リリースコンテナ第3倉庫

Glancy Binkow & Goldberg LLP, representing investors of Amarin Corporation plc (“Amarin” or the “Company”) (NASDAQ:AMRN), has filed a class action lawsuit in the United States District Court for the Southern District of New York on behalf of a class (the “Class”) comprising all persons who purchased the common stock, call options or sold put options of Amarin between July 9, 2009 and October 15, 2013 (the “Class Period”). Members of the foregoing Class have until January 3, 2014, to file a motion to be appointed as lead plaintiff in the shareholder lawsuit.

A COPY OF THE COMPLAINT IS AVAILABLE FROM THE COURT OR FROM GLANCY BINKOW & GOLDBERG LLP. PLEASE CONTACT US AT (212) 682-5340, TOLL-FREE AT (888) 773-9224, OR AT SHAREHOLDERS@GLANCYLAW.COM TO DISCUSS THIS MATTER OR IF YOU PURCHASED AMARIN SECURITIES PRIOR TO THE CLASS PERIOD. IF YOU INQUIRE BY EMAIL PLEASE INCLUDE YOUR MAILING ADDRESS, TELEPHONE NUMBER AND NUMBER OF SHARES PURCHASED.

Amarin is a biopharmaceutical company, focused on the development and commercialization of therapeutic products for the treatment for cardiovascular diseases. The Company’s lead product Vascepa is an adjunct to diet to reduce triglyceride levels in adult patients and also for the treatment of patients with high triglyceride levels who are also on statin therapy for elevated low-density lipoprotein cholesterol (the “Anchor” indication).

The Complaint alleges that defendants issued materially misleading statements concerning Amarin’s business, operations and financial prospects. Specifically, the Complaint alleges that:

• Defendants misrepresented the prospects for Food and Drug Administration approval of Vascepa for the ANCHOR indication.
• Defendants failed to disclose that the FDA had informed Amarin that there was a lack of prospective, controlled clinical trial data demonstrating that pharmaceutical reduction of triglycerides significantly reduces residual cardiovascular risk.

If you are a member of the Class described above, you may move the Court no later than January 3, 2014, to serve as lead plaintiff; however, you must meet certain legal requirements. To be a member of the Class you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the Class.

To learn more about this action, or if you purchased Amarin securities prior to the Class Period and have any questions concerning this Notice or your rights or interests with respect to these matters, please contact Michael Goldberg, Esquire, of Glancy Binkow & Goldberg LLP, 1925 Century Park East, Suite 2100, Los Angeles, California 90067, Toll-Free at (888) 773-9224, or contact Gregory Linkh, Esquire, of Glancy Binkow & Goldberg LLP at 122 E. 42nd Street, Suite 2920, New York, New York 10168, at (212) 682-5340, by e-mail to shareholders@glancylaw.com, or visit our website at http://www.glancylaw.com.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

Law Offices of Howard G. Smith announces that investors of DFC Global Corp. (“DFC Global” or the “Company”) (NASDAQ:DLLR) have until January 21, 2014, to move the Court to serve as lead plaintiff in the securities fraud class action lawsuit filed in the United States District Court for the Eastern District of Pennsylvania on behalf of a class (the “Class”) comprising all purchasers of DFC Global common stock between January 28, 2011 and August 22, 2013, inclusive (the “Class Period”).

DFC Global provides retail financial services, including unsecured short-term consumer loans, secured pawn lending, check cashing and gold buying. The Complaint alleges that the Company and certain of its executive officers failed to disclose that the Company:

• systematically issued high-fee predatory loans to consumers that had no reasonable means to be repaid;
• continuously rolled over or refinanced loans in order to delay or avoid defaults;
• failed to conduct adequate affordability assessments on its customers;
• understated its loan loss rates;
• inflated its earnings guidance for fiscal 2013; and,
• failed to comply with industry regulations and guidance.

If you are a member of the Class described above, you have certain rights and have until January 21, 2014, to move for lead plaintiff status. To be a member of the Class you need not take any action at this time or may retain counsel of your choice. If you purchased shares prior to the Class Period and wish to learn more concerning your rights or interests with respect to these matters, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020 by telephone at 215-638-4847, Toll-Free at 888-638-4847, or by email to howardsmith@howardsmithlaw.com, or visit our website at http://www.howardsmithlaw.com.

Law Offices of Howard G. Smith announces that investors of Vical Incorporated (“Vical” or the “Company”) (NASDAQ:VICL) have until December 31, 2013, to move the Court to serve as lead plaintiff in the securities fraud class action lawsuit filed in the United States District Court for the Southern District of California on behalf of a class (the “Class”) comprising all purchasers of Vical securities between February 8, 2012 and August 12, 2013, inclusive (the “Class Period”).

“Allovectin simply did not provide the expected benefits”

Vical is a biopharmaceutical company that researches and develops products based on patented DNA delivery technologies for the prevention and treatment of serious and life-threatening illnesses, including cancer. Vical’s lead product candidate for U.S. Food and Drug Administration marketing approval is Allovectin, an immunotherapy vaccine that targets cancer. The Complaint alleges that the Company misrepresented Allovectin’s efficacy and likelihood of success in the Phase 3 trial, and the overall current and future business prospects for Allovectin and the Company. On August 12, 2013, Vical announced the results of the Phase 3 Allovectin trial, which showed that the vaccine failed to show an improvement over chemotherapy, and since “Allovectin simply did not provide the expected benefits,” the Allovectin program would be terminated.

If you are a member of the Class described above, you have certain rights and have until December 31, 2013, to move for lead plaintiff status. To be a member of the Class you need not take any action at this time or may retain counsel of your choice. If you purchased shares prior to the Class Period and wish to learn more concerning your rights or interests with respect to these matters, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020 by telephone at (215) 638-4847, Toll Free at (888) 638-4847, or by email to howardsmith@howardsmithlaw.com, or visit our website at http://www.howardsmithlaw.com.

Law Offices of Howard G. Smith announces that a class action lawsuit has been filed in the United States District Court for the Northern District of California on behalf of a class (the “Class”) comprising all purchasers of the securities of Tesla Motors, Inc. (“Tesla” or the “Company”) (NASDAQ:TSLA) between May 10, 2013 and November 6, 2013, inclusive (the “Class Period”).

Tesla designs, develops, manufactures and sells electric vehicles and electric vehicle powertrain components. The Complaint alleges that during the Class Period the defendants misrepresented or failed to disclose that:

• Statements about the Model S’s highest safety rating and lack of prior fire incidents were materially misleading, due to undisclosed puncture and fire risks in its undercarriage and lithium ion battery pack.
• The Model S suffered from material defects which caused the battery pack to erupt in flames under certain driving conditions.
• Tesla’s future sales, next generation Model X introduction, and stock price were vulnerable to the inherent risk posed by the Model S’s design flaws.
• The Company was unable to maintain sufficient automobile deliveries to satisfy analyst concerns and compensate for other declining revenue streams.

If you are a member of the Class described above, you may move the Court no later than January 7, 2014, to serve as lead plaintiff. To be a member of the Class, you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the Class. If you have any questions concerning this Notice or your rights or interests with respect to these matters, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020 by telephone at (215) 638-4847, Toll Free at (888) 638-4847, or by email to howardsmith@howardsmithlaw.com, or visit our website at http://www.howardsmithlaw.com.

Hier, IBM (NYSE : IBM) a appris l'existence d'une action en justice alléguant une théorie de complot insensée. Cette action en justice cherche à semer la confusion par rapport au soutien d'IBM pour une proposition législative relative à la cybersécurité aux États-Unis -- qui n'a pas encore été mise en application -- avec le programme de surveillance de la NSA totalement sans rapport appelé PRISM. Même une lecture superficielle de la proposition législative, appelée CISPA, suffit pour établir le fait qu'elle n'a rien à voir avec le programme de surveillance récemment publié de la NSA. La législation est conçue pour aider à protéger contre les cyberattaques en encourageant le partage d'informations techniques sur les cybermenaces, comme les codes de logiciels malveillants. La capacité pour les victimes d'attaques de travailler ensemble pour aider à empêcher le cybercrime est une exigence pour les entreprises modernes et un objectif important, ce qui explique pourquoi beaucoup de sociétés, notamment IBM, soutiennent cette législation. Ce projet de loi ne se rapporte pas à la Chine et il n'autorise pas des processus de surveillance gouvernementale, faits que le plaignant et ses avocats pourraient facilement avoir déterminés s'ils s'étaient donné la peine de procéder à une simple vérification des faits.

S'appuyant sur cette relation imaginaire entre CISPA et PRISM, la plainte fait de nombreuses accusations spécieuses et fausses et IBM exhorte le cabinet juridique qui a intenté cette action de se raviser et de retirer cette action immédiatement. Le contraire nuirait gravement au système judiciaire, au public et, dans ce cas précis, à IBM.

IBM se battra vigoureusement contre cette action en justice sans fondement.

Le texte du communiqué issu d’une traduction ne doit d’aucune manière être considéré comme officiel. La seule version du communiqué qui fasse foi est celle du communiqué dans sa langue d’origine. La traduction devra toujours être confrontée au texte source, qui fera jurisprudence.

Gestern wurde IBM (NYSE:IBM) von einer Klage in Kenntnis gesetzt, in der eine haarsträubende Konspirationstheorie vorgebracht wird. Mit dieser Klage soll Verwirrung gestiftet werden zwischen der seitens IBM gezeigten Unterstützung der US-amerikanischen Gesetzesvorlage zur Cybersicherheit -- die noch nicht in Kraft getreten ist -- und dem damit in keinerlei Zusammenhang stehenden NSA-Überwachungsprogramm PRISM. Selbst nach oberflächlichem Lesen der Gesetzesvorlage, die unter der Abkürzung CISPA bekannt ist, wird deutlich, dass diese nichts mit dem kürzlich bekannt gewordenen NSA-Überwachungsprogramm zu tun hat. Das Gesetz soll dazu beitragen, Unternehmen gegen Cyberattacken zu schützen, indem der Austausch von technischen Informationen über Cyberbedrohungen, wie etwa Malware-Code, gefördert wird. Es ist heutzutage eine moderne Geschäftsnotwendigkeit und ein wichtiges Ziel, dass die von den Attacken bedrohten Unternehmen zusammenarbeiten, um der Cyberkriminalität vorzubeugen, und aus diesem Grund befürworten viele Unternehmen, darunter auch IBM, derartige Gesetze. In der Gesetzesvorlage wird nicht auf China Bezug genommen, und Überwachung seitens der Regierung ist darin nicht gestattet. Der Kläger und seine Rechtsberater hätten diese Tatsachen selbst problemlos feststellen können, wenn sie es für nötig befunden hätten, die Tatsachen auch nur in geringstem Maße zu überprüfen.

Ausgehend von diesem fiktiven Zusammenhang zwischen CISPA und PRISM werden in der Klage dann zahlreiche fadenscheinige und falsche Anschuldigungen vorgebracht, und IBM fordert die Rechtsanwaltskanzlei, die die Klage eingereicht hat, auf, sich korrekt zu verhalten und die Klage unverzüglich ad acta zu legen. Andernfalls wird dem Justizsystem, der Öffentlichkeit und in diesem Falle auch IBM ein äußerst schlechter Dienst erwiesen.

IBM wird sich mit Nachdruck gegen diese völlig unbegründete Klage verteidigen.

Die Ausgangssprache, in der der Originaltext veröffentlicht wird, ist die offizielle und autorisierte Version. Übersetzungen werden zur besseren Verständigung mitgeliefert. Nur die Sprachversion, die im Original veröffentlicht wurde, ist rechtsgültig. Gleichen Sie deshalb Übersetzungen mit der originalen Sprachversion der Veröffentlichung ab.

Law Offices of Howard G. Smith announces that a class action lawsuit has been filed in the United States District Court for the Central District of California on behalf of a class (the “Class”) comprising all purchasers of the securities of Quality Systems, Inc. (“QSI” or the “Company”) (NASDAQ:QSII) between May 26, 2011 and July 25, 2012, inclusive (the “Class Period”). Please contact Law Offices of Howard G. Smith to discuss this matter or other potential claims if you purchased QSI stock prior to May 26, 2011.

Quality Systems, Inc. develops and markets healthcare information systems that automate medical and dental practices, and networks of practices in the United States. The Complaint alleges that throughout the Class Period the Company and certain of its executive officers issued a series of material misstatements or failed to disclose material facts concerning QSI's financial prospects, including its financial guidance for fiscal years 2012 and 2013.

If you are a member of the Class described above, you may move the Court no later than January 21, 2014, to serve as lead plaintiff. To be a member of the Class, you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the Class. If you purchased shares before May 26, 2011, and still hold those shares, or if you have any questions concerning this Notice or your rights or interests with respect to these matters, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020 by telephone at (215) 638-4847, Toll Free at (888) 638-4847, or by email to howardsmith@howardsmithlaw.com, or visit our website at http://www.howardsmithlaw.com.

