24 weeks’ treatment with apremilast 30 mg BID resulted in statistically significant and clinically meaningful improvements in physical function compared with placebo, as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI; P≤0.03) and the short form health survey version 2 (SF-36 v2) Physical Functioning domain (PF; P≤0.05), in each of the three PALACE studies. Improvements were maintained or increased for those patients randomized to apremilast and completing 52 weeks of the study.
Apremilast demonstrated an acceptable safety profile, with no new safety findings, and was generally well-tolerated for up to 52 weeks. Most adverse events (AEs) were mild or moderate in severity and did not lead to discontinuation. The most common reported AEs were nausea, diarrhea, headache, upper respiratory tract infection and nasopharyngitis.
These results are from investigational studies. Apremilast is not an approved product for any indication.
The New Drug Application (NDA) and the New Drug Submission (NDS), based on the combined data from PALACE 1, 2 and 3 for psoriatic arthritis, were submitted to health authorities in the U.S. and Canada in Q1 2013 and Q2 2013, respectively. An NDA to the U.S. Food and Drug Administration for psoriasis, in addition to a combined psoriatic arthritis/psoriasis Marketing Authorization Application (MAA) in Europe, are on-track for the fourth quarter of 2013.
About PALACE Program
PALACE 1, 2, 3 and 4 are the pivotal phase III multi-center, double-blind, placebo-controlled, parallel-group studies with two active-treatment groups. In PALACE 1, 2 and 3, approximately 1,500 subjects were randomized 1:1:1 to receive either apremilast 20 mg BID, 30 mg BID or identically appearing placebo for 24 weeks, with a subsequent active treatment phase up to 52 weeks followed by a long-term safety phase in which all patients are treated with apremilast. The PALACE 1, 2 and 3 studies included a wide spectrum of patients with active psoriatic arthritis, including those who had been previously treated with oral DMARDs, and/or biologic DMARDs, including patients who had previously failed a tumor necrosis factor (TNF) blocker. PALACE 3 includes a large subset of patients with significant skin involvement with psoriasis.
In PALACE 4, more than 500 DMARD-naïve patients were randomized 1:1:1 to receive either apremilast 20 mg BID, 30 mg BID, or identically appearing placebo, for 24 weeks, with a subsequent active treatment phase up to 52 weeks, followed by a long-term safety phase in which all patients are treated with apremilast.
The primary endpoint of the PALACE 1, 2 3 and 4 studies is the modified American College of Rheumatology criteria for 20 percent improvement (ACR20) at week 16. Secondary endpoints include other measures of signs and symptoms, physical function and patient-reported outcomes at weeks 16 and 24.
Taken together, the PALACE program includes the most comprehensive psoriatic arthritis program to date intended for regulatory submission.
About Apremilast
Apremilast, an oral, targeted inhibitor of phosphodiesterase 4 (PDE4), intracellularly modulates the expression of a network of pro-inflammatory and anti-inflammatory cytokines. PDE4 is a cyclic adenosine monophosphate (cAMP)-specific PDE and the dominant PDE in inflammatory cells. PDE4 inhibition elevates intracellular cAMP levels, which in turn down-regulates the inflammatory response by modulating the expression of TNF-α, IL-23, and other inflammatory cytokines. Elevation of cAMP also increases anti-inflammatory cytokines such as IL-10.
About Psoriatic Arthritis
Psoriatic arthritis is a painful, chronic inflammatory disease associated with the skin condition psoriasis. An estimated 125 million people worldwide have psoriasis, approximately 30 percent of whom may also develop psoriatic arthritis. Psoriatic arthritis is a chronic disorder with progressive and additive joint inflammation that can lead to deleterious effects on quality of life and increases work disability. In addition to psoriatic skin lesions, common signs and symptoms of psoriatic arthritis include pain, stiffness and swelling in several to many joints, as well as inflammation of the spine. Patients often experience psoriasis on average for 10 years before the onset of joint symptoms, and many psoriatic arthritis patients go undiagnosed. To learn more about psoriatic arthritis, go to www.discoverpsa.com. To learn more about the role of PDE4 in inflammatory diseases, go to www.discoverpde4.com.
