Navigation Links
Halozyme Provides Update on ViroPharma Phase 2 Trial of Subcutaneous Cinryze (C1 Esterase Inhibitor [Human]) Formulation with rHuPH20
Date:8/1/2013

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.

(Logo:  http://photos.prnewswire.com/prnh/20100302/LA63139LOGO)

"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 www.halozyme.com.

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
858-704-8260
ir@halozyme.com

Media Contact:
Nurha Hindi
Hill+Knowlton Strategies
310-633-9434
Nurha.Hindi@hkstrategies.com

 


'/>"/>
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:
*Name:
*Comment:
*Email:
(Date:2/27/2017)...  Interpace Diagnostics Group, Inc. (NASDAQ: IDXG), a fully ... tests and pathology services, announced today the acceptance of ... United States and Canadian Academy of ... San Antonio, Texas . ... the Company,s extensive experience in molecular thyroid testing, including ...
(Date:2/27/2017)... CAESAREA , Israel and TAMPA, Fla. ... Heart Ltd., an emerging medical device company focused ... undergoing cardiac procedures, applauds the members of the ... past week for their acknowledgement of the need ... (TAVR) surgery. "The statements shared by ...
(Date:2/27/2017)... Feb. 27, 2017  RegeneRx Biopharmaceuticals, Inc. (OTCQB: ... development company focused on tissue protection, repair and ... GtreeBNT Co., Ltd., received a positive response from ... trial design for RGN-137 to treat epidermolysis bullosa ... that incorporates Thymosin beta 4 ("Tß4") as the ...
Breaking Medicine Technology:
(Date:2/27/2017)... , ... February 27, 2017 , ... ... Shamanic Healing and Spiritual Awakening, is happy to announce her “Spring Rejuvenation ... and body, these individual customized retreats offer the winter-weary soul an excellent opportunity ...
(Date:2/27/2017)... (PRWEB) , ... February 27, 2017 , ... ... provides an overview on laser diffraction analysis as a tool to characterize particle ... significance and potential to obtain improved results and novel scientific findings. It describes ...
(Date:2/27/2017)... ... February 27, 2017 , ... Silicon Valley Hair Institute, ... a new informational post on robotic hair transplantation. San Francisco residents may be ... and Follicular Unit Transplantation (FUT) can sound similar. Either treatment can be used ...
(Date:2/26/2017)... ... February 26, 2017 , ... This is ... the world’s first to be ISO/IEC 17025:2005 INAB accredited for Der p 1 ... 17025:2005 is the globally recognised standard that sets out requirements for the technical ...
(Date:2/26/2017)... ARLINGTON, VA (PRWEB) , ... February 26, 2017 , ... ... Medicaid Managed Care Summit, February 27-28 at the Sheraton Pentagon City Hotel in Arlington, ... work with PerformCARE to use behavioral health analytics to improve Medicaid population health management. ...
Breaking Medicine News(10 mins):