Law Offices of Howard G. Smith announces that investors of Fusion-io, Inc. (“Fusion-io” or the “Company”) (NYSE:FIO) have until January 21, 2014, to move the Court to serve as lead plaintiff in the securities fraud class action lawsuit filed in the United States District Court for the Northern District of California on behalf of a class (the “Class”) comprising all purchasers of Fusion-io securities between August 10, 2012 and October 23, 2013, inclusive (the “Class Period”).

Fusion-io designs and manufactures memory storage solutions using flash memory technology, primarily for a limited number of strategic customers, including Facebook, Inc. and Apple, Inc. The Complaint alleges that during the Class Period the defendants misrepresented to investors that the Company was a market leader in large-scale flash memory applications and was not facing any competitive pressure or risk from the commoditization of flash memory products, and also misrepresented that the Company was able to anticipate the demand from its strategic customers based on its years of experience as their flash memory supplier.

On January 30, 2013, the Company announced that it no longer anticipated achieving its previously issued revenue guidance for fiscal year 2013, citing a temporary two-quarter shift in the timing of purchases from Facebook and Apple. Then, on October 23, 2013, the Company revoked its prior revenue guidance and announced that its expected gross margin in 2014 would fall significantly. The Company also announced that the Chief Financial Officer and Chief Sales Officer were leaving the Company.

To be a member of the class you need not take any action at this time or may retain counsel of your choice. If you purchased shares prior to the Class Period and wish to learn more concerning your rights or interests with respect to these matters, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020 by telephone at (215) 638-4847, Toll Free at (888) 638-4847, or by email to howardsmith@howardsmithlaw.com, or visit our website at http://www.howardsmithlaw.com.

Law Offices of Howard G. Smith announces that investors of Hertz Global Holdings, Inc. (“Hertz” or the “Company”) (NYSE:HTZ) have until January 19, 2014, to move the Court to serve as lead plaintiff in the securities fraud class action lawsuit filed in the United States District Court for the District of New Jersey on behalf of a class (the “Class”) comprising all purchasers of Hertz common stock between February 25, 2013 and November 4, 2013, inclusive (the “Class Period”).

Hertz engages in the car and equipment rental businesses worldwide. Its rental car segment primarily appeals to higher-margin corporate clientele. Following the December 2012 divestiture of the U.S. operations of Advantage Rent A Car (“Advantage”), Hertz has increasingly relied upon increased sales in the so-called “opaque” market, where online customers are able to bid for travel-related products or services without knowing the brand. The Complaint alleges that the Company and certain of its executive officers misrepresented or failed to disclose that:

• Hertz was losing sales in the important airport market, which offers higher rental prices and margins than off-airport, longer-term “replacement car” locations.
• Hertz had significant undisclosed exposure to Advantage subsidiary Simply Wheelz’s insolvency resulting from its having transferred much of its older, less-valuable fleet to Advantage in the divestiture and valuing the transferred fleet at improperly high prices.
• Hertz and Advantage were engaged in a disagreement over the value of the Advantage fleet assets.
• Hertz was carrying the value of its fleet transferred to Advantage and its subsidiary Simply Wheelz on its books at an artificially inflated level.

To be a member of the Class you need not take any action at this time or may retain counsel of your choice. If you purchased shares prior to the Class Period and wish to learn more concerning your rights or interests with respect to these matters, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020 by telephone at (215) 638-4847, Toll Free at (888) 638-4847, or by email to howardsmith@howardsmithlaw.com, or visit our website at http://www.howardsmithlaw.com.

Law Offices of Howard G. Smith announces that a class action lawsuit has been filed in the United States District Court for the Eastern District of Virginia on behalf of a class (the “Class”) comprising all purchasers of the securities of Lumber Liquidators Holdings, Inc. (“Lumber Liquidators” or the “Company”) (NYSE:LL) between February 22, 2012 and November 21, 2013, inclusive (the “Class Period”). Please contact of Law Offices of Howard G. Smith to discuss this matter or other potential claims if you are a long-term shareholder.

Lumber Liquidators operates as a specialty retailer of hardwood flooring and hardwood flooring enhancements and accessories. The Complaint alleges that throughout the Class Period the Company and certain of its executive misrepresented or failed to disclose that certain of the Company’s products failed to comply with applicable laws and regulations governing formaldehyde emissions from composite wood products, and that the Company imported flooring products sourced from illegally logged wood in the Russian Far East, in violation of the Lacey Act.

If you are a member of the Class described above, you may move the Court no later than January 27, 2014, to serve as lead plaintiff. To be a member of the Class, you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the Class. If you purchased shares prior to the Class Period, and still hold those shares, or if you have any questions concerning this Notice or your rights or interests with respect to these matters, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020 by telephone at (215) 638-4847, Toll Free at (888) 638-4847, or by email to howardsmith@howardsmithlaw.com, or visit our website at http://www.howardsmithlaw.com.

The company boilerplate has been removed. The corrected release reads:

MERCURY PAYMENT SYSTEMS ANNOUNCES SUBMISSION OF CONFIDENTIAL DRAFT REGISTRATION STATEMENT FOR INITIAL PUBLIC OFFERING

Mercury Payment Systems, LLC announced today the submission of a confidential draft registration statement to the U.S. Securities and Exchange Commission in connection with a possible initial public offering.

This announcement does not constitute an offer of any securities for sale.

Ontem, chegou ao conhecimento da IBM (NYSE:IBM) uma ação judicial que está promovendo uma fantástica teoria da conspiração. Tal ação judicial visa confundir o apoio da IBM a uma proposta legislativa de segurança cibernética nos Estados Unidos, que ainda precisa ser aprovada, com um programa de vigilância da NSA (Agência de Segurança Nacional, sem relação alguma com o caso, denominado PRISM. Até mesmo uma leitura superficial da proposta legislativa, conhecida como CISPA, torna claro que esta não tem relação com o programa de vigilância recém-divulgado da NSA. A legislação foi desenvolvida para ajudar a proteger empresas contra ataques cibernéticos por meio de incentivo ao compartilhamento de informações técnicas de ameaças cibernéticas, tais como códigos malware. A capacidade de aqueles, sob ataque, trabalharem juntos para ajudar a evitar crimes cibernéticos é um requisito moderno em negócios e uma importante meta, sendo o motivo pelo qual muitas empresas, inclusive a IBM, apoiam tais legislações. Esse projeto de lei não se refere à China e não autoriza a vigilânica por parte do governo. A acusação e seus advogados poderiam ter descoberto isso se tivessem se preoupado um pouco com a apuração dos fatos.

Iniciando-se com essa conexão fictícia entre a CISPA e o PRISM, o reclamante prosseguiu com numerosas falsas acusações, sendo que a IBM convocou um escritótio de advocacia, movendo essa ação para que a coisa certa fosse feita e essa ação fosse imediatamente arquivada. Deixar de fazê-lo seria um grande desserviço ao sistema judiciário, ao público e, nesse caso, à IBM.

A IBM envidará todos os esforços para combater essa ação judicial infundada.

O texto no idioma original deste anúncio é a versão oficial autorizada. As traduções são fornecidas apenas como uma facilidade e devem se referir ao texto no idioma original, que é a única versão do texto que tem efeito legal.

Pacific Tomato Growers:

WHAT: Health Fair and holiday fun for the whole family hosted by Pacific Tomato Growers. The health fair will provide eye exams, flu shots, blood pressure testing, nutritional information and community resources to employees and their families.

WHO: Pacific Tomato Grower employees, their families, community figures and all media representatives are welcome to attend. Note: This event is not open to the public.

WHEN: Saturday, December 14, 2013, 10 a.m. to 3 p.m.

WHERE: Immokalee Farm - 9500 County Road 858 Immokalee, FL 34142

MORE: As a major employer in the Immokalee area, Pacific Tomato Growers is hosting a health fair in conjunction with their holiday party in order to show their appreciation for their employees’ hard work and dedication. The company will provide community resources and free health services during the event, including free eye exams from Eye Centers of Florida, free flu shots provided by Walgreens, glucose and blood pressure testing from Healthcare Network of Southwest Florida, and helpful nutrition information and much more.

MEDIA OP: Operating Partner of Pacific Tomato Growers, Jon Esformes, will be available for interviews at the event to discuss the company’s involvement with the Immokalee community and commitment to their employee’s health and well-being. There will also be opportunities to take photos throughout the event.

For more information contact Mackenzie Michel at mmichel@dma-solutions.com or 214-444-7456.

About Pacific Tomato Growers

Based in Palmetto, Florida, fourth generation family owned Pacific Tomato Growers provides customers with a high-quality and year-round supply of farm fresh tomatoes for retailers, foodservice distributors and operators and wholesale customers. Marketed under the Sunripe and Suncoast labels, Pacific Tomato Growers has been growing and delivering tomatoes and vegetables that exceed the standard in quality for nearly 100 years. With growing operations and strategic partnerships on both the East and West coasts of the United States and Mexico, Pacific Tomato Growers plants and harvests to provide its wide range of customers not only a high quality product, but one that is trusted 365 days of the year.

Law office of Brodsky & Smith, LLC announces that it is investigating potential claims against the Board of Directors of Given Imaging Ltd. (“Given Imaging” or the “Company”) (Nasdaq: GIVN) relating to the proposed acquisition by Covidien PLC. (“Covidien”).

Click here to learn more about the investigation http://brodsky-smith.com/681-givn-given-imaging-ltd.html, or call 877-534-2590. There is no cost or obligation to you.

Under the terms of the transaction, Given Imaging shareholders will receive only $30.00 in cash for each share of Given Imaging stock they own. The investigation concerns possible breaches of fiduciary duty and other violations of state law by the Board of Directors of Given Imaging for not acting in the Company’s shareholders' best interests in connection with the sale process. The investigation seeks to determine if the Given Imaging Board of Directors failed to conduct an adequate auction process and as a result harmed the Given Imaging shareholders by undervaluing their Company.

If you own shares of Given Imaging common stock and wish to discuss the legal ramifications of the proposed transaction, or have any questions, you may e-mail or call the law office of Brodsky & Smith, LLC who will, without obligation or cost to you, attempt to answer your questions. You may contact Jason L. Brodsky, Esquire or Evan J. Smith, Esquire at Brodsky & Smith, LLC, Two Bala Plaza, Suite 602, Bala Cynwyd, PA 19004, by e-mail at investorrelations@brodsky-smith.com, by visiting http://brodsky-smith.com/681-givn-given-imaging-ltd.html, or calling toll free 877-LEGAL-90.

Brodsky & Smith, LLC is a litigation law firm with extensive expertise representing shareholders throughout the nation in securities and case action lawsuits. The attorneys at Brodsky & Smith have been appointed by numerous courts throughout the country to serve as lead counsel in class actions and successfully recovered millions of dollars for our clients and shareholders. Attorney advertising. Prior results do not guarantee a similar outcome.

The Federal Insurance Office (FIO) has released its highly-anticipated report on how to modernize and improve insurance regulation in the United States. Mandated under the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank), the FIO’s modernization report provides practical guidance for Congress regarding federal involvement in the regulation of the insurance industry.

Mike Nelson, chairman of law firm Nelson Levine, represents insurers and reinsurers in regulatory matters as well as in complex litigation in multiple jurisdictions throughout the country. His firm publishes FIO Focus, a newsletter covering the latest developments on what many refer to as “insurance modernization” and the FIO’s activities. Below Mike answers the most pressing questions about the FIO and its long-awaited report.

The Federal Insurance Office has released its highly-anticipated report on how to modernize and improve insurance regulation in the United States. Can you explain what the Federal Insurance Office is and the purpose it serves? What did you think of the report?

The FIO was created under the Dodd-Frank Act to provide the federal government with a center for insurance expertise. It has several responsibilities which include monitoring the insurance industry and the extent to which underserved communities have access to affordable insurance, coordinating federal involvement and policymaking on prudential aspects of international insurance matters, and of course, preparing reports for Congress.

The insurance industry has been eagerly awaiting the release of this report, and its contents are going to lead to a lot of discussion. In 65 pages the FIO managed to touch on many aspects of insurance regulation. The topics in the report are vast, ranging from international regulatory activity and details of insurance rating regulation to state solvency laws. Although federal involvement in health insurance is a hot topic of late, the FIO’s authority does not extend to health insurance and it is not at issue in the report.

The focus of the report is not whether there should be federal or state regulation of insurance, but whether federal involvement in the current state based system is warranted. The FIO concludes that the state based system of insurance regulation can be modernized and improved in the near term through a combination of steps by both the states and the federal government.

The report contains a balanced discussion of the strengths and weaknesses of the current state based system and encourages implementation of many current regulatory initiatives. The industry and many regulators have previously advocated for many of the initiatives, such as a better system of agent licensing, market conduct reform and speed to market reform initiatives. But one of the main concerns for the FIO is the lack of uniformity in our current system. The report suggests that the nature and structure of the state based system presents inherent difficulties in achieving uniformity. The FIO goes beyond mere uniformity and points to areas where the laws are uniform, but the application of those laws by regulators is not.

