Daily Archives: May 11, 2015

Johnson & Johnson Expands IP Policy to Create Broad Access in 128 Countries for Development of New and Optimized HIV Medicine Formulations for Children Living with HIV

Expanded Policy will Increase Access for Darunavir Pediatric Formulations in 128 Resource-Limited Countries

RARITAN, New Jersey, May 11, 2015 / PRNewswire – Johnson & Johnson today announced that its Janssen Pharmaceutical Companies have furthered their commitment to improve the health of children living with HIV through an expanded policy aimed at enhancing access to its HIV medicine darunavir. This policy enables the development of and access to new pediatric products of darunavir in 128 low- and middle-income countries [1], home to 99.8% of children and adolescents living with HIV worldwide [2] today.

As part of efforts to help meet the needs of children and adolescents living with HIV, Janssen is working to create one of the broadest geographic territories for an access effort for pediatric HIV medicines to date. To that end, Janssen will expand the geographic scope of its 2012 policy not to enforce the patents it owns and controls on the antiretroviral (ARV) drug darunavir, for pediatric products used in low- and middle-income countries. This doubles the original territory of sub-Saharan Africa and Least Developed Countries [3] announced in 2012. The 2012 policy outlines that Janssen will not enforce its darunavir patent rights, provided the generic versions of darunavir are quality, medically acceptable, and only used in the indicated countries. Today’s expanded policy is applicable only for pediatric darunavir products used in the defined territory. Manufacturers are still responsible for obtaining permissions from other darunavir patent holders and health authorities where appropriate.

These renewed efforts are an outcome of engagement between Janssen and the Medicines Patent Pool (MPP), directly supporting the recently-launched Pediatric HIV Treatment Initiative (PHTI). PHTI is a partnership between the MPP, UNITAID, the Drugs for Neglected Diseases initiative (DNDi) and the Clinton Health Access Initiative (CHAI) dedicated to speeding the development of high-priority pediatric co-formulations of HIV medicines and addressing other potential barriers to treatment access for children living with HIV.

Janssen will collaborate with PHTI partners to develop critical new formulations of pediatric HIV medicines to help safeguard the lives of children and adolescents living with HIV. Janssen and PHTI organizations will explore the possible development of a fixed-dose combination (FDC) of darunavir with the boosting agent ritonavir for children living with HIV. Darunavir administered with ritonavir and in combination with other antiretroviral medicines is currently indicated for highly treatment-experienced adult and pediatric HIV patients (third-line) in resource-limited settings and has been recommended by the World Health Organization [4]. A novel FDC that is safe, effective and child-friendly would be an important step in realizing the global health imperative to close the pediatric HIV treatment gap.

“Our vision is that children living with HIV can receive the treatments they need to stay strong and grow to become productive young adults,” said Paul Stoffels, M.D., Chief Scientific Officer, Johnson & Johnson and Worldwide Chairman, Janssen. “We are committed to ensuring that no child is without access to appropriate, child-friendly HIV treatment options and, most importantly, the hope of a healthy future.”

Janssen and Johnson & Johnson have a longstanding commitment to helping children living with HIV and enhancing access to its medicines for those in need. For more than a decade, Johnson & Johnson has supported efforts to reduce the number of new HIV infections among children, and in 2011, the company pledged an additional $15 million to support the Global Plan to eliminate pediatric HIV. In December 2013, Janssen launched the New Horizons Advancing HIV Care initiative, a collaborative effort to strengthen country-level capacity, knowledge, and action around the needs of HIV treatment-experienced children. A key feature of this initiative is a treatment donation program for PREZISTA® (darunavir) and INTELENCE® (etravirine) for HIV treatment-experienced children and adolescents.

Johnson & Johnson and Janssen are committed to advancing global health. Its family of companies has launched and continues to support a variety of comprehensive efforts toward strengthening the health of communities, improving maternal and child health, and preventing the spread of infectious and preventable diseases worldwide. For more information on Johnson & Johnson global health programs, visit www.jnj.com.

