Click here to close now.




















Welcome!

Agile Computing Authors: Eric Aarrestad, Liz McMillan, Pat Romanski, Dana Gardner, Qamar Qrsh

News Feed Item

Halozyme Announces Roche Marketing Authorization For MabThera SC For Patients With Common Forms Of Non-Hodgkin Lymphoma In European Union

MabThera SC offers a faster administration time for patients in Europe while potentially saving valuable time for health systems

SAN DIEGO, March 28, 2014 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) announced today that the European Commission (EC) has approved Roche's new subcutaneous (SC) formulation of MabThera® (rituximab) for the treatment of patients with follicular lymphoma and diffuse large B-cell lymphoma. Following the approval of Herceptin SC in September 2013, this is the second European approval for a novel subcutaneous formulation of one of Roche's oncology products using Halozyme's patented Enhanze (recombinant human hyaluronidase) technology.

Halozyme Therapeutics, Inc. Logo.

"Today's approval in the EU offers another treatment option for patients with common forms of non-Hodgkin lymphoma and is yet another validating milestone for our proprietary technology," said Dr. Helen Torley, President and Chief Executive Officer. "With an administration time of approximately five minutes compared to the approximately 2.5 hour infusion time for intravenous MabThera, this innovative formulation could potentially save time for patients, physicians and other health care providers in Europe."

The European approval was primarily based on data from the pivotal SABRINA study, which was recently published in the Lancet Oncology[i].

Roche has stated that they expect to begin launching MabThera SC in a number of European markets throughout 2014.

About non-Hodgkin lymphoma
There are two main types of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma (NHL). NHL represents approximately 85% of all lymphoma diagnosed[ii] and was responsible for approximately 200,000 annual deaths worldwide in 2012[iii].

Lymphomas are a cancer of the lymphatic system (composed of lymph vessels, lymph nodes and organs) which helps to keep the bodily fluid levels balanced and to defend the body against invasion by disease. 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.

Halozyme-Roche Collaboration
In December 2006, Halozyme entered into an agreement with Roche to apply Halozyme's patented Enhanze™ technology (recombinant human hyaluronidase or rHuPH20) 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.  

About Halozyme
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 oncology, diabetes and dermatology that have significant unmet medical need today. The Company markets Hylenex® recombinant (hyaluronidase human injection) and has partnerships with Roche, Pfizer and Baxter. 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 Halozyme-Roche 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 product candidates under the Halozyme-Roche collaboration by applicable regulatory authorities; 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 Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2014. Halozyme does not undertake to update its forward-looking statements.

References:


[i] Davies, A. et al. (2014) Pharmacokinetics and safety of subcutaneous rituximab in follicular lymphoma (SABRINA): stage 1 analysis of a randomised phase 3 study The Lancet Oncology, Early Online Publication, 10 February 2014
doi:10.1016/S1470-2045(14)70005-1
[ii] Globocan (2012) Table by cancers. Worldwide incidence of cancers in males and females.
http://globocan.iarc.fr/ (URL accessed 3.03.14).
[iii] Globocan (2012) Cancer Incidence and Mortality Worldwide. World, non-Hodgkin lymphoma, 2010. (URL accessed 18.09.13). http://globocan.iarc.fr/Pages/fact_sheets_population.aspx
(URL accessed 03.03.14).

Investor Contact:
Schond Greenway
Halozyme Therapeutics
858-704-8352
[email protected]

Logo - http://photos.prnewswire.com/prnh/20100302/LA63139LOGO

SOURCE Halozyme Therapeutics, Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

