|By PR Newswire||
|September 4, 2014 12:01 AM EDT||
NEW BRUNSWICK, N.J., Sept. 4, 2014 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced it will fast-track the development of a promising new combination vaccine regimen against Ebola and broadly collaborate with its partners in global health to deliver immediate relief aid to address the current Ebola outbreak.
The accelerated vaccine program features a prime-boost regimen, in which one vector is used to prime and the other to boost the immune response. It consists of two vaccine components that are based on AdVac® technology from Crucell N.V. (part of the Janssen pharmaceutical companies of Johnson & Johnson, based in the Netherlands) and the MVA-BN® technology from Bavarian Nordic, (a biotech company, based in Denmark). The program has received direct funding and is also utilizing vaccine preclinical services from the National Institute of Allergy and Infectious Diseases (NIAID), part of National Institutes of Health (NIH). Crucell will bring this development program forward, in close collaboration with Bavarian Nordic and the NIAID, to allow for initiation of a clinical trial of this combined regimen in humans in early 2015.
The company's expedited vaccine development schedule is in response to the current Ebola outbreak in West Africa and is aligned with the World Health Organization's Ebola Response Roadmap, including its call to fast-track access to treatment and vaccine options to address the Ebola virus outbreak.
Johnson & Johnson's multi-pronged approach, as part of their overall commitment to prevent disease in vulnerable populations, includes:
- an intensive review of known pathways in Ebola pathophysiology to determine whether previously tested medicines can be used to help patients survive an Ebola infection, and
- additional support to the non-profit organization Direct Relief International to facilitate the air transport of a variety of infection prevention products to Liberia and Sierra Leone.
"Patients are at the heart of everything we do. Our primary goal in this escalating Ebola epidemic is to assist governments in protecting health care workers, families and populations who are at high risk of being infected with Ebola as soon as possible in an effort to stop the disease from spreading further," said Paul Stoffels, M.D., Chief Scientific Officer of Johnson & Johnson. "With a strong heritage in collaborative partnerships and a proven track record in the rapid development and access of innovative products, we aim to ultimately eradicate deadly diseases like Ebola and save lives around the world."
Crucell and Bavarian Nordic are both currently developing preventive vaccines against filoviruses, including Ebola virus, with direct funding and vaccine preclinical services from NIAID. In addition, the two companies have developed a combination regimen that harnesses the potency of both vaccines and could be used to elicit protective immunity against the Zaïre species of the Ebola virus, which is responsible for the current outbreak in West Africa. The combination vaccine provided complete protection of vaccinated macaques against disease and death after exposure to a highly virulent wildtype Ebola Zaire strain.
Based on these promising results, Bavarian Nordic, Crucell and NIAID intend to advance this development program to allow for initiation of a human trial in early 2015.
The combination regimen uses proven vaccine technology platforms from both companies that have shown to be immunogenic and safe when used in humans for other applications: to date more than 1,000 humans have received Crucell's adeno-platform based vaccine in clinical trials, while Bavarian Nordic's MVA-BN platform is the basis of the smallpox vaccine registered in Canada and Europe and stockpiled in the rest of the world with a safety record of use in more than 7,300 humans. In addition to the clinical advantage of the combination regimen, the collaboration also allows for faster production with each company taking on the production of one element of the combination regimen.
Crucell has been exploring vaccines as well as other related programs targeting diseases with potential widespread social impact in partnership with the NIH since 2002. This new research collaboration for a monovalent vaccine targeting the Zaire strain of the Ebola virus is part of an ongoing development program for a multivalent vaccine against all filoviruses that cause disease in humans, including Ebola and Marburg viruses.
"In light of the current emergency in West Africa and given the evident, huge unmet medical need, we are stepping up our efforts and accelerating the Ebola program currently in pre-clinical development," said Johan Van Hoof, M.D., Global Head, Infectious Diseases and Vaccines, Janssen and Managing Director, Crucell. "We recognize the urgency of the situation and the need to collaborate with multiple partners to develop treatment and preventive solutions for Ebola."