About Celgene
Celgene International SÃ rl, located in Boudry, Switzerland, is a wholly-owned subsidiary and international headquarters of Celgene Corporation. Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit www.celgene.com.
Forward-Looking Statements
This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in Celgene Corporation’s Annual Report on Form 10-K and other reports filed with the Securities and Exchange Commission.
Contacts
Investors:
+41 32 729 8303 ir@celgene.com
Media:
+41 32 729 8304 media@celgene.com
Permalink: http://www.me-newswire.net/news/8978/en
BOUDRY, Switzerland - Monday, October 28th 2013
At week 52, median percent improvement in swollen joint counts reached up to an 87.5% reduction and median percent improvement in tender joint count reached up to a 70.0% reduction
Significant and clinically meaningful improvements were shown in physical function at weeks 16 and 24 and were sustained over 52 weeks
Celgene International SÃ rl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced research findings on apremilast, the Company’s first-in-class, oral, targeted inhibitor of phosphodiesterase 4 (PDE4), based on pooled data analyses from three randomized, controlled, phase III trials in psoriatic arthritis—PALACE 1, 2 and 3—at the 2013 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) annual meeting in San Diego.
Pre-specified analyses from PALACE 1, 2 and 3 pooled data demonstrated that treatment with apremilast in patients with pre-existing enthesitis or dactylitis, two key manifestations of psoriatic disease, resulted in statistically significant and clinically meaningful improvements in enthesitis and dactylitis scores. At week 24, mean change from baseline in the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) reached statistical significance for apremilast 30 mg twice daily (BID; -1.4 vs. -0.8 for placebo; p=0.0159), but not for apremilast 20 mg BID (-1.2; P=NS). At week 24, mean changes from baseline in dactylitis count (a count of fingers and toes with dactylitis) were -1.5 (P=NS) for apremilast 20 mg BID and -1.8 (P=0.0121) for apremilast 30 mg BID, versus -1.2 for placebo.
For those patients randomized to apremilast and completing 52 weeks of the study, the median percent change from baseline in MASES and dactylitis count were -66.7% and -100% for both apremilast treatment arms, respectively.
“Psoriatic arthritis is a serious, painful arthritic condition with signs and symptoms that can make day-to-day activities difficult and impede quality of life for many patients,” said Dafna Gladman, M.D., FRCPC, Professor of Medicine, University of Toronto. “Data from these pooled phase III trials showed that apremilast treatment significantly controlled multiple manifestations of psoriatic arthritis and suggest apremilast may provide patients who are living with painful, persistent signs and symptoms of the disease with a new long-term treatment option.”
Patients treated with apremilast achieved significant reduction in number of swollen and tender joints after 16 weeks, which was maintained over 52 weeks.
A characteristic of psoriatic arthritis is tenderness and swelling in and around the joints and places where tendons and ligaments connect to bone, which can be potentially disabling if untreated. Results from all three of the PALACE studies (PALACE 1, 2 and 3) demonstrated that the number of swollen joints and the number of tender joints were both significantly reduced in patients with psoriatic arthritis who were treated with apremilast for 16 weeks compared with placebo.
These improvements were sustained over 52 weeks of treatment. Across all three studies, for those patients randomized to apremilast and completing 52 weeks of the study, the median percent reduction in swollen joint counts reached up to 87.5% and the median percent reduction in tender joint count reached up to 70.0%.
Statistically significant and clinically meaningful improvements in physical function were demonstrated after 16 and 24 weeks of treatment with apremilast 30 mg BID and were sustained over 52 weeks.
The results of physical function analyses from the PALACE 1, 2 and 3 studies demonstrated that 16 or 24 weeks’ treatment with apremilast 30 mg BID resulted in statistically significant and clinically meaningful improvements in physical function compared with placebo, as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI; P≤0.03) and the short form health survey version 2 (SF-36 v2) Physical Functioning domain (PF; P≤0.05), in each of the three PALACE studies. Improvements were maintained or increased for those patients randomized to apremilast and completing 52 weeks of the study.