The FIO outlines an active role for itself, indicating that it will monitor whether and how states implement FIO’s recommendations. The report does not recommend federal regulation of insurance, but it does suggest that Congress should strongly consider direct federal involvement if states do not implement the FIO’s recommendations.

It will take time for the insurance industry and regulators to digest all of the implications of this report. The FIO is clear that states should address its recommendations in the short term, but no exact timeframe is suggested.

There has been a lot of speculation regarding what the report would contain. Were you surprised by any of the topics discussed in the report?

I was surprised by the breadth of the report as it touches on all aspects of insurance regulation and, in some cases, at a granular level. I was also struck by the amount of monitoring of states’ activities that the FIO intends to do. One recommendation that seemed to insert the FIO directly into the regulatory process, despite not having any regulatory authority, was the FIO’s recommendation that it participate in supervisory colleges for large national insurers and internationally active insurers. The FIO apparently wants information from those supervisory colleges to assist it in its role as monitor of financial stability for the insurance industry.

State regulators will have to decide how cooperative they will be with respect to the monitoring and the colleges. I think that the failure to cooperate would not be a positive thing for state regulation. Some regulators may welcome the oversight as a mechanism for promoting uniformity.

Perhaps most surprising was the FIO’s statement that if states do not reform their laws and processes to meet the recommendations of the report, they could face federal action. The FIO did not shy away from controversial topics. The report includes discussions of the implementation of principles-based reserving (PBR) and the use of reinsurance captives, both of which have been the subject of considerable debate among state regulators.

Some of the FIO’s suggestions may raise concerns among state regulators and others about the FIO’s longer term intentions. For instance, regulatory supervision and rate and form regulation are both at the heart of state regulation. While the FIO says it is simply going to monitor some issues related to those topics, many may worry that this could be the first step towards broader federal involvement.

Now that the report has been released, what do you anticipate will happen next? Will the report lead to any immediate changes in the regulation of the insurance industry?

The modernization report may foreshadow a potentially active FIO, but it is not going to lead to any immediate changes in the way insurance is regulated. The FIO does not have regulatory authority, and the recommendations in its report could be viewed as advisory in nature. Most suggestions for federal standards and involvement would require Congressional action. However, the report will undoubtedly influence the discussions and actions of state insurance commissioners. We can also expect to see the FIO asking more questions of state regulators on substantive issues as it monitors the progress of regulatory reforms and modernization initiatives.

Perhaps the suggestion that will have the most immediate effect is the recommendation that the Treasury and the United States Trade Representative pursue a covered agreement for collateral requirements for foreign reinsurers. Negotiating and implementing such an agreement, however, will be complicated and time consuming.

It is important to keep in mind that this report is just one of many the FIO will prepare. FIO Director Michael McRaith previously indicated that after the release of the modernization report, other overdue reports will not be far behind. The modernization report includes a reference to a forthcoming report on natural catastrophes. The FIO is also currently preparing a report on the Terrorism Risk Insurance Program. The reinsurance industry is awaiting the release of the global reinsurance report.

This weekend, state insurance commissioners are meeting in Washington, DC for the Fall National Meeting of the National Association of Insurance Commissioners. The FIO’s modernization report is going to be a central topic of conversation. It will be interesting to see how state regulators, legislators, the industry and Congress will respond to the FIO’s recommendations.

Independent toy manufacturer, Imaginary Kidz is launching a charitable bus tour to give out hundreds of Reindeer on the Roof toys valued at thousands of dollars to help give inner city kids a happy holiday.

“The holidays are time for joy, and I couldn’t think of a unique holiday toy better to give out then Reindeer on the Roof”

The first phase of the Reindeer on the Roof tour will be in the second biggest city in New England, Providence, Rhode Island, where hundreds of inner city kids will receive Imaginary Kidz toys. For the first time, since their start, Imaginary Kidz products are now being sold in select Walmarts across the country, and have even been featured on the A&E hit show Duck Dynasty.

The Reindeer on the Roof toys will arrive in Santa’s Christmas decorated bus with Santa and dignitaries from the various cities where the toys will be handed out. The launch will take place on December 18^th, with Providence, Mayor Angel Tavares. The bus has state of the art lighting; with life size Reindeer on the Roof toys that accompany Santa on his toy give away.

“The holidays are time for joy, and I couldn’t think of a unique holiday toy better to give out then Reindeer on the Roof,” said Mike Bovill, Imaginary Kidz, President and CEO “The toys offer a great interactive experience, and a merry memory that will become a tradition for years to come.”

The Reindeer on the Roof comes with a book and an interactive code that allows children to name, customize and interact with their reindeer. Children are encouraged to give their Christmas letter to their reindeer and the reindeer will report back to Santa Claus. The interaction doesn’t stop there, children have the opportunity to constantly have interactions with their reindeer and get feedback from Santa Claus.

About Imaginary Kidz: Imaginary Kidz is a toy manufacturer located in Rhode Island. It offers a wide array of toys that are sold online and in select WalMart Stores and various retail stores around the country.

Le Financial Times et Citi sont heureux d'annoncer que Sanergy a été nommée lauréate mondiale des prix FT/Citi Ingenuity Awards 2013: Idées urbaines dans le programme d'action. L'organisation à but non lucratif basée à Nairobi a été choisie par un panel de juges éminents, dont le gagnant de l'année dernière, pour l'élaboration d'un système d'assainissement durable et hygiénique qui recycle les déchets humains afin de produire de l'électricité et des engrais pour les agriculteurs locaux.

«Face à l'urbanisation mondiale rapide, leur ingéniosité et leur leadership sont essentiels. Ils sont de vrais producteurs de progrès avec qui nous partageons un engagement afin d’aider les villes à se développer et à s’agrandir»

Les lauréats régionaux ont également été reconnus pour leur travail dans le financement du progrès urbain:

• L’Afrique et le Moyen-Orient: Sanergy, Nairobi
• L’Asie-Pacifique: Parinaam Foundation, Bangalore
• L’Europe: 3Space, Londres
• L’Amérique latine: Fundación Calicanto, Panama City
• L’Amérique du Nord et les Caraïbes: SeeClickFix, New Haven, Connecticut

Le programme mondial des prix, parrainé par Citi et en collaboration avec l'INSEAD, a été créé pour reconnaître les solutions les plus innovantes développées face aux défis urbains. Les prix ont été remis hier soir à New York par le rédacteur en chef de Financial Times aux États-Unis Martin Dickson et Ed Skyler, vice-président exécutif des Affaires publiques mondiales, à Citi.

«Nous sommes ravis de reconnaître des organisations du monde entier, petites et grandes à la fois, pour leur incroyable travail concernant certains des plus grands défis environnementaux, sociaux et économiques dans la société», a déclaré Martin Dickson. «Dans sa deuxième année consécutive, ce prix important continue de mettre la lumière sur les questions auxquelles font face les villes dans leurs efforts de prospérer et accueillir un nombre croissant de personnes».

«Nous tenons à féliciter tous les gagnants et les finalistes pour le développement de solutions face aux défis urbains qui sont novateurs et reproductibles», a affirmé Ed Skyler. «Face à l'urbanisation mondiale rapide, leur ingéniosité et leur leadership sont essentiels. Ils sont de vrais producteurs de progrès avec qui nous partageons un engagement afin d’aider les villes à se développer et à s’agrandir».

Les demandes ont été reçues de 44 pays et les juges ont sélectionné les lauréats en fonction des solutions les plus innovantes permettant un progrès urbain dans l'administration de la ville, les systèmes de transport, de l'énergie et des services publics ainsi que la gestion de l'éducation et des ressources, le logement, la santé, les services sociaux, les technologies mobiles, l'engagement communautaire et les plates-formes de collaboration.

Le jury est composé des personnes suivantes :

• Abhijit Banerjee, professeur et économiste
• John Bowis, OBE, président d'honneur, Health First Europe
• Sir Terry Farrell, CBE, champion et directeur international de l'architecture et du design, Terry Farrell and Partners
• Edwin Heathcote, critique d'architecture et de design, Financial Times (coprésident)
• Bruno Lanvin, directeur exécutif, European Competitiveness Initiative (initiative pour la compétitivité de l'Europe, INSEAD (coprésident)
• Janice Muthui, directrice de la Fondation, Community Cooker Foundation, lauréate mondiale des prix FT/Citi Ingenuity Awards 2012
• Carlo Ratti, professeur, architecte et ingénieur italien
• Anne-Marie Slaughter, professeure, présidente, New America Foundation
• Luanne Zurlo, fondatrice et présidente, Worldfund

Pour plus de détails sur les prix FT/Citi Ingenuity Awards, veuillez visiter www.ft.com/ingenuity ou suivre la conversation à l'aide du mot-clé #FTCitiAwards.

LES GAGNANTS DES PRIX FT/CITI INGENUITY AWARDS 2013

AFRIQUE et MOYEN-ORIENT

Sanergy

Sanergy fournit un service d'assainissement durable et hygiénique dans les bidonvilles de Nairobi au moyen d'un réseau de toilettes novateur, franchise qui génère des revenus supplémentaires grâce au recyclage des ordures ménagères et des déjections humaines pour créer de l'électricité et de l'engrais biologique aux exploitants agricoles.

Cette initiative passe par l'établissement de petits réseaux de toilettes sèches, ou chimiques de qualité supérieure, fabriquées à l'aide de matériaux locaux, qui sont exploités dans les bidonvilles et payables à l'utilisation par les micro-entrepreneurs résidents.

On dépose les ordures ramassées selon des procédures sécuritaires dans des conteneurs hermétiques de 30 litres transportés tous les jours dans un centre de traitement principal. Sanergy transforme ces ordures en sous-produits sûrs réutilisables, dont l'engrais biologique vendu aux exploitations agricoles, et l'électricité, vendue au réseau électrique. Ce programme permet de créer des emplois et des débouchés, et de régler du même souffle de graves enjeux environnementaux, sociaux et économiques.

ASIE-PACIFIQUE

Parinaam Foundation

L'Urban Ultra Poor Programme, lancé par la Parinaam Foundation, consiste à soutenir les femmes en situation d'extrême pauvreté sur les plans économique et social qui habitent les quartiers pauvres de Bangalore.

Ce programme couvre quatre éléments essentiels fournis pendant 12 mois pour aider les participantes à établir un mode de vie plus stable : développement d'un gagne-pain, aide en matière de soins de santé, soins pour enfants et éducation, et connaissances financières et soutien aux services sociaux.

On vise à ce que, à la fin du programme, les participantes soient en mesure de gagner un revenu stable, jouissent d'un moyen de s'affirmer dans la société, procurent à leurs enfants une éducation, un accès aux soins de santé et gèrent leurs finances.

EUROPE

3Space

3Space est une organisation caritative établie à Londres qui collabore avec les propriétaires et les locataires dans le but d’exploiter la valeur des propriétés commerciales libres pour les rendre disponibles gratuitement pendant une durée limitée à d'autres organisations à but non lucratif pour mener des projets profitables pour la collectivité.

3Space a géré l'utilisation à court terme de la propriété dans 45 immeubles dans le Royaume-Uni depuis 2010, laissant de l'espace aux 140 organisations caritatives, aux groupes locaux et aux entreprises d'économie sociale. Les propriétaires profitent de tarifs réduits d'assurance, d'entretien et d'exploitation ainsi que de frais de sécurité, et peuvent donc reprendre leurs propriétés sans long délai.

3Space offre un moyen évolutif de gestion de l'espace commercial libre, de réduction des déchets tout en offrant des avantages socioéconomiques tangibles et en stimulant le renouveau urbain.

AMÉRIQUE LATINE

Fundación Calicanto

Fundación Calicanto, un organisme à but non lucratif dédié à la restauration du patrimoine historique et humain du quartier Casco Antiguo (ou vieille ville) de Panamá, a créé CAPTA, un programme pour fournir aux nombreuses femmes sans emploi et défavorisées de ce quartier une formation professionnelle pour des emplois de premier échelon dans l'industrie hôtelière et touristique, ainsi que de leur enseigner des connaissances en auto-entrepreneuriat.

Un cours de cinq semaines en perfectionnement psychologique suivi d'un stage de deux semaines dans un hôtel, de l'aide à la rédaction de leur CV et du placement professionnel. Le but ne se réduit pas à aider les femmes à trouver un emploi, mais aussi à leur donner l'inspiration et l'estime de soi dont elles ont besoin pour sortir leur famille de la pauvreté.

Lancé en 2006, le programme CAPTA forme 120 femmes par an, offrant un emploi permanent à 80 % des diplômées, même dans des entreprises situées à l'extérieur de Casco Antiguo.

AMÉRIQUE DU NORD et CARAÏBE

SeeClickFix

SeeClickFix, projet lancé à New Haven il y a quatre ans, Connecticut, reproduit dans plus de 130 villes des États-Unis, est un site Web et une application mobile qui permet aux citoyens de régler les problèmes de la vie quotidienne dans leur quartier grâce à la diffusion de renseignements publics et leur acheminement à l'administration de leur localité.

Parallèlement, cela facilite une intervention plus efficace et plus transparente des gouvernements à ces demandes grâce à un tableau de bord adapté.