About Janssen, the Pharmaceutical Companies of Johnson & Johnson
At Janssen, we are dedicated to addressing and solving the most important unmet medical needs of our time, including in oncology (e.g., multiple myeloma and prostate cancer), immunology (e.g., rheumatoid arthritis, IBD and psoriasis), neuroscience (e.g., schizophrenia, dementia and pain), infectious disease (e.g., HIV/AIDS, Hepatitis C and tuberculosis), and cardiovascular and metabolic diseases (e.g., diabetes).

Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency. To learn more, visit www.janssen.com.

About Johnson & Johnson
Caring for the world, one person at a time…inspires and unites the people of Johnson & Johnson. We embrace research and science ‒ bringing innovative ideas, products and services to advance the health and well-being of people. Our approximately 126,500 employees at more than 265 Johnson & Johnson operating companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

References

[1] In addition to all Least Developed Countries (LDCs) as defined by the United Nations and the countries of sub-Saharan Africa (SSA), countries included in this policy expansion are Algeria, American Samoa, Anguilla, Antigua and Barbuda, Aruba, Bahamas, Barbados, Belize, Bolivia, British Virgin Islands, Colombia, Costa Rica, Cuba, Democratic People’s Republic of Korea, Dominica, Dominican Republic, Ecuador, Egypt, El Salvador, Fiji, Grenada, Guatemala, Guyana, Honduras, India, Indonesia, Iran, Iraq, Jamaica, Jordan, Lebanon, Libya, Malaysia, Marshall Islands, Micronesia, Moldova, Mongolia, Montserrat, Morocco, Nauru, Nicaragua, Pakistan, Palau, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Saint Kitts and Nevis, Saint Lucia, Saint Vincent and the Grenadines, Sri Lanka, Suriname, Syrian Arab Republic, Thailand, Tonga, Trinidad and Tobago, Tunisia, Turks and Caicos, Ukraine, Uruguay, Venezuela, Vietnam, and West Bank and Gaza.

[2] Calculated using data from: UNICEF. Children, Adolescents and AIDS (2014 Statistical Update). http://www.childrenandaids.org/

[3] Resource-limited settings under this policy include all Least Developed Countries (“LDCs”) as defined by the United Nations (http://www.unohrlls.org/en/ldc/25/) and the countries of sub-Saharan Africa (SSA) which are not classified as LDCs.

[4] World Health Organization. Antiretroviral Therapy for HIV Infection in Adults and Adolescents: Recommendations for a Public Health Approach, 2010 Revision. http://whqlibdoc.who.int/publications/2010/9789241599764_eng.pdf

Caterpillar to Establish Regional Training Center in Dubai

– Technical and Sales Training Center will support over 7,000 Cat dealer technicians in the Africa and Middle East region

DUBAI, United Arab Emirates, May 11, 2015 /PRNewswire — Caterpillar (NYSE: CAT) today announced that it will build a Regional Training Center for the African and Middle East Region (AME) in Dubai, United Arab Emirates. The Center will offer hands-on machines and power systems technical and sales training to Caterpillar’s dealers and customers in the AME region.

At an investment of more than $7 million, the approximately 1,700 m2 center will employ about 40 people, mostly high-level technical staff who will primarily be recruited from the region. The more than 7,000 technicians at AME Cat dealers have some of the most direct connections with Caterpillar customers as they service and maintain their equipment. The training they’ll receive at the new Center in Dubai will help to enhance their skills and knowledge on both product and the latest product support technologies.

“Our Training Center in Dubai is a key part of our plans for the Middle East and Africa and will ensure Caterpillar and our dealers can be relied upon for providing unsurpassed support to our customers. This is an important region for Caterpillar and we expect to see strong, continued growth for our customers, and we will grow to support that,” commented Nigel Lewis, Vice President with responsibility for Caterpillar’s EAME Distribution Division.

The Center will also feature a lab for Scheduled Oil Sampling analysis that will help meet critical customer required turnaround time of emergency samples and reduce downtime of Caterpillar products in the region. The Center will be located at Caterpillar’s Middle East parts distribution center and Regional Sales and Marketing office in Jebel Ali, Dubai.