The emergence of Ebola in West Africa has also strained the health care systems of Liberia, Sierra Leone and Guinea. The company's long tradition of disaster response has prompted support of Direct Relief International's efforts in this area. Johnson & Johnson is also participating in the ongoing efforts by public health authorities, including the Centres for Disease Control and the WHO, to mount a coordinated world response to address the immediate needs raised by the Ebola outbreaks.
The Ebola virus belongs to a virus family called Filoviridae and can cause severe hemorrhagic fever in humans and nonhuman primates. Ebola has a mortality rate ranging from 50% to 90% according to the World Health Organization. The virus is highly prioritized by the U.S. Government, who has defined the virus as a "Category A" agent, due to its high mortality rate. Currently, no licensed vaccine, treatment or cure exists for this disease.
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 126,000 employees at more than 270 Johnson & Johnson operating companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
Crucell is part of the Janssen Pharmaceutical Companies of Johnson & Johnson, and is focused on research development and production of vaccines, proteins and antibodies that prevent and/or treat infectious diseases. Crucell is a major supplier of vaccines to UNICEF and the developing world. Crucell was the first manufacturer to launch a fully-liquid pentavalent vaccine named Quinvaxem®. With this innovation, Crucell has become a major partner in protecting children in developing countries against major infectious diseases. Crucell has a broad development pipeline, with several product candidates based on its unique AdVac® and/or PER.C6® production technology. Crucell licenses its PER.C6® technology and other technologies to the biopharmaceutical industry.
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in infectious diseases and vaccines, oncology, immunology, neuroscience, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Crucell N.V. and/or Johnson & Johnson.
Risks and uncertainties include, but are not limited to, challenges and uncertainties inherent in product development, including the timeline for the potential availability of a vaccine against Ebola.
A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2013, including in Exhibit 99 thereto, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statements as a result of new information or future events or developments.)
SOURCE Johnson & Johnson
The consumption economy is here and so are cloud applications and solutions that offer more than subscription and flat fee models and at the same time are available on a pure consumption model, which not only reduces IT spend but also lowers infrastructure costs, and offers ease of use and availability. In their session at 15th Cloud Expo, Ermanno Bonifazi, CEO & Founder of Solgenia, and Ian Khan, Global Strategic Positioning & Brand Manager at Solgenia, discussed this shifting dynamic with an ...
May. 26, 2015 02:00 AM EDT Reads: 3,109
As enterprises engage with Big Data technologies to develop applications needed to meet operational demands, new computation fabrics are continually being introduced. To leverage these new innovations, organizations are sacrificing market opportunities to gain expertise in learning new systems. In his session at Big Data Expo, Supreet Oberoi, Vice President of Field Engineering at Concurrent, Inc., discussed how to leverage existing infrastructure and investments and future-proof them against e...
May. 26, 2015 02:00 AM EDT Reads: 3,004
Due of the rise of Hadoop, many enterprises are now deploying their first small clusters of 10 to 20 servers. At this small scale, the complexity of operating the cluster looks and feels like general data center servers. It is not until the clusters scale, as they inevitably do, when the pain caused by the exponential complexity becomes apparent. We've seen this problem occur time and time again. In his session at Big Data Expo, Greg Bruno, Vice President of Engineering and co-founder of StackI...
May. 26, 2015 01:00 AM EDT Reads: 4,371
Once the decision has been made to move part or all of a workload to the cloud, a methodology for selecting that workload needs to be established. How do you move to the cloud? What does the discovery, assessment and planning look like? What workloads make sense? Which cloud model makes sense for each workload? What are the considerations for how to select the right cloud model? And how does that fit in with the overall IT transformation?
May. 26, 2015 12:00 AM EDT Reads: 4,169
The recent trends like cloud computing, social, mobile and Internet of Things are forcing enterprises to modernize in order to compete in the competitive globalized markets. However, enterprises are approaching newer technologies with a more silo-ed way, gaining only sub optimal benefits. The Modern Enterprise model is presented as a newer way to think of enterprise IT, which takes a more holistic approach to embracing modern technologies.