En plus des centaines de milliers d'enjeux qui ont été résolus par les autorités locales grâce à ce programme, SeeClickFix a amené les citoyens à régler des problèmes dans leurs quartiers, qu'ils laissaient aux soins de leur municipalité auparavant.

SeeClickFix permet aux municipalités et aux citoyens de discuter en misant sur la collaboration et la transparence pour développer la confiance et renforcer l'esprit civique, tout en rehaussant le niveau de vie des collectivités de manière pragmatique.

À propos de Financial Times :

Le Financial Times, un des chefs de file mondiaux des actualités d'affaires, est reconnu à l'échelle mondiale pour son autorité, son intégrité et sa précision. Fournissant les actualités essentielles, les commentaires, les données et l'analyse pour les milieux d'affaires mondiaux, la production de Financial Times totalise plus de 629 000 empreintes en circulation, imprimés et numériques combinés (chiffre vérifié par Deloitte, deuxième trimestre de 2013). La version mobile des publications est un canal de distribution de plus en plus important pour Financial Times, constituant maintenant un tiers du trafic sur FT.com et un quart des abonnements aux publications numériques. Les produits éducatifs de Financial Times servent maintenant 32 des 50 meilleures écoles de commerce au monde.

À propos de Citi :

Citi, la banque mondiale de premier plan, elle dispose de près de 200 millions de comptes clients et exerce ses activités dans plus de 160 pays et juridictions. Citi offre aux particuliers, aux entreprises, aux gouvernements et aux institutions une large gamme de produits et de services financiers, dont des services bancaires et de crédit pour les particuliers, des services bancaires d'investissement et pour les entreprises, le courtage de valeurs mobilières, des services transactionnels et la gestion de patrimoine.

Pour en savoir plus, vous pouvez consulter www.citigroup.com | Twitter : @Citi | YouTube : www.youtube.com/citi | Blogue : http://blog.citigroup.com | Facebook : www.facebook.com/citi | LinkedIn : www.linkedin.com/company/citi.

À propos de Citi for Cities :

Citi for Cities est une initiative qui tire le meilleur parti des ressources de Citi à travers le monde afin de contribuer à ce que les villes deviennent plus efficaces en offrant le financement qui facilite le commerce et la modernisation puis en permettant aux citoyens d'accéder à des services favorisant une qualité de vie et une prospérité accrues. Citi s'efforce d'aider les villes à réaliser leurs ambitions dans les principaux écosystèmes essentiels qui font fonctionner une ville, notamment l'administration, les routes et le réseau des transports, les points d'entrée, l'énergie et les services publics, les lieux de travail et le système éducatif, la santé, la sécurité, ainsi que la régénération et le développement. L'engagement de Citi en faveur des villes englobe le secteur public et le secteur privé, le secteur financier ainsi que les citoyens et les communautés dans lesquelles ils vivent. Pour de plus amples renseignements, veuillez consulter le site www.citiforcities.com.

À propos de FT/Citi Ingenuity Awards :

Plus de la moitié de la population mondiale vit en milieu urbain aujourd'hui, et ce nombre augmenterait pendant les prochaines décennies. Par conséquent, il est urgent que les villes se mobilisent pour relever les défis que pose l'urbanisation et qu'elles trouvent des solutions pour moderniser l'infrastructure, accroître l'efficacité et améliorer la qualité de vie, et qu'elles consolident la croissance et le développement durables.

Les prix FT/Citi Ingenuity Awards : Urban Ideas in Action, un programme mondial financé par Citi, a été conçu pour récompenser les leaders, les équipes, les organisations et les organismes communautaires ayant mis au point des solutions novatrices aux problèmes urbains qui profitent aux villes, aux citoyens et aux communautés urbaines.

Les meilleurs candidats seront présentés dans deux versions internationales supplémentaires du magazine Financial Times et seront invités à participer à des événements visant à étoffer le dialogue sur les défis et les solutions pour les milieux urbains. Les finalistes feront l'objet d'une sélection régionale. Un lauréat sera choisi pour chaque région.

Les demandes seront évaluées à partir d'un ensemble de critères, dont l'originalité, l'impact, l'efficacité et le résultat. C'est INSEAD, une des plus importantes et grandes écoles de commerce au monde, qui a établi les critères. Financial Times et INSEAD étudieront toutes les candidatures pour déterminer leur qualification. Un jury formé d'experts mondiaux en la matière sélectionnera les lauréats. À titre de sponsor, Citi ne procédera ni à l’examinassions ni à l’évaluation des candidatures. On peut consulter les critères d'admissibilité et d'autres détails au sujet de ce programme sur www.FTCitiawards.com. Suivez la conversation à l'aide du mot-clé #FTCitiAwards.

Le texte du communiqué issu d’une traduction ne doit d’aucune manière être considéré comme officiel. La seule version du communiqué qui fasse foi est celle du communiqué dans sa langue d’origine. La traduction devra toujours être confrontée au texte source, qui fera jurisprudence.

Gilead Sciences, Inc. (Nasdaq: GILD) ha annunciato in data odierna che l'ente statunitense preposto al controllo dei farmaci e degli alimenti (Food and Drug Administration, FDA) ha approvato il regime monocompressa anti-HIV-1 Complera^® (emtricitabina/rilpivirina/tenofovir disoproxil fumarato) per l'uso in taluni pazienti adulti virologicamente soppressi (HIV RNA inferiore a 50 copie/ml) sottoposti a un regime antiretrovirale stabile allo scopo di sostituire la terapia antiretrovirale loro somministrata al momento. Complera è stato dapprima approvato nel 2011 per i pazienti naïve al trattamento ed è ora uno dei regimi anti-HIV più prescritti negli Stati Uniti.

“Complera è un'efficace terapia monocompressa con un profilo di sicurezza comprovato e si è affermato rapidamente quale opzione importante per pazienti affetti da HIV idonei in procinto di iniziare una terapia antiretrovirale”

“Complera è un'efficace terapia monocompressa con un profilo di sicurezza comprovato e si è affermato rapidamente quale opzione importante per pazienti affetti da HIV idonei in procinto di iniziare una terapia antiretrovirale” ha affermato il dottor Calvin J. Cohen, M.Sc., direttore del reparto di ricerca del Community Research Initiative of New England, nonché sperimentatore delle sperimentazioni cliniche su Complera. “I dati che avvalorano l'approvazione rilasciata quest'oggi dimostrano che Complera potrebbe potenzialmente aiutare un numero più folto di pazienti affetti da HIV in cui si è ottenuto il controllo della carica virale attraverso un altro regime.”

Complera riunisce in una singola compressa a somministrazione monogiornaliera un regime terapeutico completo contenente tre farmaci antiretrovirali. Il prodotto contiene Truvada^® di Gilead, già di per sé una terapia combinata a dosaggio fisso contenente due farmaci anti-HIV, e la rilpivirina di Janssen R&D Ireland (commercializzata con il marchio Edurant^®). Sono considerati idonei all'assunzione di Complera i pazienti che non presentano un'anamnesi di fallimento virologico, in cui la carica virale risulta soppressa da almeno sei mesi, che stanno seguendo la loro prima o seconda terapia antiretrovirale e che non hanno evidenziato, in passato o al momento, resistenza ai componenti di Complera. L'efficacia di Complera è stata determinata in pazienti virologicamente soppressi (HIV RNA inferiore a 50 copie/ml) sottoposti a un regime terapeutico stabile contenente un inibitore della proteasi potenziato con ritonavir.

L'approvazione rilasciata in data odierna è avvalorata dai dati clinici derivati dalla sperimentazione clinica di Fase 3 SPIRIT (Studio 106). In questo studio randomizzato e in aperto, parte dei pazienti virologicamente soppressi assumenti una terapia anti-HIV combinata contenente un inibitore della proteasi (IP) potenziato con ritonavir, è passata a Complera, mentre altri hanno continuato a seguire la loro terapia a base IP. Nello studio in oggetto, dopo 48 settimane di trattamento con Complera, si è riscontrato che nell'89 per cento (n=283/317) dei pazienti provenienti da un'altra terapia la carica virale era inferiore a 50 copie/ml, rispetto al 90 per cento (143/159) dei pazienti che hanno invece continuato a seguire una terapia a base IP per 24 settimane. Complera è risultato ben tollerato nello studio SPIRIT e il tasso di interruzione della terapia a causa di eventi avversi è risultato alquanto esiguo. Gli effetti collaterali segnalati con maggiore frequenza negli studi clinici precedentemente condotti su Complera sono: cefalea, disturbi depressivi e insonnia (complessivamente 2 per cento). Nello studio SPIRIT non è stata identificata alcuna nuova reazione avversa, sebbene la frequenza delle reazioni avverse sia aumentata dal 2 al 2,4 per cento. Le avvertenze in riquadro nero per Complera riguardano il rischio di acidosi lattica/epatotossicità grave con steatosi ed esacerbazione acuta dell’epatite B; si vedano le Informazioni importanti sulla sicurezza riportate nel seguito.

Commercializzato nell'Unione Europea con il marchio Eviplera^® (emtricitabina/rilpivirina/tenofovir disoproxil (fumarato)), il regime è stato inoltre approvato di recente in Europa per il trattamento di pazienti adulti affetti da HIV senza mutazioni note associate a resistenza alla classe degli inibitori non nucleosidici della trascrittasi inversa (NNRTI), tenofovir o emtricitabina, e con una carica virale HIV-1 RNA pari o inferiore a 100.000 copie/ml.

Informazioni importanti sulla sicurezza di Complera

AVVERTENZE IN RIQUADRO NERO: ACIDOSI LATTICA/EPATOMEGALIA GRAVE ACCOMPAGNATA DA STEATOSI ed ESACERBAZIONE ACUTA POST-TRATTAMENTO DELL'EPATITE B

Sono stati segnalati casi di acidosi lattica e grave epatomegalia con steatosi, compresi casi letali, associati all'assunzione di analoghi nucleosidici, tra cui il tenofovir disoproxil fumarato (tenofovir DF), un componente di COMPLERA, in combinazione con altri agenti antiretrovirali.

COMPLERA non è stato approvato per il trattamento dell'infezione da virus dell'epatite B cronica (HBV) e la sua sicurezza ed efficacia non sono state stabilite nei pazienti con coinfezione da HBV e HIV-1. Sono state segnalate gravi esacerbazioni acute di epatite B in pazienti con coinfezione da HBV e HIV-1 che hanno interrotto pertanto l'assunzione di emtricitabina o tenofovir DF, che sono componenti di COMPLERA. La funzionalità epatica deve essere monitorata attentamente con follow-up sia a livello clinico che di esami di laboratorio almeno per diversi mesi nei pazienti con coinfezione da HIV-1 e HBV che interrompono l'assunzione di COMPLERA. Laddove opportuno, potrebbe essere necessario avviare una terapia anti-epatite B.

CONTROINDICAZIONI

• Somministrazione concomitante: COMPLERA non va somministrato in concomitanza con farmaci che inducono il CYP3A o che determinano un aumento del pH gastrico, giacché ciò potrebbe provocare una perdita di risposta virologica e possibile resistenza a COMPLERA. La somministrazione di COMPLERA insieme ai seguenti farmaci è controindicata: carbamazepina, oxcarbazepina, fenobarbital, fenitoina, rifabutina, rifampin, rifapentina, inibitori della pompa protonica (ovvero, esomeprazolo, lansoprazolo, dexlansoprazolo, omeprazolo, pantoprazolo, rabeprazolo), desametasone sistemico (più di una dose) ed erba di San Giovanni.

AVVERTENZE E PRECAUZIONI

• Insorgenza o peggioramento di danni renali: sono stati segnalati dei casi di insufficienza renale acuta e sindrome di Fanconi associati all'assunzione di tenofovir DF. Prima dell'avvio e durante la terapia, è opportuno valutare in tutti i pazienti la clearance della creatinina (CrCl) stimata. Nei pazienti a rischio di deficit renale occorre inoltre monitorare il livello di fosforo nel siero e rilevare l'eventuale presenza di glucosio e proteine nelle urine. Non somministrare COMPLERA in pazienti con una CrCl inferiore a 50 ml/min. Non somministrare in concomitanza o dopo l'assunzione recente di un agente nefrotossico. Sono stati segnalati casi di insufficienza renale acuta, per alcuni dei quali si sono resi necessari il ricovero ospedaliero e la somministrazione di terapia di sostituzione renale, in seguito all'assunzione di farmaci antinfiammatori non steroidei (NSAID) multipli o a dosaggi elevati in pazienti a rischio di deficit renale; occorre pertanto vagliare opzioni alternative ai farmaci NSAID per questi pazienti. Dolore alle ossa persistente o ingravescente, dolore alle estremità, fratture e/o dolore o debolezza muscolare potrebbero essere sintomi di tubulopatia renale prossimale e rendono quindi opportuna una valutazione della funzionalità renale.

