Click here to close now.


News Feed Item

Halozyme Announced Roche Filed A Marketing Authorization Application For Subcutaneous MabThera

Filing Triggered a $4 Million Milestone Payment to Halozyme From Roche

SAN DIEGO, Dec. 8, 2012 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that Roche has submitted a line extension application to the European Medicines Agency for a subcutaneous (SC) formulation of MabThera® (rituxumab). The filing of the application triggered a $4 million milestone payment to Halozyme under the License and Collaboration Agreement between Halozyme and Roche.


"This regulatory filing brings patients and physicians one step closer to an enhanced treatment option for Non-Hodgkin Lymphoma," said Gregory I. Frost, Ph.D., Halozyme's President and Chief Executive Officer. "Offering a subcutaneous formulation of MabThera could provide patients with a therapy which is less invasive, shortens administration times and potentially reduces healthcare costs."

Roche reported positive data today from two clinical studies of MabThera given by subcutaneous injection at the 54th annual meeting of the American Society of Hematology (ASH). The pivotal study data presented showed that SC administration of MabThera enabled the delivery of MabThera over approximately five minutes without compromising its proven efficacy and safety. Both studies showed that a fixed dose of MabThera can be administered subcutaneously, potentially allowing patients to spend less time in infusion centers receiving their MabThera treatment. Specifically, the studies showed that SC injection resulted in non-inferior MabThera concentrations in the blood (pharmacokinetics; PK) compared with standard intravenous (IV) infusion. Overall, SC and IV adverse event profiles were similar and administration related reactions were mostly of mild to moderate intensity. (For more detailed information on the studies, see Roche's media release issued earlier today.)

Currently, MabThera is available as an IV formulation. MabThera SC uses Halozyme's Enhanze™ Technology which enables the injection of large volumes of a medication under the skin. In a clinical study, patients were able to receive MabThera over approximately 5 minutes via SC injection versus a few hours with IV-infused MabThera.

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, that increase the absorption and dispersion of biologics. Halozyme's pipeline addresses therapeutic areas, such as diabetes, oncology and dermatology that have significant unmet medical need. The Company markets HYLENEX® recombinant (hyaluronidase human injection) and has partnerships with Roche, Baxter, ViroPharma and Intrexon. Halozyme is headquartered in San Diego, CA. For more information on how we are innovating, please visit our corporate website at

Safe Harbor Statement

In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the potential regulatory approval and commercial availability of MabThera SC and the potential benefits and attributes of MabThera SC) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are also identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including unexpected clinical trial results, delays in development and regulatory review, regulatory approval requirements, unexpected adverse event and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the company's reports on Forms 10-K, 10-Q, and other filings with the Securities and Exchange Commission.

Media/Investor Contact:
Anne Erickson
Executive Director
Halozyme Therapeutics
[email protected]

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.

