|By PR Newswire||
|January 24, 2014 11:33 AM EST||
SAN DIEGO, Jan. 24, 2014 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) announced today that the EU Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Commission approve Roche's subcutaneous (SC) formulation of MabThera® (rituximab) using Halozyme's recombinant human hyaluronidase (rHuPH20) for the treatment of patients with common forms of non-Hodgkin lymphoma (NHL).
"This subcutaneous formulation of MabThera, pending approval in the EU, provides a new route of administration and a shortened treatment time of approximately five minutes that could potentially save time for NHL patients, physicians and other health care providers in Europe," said Dr. Helen Torley, President and Chief Executive Officer, Halozyme Therapeutics. "We are excited that our technology has helped enable this potential new treatment option for patients in Europe."
Currently, MabThera is delivered by an intravenous infusion which takes approximately 2.5 hours. The new MabThera SC formulation comes as a ready-to-use, fixed dose, 1,400 mg solution, which shortens pharmacy preparation time and reduces the overall impact on hospital resources.
The CHMP opinion is based primarily on data from Roche's Phase 3 SABRINA study. Roche expects a final decision from the European Commission in the coming months.
About Non-Hodgkin Lymphoma
There are two main types of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Non-Hodgkin lymphomas are difficult-to-treat and represent approximately 84% of lymphoma diagnoses1. NHL was responsible for over 200,000 annual deaths worldwide in 20102.
Lymphomas are a cancer of the lymphatic system (composed of lymph vessels, lymph nodes and organs) which helps to keep the body fluid levels balanced and to defend the body against infectious diseases. Lymphoma develops when white blood cells (usually B-lymphocytes) in the lymph fluid become cancerous and begin to multiply and collect in the lymph nodes or lymphatic tissues such as the spleen. Some of these cells are released into the bloodstream and spread around the body, interfering with the body's production of healthy blood cells.
In December 2006, Halozyme entered into an agreement with Roche to apply Halozyme's proprietary Enhanze™ technology to Roche's biological therapeutic compounds. To date, Roche has elected to explore the use of rHuPH20 for up to a total of five exclusive targets, and Roche retains the option to apply rHuPH20 to three additional targets through the payment of annual license maintenance fees. Subject to the successful achievement of clinical, regulatory, and sales events, Roche will pay Halozyme additional milestones as well as royalties on product sales for Herceptin SC, MabThera SC and any other product candidates which would be successfully developed and commercialized under the agreement.
Halozyme Therapeutics is a biopharmaceutical company dedicated to developing and commercializing innovative products that advance patient care. With a diversified portfolio of enzymes that target the extracellular matrix, the Company's research focuses primarily on a family of human enzymes, known as hyaluronidases, which increase the dispersion and absorption of biologics, drugs and fluids. Halozyme's pipeline addresses therapeutic areas, including diabetes, oncology and dermatology that have significant unmet medical need. The Company markets Hylenex® recombinant (hyaluronidase human injection) and has partnerships with Roche, Pfizer, Baxter, and Intrexon. Halozyme is headquartered in San Diego, CA. For more information on how we are innovating, please visit our corporate website at www.halozyme.com and follow us on Twitter @HALOTherapeutic.
Safe Harbor Statement
This release includes forward-looking statements such as the potential benefits of MabThera SC to patients, physicians and the healthcare system, and the possible receipt by Halozyme of future milestones and royalties under the Roche/Halozyme collaboration agreement. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: the approval of MabThera SC and other product candidates under the Halozyme-Roche Collaboration by the European Commission; satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; issues encountered in the sale of MabThera SC and other product candidates under the Halozyme-Roche Collaboration including the countries where the product is approved, approval timelines, the rate of conversion of IV formulation users to SC users, pricing and other commercial factors; unexpected adverse events; changes in laws and regulations; competitive conditions; and other risks identified in Halozyme's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 8, 2013. Halozyme does not undertake to update its forward-looking statements.