• Interazioni farmacologiche: esercitare la debita cautela nel somministrare COMPLERA in concomitanza con farmaci che potrebbero ridurre l'esposizione della rilpivirina o in concomitanza con farmaci associati a rischio noto di torsione di punta. È stato dimostrato che la somministrazione di dosi sovraterapeutiche di rilpivirina determina un prolungamento dell'intervallo QT dell'elettrocardiogramma (ECG) in soggetti sani.

• Disturbi depressivi: il tasso d'incidenza di disturbi depressivi (umore depresso, depressione, disforia, depressione grave, alterazione dell’umore, pensieri negativi, tentativo di suicidio, ideazione suicida) osservato nelle sperimentazioni cliniche (N=686) è stato del 9% (nella maggior parte dei casi di entità lieve o moderata); mentre il tasso di incidenza di disturbi depressivi di Grado 3 e 4 (a prescindere dalla causalità) è stato dell’1%. Quattro (4) pazienti hanno manifestato ideazione suicida e sono stati segnalati due (2) casi di tentativo di suicidio. I pazienti con sintomi depressivi gravi vanno prontamente sottoposti a valutazione medica, ove occorre vagliare attentamente i rischi in caso di proseguimento della terapia.

• Epatotossicità: sono stati segnalati alcuni eventi avversi di natura epatica, tra cui casi di tossicità epatica in pazienti senza malattia epatica pregressa o altri fattori di rischio rilevabili. Il rischio potrebbe essere maggiore nei pazienti con epatite B o C pregressa o nei pazienti i cui esami di funzionalità renale rivelano un innalzamento marcato dei valori. Si raccomandano l'esecuzione delle opportune analisi di laboratorio e il monitoraggio prima e durante la terapia per i pazienti con malattia epatica pregressa o per i pazienti i cui esami di funzionalità renale rivelano un innalzamento marcato dei valori prima di avviare la terapia; considerare invece l'esecuzione di esami e il monitoraggio per i pazienti senza deficit epatico pregresso o altri fattori di rischio.

• Effetti sulle ossa: in pazienti trattati con tenofovir DF si sono osservati una riduzione della densità minerale ossea e difetti di mineralizzazione, inclusa l'osteomalacia. Il monitoraggio della densità minerale ossea va considerato per i pazienti con anamnesi di fratture patologiche o rischio di perdita di tessuto osseo. Nei pazienti a rischio di deficit renale che evidenziano sintomi ossei o muscolari persistenti o ingravescenti, occorre considerare l'ipofosfatemia e l'osteomalacia secondaria a tubulopatia renale prossimale.

• Altri farmaci antiretrovirali: COMPLERA è un regime completo per il trattamento dell'infezione da HIV-1. Non va somministrato in concomitanza con altri farmaci antiretrovirali, compresi prodotti contenenti uno o più degli stessi principi attivi, prodotti contenenti lamivudina o in concomitanza con adefovir dipivoxil.

• In pazienti sottoposti a terapie antiretrovirali si sono osservati accumulo e ridistribuzione del grasso corporeo.

• Sono stati segnalati casi di sindrome da immuno-ricostituzione, compresa la comparsa di disturbi autoimmuni con tempi di insorgenza variabili.

REAZIONI AVVERSE

• Negli adulti mai sottoposti a terapia antiretrovirale: le reazioni avverse comuni segnalate negli studi clinici (tasso di incidenza pari o superiore al 2%, Gradi 2-4) sono: disturbi depressivi (2%), insonnia (2%) e cefalea (2%).
• Negli adulti virologicamente soppressi: nei pazienti virologicamente soppressi stabili, che sono passati a COMPLERA non è stata osservata alcuna nuova reazione avversa al farmaco; tuttavia la frequenza delle reazioni avverse è aumentata nella misura del 20%.

INTERAZIONI FARMACOLOGICHE

• Induttori del CYP3A: i farmaci che inducono il CYP3A potrebbero determinare una riduzione delle concentrazioni di rilpivirina nel plasma, il che potrebbe causare una perdita di risposta virologica e possibile resistenza a COMPLERA.
• Inibitori del CYP3A: i farmaci che inibiscono il CYP3A potrebbero determinare un aumento delle concentrazioni di rilpivirina nel plasma.
• I farmaci che inducono un aumento del pH gastrico potrebbero determinare una riduzione significativa delle concentrazioni di rilpivirina nel plasma, con conseguente perdita di risposta virologica e possibile resistenza a COMPLERA.
  • È controindicata la somministrazione di COMPLERA insieme a inibitori della pompa protonica.
  • Gli antiacidi vanno somministrati non meno di 2 ore prima oppure non meno 4 ore dopo l'assunzione di COMPLERA.
  • Gli antagonisti del recettore H₂ vanno somministrati non meno di 12 ore prima oppure non meno di 4 ore dopo l'assunzione di COMPLERA.
• Farmaci influenzanti la funzionalità renale: la somministrazione di COMPLERA in concomitanza con farmaci che riducono la funzionalità renale o che competono per la secrezione tubulare attiva potrebbe indurre un aumento delle concentrazioni di emtricitabina e tenofovir.
• Informazioni sulla prescrizione: per ulteriori informazioni su interazioni farmacologiche potenzialmente significative, inclusi eventuali commenti clinici, consultare per esteso le informazioni sulla prescrizione di COMPLERA.

Gravidanza e allattamento

• Gravidanza di categoria B: non sono stati condotti studi adeguati e ben controllati sulle donne in gravidanza. Somministrare durante la gravidanza solo se i potenziali benefici giustificano i potenziali rischi. È stato istituito un registro per le terapie antiretrovirali durante la gravidanza.
• Allattamento: tracce di emtricitabina e tenofovir sono state rilevate nel latte materno. In considerazione del rischio di trasmissione dell'HIV e del rischio di gravi reazioni avverse nei lattanti è opportuno chiedere alle madri di astenersi dall'allattamento.

POSOLOGIA E SOMMINISTRAZIONE

Adulti: una compressa per via orale una volta al giorno a stomaco pieno.

Insufficienza renale: non somministrare a pazienti richiedenti un aggiustamento posologico o a pazienti con una CrCl stimata inferiore a 50 ml/min.

Informazioni su Gilead Sciences

Gilead Sciences è un’azienda biofarmaceutica impegnata nella scoperta, nello sviluppo e nella commercializzazione di terapie innovative nei settori della medicina che presentano problemi ancora irrisolti. La missione dell’azienda consiste nel promuovere l’avanzamento delle cure nei pazienti affetti da malattie potenzialmente fatali in tutto il mondo. Gilead, la cui sede generale è a Foster City, California, opera nel Nord America e nel Sud America, in Europa e nella regione Asia Pacifica.

Dichiarazioni rilasciate a titolo di previsione

Il presente comunicato stampa contiene dichiarazioni di previsione secondo il significato attribuito a tale espressione dalla legge statunitense Private Securities Litigation Reform Act del 1995, in quanto tali soggette a rischi, incertezze e altri fattori, compreso il rischio che gli operatori sanitari negli Stati Uniti e nell'Unione Europea non riscontrino alcun vantaggio nel passaggio dei pazienti affetti da HIV virologicamente soppressi a Complera/Eviplera e potrebbe quindi dimostrarsi riluttanti a prescrivere il prodotto. I risultati effettivi potrebbero discostarsi in maniera sostanziale da quelli riportati nelle dichiarazioni di previsione in considerazione di tali rischi, incertezze e altri fattori. Si invitano i lettori a non fare eccessivo affidamento sulle presenti dichiarazioni di previsione. I suddetti rischi e altri sono descritti in dettaglio nella relazione trimestrale di Gilead contenuta nel Modulo 10-Q relativa al trimestre conclusosi il 30 settembre 2013 e depositata presso l’ente statunitense Securities & Exchange Commission. Tutte le dichiarazioni di previsione sono basate sulle informazioni attualmente a disposizione di Gilead, la quale non si assume alcun obbligo riguardo all’aggiornamento delle stesse.

Informazioni esaustive sulla prescrizione di Complera e Truvada negli Stati Uniti, comprese le AVVERTENZE NEL RIQUADRO NERO per entrambi i prodotti, sono rinvenibili all'indirizzo www.gilead.com.

I riassunti delle caratteristiche del prodotto per l’UE di Eviplera e Truvada sono disponibili all’indirizzo www.ema.europa.eu.

Complera, Eviplera e Truvada sono marchi commerciali registrati di Gilead Sciences, Inc. o delle relative consociate.

Edurant è un marchio commerciale registrato di Janssen R&D Ireland.

Per ulteriori informazioni su Gilead Sciences, consultare il sito web dell’azienda all’indirizzo www.gilead.com, seguire Gilead su Twitter (@GileadSciences) o chiamare l’ufficio Relazioni pubbliche di Gilead ai numeri 1-800-GILEAD-5 o 1-650-574-3000.

Il testo originale del presente annuncio, redatto nella lingua di partenza, è la versione ufficiale che fa fede. Le traduzioni sono offerte unicamente per comodità del lettore e devono rinviare al testo in lingua originale, che è l'unico giuridicamente valido.

Box hat heute bekannt gegeben, dass Chevron, Safeway und Pearson jetzt zu den 200.000 Unternehmen gehören, die mit Box zusammenarbeiten, um ihre Partnerschaften und Informationen besser zu verwalten. Ganz im Zeichen der Dynamik des Unternehmens hat die Firma wesentliche Updates in ihre Admin-Konsole eingeführt, und zwar mit einer Reihe fortschrittlicher Methoden und Automatisierungstools sowie einem erneuertem Content Management, das IT- Administratoren beim Verwalten der Informationen in einem komplexen Unternehmensumfeld hilft. Box hat zudem seine Unterstützung für Unternehmen mit Box Consulting erweitert, das den maßgeschneiderten Einsatz der engagierten Profis des Box Service-Teams im großen Maßstab bietet, und arbeitet jetzt mit Capgemini zusammen, einem der weltweit führenden Anbieter von Beratungs-, Technologie- und Outsourcingservice, der die größten Organisationen der Welt produktiver, innovativer und effizienter gestaltet.

„Viele der größten Unternehmen der Welt aus den am stärksten regulierten Branchen nutzen Box, um ihre Informationen sicher in der Cloud zu speichern, zu verwalten und darauf zuzugreifen“

„Viele der größten Unternehmen der Welt aus den am stärksten regulierten Branchen nutzen Box, um ihre Informationen sicher in der Cloud zu speichern, zu verwalten und darauf zuzugreifen“, sagte Whitney Bouck, General Manager von Enterprise bei Box. „Wir haben einen Service aufgebaut, der von den Mitarbeitern der Unternehmen gern genutzt wird und zugleich das Niveau an Kontrolle und Transparenz bietet, das IT-Abteilungen verlangen. Die neuen Produkte, Dienstleistungen und Partnerschaften von heute erfordern einen nachhaltigen Einsatz für die Unternehmen, und wir freuen uns, unsere Führungsposition auf dem Markt ausbauen zu können.“

Unternehmen – Kundendynamik

Box ist der Motor für Unternehmenskooperationen zwischen einigen der größten und innovativsten Organisationen der Welt, darunter Chevron, Safeway, Pearson, Procter & Gamble, Schneider Electric, Nationwide Insurance und Electronic Arts. Im Jahr 2013 ist die Zahl der Box-Anwendungen bei Kunden mit insgesamt über 5.000 Sitzen um 300 Prozent im Vergleich zu 2012 gewachsen.

Unternehmen – Admin-Konsole

Mit der effizienten Integration eines umfangreichen Regelwerkes in die Box-Plattform zentralisiert die neue Enterprise Admin-Konsole Sicherheitsregeln, automatisiert Aufgaben und führt neue Verwaltungstools ein, die den Unternehmen bei der Kontrolle der in Box gespeicherten Inhalte sowie der Überwachung extern geteilter Informationen helfen und einfache, wiederholbare Prozesse auf der Grundlage von Ordnern und Tasks aufbauen.

• Richtlinien: Box-Kunden können sich gegen das Hochladen vertraulicher oder sensibler Informationen, wie Kreditkarten- und Sozialversicherungsdaten oder spezifische Wörter und Sätze, schützen, indem das Hochladen von Inhalten mit Schlüsselwörtern verbunden wird. Zusätzlich können Administratoren Funktionen erstellen, die Mitteilungen in Echtzeit senden, wenn verwaltete Benutzer große Mengen Inhalt herunterladen.
• Automation: Die Automationsoptionen der neuen Admin-Konsole ermöglichen Administratoren, einfache Datenflüsse zum Verwalten von Tasks wie Rechnungsfreigaben, kollaterale Abschreibungen und andere mehrstufige Informationsflüsse innerhalb ihrer Organisation zu automatisieren.
• Content Manager: Box hat eine neue Management-Funktion in die Admin-Konsole eingefügt – vorher in Beta verfügbar – die Administratoren ermöglicht, Inhalte und Benutzer zentral zu verwalten. Das Tool ermöglicht Administratoren, nach spezifischen Dateien und Ordnern zu suchen, auf Inhalte zuzugreifen, zu denen die Benutzer jeweils Zugang haben, und Änderungen an den Berechtigungen und Sharing-Einstellungen vorzunehmen. Es handelt sich um ein leistungsfähiges Steuerungszentrum, das Administratoren Einblick in ihre Konfiguration gibt und zusätzlich die Managementfunktion bietet, die sie benötigen, falls sie Maßnahmen ergreifen müssen.