Latest Stories
SYS-CON Events announced today that G2G3 will exhibit at SYS-CON's @DevOpsSummit Silicon Valley, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Based on a collective appreciation for user experience, design, and technology, G2G3 is uniquely qualified and motivated to redefine how organizations and people engage in an increasingly digital world.
According to Forrester, public cloud platforms are evolving, blurring the lines between Software as a Service (SaaS), Infrastructure as a Service (IaaS), and Platform as a Service (PaaS) in order to satisfy the needs of enterprises and widen their appeal to developers. In The Forrester Wave™: Enterprise Public Cloud Platforms, Q4 2014, Forrester evaluates the 16 most significant Enterprise Public Cloud Platforms and details how each vendor fulfills the 19 evaluation criteria points.
Scott Guthrie's keynote presentation "Journey to the intelligent cloud" is a must view video. This is from AzureCon 2015, September 29, 2015 I have reproduced some screen shots in case you are unable to view this long video for one reason or another. One of the highlights is 3 datacenters coming on line in India.
The broad selection of hardware, the rapid evolution of operating systems and the time-to-market for mobile apps has been so rapid that new challenges for developers and engineers arise every day. Security, testing, hosting, and other metrics have to be considered through the process. In his session at Big Data Expo, Walter Maguire, Chief Field Technologist, HP Big Data Group, at Hewlett-Packard, will discuss the challenges faced by developers and a composite Big Data applications builder, foc...
In his session at @ThingsExpo, Tony Shan, Chief Architect at CTS, will explore the synergy of Big Data and IoT. First he will take a closer look at the Internet of Things and Big Data individually, in terms of what, which, why, where, when, who, how and how much. Then he will explore the relationship between IoT and Big Data. Specifically, he will drill down to how the 4Vs aspects intersect with IoT: Volume, Variety, Velocity and Value. In turn, Tony will analyze how the key components of IoT ...
Recently announced Azure Data Lake addresses the big data 3V challenges; volume, velocity and variety. It is one more storage feature in addition to blobs and SQL Azure database. Azure Data Lake (should have been Azure Data Ocean IMHO) is really omnipotent. Just look at the key capabilities of Azure Data Lake:
The cloud has reached mainstream IT. Those 18.7 million data centers out there (server closets to corporate data centers to colocation deployments) are moving to the cloud. In his session at 17th Cloud Expo, Achim Weiss, CEO & co-founder of ProfitBricks, will share how two companies – one in the U.S. and one in Germany – are achieving their goals with cloud infrastructure. More than a case study, he will share the details of how they prioritized their cloud computing infrastructure deployments ...
Interested in leveraging automation technologies and a cloud architecture to make developers more productive? Learn how PaaS can benefit your organization to help you streamline your application development, allow you to use existing infrastructure and improve operational efficiencies. Begin charting your path to PaaS with OpenShift Enterprise.
Decisions about budgets and resources are often made without IT even having a seat at the table. As technologist we understand the value of DevOps - but do your business counterparts? If they don't, your DevOps initiatives could lose funding before they start. In her session at DevOps Summit, Jeanne Morain, Strategist / Author at iSpeak Cloud, LLC, will provide insights on how to bridge the gap between business and technology leaders. Attendees will learn prescriptive guidance on balancing wor...
The modern software development landscape consists of best practices and tools that allow teams to deliver software in a near-continuous manner. By adopting a culture of automation, measurement and sharing, the time to ship code has been greatly reduced, allowing for shorter release cycles and quicker feedback from customers and users. Still, with all of these tools and methods, how can teams stay on top of what is taking place across their infrastructure and codebase? Hopping between services a...
SYS-CON Events announced today that Secure Infrastructure & Services will exhibit at 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. Secure Infrastructure & Services (SIAS) is a managed services provider of cloud computing solutions for the IBM Power Systems market. The company helps mid-market firms built on IBM hardware platforms to deploy new levels of reliable and cost-effective computing and hig...
When it comes to IoT in the enterprise, namely the commercial building and hospitality markets, a benefit not getting the attention it deserves is energy efficiency, and IoT’s direct impact on a cleaner, greener environment when installed in smart buildings. Until now clean technology was offered piecemeal and led with point solutions that require significant systems integration to orchestrate and deploy. There didn't exist a 'top down' approach that can manage and monitor the way a Smart Buildi...
SYS-CON Events announced today that IBM Cloud Data Services has been named “Bronze Sponsor” of SYS-CON's 17th Cloud Expo, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. IBM Cloud Data Services offers a portfolio of integrated, best-of-breed cloud data services for developers focused on mobile computing and analytics use cases.
Today, we are in the middle of a paradigm shift as we move from managing applications on VMs and containers to embracing everything that the cloud and XaaS (Everything as a Service) has to offer. In his session at 17th Cloud Expo, Kevin Hoffman, Advisory Solutions Architect at Pivotal Cloud Foundry, will provide an overview of 12-factor apps and migrating enterprise apps to the cloud. Kevin Hoffman is an Advisory Solutions Architect for Pivotal Cloud Foundry, and has spent the past 20 years b...
While testing is often ignored when it comes to DevOps - it could be the most important aspect of achieving true DevOps success. Without rethinking automated testing from the ground-up, the entire DevOps productivity gain cannot be realized. Large tech companies build their own rapid test automation that runs in minutes across functional, performance, security and other tests. In his session at DevOps Summit, Kevin Surace, CEO of Appvance, will discuss how we learn from these real-world succe...