1Globocan (2008) Table by cancers.Worldwide incidence of cancers in males and females.
http://globocan.iarc.fr/ (URL accessed 18.09.13).
2Globocan (2008) Cancer Incidence and Mortality Worldwide.World, non-Hodgkin lymphoma, 2010.http://globocan.iarc.fr/burden.asp?selection_pop=220900&Text-p=World&selection_cancer=18250&Text-c=Non-Hodgkin+lymphoma&pYear=2&type=1&window=1&submit=%A0Execute%A0(URL accessed 18.09.13).
SOURCE Halozyme Therapeutics, Inc.
The IoTs will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform. In his session at @ThingsExpo, Craig Sproule, CEO of Metavine, will demonstrate how to move beyond today's coding paradigm and share the must-have mindsets for removing complexity from the development proc...
May. 30, 2016 06:00 AM EDT Reads: 2,000
SYS-CON Events announced today TechTarget has been named “Media Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. TechTarget is the Web’s leading destination for serious technology buyers researching and making enterprise technology decisions. Its extensive global networ...
May. 30, 2016 05:30 AM EDT Reads: 3,292
SYS-CON Events announced today that Commvault, a global leader in enterprise data protection and information management, has been named “Bronze Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Commvault is a leading provider of data protection and information management...
May. 30, 2016 04:45 AM EDT Reads: 3,298
The essence of data analysis involves setting up data pipelines that consist of several operations that are chained together – starting from data collection, data quality checks, data integration, data analysis and data visualization (including the setting up of interaction paths in that visualization). In our opinion, the challenges stem from the technology diversity at each stage of the data pipeline as well as the lack of process around the analysis.
May. 30, 2016 03:15 AM EDT Reads: 1,532
A strange thing is happening along the way to the Internet of Things, namely far too many devices to work with and manage. It has become clear that we'll need much higher efficiency user experiences that can allow us to more easily and scalably work with the thousands of devices that will soon be in each of our lives. Enter the conversational interface revolution, combining bots we can literally talk with, gesture to, and even direct with our thoughts, with embedded artificial intelligence, wh...
May. 30, 2016 03:00 AM EDT Reads: 2,083
Designing IoT applications is complex, but deploying them in a scalable fashion is even more complex. A scalable, API first IaaS cloud is a good start, but in order to understand the various components specific to deploying IoT applications, one needs to understand the architecture of these applications and figure out how to scale these components independently. In his session at @ThingsExpo, Nara Rajagopalan is CEO of Accelerite, will discuss the fundamental architecture of IoT applications, ...
May. 30, 2016 03:00 AM EDT Reads: 1,387
SYS-CON Events announced today that Tintri Inc., a leading producer of VM-aware storage (VAS) for virtualization and cloud environments, will exhibit at the 18th International CloudExpo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, New York, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
May. 30, 2016 02:45 AM EDT Reads: 2,522
SYS-CON Events announced today that MangoApps will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. MangoApps provides modern company intranets and team collaboration software, allowing workers to stay connected and productive from anywhere in the world and from any device. For more information, please visit https://www.mangoapps.com/.
May. 30, 2016 02:45 AM EDT Reads: 1,066
SYS-CON Events announced today that Alert Logic, Inc., the leading provider of Security-as-a-Service solutions for the cloud, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Alert Logic, Inc., provides Security-as-a-Service for on-premises, cloud, and hybrid infrastructures, delivering deep security insight and continuous protection for customers at a lower cost than traditional security solutions. Ful...
May. 30, 2016 02:15 AM EDT Reads: 3,003
In his session at 18th Cloud Expo, Bruce Swann, Senior Product Marketing Manager at Adobe, will discuss how the Adobe Marketing Cloud can help marketers embrace opportunities for personalized, relevant and real-time customer engagement across offline (direct mail, point of sale, call center) and digital (email, website, SMS, mobile apps, social networks, connected objects). Bruce Swann has more than 15 years of experience working with digital marketing disciplines like web analytics, social med...