May. 25, 2015 11:00 PM EDT Reads: 5,908
For better or worse, DevOps has gone mainstream. All doubt was removed when IBM and HP threw up their respective DevOps microsites. Where are we on the hype cycle? It's hard to say for sure but there's a feeling we're heading for the "Peak of Inflated Expectations." What does this mean for the enterprise? Should they avoid DevOps? Definitely not. Should they be cautious though? Absolutely. The truth is that DevOps and the enterprise are at best strange bedfellows. The movement has its roots in t...
May. 25, 2015 10:00 PM EDT Reads: 6,201
The true value of the Internet of Things (IoT) lies not just in the data, but through the services that protect the data, perform the analysis and present findings in a usable way. With many IoT elements rooted in traditional IT components, Big Data and IoT isn’t just a play for enterprise. In fact, the IoT presents SMBs with the prospect of launching entirely new activities and exploring innovative areas. CompTIA research identifies several areas where IoT is expected to have the greatest impac...
May. 25, 2015 09:00 PM EDT Reads: 4,735
There is little doubt that Big Data solutions will have an increasing role in the Enterprise IT mainstream over time. 8th International Big Data Expo, co-located with 17th International Cloud Expo - to be held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA - has announced its Call for Papers is open. As advanced data storage, access and analytics technologies aimed at handling high-volume and/or fast moving data all move center stage, aided by the cloud computing bo...
May. 25, 2015 08:45 PM EDT Reads: 1,352
Every day we read jaw-dropping stats on the explosion of data. We allocate significant resources to harness and better understand it. We build businesses around it. But we’ve only just begun. For big payoffs in Big Data, CIOs are turning to cognitive computing. Cognitive computing’s ability to securely extract insights, understand natural language, and get smarter each time it’s used is the next, logical step for Big Data.
May. 25, 2015 08:00 PM EDT Reads: 1,858
There's no doubt that the Internet of Things is driving the next wave of innovation. Google has spent billions over the past few months vacuuming up companies that specialize in smart appliances and machine learning. Already, Philips light bulbs, Audi automobiles, and Samsung washers and dryers can communicate with and be controlled from mobile devices. To take advantage of the opportunities the Internet of Things brings to your business, you'll want to start preparing now.
May. 25, 2015 07:00 PM EDT Reads: 5,703
The 4th International Internet of @ThingsExpo, co-located with the 17th International Cloud Expo - to be held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA - announces that its Call for Papers is open. The Internet of Things (IoT) is the biggest idea since the creation of the Worldwide Web more than 20 years ago.
May. 25, 2015 07:00 PM EDT Reads: 1,510
Enterprises are fast realizing the importance of integrating SaaS/Cloud applications, API and on-premises data and processes, to unleash hidden value. This webinar explores how managers can use a Microservice-centric approach to aggressively tackle the unexpected new integration challenges posed by proliferation of cloud, mobile, social and big data projects. Industry analyst and SOA expert Jason Bloomberg will strip away the hype from microservices, and clearly identify their advantages and d...
May. 25, 2015 07:00 PM EDT Reads: 1,311
In a world of ever-accelerating business cycles and fast-changing client expectations, the cloud increasingly serves as a growth engine and a path to new business models. Dynamic clouds enable businesses to continuously reinvent themselves, adapting their business processes, their service and software delivery and their operations to achieve speed-to-market and quick response to customer feedback. As the cloud evolves, the industry has multiple competing cloud technologies, offering on-premises ...
May. 25, 2015 06:00 PM EDT Reads: 3,945
The 5th International DevOps Summit, co-located with 17th International Cloud Expo – being held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA – announces that its Call for Papers is open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the...
May. 25, 2015 05:30 PM EDT Reads: 3,925
Over the years, a variety of methodologies have emerged in order to overcome the challenges related to project constraints. The successful use of each methodology seems highly context-dependent. However, communication seems to be the common denominator of the many challenges that project management methodologies intend to resolve. In this respect, Information and Communication Technologies (ICTs) can be viewed as powerful tools for managing projects. Few research papers have focused on the way...
May. 25, 2015 05:00 PM EDT Reads: 1,667