„Unternehmen erkennen, dass man Gewinne erzielen kann, wenn man sein System auf die Cloud umstellt, aber die Notwendigkeit besserer Sicherheit und Regeldurchsetzung ist immer noch eine Hürde für viele Organisationen, die Cloud-Plattformen einsetzen wollen“, sagte Alan Lepofsky, Vice President und Chefanalytiker bei Constellation Research. „Diese neuen Funktionen unterscheiden Box von anderen Verkäufern auf dem Markt, die einfach nur grundlegende Cloud-Dateispeicherung bieten. Diese Tools bieten IT-Abteilungen verbesserte Transparenz und Kontrolle ihrer Inhalte und legen den Grundstein für die Automation einer Vielzahl von Funktionen in ihren inhaltszentrierten Applikationen.“

Box Sync 4.0

Der gesamte Box Sync Client wurde umgestaltet, um die Geschwindigkeit, Stabilität und Größenordnung zu bieten, die für Unternehmen zur nahtlosen Zusammenarbeit mit Mobil- und Desktopgeräten quer durch das gesamte Web erforderlich sind. Sync ist über 4 Mal schneller als der vorherige Sync Client von Box und es unterstützt Sub-Folder Sync für über 100.000 Dateien und reduziert die CPU-Belastung um 25 Prozent.

Box Consulting und Capgemini

Box führt sein professionelles Service Team – Box Consulting – ein, das Unternehmen aller Größenordnungen hilft, auf die Beine zu kommen und effizient und im richtigen Maßstab mit Box zu arbeiten. Zudem arbeitet Box mit Capgemini zusammen, um dessen globale Reichweite und industrielle Durchdringung zu nutzen und kundenspezifische App-Entwicklungen, Unternehmensniveau, Cloud-Integration, bewährte Verfahren zur Benutzerakzeptanz und Implementierungsservices zu bieten. Die Beziehung zwischen Box Consulting und Capgemini gewährleistet die Unterstützung und den Service, die für erfolgreiche Entwicklungen in komplexen IT-Umgebungen erforderlich sind.

„Wir freuen uns über die Gelegenheit für Box, mit Capgemini ein Team zu bilden, das Lösungen aus einer Hand für eine skalierbare, inhaltliche Zusammenarbeit für globale und regionale Unternehmen in zahlreichen Branchen bietet“, sagte Vikrant Karnik, Senior Vice President und Chef von Enterprise Cloud Services für Application Services One¹ bei Capgemini.

Preise und Verfügbarkeit

Der Content Manager wird den Kunden im Rahmen der Enterprise- und Elite-Pläne allgemein in den kommenden Wochen zur Verfügung stehen. Regelwerke und Automatisierungstools werden den Kunden im Rahmen der Enterprise- und Elite-Pläne in den kommenden Monaten allgemein zur Verfügung stehen. Box Sync 4.0 ist für Box-Benutzer mit allen Plänen bereits jetzt verfügbar. Box Consulting Services stehen ebenfalls bereits jetzt zur Verfügung. Weitere Informationen finden Sie im Box-Blog.

Über Capgemini

Mit über 130.000 Mitarbeitern in 44 Ländern ist Capgemini einer der weltweit führenden Anbieter von Beratungs-, Technologie- und Outsourcingservice. Der Konzern erzielte 2012 einen weltweiten Umsatz von 10,3 Milliarden Euro. Zusammen mit seinen Kunden konzipiert und liefert Capgemini Unternehmens- und Technologielösungen, die den Kundenbedarf erfüllen und die gewünschten Ergebnisse erzielen. Capgemini hat ihre eigene Arbeitsweise entwickelt, die Collaborative Business Experience^TM, und setzt auf Rightshore®, ihren weltweiten Vertriebskanal. Weitere Informationen über uns erhalten Sie unter www.capgemini.com.

Rightshore® ist ein Warenzeichen von Capgemini.

Über Box

Die Aufgabe der Firma Box ist es, Unternehmen aller Größen produktiver, wettbewerbsfähiger und leistungsfähiger zu gestalten, indem sie Menschen und ihre wichtigsten Informationen zusammenbringt. Inhalte können bei Box sicher ausgetauscht werden, sind über iOS-, Android- und Windows Phone-Anwendungen leicht im Web zugänglich und lassen sich auf Partneranwendungen wie Google Apps, NetSuite und Salesforce ausweiten. Box hat seinen Hauptsitz im kalifornischen Los Altos und ist ein privat geführtes Unternehmen, das unterstützt wird von Andreessen Horowitz, Bessemer Venture Partners, Draper Fisher Jurvetson, Emergence Capital Partners, General Atlantic, Meritech Capital Partners, NEA, Scale Venture Partners und U.S. Venture Partners sowie den strategischen Investoren salesforce.com, SAP Ventures und Intel Ventures. Weitere Informationen über Box erhalten Sie unter www.box.com.

¹ Nordamerika, das Vereinigte Königreich, Asien-Pazifik und der Finanzdienstleistungssektor

Die Ausgangssprache, in der der Originaltext veröffentlicht wird, ist die offizielle und autorisierte Version. Übersetzungen werden zur besseren Verständigung mitgeliefert. Nur die Sprachversion, die im Original veröffentlicht wurde, ist rechtsgültig. Gleichen Sie deshalb Übersetzungen mit der originalen Sprachversion der Veröffentlichung ab.

Box a annoncé aujourd'hui que Chevron, Safeway et Pearson avaient rejoint les 200 000 entreprises qui utilisent Box pour optimiser la collaboration et la gestion des informations. Pour maintenir son élan dans l'entreprise, la société a apporté des mises à jour majeures à sa console d'administration, avec des politiques avancées, des outils d'automatisation et de nouvelles offres de gestion de contenu qui aident les administrateurs système à gérer facilement des informations dans des environnements d'entreprise complexes. Box a également amélioré son soutien aux entreprises déployant et personnalisant Box à l'échelle avec une équipe de services professionnels dédiée, Box Consulting, et a fait équipe avec Capgemini, un des plus éminents prestataires de services de consultation, technologie et externalisation, pour aider les plus grandes organisations au monde à améliorer leur productivité, leur innovation et leur efficacité.

« Nombreuses sont les plus grandes entreprises internationales représentant certains des secteurs les plus réglementés qui utilisent Box pour stocker, gérer et accéder en toute sécurité aux informations dans le nuage »

« Nombreuses sont les plus grandes entreprises internationales représentant certains des secteurs les plus réglementés qui utilisent Box pour stocker, gérer et accéder en toute sécurité aux informations dans le nuage », a déclaré Whitney Bouck, directeur général, Entreprise, chez Box. « Nous avons élaboré un service que les employés adorent utiliser tout en fournissant le niveau de contrôle et de visibilité que réclament les services informatiques. Les nouveaux produits, services et partenariats d’aujourd'hui permettent de poursuivre notre engagement vis-à-vis de l'entreprise et nous nous réjouissons à l'idée de maintenir notre leadership sur le marché ».

Dynamisme des clients d'entreprise

Box alimente la collaboration commerciale pour certaines des organisations les plus grandes et les plus innovantes au monde, y compris Chevron, Safeway, Pearson, Procter & Gamble, Schneider Electric, Nationwide Insurance et Electronic Arts. En 2013, le nombre de déploiements de clients de Box totalisant plus de 5 000 sièges a augmenté de 300 % comparé à 2012.

Console d'administration d'entreprise

En exploitant un moteur de règles robuste à l’intérieur de la plate-forme Box, la nouvelle console d'administration d'entreprise centralise des politiques de sécurité, automatise des tâches et introduit de nouveaux outils de gestion qui aident les entreprises à contrôler le contenu stocké dans Box, surveiller les moments de partage extérieur des informations, et élaborer des processus simples, répétables, fondés sur des dossiers et des tâches.

• Politiques : Les clients de Box peuvent se protéger contre le téléchargement d'informations confidentielles ou sensibles, telles que des numéros de cartes de crédit et de sécurité sociale ou des mots et des phrases spécifiques en créant des politiques de chargement de contenu associées à des mots clés. Les administrateurs peuvent également créer des politiques qui envoient des notifications en temps réel quand les utilisateurs gérés téléchargent de grandes quantités de contenu.
• Automatisation : Les options d'automatisation intégrées à la nouvelle console d'administration permettent aux administrateurs de créer de simples flux pour gérer des tâches, telles que les approbations de factures, les signatures collatérales et d'autres flux d'information multiniveaux à travers leur organisation.
• Gestionnaire de contenu : Box a ajouté une nouvelle fonctionnalité de gestion à la console d'administration – précédemment disponible en bêta – qui permet aux administrateurs de gérer centralement le contenu et les utilisateurs. Cet outil aide les administrateurs à chercher des fichiers et des dossiers spécifiques, visualiser le contenu accessible à chaque utilisateur, et modifier les permissions et les paramètres de partage. Ce centre de commande puissant donne aux administrateurs une idée de ce qui se passe dans leur déploiement, ainsi que la fonctionnalité de gestion dont ils ont besoin pour agir si nécessaire.

« Les entreprises reconnaissent que des gains transformateurs peuvent être réalisés en passant au nuage, mais le besoin qui existe pour une meilleure application de la sécurité et des politiques constitue encore un obstacle pour de nombreuses organisations désireuses d'adopter des plates-formes dans le nuage », a commenté Alan Lepofsky, VP et analyste principal chez Constellation Research. « Avec ces nouvelles fonctionnalités, Box fournit un avantage concurrentiel comparé aux autres fournisseurs qui ne fournissent qu'un stockage de fichiers de base dans le nuage. Ces outils offrent aux services informatiques une visibilité et un contrôle améliorés de leur contenu et jettent les bases permettant aux organisations d'automatiser une variété d'actions dans leurs applications métier axées sur le contenu ».

Box Sync 4.0

Le client Box Sync a été ré-architecturé du tout au tout pour fournir la vitesse, la stabilité et l'échelle requises par les entreprises pour réaliser une collaboration métier sans couture sur le Web, les dispositifs mobiles et le bureau. Sync 4 est plus de dix fois plus rapide que le client sync précédent de Box ; il prend en charge une synchronisation de sous-dossier pour plus de 100 000 fichiers et l'usage de l’UC a été réduit de 25 %.

Box Consulting & Capgemini

Box introduit une équipe de services professionnels avancés – Box Consulting – pour aider les entreprises de toutes tailles à démarrer rapidement avec efficacité et à l'échelle sur Box. En outre, Box fait équipe avec Capgemini pour utiliser sa portée mondiale et son expertise industrielle approfondie dans le but d'offrir un développement d'applications personnalisées, une échelle d'entreprise, une intégration dans le cloud, des meilleures pratiques d'adoption utilisateur, et des services d'implémentation. Box Consulting et sa relation avec Capgemini permettent aux environnements informatiques les plus complexes de disposer du soutien et des services dont ils ont besoin pour réaliser les déploiements les plus performants.

« Nous sommes ravis à l'idée de l'opportunité qui se présente à Box de faire équipe avec Capgemini pour fournir une source unique de collaboration de contenu évolutive dans de multiples domaines et secteurs aux entreprises internationales ou régionales », a confié Vikrant Karnik, vice-président senior et directeur des services cloud d'entreprise pour Application Services One¹ chez Capgemini.

Prix et disponibilité

Le gestionnaire de contenu sera généralement disponible dans les prochaines semaines aux clients sur forfaits Enterprise et Elite. Les politiques et l'automatisation seront généralement disponibles dans les prochaines semaines aux clients sur forfaits Enterprise et Elite. Box Sync 4.0 est disponible aujourd'hui pour les utilisateurs Box sur tous les forfaits. Les services de Box Consulting sont disponibles dès aujourd'hui. Pour en savoir plus, veuillez consulter le blog de Box.

À propos de Capgemini

Avec plus de 130 000 employés dans 44 pays, Capgemini est l'un des prestataires de services de consultation, technologie et externalisation les plus éminents au monde. Le groupe a déclaré un chiffre d'affaires global de 10,3 milliards d'euros en 2012. Avec ses clients, Capgemini crée et fournit des solutions d'entreprise et de technologie adaptées à leurs besoins, et générant les résultats ciblés. Capgemini, une entreprise profondément multiculturelle, a développé sa propre façon de travailler, la Collaborative Business Experience^TM, et exploite Rightshore®, son modèle de prestation mondial. Pour en savoir plus sur nous, consulter www.capgemini.com.

Rightshore® est une marque commerciale de Capgemini.