May. 30, 2016 02:00 AM EDT Reads: 1,479
SYS-CON Events announced today Object Management Group® has been named “Media Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
May. 30, 2016 01:00 AM EDT Reads: 2,688
SYS-CON Events announced today that EastBanc Technologies will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. EastBanc Technologies has been working at the frontier of technology since 1999. Today, the firm provides full-lifecycle software development delivering flexible technology solutions that seamlessly integrate with existing systems – whether on premise or cloud. EastBanc Technologies partners with p...
May. 29, 2016 10:00 PM EDT Reads: 2,413
SYS-CON Events announced today that ContentMX, the marketing technology and services company with a singular mission to increase engagement and drive more conversations for enterprise, channel and SMB technology marketers, has been named “Sponsor & Exhibitor Lounge Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York City, New York. “CloudExpo is a great opportunity to start a conversation with new prospects, but what happens after the...
May. 29, 2016 04:45 PM EDT Reads: 1,343
WebRTC is bringing significant change to the communications landscape that will bridge the worlds of web and telephony, making the Internet the new standard for communications. Cloud9 took the road less traveled and used WebRTC to create a downloadable enterprise-grade communications platform that is changing the communication dynamic in the financial sector. In his session at @ThingsExpo, Leo Papadopoulos, CTO of Cloud9, will discuss the importance of WebRTC and how it enables companies to fo...
May. 29, 2016 04:15 PM EDT Reads: 2,615
The IoT is changing the way enterprises conduct business. In his session at @ThingsExpo, Eric Hoffman, Vice President at EastBanc Technologies, discuss how businesses can gain an edge over competitors by empowering consumers to take control through IoT. We'll cite examples such as a Washington, D.C.-based sports club that leveraged IoT and the cloud to develop a comprehensive booking system. He'll also highlight how IoT can revitalize and restore outdated business models, making them profitable...
May. 29, 2016 02:00 PM EDT Reads: 3,009
Customer experience has become a competitive differentiator for companies, and it’s imperative that brands seamlessly connect the customer journey across all platforms. With the continued explosion of IoT, join us for a look at how to build a winning digital foundation in the connected era – today and in the future. In his session at @ThingsExpo, Chris Nguyen, Group Product Marketing Manager at Adobe, will discuss how to successfully leverage mobile, rapidly deploy content, capture real-time d...
May. 29, 2016 12:45 PM EDT Reads: 1,704
What a difference a year makes. Organizations aren’t just talking about IoT possibilities, it is now baked into their core business strategy. With IoT, billions of devices generating data from different companies on different networks around the globe need to interact. From efficiency to better customer insights to completely new business models, IoT will turn traditional business models upside down. In the new customer-centric age, the key to success is delivering critical services and apps wit...
May. 29, 2016 10:30 AM EDT Reads: 1,313
Join us at Cloud Expo | @ThingsExpo 2016 – June 7-9 at the Javits Center in New York City and November 1-3 at the Santa Clara Convention Center in Santa Clara, CA – and deliver your unique message in a way that is striking and unforgettable by taking advantage of SYS-CON's unmatched high-impact, result-driven event / media packages.
May. 29, 2016 10:00 AM EDT Reads: 2,562
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, will provide an overview of the evolution of the Internet and the Database and the future of their combination – the Blockchain. Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life ...
May. 29, 2016 09:45 AM EDT Reads: 2,047
SYS-CON Events announced today that BMC Software has been named "Siver Sponsor" of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. BMC is a global leader in innovative software solutions that help businesses transform into digital enterprises for the ultimate competitive advantage. BMC Digital Enterprise Management is a set of innovative IT solutions designed to make digital business fast, seamless, and optimized from mainframe to mo...
May. 29, 2016 09:30 AM EDT Reads: 2,331