The Center is expected to be operational in the last quarter of this year.

About Caterpillar
For nearly 90 years, Caterpillar Inc. has been making sustainable progress possible and driving positive change on every continent. Customers turn to Caterpillar to help them develop infrastructure, energy and natural resource assets. With 2014 sales and revenues of $55.184 billion, Caterpillar is the world’s leading manufacturer of construction and mining equipment, diesel and natural gas engines, industrial gas turbines and diesel-electric locomotives. The company principally operates through its three product segments – Resource Industries, Construction Industries and Energy & Transportation – and also provides financing and related services through its Financial Products segment. For more information, visit caterpillar.com. To connect with us on social media, visit caterpillar.com/social-media.

Forward-Looking Statements
Certain statements in this filing relate to future events and expectations and are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “estimate,” “will be,” “will,” “would,” “expect,” “anticipate,” “plan,” “project,” “intend,” “could,” “should” or other similar words or expressions often identify forward-looking statements. All statements other than statements of historical fact are forward-looking statements, including, without limitation, statements regarding our outlook, projections, forecasts or trend descriptions. These statements do not guarantee future performance, and we do not undertake to update our forward-looking statements.

Caterpillar’s actual results may differ materially from those described or implied in our forward-looking statements based on a number of factors, including, but not limited to: (i) global and regional economic conditions and economic conditions in the industries we serve; (ii) government monetary or fiscal policies and infrastructure spending; (iii) commodity price changes, component price increases, fluctuations in demand for our products or significant shortages of component products; (iv) disruptions or volatility in global financial markets limiting our sources of liquidity or the liquidity of our customers, dealers and suppliers; (v) political and economic risks, commercial instability and events beyond our control in the countries in which we operate; (vi) failure to maintain our credit ratings and potential resulting increases to our cost of borrowing and adverse effects on our cost of funds, liquidity, competitive position and access to capital markets; (vii) our Financial Products segment’s risks associated with the financial services industry; (viii) changes in interest rates or market liquidity conditions; (ix) an increase in delinquencies, repossessions or net losses of Cat Financial’s customers; (x) new regulations or changes in financial services regulations; (xi) a failure to realize, or a delay in realizing, all of the anticipated benefits of our acquisitions, joint ventures or divestitures; (xii) international trade policies and their impact on demand for our products and our competitive position; (xiii) our ability to develop, produce and market quality products that meet our customers’ needs; (xiv) the impact of the highly competitive environment in which we operate on our sales and pricing; (xv) failure to realize all of the anticipated benefits from initiatives to increase our productivity, efficiency and cash flow and to reduce costs; (xvi) additional restructuring costs or a failure to realize anticipated savings or benefits from past or future cost reduction actions; (xvii) inventory management decisions and sourcing practices of our dealers and our OEM customers; (xviii) compliance with environmental laws and regulations; (xix) alleged or actual violations of trade or anti-corruption laws and regulations; (xx) additional tax expense or exposure; (xxi) currency fluctuations; (xxii) our or Cat Financial’s compliance with financial covenants; (xxiii) increased pension plan funding obligations; (xxiv) union disputes or other employee relations issues; (xxv) significant legal proceedings, claims, lawsuits or government investigations; (xxvi) changes in accounting standards; (xxvii) failure or breach of IT security; (xxviii) adverse effects of unexpected events including natural disasters; and (xxix) other factors described in more detail under “Item 1A. Risk Factors” in our Form 10-K filed with the SEC on February 17, 2015 for the year ended December 31, 2014.

Caterpillar construit un Centre de Formation Régional à Dubaï

– Le Centre proposera des formations techniques et commerciales aux 7000 techniciens des concessionnaires CAT en Afrique et au Moyen-Orient

DUBAI, Émirats arabes unis, 11 mai 2015 / PRNewswire — Caterpillar (NYSE: CAT) a annoncé aujourd’hui qu’il a entamé la construction d’un Centre de Formation Régional pour l’Afrique et le Moyen Orient (AME) à Dubaï, Emirats arabes unis. Ce Centre offrira des formations techniques et commerciales portant sur les machines et les systèmes de production d’énergie aux concessionnaires et aux clients de Caterpillar de la région AME.

