Navigation Links
Halozyme Provides Update on ViroPharma Phase 2 Trial of Subcutaneous Cinryze (C1 Esterase Inhibitor [Human]) Formulation with rHuPH20

SAN DIEGO, Aug. 1, 2013 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) announced that following discussions with the Center for Biologics Evaluation and Research (CBER) division of the U.S. Food and Drug Administration, ViroPharma will be discontinuing their Phase 2 study of subcutaneous Cinryze (C1 Esterase Inhibitor [Human]) with recombinant human hyaluronidase (rHuPH20).  The discontinuation of the study is a precaution related to the emergence of an unexpected incidence and titer of non-neutralizing anti-rHuPH20 antibodies in a number of patients with the formulation being used in this study. These antibodies have not been associated with any adverse clinical effects.


"Given the profile of this clinical formulation and the time required to enable ViroPharma to move forward with this formulation, we support ViroPharma's business decision," said Gregory I. Frost, Ph.D., President and Chief Executive Officer, Halozyme.  "We have accumulated a robust data set regarding the clinical use of rHuPH20 across many different programs and indications, and feel confident about the safety profile of the rHuPH20 platform that has emerged from this clinical use and its continued application in our other products and programs around the world."

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 absorption and dispersion 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, ViroPharma and Intrexon. Halozyme is headquartered in San Diego, CA. For more information on how we are innovating, please visit our corporate website at

Halozyme Safe Harbor Statement

In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning our product candidates in development, potential benefits and attributes of rHuPH20 and our product candidates including safety and clinical profile, anticipated clinical and regulatory events and our intended actions, 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 usually (but not always) 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 risks and uncertainties including clinical trial enrollment and results, regulatory approval requirements, unexpected expenditures and costs, unexpected results or delays in development and regulatory review, unexpected adverse events and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 8, 2013. Halozyme does not undertake to update these forward-looking statements.

Investor Contact:
David Ramsay
Halozyme Therapeutics

Media Contact:
Nurha Hindi
Hill+Knowlton Strategies


SOURCE Halozyme Therapeutics, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Halozyme to Host Second Quarter 2013 Financial Results Conference Call
2. Halozymes Phase 1b Clinical Trial Of PEGPH20 With Gemcitabine Indicates Positive Activity Against Pancreatic Cancer
3. Halozyme Therapeutics Names David A. Ramsay Chief Financial Officer
4. Halozyme Reports First Quarter 2013 Financial Results
5. Halozyme Therapeutics To Present At The Bank Of America Merrill Lynch 2013 Health Care Conference
6. Halozyme Therapeutics Names Matt Posard to Board of Directors
7. Baxter And Halozyme Announce Positive Opinion For HyQvia For Treatment Of Primary And Secondary Immunodeficiencies In The European Union
8. Halozyme Therapeutics to Present at the Barclays 2013 Global Healthcare Conference
9. Halozyme Reports Fourth Quarter and Year End 2012 Financial Results
10. Halozyme Announced Roche Filed A Marketing Authorization Application For Subcutaneous MabThera
11. Halozyme Therapeutics To Present At The Lazard Capital Markets 9th Annual Healthcare Conference
Post Your Comments:
(Date:10/13/2015)... , Oct. 13, 2015  EndoChoice Holdings, Inc. ... third quarter 2015 financial results on Thursday, November 5, ... . --> . ... Thursday, November 5, 2015 at 9:00 a.m. ET to ... for domestic callers and (412) 317-5469 for international callers. ...
(Date:10/13/2015)... , Oct. 13, 2015   Rosa & ... firm in Quantitative Systems Pharmacology (QSP)/ PhysioPD™ , today ... will lead a workshop at the QSP Congress ... Boston, MA.  The conference focuses ... drug development.  Dr. Friedrich,s workshop is entitled "Using Mechanistic ...
(Date:10/13/2015)... 13, 2015  Yesterday Congresswoman Renee Ellmers ... manufacturing site located in Holly Springs, NC ... produced Flucelvax ® (Influenza Vaccine) using cell-culture technology, a ... start-up and is not reliant on chicken eggs. 1,2 ... influenza vaccines business of Novartis AG in the US, ...
Breaking Medicine Technology:
(Date:10/13/2015)... ... 2015 , ... Tempe Dental Care, a leading Tempe dentists’ office, celebrates offering ... dentistry for more than 5 years. A leading cause of emergency room visits, ... treatment is not timely. , Sedation dentistry provides an anxiety-free dental ...
(Date:10/13/2015)... (PRWEB) , ... October 13, 2015 , ... Local Gold’s ... Gold’s Gym International Conference on August 26. Berry, who owns and operates Gold's ... for the fastest growing Gold’s Gyms in the United States. A brand leader in ...
(Date:10/13/2015)... , ... October 13, 2015 , ... ... Bill Saye as the newest professional to introduce the latest development, ThermiVa® temperature ... recognized as a leading professional in Obstetrics and Gynecology and a pioneer in ...
(Date:10/13/2015)... ... 13, 2015 , ... In an ongoing effort to provide ... Southlake, Texas, child development and pediatric therapy center, is working with TRICARE to ... their options for receiving this kind of care for affected children. Because of ...
(Date:10/13/2015)... ... ... Just under three months ago, eMarketing Concepts forever changed the ... offering all of their services for just a buck in the first month. The ... calls from interested buyers. As a genuine one-stop-shop for internet marketing, EMC has cornered ...
Breaking Medicine News(10 mins):