@ThingsExpo Stories
For IoT to grow as quickly as analyst firms’ project, a lot is going to fall on developers to quickly bring applications to market. But the lack of a standard development platform threatens to slow growth and make application development more time consuming and costly, much like we’ve seen in the mobile space. In his session at @ThingsExpo, Mike Weiner, Product Manager of the Omega DevCloud with KORE Telematics Inc., discussed the evolving requirements for developers as IoT matures and conducted a live demonstration of how quickly application development can happen when the need to comply wit...
Explosive growth in connected devices. Enormous amounts of data for collection and analysis. Critical use of data for split-second decision making and actionable information. All three are factors in making the Internet of Things a reality. Yet, any one factor would have an IT organization pondering its infrastructure strategy. How should your organization enhance its IT framework to enable an Internet of Things implementation? In his session at @ThingsExpo, James Kirkland, Red Hat's Chief Architect for the Internet of Things and Intelligent Systems, described how to revolutionize your archit...
SYS-CON Events announced today that HPM Networks will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. For 20 years, HPM Networks has been integrating technology solutions that solve complex business challenges. HPM Networks has designed solutions for both SMB and enterprise customers throughout the San Francisco Bay Area.
MuleSoft has announced the findings of its 2015 Connectivity Benchmark Report on the adoption and business impact of APIs. The findings suggest traditional businesses are quickly evolving into "composable enterprises" built out of hundreds of connected software services, applications and devices. Most are embracing the Internet of Things (IoT) and microservices technologies like Docker. A majority are integrating wearables, like smart watches, and more than half plan to generate revenue with APIs within the next year.
The Internet of Everything (IoE) brings together people, process, data and things to make networked connections more relevant and valuable than ever before – transforming information into knowledge and knowledge into wisdom. IoE creates new capabilities, richer experiences, and unprecedented opportunities to improve business and government operations, decision making and mission support capabilities.
Growth hacking is common for startups to make unheard-of progress in building their business. Career Hacks can help Geek Girls and those who support them (yes, that's you too, Dad!) to excel in this typically male-dominated world. Get ready to learn the facts: Is there a bias against women in the tech / developer communities? Why are women 50% of the workforce, but hold only 24% of the STEM or IT positions? Some beginnings of what to do about it! In her Opening Keynote at 16th Cloud Expo, Sandy Carter, IBM General Manager Cloud Ecosystem and Developers, and a Social Business Evangelist, d...
In his keynote at 16th Cloud Expo, Rodney Rogers, CEO of Virtustream, discussed the evolution of the company from inception to its recent acquisition by EMC – including personal insights, lessons learned (and some WTF moments) along the way. Learn how Virtustream’s unique approach of combining the economics and elasticity of the consumer cloud model with proper performance, application automation and security into a platform became a breakout success with enterprise customers and a natural fit for the EMC Federation.
The Internet of Things is not only adding billions of sensors and billions of terabytes to the Internet. It is also forcing a fundamental change in the way we envision Information Technology. For the first time, more data is being created by devices at the edge of the Internet rather than from centralized systems. What does this mean for today's IT professional? In this Power Panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists addressed this very serious issue of profound change in the industry.
Discussions about cloud computing are evolving into discussions about enterprise IT in general. As enterprises increasingly migrate toward their own unique clouds, new issues such as the use of containers and microservices emerge to keep things interesting. In this Power Panel at 16th Cloud Expo, moderated by Conference Chair Roger Strukhoff, panelists addressed the state of cloud computing today, and what enterprise IT professionals need to know about how the latest topics and trends affect their organization.
It is one thing to build single industrial IoT applications, but what will it take to build the Smart Cities and truly society-changing applications of the future? The technology won’t be the problem, it will be the number of parties that need to work together and be aligned in their motivation to succeed. In his session at @ThingsExpo, Jason Mondanaro, Director, Product Management at Metanga, discussed how you can plan to cooperate, partner, and form lasting all-star teams to change the world and it starts with business models and monetization strategies.
Converging digital disruptions is creating a major sea change - Cisco calls this the Internet of Everything (IoE). IoE is the network connection of People, Process, Data and Things, fueled by Cloud, Mobile, Social, Analytics and Security, and it represents a $19Trillion value-at-stake over the next 10 years. In her keynote at @ThingsExpo, Manjula Talreja, VP of Cisco Consulting Services, discussed IoE and the enormous opportunities it provides to public and private firms alike. She will share what businesses must do to thrive in the IoE economy, citing examples from several industry sectors.
There will be 150 billion connected devices by 2020. New digital businesses have already disrupted value chains across every industry. APIs are at the center of the digital business. You need to understand what assets you have that can be exposed digitally, what their digital value chain is, and how to create an effective business model around that value chain to compete in this economy. No enterprise can be complacent and not engage in the digital economy. Learn how to be the disruptor and not the disruptee.
Akana has released Envision, an enhanced API analytics platform that helps enterprises mine critical insights across their digital eco-systems, understand their customers and partners and offer value-added personalized services. “In today’s digital economy, data-driven insights are proving to be a key differentiator for businesses. Understanding the data that is being tunneled through their APIs and how it can be used to optimize their business and operations is of paramount importance,” said Alistair Farquharson, CTO of Akana.
Business as usual for IT is evolving into a "Make or Buy" decision on a service-by-service conversation with input from the LOBs. How does your organization move forward with cloud? In his general session at 16th Cloud Expo, Paul Maravei, Regional Sales Manager, Hybrid Cloud and Managed Services at Cisco, discusses how Cisco and its partners offer a market-leading portfolio and ecosystem of cloud infrastructure and application services that allow you to uniquely and securely combine cloud business applications and services across multiple cloud delivery models.
The enterprise market will drive IoT device adoption over the next five years. In his session at @ThingsExpo, John Greenough, an analyst at BI Intelligence, division of Business Insider, analyzed how companies will adopt IoT products and the associated cost of adopting those products. John Greenough is the lead analyst covering the Internet of Things for BI Intelligence- Business Insider’s paid research service. Numerous IoT companies have cited his analysis of the IoT. Prior to joining BI Intelligence, he worked analyzing bank technology for Corporate Insight and The Clearing House Payment...
"Optimal Design is a technology integration and product development firm that specializes in connecting devices to the cloud," stated Joe Wascow, Co-Founder & CMO of Optimal Design, in this SYS-CON.tv interview at @ThingsExpo, held June 9-11, 2015, at the Javits Center in New York City.
SYS-CON Events announced today that CommVault has been named “Bronze Sponsor” of SYS-CON's 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. A singular vision – a belief in a better way to address current and future data management needs – guides CommVault in the development of Singular Information Management® solutions for high-performance data protection, universal availability and simplified management of data on complex storage networks. CommVault's exclusive single-platform architecture gives companies unp...
Electric Cloud and Arynga have announced a product integration partnership that will bring Continuous Delivery solutions to the automotive Internet-of-Things (IoT) market. The joint solution will help automotive manufacturers, OEMs and system integrators adopt DevOps automation and Continuous Delivery practices that reduce software build and release cycle times within the complex and specific parameters of embedded and IoT software systems.
"ciqada is a combined platform of hardware modules and server products that lets people take their existing devices or new devices and lets them be accessible over the Internet for their users," noted Geoff Engelstein of ciqada, a division of Mars International, in this SYS-CON.tv interview at @ThingsExpo, held June 9-11, 2015, at the Javits Center in New York City.
Internet of Things is moving from being a hype to a reality. Experts estimate that internet connected cars will grow to 152 million, while over 100 million internet connected wireless light bulbs and lamps will be operational by 2020. These and many other intriguing statistics highlight the importance of Internet powered devices and how market penetration is going to multiply many times over in the next few years.