Le Centre nécessitera un investissement de plus de 7 millions dollars et aura une surface de 1.700 m2. Il emploiera environ 40 personnes, dont la majorité sera composée de techniciens hautement qualifiés et recrutés principalement dans la région. Les 7000 techniciens des concessionnaires CAT en Afrique et au Moyen-Orient sont en contact direct avec les clients de Caterpillar car ils assurent le service après-vente et l’entretien de leurs équipements. Les formations qu’ils pourront suivre au nouveau Centre basé à Dubaï leur permettront de perfectionner leurs compétences et leur savoir-faire en matière de machines et de nouvelles technologies.

« Notre Centre de Formation à Dubaï représente un élément important de nos ambitions au Moyen-Orient et en Afrique. Il permettra à Caterpillar et à nos concessionnaires de fournir un niveau de service inégalé à nos clients. Il s’agit d’une région importante pour Caterpillar et nous prévoyons une croissance forte et soutenue pour nos clients. Nous allons donc croître avec eux pour les soutenir, » a déclaré Nigel Lewis, Vice-Président en charge de la division Distribution de Caterpillar pour l’Europe, l’Afrique et le Moyen-Orient.

Le Centre sera également équipé d’un laboratoire dédié aux analyses de fluides (Scheduled Oil Sampling) afin de répondre rapidement aux demandes urgentes des clients et de réduire les temps d’arrêt des machines dans la région. Le Centre sera construit sur le site du Centre de distribution de pièces de rechange pour le Moyen Orient et du Bureau régional des ventes et du marketing à Djébel Ali, Dubaï.

Il sera opérationnel à partir du quatrième trimestre de 2015.

A propos de Caterpillar
Depuis 90 ans, Caterpillar Inc. a contribué au développement durable et a aidé à alimenter le changement positif sur chaque continent. Les clients font appel à Caterpillar pour les aider à construire des infrastructures et pour les aider à exploiter les sources d’énergie et les ressources naturelles. Avec des ventes de 55,184 milliards US dollars en 2014, Caterpillar est le plus important producteur d’engins de construction et miniers, de moteurs au diesel et au gaz naturel, des turbines au gaz industrielles et de locomotives diesel-électrique. La société est composée de trois segments principaux, à savoir les industries de ressources, les industries de la construction et l’énergie & le transport. Notre segment des produits financiers fournit également des services financiers. Visitez caterpillar.com pour plus d’information. Ou connectez-vous sur caterpillar.com/social media.

Déclarations prospectives
Certaines parties de ce communiqué de presse se rapportent à des événements futurs ou attendus. Il s’agit donc de déclarations de nature prospective au sens du Private Securities Litigation Reform Act de 1995. Les structures grammaticales comme le futur et le conditionnel, ainsi que des mots comme « penser », « estimer », « prévoir », « anticiper », « planifier », « projeter », « pouvoir », « devoir” et autres termes ou expressions similaires expriment souvent le caractère prévisionnel d’une information. Toutes les déclarations autres que la narration de faits passés sont des déclarations de nature prospective, y compris, de façon non restrictive, les déclarations relatives à nos perspectives, projections, prévisions ou tendances. Ces déclarations ne constituent pas une garantie de performance et Caterpillar ne s’engage pas à mettre à jour ses déclarations de nature prospective.