Apremilast demonstrated an acceptable safety profile, with no new safety findings, and was generally well-tolerated for up to 52 weeks. Most adverse events (AEs) were mild or moderate in severity and did not lead to discontinuation. The most common reported AEs were nausea, diarrhea, headache, upper respiratory tract infection and nasopharyngitis.
These results are from investigational studies. Apremilast is not an approved product for any indication.
The New Drug Application (NDA) and the New Drug Submission (NDS), based on the combined data from PALACE 1, 2 and 3 for psoriatic arthritis, were submitted to health authorities in the U.S. and Canada in Q1 2013 and Q2 2013, respectively. An NDA to the U.S. Food and Drug Administration for psoriasis, in addition to a combined psoriatic arthritis/psoriasis Marketing Authorization Application (MAA) in Europe, are on-track for the fourth quarter of 2013.
About PALACE Program
PALACE 1, 2, 3 and 4 are the pivotal phase III multi-center, double-blind, placebo-controlled, parallel-group studies with two active-treatment groups. In PALACE 1, 2 and 3, approximately 1,500 subjects were randomized 1:1:1 to receive either apremilast 20 mg BID, 30 mg BID or identically appearing placebo for 24 weeks, with a subsequent active treatment phase up to 52 weeks followed by a long-term safety phase in which all patients are treated with apremilast. The PALACE 1, 2 and 3 studies included a wide spectrum of patients with active psoriatic arthritis, including those who had been previously treated with oral DMARDs, and/or biologic DMARDs, including patients who had previously failed a tumor necrosis factor (TNF) blocker. PALACE 3 includes a large subset of patients with significant skin involvement with psoriasis.
In PALACE 4, more than 500 DMARD-naïve patients were randomized 1:1:1 to receive either apremilast 20 mg BID, 30 mg BID, or identically appearing placebo, for 24 weeks, with a subsequent active treatment phase up to 52 weeks, followed by a long-term safety phase in which all patients are treated with apremilast.
The primary endpoint of the PALACE 1, 2 3 and 4 studies is the modified American College of Rheumatology criteria for 20 percent improvement (ACR20) at week 16. Secondary endpoints include other measures of signs and symptoms, physical function and patient-reported outcomes at weeks 16 and 24.
Taken together, the PALACE program includes the most comprehensive psoriatic arthritis program to date intended for regulatory submission.
About Apremilast
Apremilast, an oral, targeted inhibitor of phosphodiesterase 4 (PDE4), intracellularly modulates the expression of a network of pro-inflammatory and anti-inflammatory cytokines. PDE4 is a cyclic adenosine monophosphate (cAMP)-specific PDE and the dominant PDE in inflammatory cells. PDE4 inhibition elevates intracellular cAMP levels, which in turn down-regulates the inflammatory response by modulating the expression of TNF-α, IL-23, and other inflammatory cytokines. Elevation of cAMP also increases anti-inflammatory cytokines such as IL-10.
About Psoriatic Arthritis
Psoriatic arthritis is a painful, chronic inflammatory disease associated with the skin condition psoriasis. An estimated 125 million people worldwide have psoriasis, approximately 30 percent of whom may also develop psoriatic arthritis. Psoriatic arthritis is a chronic disorder with progressive and additive joint inflammation that can lead to deleterious effects on quality of life and increases work disability. In addition to psoriatic skin lesions, common signs and symptoms of psoriatic arthritis include pain, stiffness and swelling in several to many joints, as well as inflammation of the spine. Patients often experience psoriasis on average for 10 years before the onset of joint symptoms, and many psoriatic arthritis patients go undiagnosed. To learn more about psoriatic arthritis, go to www.discoverpsa.com. To learn more about the role of PDE4 in inflammatory diseases, go to www.discoverpde4.com.
About Celgene
Celgene International SÃ rl, located in Boudry, Switzerland, is a wholly-owned subsidiary and international headquarters of Celgene Corporation. Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit www.celgene.com.
Forward-Looking Statements
This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in Celgene Corporation’s Annual Report on Form 10-K and other reports filed with the Securities and Exchange Commission.
Contacts
Investors:
+41 32 729 8303 ir@celgene.com
Media:
+41 32 729 8304 media@celgene.com
Permalink: http://www.me-newswire.net/news/8978/en
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