À propos de Box

Box a pour mission de rendre les entreprises de toutes tailles plus productives, compétitives, et puissantes en reliant les gens et leurs informations les plus importantes. Le contenu sur Box peut être partagé en toute sécurité et est facilement accessible sur le web, via les applications iOS, Android et Windows Phone, et étendu à des applications partenaires, telles que Google Apps, NetSuite et Salesforce. Box, qui a son siège à Los Altos, en Californie, est une société privée qui bénéficie du soutien d'Andreessen Horowitz, Bessemer Venture Partners, Draper Fisher Jurvetson, Emergence Capital Partners, General Atlantic, Meritech Capital Partners, NEA, Scale Venture Partners et U.S. Venture Partners, ainsi que de celui des investisseurs stratégiques salesforce.com, SAP Ventures et Intel Ventures. Pour en savoir plus sur Box, visiter www.box.com.

¹ Amérique du Nord, Royaume-Uni, Asie-Pacifique et le secteur des Services financiers

Le texte du communiqué issu d’une traduction ne doit d’aucune manière être considéré comme officiel. La seule version du communiqué qui fasse foi est celle du communiqué dans sa langue d’origine. La traduction devra toujours être confrontée au texte source, qui fera jurisprudence.

Gilead Sciences, Inc. (Nasdaq: GILD) heeft vandaag aangekondigd dat de U.S. Food and Drug Administration (FDA) het uit een enkel tablet bestaande hiv-1-regime Complera^® (emtricitabine/rilpivirine/tenofovirdisoproxilfumaraat) heeft goedgekeurd voor gebruik bij bepaalde volwassen patiënten met virologische suppressie (hiv-RNA <50 kopieën/ml) op een stabiel antiretroviraal regime ter vervanging van hun huidige antiretrovirale behandelingsregime. Complera werd voor het eerst goedgekeurd in 2011 voor patiënten die nieuw waren voor behandeling en is nu één van de meest breed voorgeschreven hiv-regimes in de Verenigde Staten.

“De gegevens die de goedkeuring van vandaag ondersteunen laten zien dat Complera het potentieel heeft een bredere groep hiv-geïnfecteerde patiënten te helpen die virologische controle heeft bereikt op een ander regime.”

“Complera is een effectieve, uit een enkele pil bestaande behandeling met een aangetoond veiligheidsprofiel en is snel een belangrijke optie geworden voor geschikte hiv-patiënten die starten met antiretrovirale behandeling,” aldus Calvin J. Cohen, MD, M.Sc., Research Director, Community Research Initiative of New England en onderzoeker van klinische trials van Complera. “De gegevens die de goedkeuring van vandaag ondersteunen laten zien dat Complera het potentieel heeft een bredere groep hiv-geïnfecteerde patiënten te helpen die virologische controle heeft bereikt op een ander regime.”

Complera combineert een complete kuur van drie antiretrovirale medicaties in een enkel, eenmaal daags tablet. Het product combineert Gilead’s Truvada^® , dat zelf een vaste dosiscombinatie is van twee hiv-geneesmiddelen met rilpivirine van Janssen R&D Ierland (op de markt als Edurant^®). Patiënten die overgaan op Complera mogen geen voorgeschiedenis van virologisch falen hebben, hebben ten minste zes maanden onderdrukte viral load, zijn op hun eerste of tweede antiretrovirale regime en hebben geen huidige of eerdere resistentie tegen bestanddelen van Complera. De werkzaamheid van Complera werd vastgesteld bij patiënten met virologische suppressie (hiv-RNA <50 kopieën/ml) op een stabiel regime dat een met ritonavir gebooste proteaseremmer bevatte.

De goedkeuring van vandaag wordt ondersteund door klinische gegevens van de fase 3 SPIRIT (Studie 106) klinische trial. In deze gerandomiseerde, open-label studie, stapten patiënten met virologische suppressie, die een uit meerdere tabletten bestaande hiv-therapie kregen dat een met ritonavir gebooste proteaseremmer (PI) bevatte, over op Complera of bleven op hun op PI gebaseerd regime. Uit het onderzoek kwam naar voren dat na 48 weken behandeling met Complera, 89 procent (n=283/317) van de overgestapte patiënten een virale belasting had van minder dan 50 kopieën/ml, vergeleken met 90 procent (143/159) van de patiënten die gedurende 24 weken op een PI-regime bleven. Complera werd in SPIRIT goed verdragen en stoppen met de behandeling vanwege bijwerkingen kwam weinig voor. De meest voorkomende bijwerkingen bij eerdere klinische trials van Complera waren hoofdpijn, depressieve stoornissen en slapeloosheid (2 procent voor elk). Er werden bij SPIRIT geen nieuwe bijwerkingen vastgesteld, maar de frequentie van bijwerkingen nam toe van 2 naar 2,4 procent. Complera heeft een omkaderde waarschuwing over de risico's van lactaatacidose/ernstige hepatotoxiteit met steatose en acute exacerbatie van hepatitis B; zie hieronder voor belangrijke veiligheidsinformatie.

Het regime dat in de Europese Unie op de markt is als Eviplera ^® (emtricitabine/rilpivirine/tenofovir disoproxil (als fumaraat)) ontving recent Europese goedkeuring van de regelgevende instantie voor alle hiv-geïnfecteerde volwassen patiënten zonder bekende mutaties geassocieerd met resistentie tegen de klasse non-nucleoside reverse transcriptaseremmer (NNRTI), tenofovir of emtricitabine en met een viral load ≤ 100,000 HIV-1 RNA kopieën/ml.

Belangrijke veiligheidsinformatie voor Complera

OMKADERDE WAARSCHUWING: LACTAATACIDOSE/ERNSTIGE HEPATOMEGALIE MET STEATOSE en ACUTE EXACERBATIE VAN HEPATITIS B NA BEHANDELING

Lactaatacidose en ernstige hepatomegalie met steatose, waaronder fatale gevallen, zijn gemeld bij het gebruik van nucleoside-analogen, waaronder tenofovirdisoproxilfumaraat (tenofovir-DF), een bestanddeel van COMPLERA, in combinatie met andere antiretrovirale middelen.

COMPLERA is niet goedgekeurd voor de behandeling van chronische hepatitis-B-virusinfectie (HBV) en de veiligheid en werkzaamheid van COMPLERA zijn niet vastgesteld bij patiënten die geïnfecteerd zijn met zowel HBV als hiv-1. Ernstige acute exacerbaties van hepatitis B zijn gemeld bij patiënten die gelijktijdig zijn geïnfecteerd met HBV en hiv-1 en zijn gestopt met emtricitabine of tenofovir-DF, welke componenten zijn van COMPLERA. De leverfunctie moet nauwgezet worden gecontroleerd, met zowel klinische als laboratorium-follow-up, gedurende ten minste enkele maanden bij patiënten die zijn geïnfecteerd met zowel hiv-1 als HBV en die stoppen met COMPLERA. Indien aangewezen, zou beginnen met anti-hepatitis-B-therapie gerechtvaardigd kunnen zijn.

Contra-indicaties

• Gelijktijdige toediening: COMPLERA moet niet samen worden toegediend met geneesmiddelen die leiden tot CYP3A of toename van de pH van het maagzuur omdat dit kan leiden tot verlies van virologische respons en mogelijke resistentie tegen COMPLERA. Gebruik van de volgende geneesmiddelen met COMPLERA is gecontra-indiceerd: carbamazepine, oxcarbazepine, fenobarbital, fenytoïne, rifabutine, rifampin, rifapentine, protonpompremmers (bijv. esomeprazol, lansoprazol, dexlansoprazol, omeprazol, pantoprazol, rabeprazol), systemische dexamethason (>1 dosis) en sint-janskruid.

Waarschuwingen en voorzorgsmaatregelen

• Voor het eerst optreden of verslechtering van nierfunctiestoornis: Gevallen van acuut nierfalen en het syndroom van Fanconi zijn gemeld bij het gebruik van tenofovir-DF. Beoordeel bij alle patiënten de geschatte creatinineklaring (CrCl) voor het starten met de behandeling en tijdens de behandeling. Controleer bij patiënten met risico op nierdisfunctie daarnaast ook serumfosfor, urineglucose en urine-eiwit. Dien COMPLERA niet toe bij patiënten met CrCl <50 ml/min. Vermijd gelijktijdig of recent gebruik met een nefrotoxische stof. Gevallen van acuut nierfalen, waarvan bij enkelen ziekenhuisopname en renale vervangingstherapie nodig waren, zijn gemeld na starten van een hoge dosis of meerdere NSAID's bij patiënten met risicofactoren voor nierdisfunctie; overweeg bij deze patiënten alternatieven voor NSAID's. Aanhoudende of verergerde botpijn, pijn in de ledematen, fracturen en/of spierpijn of -zwakte kunnen manifestaties zijn van proximale renale tubulopathie en moeten aanzetten tot een beoordeling van de nierfunctie.

• Geneesmiddelinteracties: Complera moet behoedzaam worden gebruikt wanneer gegeven met geneesmiddelen die de blootstelling van rilpivirine verminderen of wanneer het gelijktijdig wordt gegeven met een geneesmiddel met een bekend risico op Torsade de Pointes. Bij gezonde proefpersonen hebben supratherapeutische doses rilpivirine verlenging van het QTc-interval van het elektrocardiogram laten zien.

• Depressieve stoornissen: De incidentie van depressieve stoornissen (neerslachtige stemming, depressie, dysforie, ernstige depressie, veranderde stemming, negatieve gedachten, suïcidepoging, suïcidale gedachten) die in klinische trials werden gerapporteerd (N=686) was 9% (de meesten waren mild of gemiddeld van ernst); en graad 3 en 4 depressieve stoornissen (ongeacht de oorzaak) was 1%. Suïcidale gedachten werden gerapporteerd bij 4 proefpersonen en suïcidepogingen werden gemeld bij 2 proefpersonen. Patiënten met ernstige depressieve symptomen moeten onmiddellijke medische beoordeling vragen en de risico's van doorgaan met de behandeling moeten worden vastgesteld.

• Hepatotoxiciteit: Hepatische bijwerkingen werden gerapporteerd, waaronder hepatische toxiciteit bij patiënten zonder voordien bestaande hepatische ziekte of andere identificeerbare risicofactoren. Voor patiënten met onderliggende hepatitis B of C, of degenen met duidelijke verhogingen van met de lever geassocieerde tests kan een verhoogd risico gelden. Van toepassing zijnde laboratoriumtesten en monitoring voor en tijdens behandeling wordt aanbevolen bij patiënten met onderliggende hepatische ziekte of bij patiënten met duidelijke verhogingen van met de lever geassocieerde tests voor het starten van de behandeling; overweeg testen en monitoring bij patiënten met reeds bestaande hepatische disfunctie of andere risicofactoren.

• Boteffecten: Afname van botmineraaldichtheid (BMD) en mineralisatiedefecten, waaronder osteomalacie, zijn waargenomen bij patiënten die behandeld zijn met tenofovir-DF. Het wordt aanbevolen BMD-monitoring te overwegen bij patiënten met een voorgeschiedenis van pathologische fractuur of bij patiënten die risico lopen op botverlies. Bij patiënten die risico lopen op renale disfunctie die aanhoudende of die verergering van bot- of spiersymptomen laten zien, moet hypofosfatemie en osteomalacie secondair aan proximale renale tubulopathie worden overwogen.

• Andere antiretroviralen: COMPLERA is een volledig regime voor de behandeling van hiv-1-infectie. Niet gelijktijdig toedienen met andere antiretrovirale producten, waaronder producten die een van dezelfde actieve componenten bevatten; producten die lamivudine bevatten of producten die adefovir dipivoxil bevatten.

• Vetherdistributie en ophoping van lichaamsvet is waargenomen bij patiënten die antiretrovirale therapie kregen.

• Immuunreconstitutiesyndroom, waaronder het optreden van auto-immuunziekten met variabele tijd tot eerste optreden, zijn gerapporteerd.

Bijwerkingen

• Bij volwassenen zonder geschiedenis van ARV-behandeling: Algemene bijwerkingen gerapporteerd bij klinisch onderzoek (incidentie ≥2%, graden 2-4) waren depressieve stoornissen (2%), slapeloosheid (2%) en hoofdpijn (2%).
• Bij volwassenen met virologische suppressie: Er zijn geen nieuwe typen bijwerkingen van COMPLERA geïdentificeerd bij stabiele patiënten met virologische suppressie die overstappen op COMPLERA; de frequentie van bijwerkingen is met 20% gestegen.

GENEESMIDDELINTERACTIES

• CYP3A inductoren: Geneesmiddelen die CYP3A induceren kunnen de rilpivirineplasmaconcentraties verlagen, wat kan leiden tot verlies van virologische respons en mogelijke resistentie tegen COMPLERA.
• CYP3A-remmers: Geneesmiddelen die CYP3A remmen, kunnen de rilpivirineplasmaconcentraties verhogen.
• Geneesmiddelen die de pH in de maag verhogen, kunnen de rilpivirineplasmaconcentraties aanzienlijk verlagen en leiden tot verlies van virologische respons en mogelijke resistentie tegen COMPLERA.
  • Gebruik van protonpompremmers met COMPLERA is gecontra-indiceerd.
  • Antacida moeten ≥2 uur voorafgaand of ≥4 uur na COMPLERA worden toegediend.
  • H₂ receptorantagonisten moeten ≥12 uur voorafgaand of ≥4 uur na COMPLERA worden toegediend.
• Geneesmiddelen die de nierfunctie beïnvloeden: Gelijktijdige toediening van COMPLERA met geneesmiddelen die de nierfunctie verminderen of concurreren voor actieve tubulaire secretie, kan de concentraties van emtricitabine en tenofovir verhogen.
• Voorschrijfinformatie: Raadpleeg de volledige productinformatie van COMPLERA voor meer informatie over potentieel belangrijke geneesmiddelinteracties, waaronder klinische opmerkingen.