Les résultats réels de Caterpillar peuvent différer significativement des résultats annoncés dans les déclarations prospectives ou susceptibles d’en d’être déduits, en raison d’un certain nombre de facteurs, notamment, mais non exclusivement : (i) les conditions économiques mondiales et régionales et les conditions économiques dans les industries que nous servons ; (ii) les politiques monétaires et fiscales gouvernementales et les dépenses gouvernementales affectées au développement infrastructurel ; (iii) les changements de prix des matières premières, la hausse des prix des composants, les fluctuations de la demande pour nos produits ou des pénuries importantes de composants ; (iv) les perturbations ou de la volatilité des marchés financiers mondiaux limitant nos sources de liquidités ou de la liquidité de nos clients, concessionnaires et fournisseurs ; (v) les risques politiques et économiques, l’instabilité commerciale et des événements hors de notre contrôle dans les pays dans lesquels nous exerçons nos activités ; (vi) l’échec de maintenir nos cotes de crédit avec des augmentations potentielles de nos coûts d’emprunt qui en résultent et des effets négatifs sur nos coûts d’appel de fonds et de liquidités, notre position concurrentielle et l’accès aux marchés de capitaux ; (vii) les risques de notre segment des produits financiers liés à l’industrie des services financiers ; (viii) des changements dans les taux d’intérêt ou des conditions de liquidité du marché ; (ix) une augmentation des défauts de paiement, saisies ou des pertes nettes de clients de Cat Financial; (x) de nouveaux règlements ou des changements dans la réglementation des services financiers ; (xi) le défaut de réalisation ou un retard dans la réalisation des avantages attendus de nos acquisitions, les coentreprises ou des désinvestissements ; (xii) des politiques commerciales internationales et leur impact sur la demande pour nos produits et notre position concurrentielle ; (xiii) notre capacité à développer, produire et vendre des produits de qualité qui répondent aux besoins de nos clients ; (xiv) l’impact de l’environnement très compétitif dans lequel nous évoluons sur nos ventes et les prix ; (xv) l’impossibilité de réaliser tous les gains attendus des projets pour augmenter notre productivité, l’efficacité et les flux de trésorerie et les réductions de coûts ; (xvi) des coûts de restructuration supplémentaires ou le manque d’économies ou des gains escomptés des actions de réduction des coûts dans le passé ou dans le futur ; (xvii) les décisions de gestion de l’inventaire et des pratiques d’approvisionnement de nos concessionnaires et nos clients OEM ; (xviii) le respect des lois et règlements environnementaux ; (xix) des violations présumées ou réelles de lois et réglementations commerciales ou anti-corruption ; (xx) des charges d’impôt supplémentaires ou potentielles ; (xxi) des fluctuations de devises ; (xxii) le respect des engagements financiers par nous ou par Cat Financial ; (xxiii) des augmentations dans les obligations de financement des plans de retraite ; (xxiv) des conflits avec les syndicats ou d’autres problèmes liés aux relations de travail ; (xxv) des actions judiciaires, réclamations, de poursuites ou d’enquêtes significatives ; (xxvi) des changements dans les normes comptables ; (xxvii)  des manques dans la sécurité informatique ; (xxviii) des effets indésirables d’événements inattendus, y compris de catastrophes naturelles; et (xxix) d’autres facteurs décrits plus en détail sous la rubrique « Item 1A. Risk Factors »dans notre formulaire 10-K déposé auprès de la SEC le 17 février 2015, pour l’exercice clos le 31 Décembre 2014.

EU planning military attacks on trafficking networks in Libya to stop migrant boats

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African securityEU planning military attacks on trafficking networks in Libya to stop migrant boats

Published 11 May 2015

The European Union (EU) is planning military attacks on trafficking networks in Libya to try and stop the influx of migrants across the Mediterranean. Today (Monday) several EU member states will try to secure a UN mandate for armed action by NATO in Libya’s territorial waters. Britain is drafting the UN Security Council resolution to authorize the mission in Libya’s territorial waters, and Federica Mogherini, the EU’s chief foreign and security policy coordinator, will be briefing the UN Security Council today (Monday) on the plans for a “chapter seven” resolution authorizing the use of force. Military experts say such action would require EU vessels to operate in Libyan territorial waters, accompanied by helicopter gunships to “neutralize” identified traffickers’ ships used to send tens of thousands of migrants from sub-Saharan Africa and the Middle East on the perilous voyage from the Libyan coast to southern Italy.

The European Union (EU) is planning military attacks on trafficking networks in Libya to try and stop the influx of migrants across the Mediterranean. Today (Monday) several EU member states will try to secure a UN mandate for armed action by NATO in Libya’s territorial waters.

A senior EU official in Brussels said Britain is drafting the UN Security Council resolution to authorize the mission in Libya’s territorial waters. The naval force would be under Italian command and include naval units from ten EU countries, among them Britain, France, Spain, and Italy. NATO may eventually become involved in the anti-trafficking operations, but there are no current plans for such involvement.

Today, Federica Mogherini, the EU’s chief foreign and security policy coordinator, will be briefing the UN Security Council on the plans for a “chapter seven” resolution authorizing the use of force. Knowledgeable sources told the Guardian that the British draft calls for the “use of all means to destroy the business model of the traffickers.”

Military experts say such action would require EU vessels to operate in Libyan territorial waters, accompanied by helicopter gunships to “neutralize” identified traffickers’ ships used to send tens of thousands of migrants from sub-Saharan Africa and the Middle East on the perilous voyage from the Libyan coast to southern Italy.

A British Ministry of Defense (MoD) spokesperson said: “Working closely with Italy and EU partners, HMS Bulwark and three Royal Naval Merlin Helicopters are providing wide ranging search and rescue capabilities in the Mediterranean, already rescuing over 100 people. The U.K. is now considering how best to support the proposed EU mission to counter the smuggling networks.”

The Guardian notes that Libyan militias, jihadi groups, and Islamic State affiliates who are in cahoots with the trafficking networks have deployed heavy artillery and anti-aircraft batteries close to the coast. Attacks on EU vessels and aircraft could trigger an escalation and force NATO to get involved.

EU sources say that they were told by Chinese diplomats that China would veto a Security Council resolution authorizing military action against Libyan traffickers, and that Russia, despite current tensions with the West over Ukraine, can be persuaded not to use its veto power against the resolution.

Libya’s ambassador to the UN, Ibrahim Dabbashi, told the AP that he had not been consulted on the plans and opposed them.

So far, six EU states have committed to contribute forces to the naval operation, with several more expected to offer participation. All twenty-eight member states have already expressed support for the proposed campaign.

In parallel to the preparation for military action, on Wednesday the European Commission (EC), the governing body of the EU, will unveil a new European “migration agenda.” The new policy calls for creating new and binding rules establishing a quota system of sharing refugees among the EU twenty-eight member states.

The proposal is promoted by Germany but it has already been rejected by Britain and east European countries.

“The EU needs a permanent system for sharing the responsibility for large numbers of refugees and asylum seekers among member states,” says the commission proposal obtained by the Guardian. By the end of the year Brussels is to table new legislation “for a mandatory and automatically-triggered relocation system to distribute those in clear need of international protection within the EU when a mass influx emerges.”

Currently, Germany and Sweden between them take nearly half of asylum-seekers in the EU, and Berlin says that the number this year could almost double to around 400,000 in Germany alone, two-thirds of the total number in the EU last year.

“Some member states have already made a major contribution to [refugee] resettlement efforts. But others offer nothing,” the commission paper complains. The document also insists that Europe has to open up legal avenues for migrants to enter the union safely, an idea which is strongly opposed by Theresa May, Britain’s home secretary.

“Such vulnerable people cannot be left to resort to the criminal networks of smugglers and traffickers. There must be safe and legal ways for them to reach the EU,” the commission document says.

The proposal now circulating in Brussels proposes to invoke “emergency mechanisms” by the end of the month making it mandatory for the twenty-eight member states to share the numbers of “persons in clear need of international protection” and “to ensure a fair and balanced participation of all member states to this common effort. This step will be the precursor of a lasting solution.”

The new blueprint, to be presented by commissioner Dimitris Avramopoulos on Wednesday, includes a distribution “key” system based on various criteria from national wealth levels to unemployment rates to determine what proportion of refugees each of the twenty-eight member states should each admit.

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