Zwangerschap en borstvoeding

• Zwangerschap categorie B: Er zijn geen adequate en goed gecontroleerde studies bij zwangere vrouwen uitgevoerd. Gebruik tijdens zwangerschap alleen wanneer de mogelijke voordelen het mogelijke risico rechtvaardigt. Een antiretroviraal zwangerschapsregister is opgesteld.
• Borstvoeding: Emtricitabine en tenofovir zijn gedetecteerd in de moedermelk. Vanwege zowel de mogelijkheid van overdracht van hiv en de kans op ernstige bijwerkingen bij zuigelingen, dienen moeders te worden geïnstrueerd geen borstvoeding te geven.

DOSERING EN TOEDIENING

Volwassenen: Eén tablet per dag, oraal ingenomen tijdens het eten.

Nierfunctiestoornis: Niet gebruiken bij patiënten bij wie de dosis moet worden aangepast of bij patiënten met een geschatte CrCl <50 ml/min.

Over Gilead Sciences

Gilead Sciences is een biofarmaceutisch bedrijf dat nieuwe therapieën ontdekt, ontwikkelt en op de markt brengt voor medische behoeften waar nog geen oplossingen voor zijn. De missie van het bedrijf is om wereldwijd de zorg te verbeteren voor patiënten die aan levensbedreigende ziekten lijden. Gilead heeft zijn hoofdkantoor in Foster City, Californië (VS) en is actief in Noord- en Zuid-Amerika, Europa en de regio Azië-Pacific.

Toekomstgerichte verklaring

Dit persbericht bevat toekomstgerichte verklaringen, in de betekenis van de Private Securities Litigation Reform Act van 1995, die onderhevig zijn aan risico's, onzekerheden en andere factoren, waaronder het risico dat artsen in de Verenigde Staten en de Europese Unie de voordelen niet zien van het overzetten van hiv-patiënten met virologische suppressie op Complera/Eviplera en daarom terughoudend kunnen zijn het product voor te schrijven. Deze risico’s, onzekerheden en andere factoren kunnen ertoe leiden dat de werkelijke resultaten aanzienlijk afwijken van de resultaten zoals die worden genoemd in de toekomstgerichte verklaringen. De lezer wordt gewaarschuwd zich niet te baseren op deze toekomstgerichte verklaringen. Deze en andere risico's staan in detail beschreven in het kwartaalverslag van Gilead op formulier 10-Q voor het kwartaal dat eindigde op 30 september 2013, zoals ingediend bij de Amerikaanse Securities en Exchange Commission. Alle toekomstgerichte verklaringen zijn gebaseerd op informatie waarover Gilead nu beschikt. Gilead neemt geen verplichting op zich om dergelijke toekomstgerichte verklaringen te actualiseren..

Volledige voorschrijfinformatie voor de VS voor Complera en Truvada, inclusief OMKADERDE WAARSCHUWING voor beide producten, is beschikbaar op www.Gilead.com.

EU Samenvattingen van Productkenmerken voor Eviplera en Truvada zijn beschikbaar op www.ema.europa.eu.

Complera, Eviplera en Truvada zijn geregistreerde handelsmerken van Gilead Sciences, Inc. of de aan haar gelieerde bedrijven.

Edurant is een geregistreerd handelsmerk van Janssen R&D Ierland.

Ga voor meer informatie over Gilead Sciences naar de website van het bedrijf: www.gilead.com, volg Gilead op Twitter (@GileadSciences) of bel met Gilead Public Affairs: +1-800-GILEAD-5 of +1-650-574-3000.

Deze bekendmaking is officieel geldend in de originele brontaal. Vertalingen zijn slechts als leeshulp bedoeld en moeten worden vergeleken met de tekst in de brontaal, welke als enige rechtsgeldig is.

WWE (NYSE:WWE) today announced that it will bring WWE LIVE™ to The Green Halls Stadium, Prince Faisal bin Fahad Olympic Games Complex in Riyadh, Saudi Arabia for the first time ever with three shows from Thursday, February 13 through Saturday, February 15, 2014. Tickets will go on sale Monday, December 16, 2013 at 12:00pm KSA.

“We are very excited to be returning to the Middle East with events in a debut market after successful shows in Abu Dhabi and Qatar earlier this year.”

Fans attending WWE LIVE™ will be able to see their favorite Superstars, including current World Heavyweight Champion John Cena^™, WWE Champion Randy Orton^™, Daniel Bryan^™, Mark Henry^™, Ryback^™, Kofi Kingston^™ and many more.**

WWE currently has a strong TV presence in Saudi Arabia with its flagship weekly shows, WWE Raw® and WWE SmackDown®. WWE Raw is broadcasted on MBC and the Abu Dhabi Sports Channel and WWE SmackDown can be seen on Orbit Showtime Network.

“Holding three live events in Saudi Arabia for the first time is a testament to the growing demand for WWE’s brand in this region,” said Gerrit Meier, Executive Vice President, International, WWE. “We are very excited to be returning to the Middle East with events in a debut market after successful shows in Abu Dhabi and Qatar earlier this year.”

The event also represents a significant milestone for FLASH Entertainment headquartered in Abu Dhabi who, alongside their local Saudi partners Time Events, has worked with WWE to bring WWE LIVE™ events to the Middle East.

“As the region’s premier event organization we are delighted to be partnering with WWE and Time Events on this historic event,” said John Lickrish, CEO of FLASH Entertainment. “WWE is one of the most popular brands in the world, and we are all hugely excited to be bringing it to the people of Saudi Arabia.”

"TIME Events is all about making a difference and adding to life. We would like to thank FLASH Entertainment and WWE for giving us the opportunity to work side-by-side in bringing WWE to Saudi Arabia for the very first time,” said Ahmed Mashhadi, Managing Director of Time Events. “It plans to be a memorable occasion and one that will be enjoyed by WWE fans across Saudi Arabia.”

Tickets for the three shows will go on sale Monday, December 16, 2013 at 12:00pm KSA time and can be purchased from www.ticketmaster.ae.

** Talent line-up subject to change

About WWE

WWE, a publicly traded company (NYSE: WWE), is an integrated media organization and recognized leader in global entertainment. The company consists of a portfolio of businesses that create and deliver original content 52 weeks a year to a global audience. WWE is committed to family friendly entertainment on its television programming, pay-per-view, digital media and publishing platforms. WWE programming is broadcast in more than 150 countries and 30 languages and reaches more than 650 million homes worldwide. The company is headquartered in Stamford, Conn., with offices in New York, Los Angeles, London, Miami, Mumbai, Munich, Shanghai, Singapore and Tokyo.

Additional information on WWE (NYSE: WWE) can be found at wwe.com and corporate.wwe.com. For information on our global activities, go to http://www.wwe.com/worldwide/.

About Flash

Based in Abu Dhabi, FLASH Entertainment is the region’s premier live events company, with a proven track record in delivering world-class events from movie premieres and classical shows to international sports events and megastar music concerts. FLASH offers comprehensive event management solutions from concepts and designs through to coordinating every stage of production. The company is committed to providing the region with diverse entertainment programmes, grass roots creativity and stimulating the local economy and events’ industry.

In just 4 years, FLASH has diversified its business portfolio developing entertainment that has seen close to two million fans through the doors. Partnering with leading international sports and entertainment organizations such as Live Nation, Cream and UFC, the company is well on its way to achieve its mission of growing from the region’s premier live events company, to a globally recognized peerless entertainment organization. FLASH owns a 10% stake in UFC and manages a multi-million-dirham portfolio of assets including the du Arena and du Forum on Yas Island, Abu Dhabi.

About Time Events

TIME Events is an events development company that is based in Riyadh, Saudi Arabia, aimed in developing localized event content, giving different target segments in Saudi and the Middle East an entertaining, rich and memorable experience outside their homes. Other than events development TIME Events is also aimed to host global event content in the region such as WWE."

Trademarks: All WWE programming, talent names, images, likenesses, slogans, wrestling moves, trademarks, logos and copyrights are the exclusive property of WWE and its subsidiaries. All other trademarks, logos and copyrights are the property of their respective owners.

Forward-Looking Statements: This press release contains forward-looking statements pursuant to the safe harbor provisions of the Securities Litigation Reform Act of 1995, which are subject to various risks and uncertainties. These risks and uncertainties include, without limitation, risks relating to maintaining and renewing key agreements, including television and pay-per-view programming distribution agreements; the need for continually developing creative and entertaining programming; the continued importance of key performers and the services of Vincent McMahon; the conditions of the markets in which we compete and acceptance of the Company's brands, media and merchandise within those markets; our exposure to bad debt risk; uncertainties relating to regulatory and litigation matters; risks resulting from the highly competitive nature of our markets; uncertainties associated with international markets; the importance of protecting our intellectual property and complying with the intellectual property rights of others; risks associated with producing and travelling to and from our large live events, both domestically and internationally; the risk of accidents or injuries during our physically demanding events; risks relating to our film business; risks relating to increasing content production for distribution on various platforms, including the potential creation of a WWE Network; risks relating to our computer systems and online operations; risks relating to the large number of shares of common stock controlled by members of the McMahon family and the possibility of the sale of their stock by the McMahons or the perception of the possibility of such sales; the relatively small public float of our stock; and other risks and factors set forth from time to time in Company filings with the Securities and Exchange Commission. Actual results could differ materially from those currently expected or anticipated. In addition, our dividend is dependent on a number of factors, including, among other things, our liquidity and historical and projected cash flow, strategic plan (including alternative uses of capital), our financial results and condition, contractual and legal restrictions on the payment of dividends, general economic and competitive conditions and such other factors as our Board of Directors may consider relevant.

Regulatory News:

Dates for publishing of EOC Limited financial reports:

1st quarter FY2013 - 6th January 2014

2nd quarter FY2013 - 15th April 2014

3rd quarter FY2013 - 15th July 2014

4th quarter FY2013 - 14th October 2014

The Annual General Meeting for FY2013 will be held on 6th January 2014.

`FY` - Financial year ending 31 August

The above dates may be subject to changes.

ABOUT THE COMPANY

www.emasoffshore-cnp.com

Oslo Børs listing: October 2007

EOC Limited offers offshore floating production services that support the full life cycle of offshore oil and gas (O&G) production. It owns and operates two floating production, storage and offloading (FPSO) vessels, the Lewek Arunothai and the Lewek EMAS, and a fleet of construction vessels. The Group has conducted operations in Australia, Brunei, India, Indonesia, Malaysia, the Middle East, the Philippines, Vietnam and Thailand, and continues to do so currently.

EOC’s successful operational and HSE (health, safety and environment) track records have enabled the Group to establish strong working relationships with leading international oil majors, national oil companies and various independent operators. In addition, these ties have brought in a steady stream of repeat business and recurring income.

The Group is an associate company of Singapore Exchange-listed Ezra Holdings Limited, a leading global offshore contractor and provider of integrated offshore solutions to the O&G industry.

This information was brought to you by Cision http://news.cision.com

)--Regulatory News:

EOC Limited will host a conference call on 7th January 2014 at 1630 hrs (Singapore Time) and Mr. Chan Eng Yew (CFO) will present the 1Q FY2014 unaudited financial results and engage in a Q&A session.

Conference Call Details:
Dial-in Number: +65 6668 7508
Code: 850 536#

The presentation and unaudited financial report for 1Q FY2014 will be available under the Newsroom tab in the company's website. Please kindly revert via email to investor_relations@emasoffshore-cnp.com to indicate your participation in this call. Thank you

ABOUT THE COMPANY

www.emasoffshore-cnp.com

Oslo Børs listing: October 2007

EOC Limited offers offshore floating production services that support the full life cycle of offshore oil and gas (O&G) production. It owns and operates two floating production, storage and offloading (FPSO) vessels, the Lewek Arunothai and the Lewek EMAS, and a fleet of construction vessels. The Group has conducted operations in Australia, Brunei, India, Indonesia, Malaysia, the Middle East, the Philippines, Vietnam and Thailand, and continues to do so currently.

EOC’s successful operational and HSE (health, safety and environment) track records have enabled the Group to establish strong working relationships with leading international oil majors, national oil companies and various independent operators. In addition, these ties have brought in a steady stream of repeat business and recurring income.

The Group is an associate company of Singapore Exchange-listed Ezra Holdings Limited, a leading global offshore contractor and provider of integrated offshore solutions to the O&G industry.

This information was brought to you by Cision http://news.cision.com

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