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Latest News

• May 16: Governor of Puerto Rico signs bill to make May 16th official HAE Awareness Day
• Apr 22: Pharming And Santarus Announce Submission Of Ruconest Biologics License Application To FDA
• Apr 15: A global awareness day for a life-threatening condition
• Mar 25: BioCryst Announces Initiation of a Phase 1 Clinical Trial of BCX4161 for the Treatment of Hereditary Angioedema
• Mar 25: Presentan proyecto para conmemorar día de Angioedema Hereditario (Legislation introduced to declare official HAE Day in Puerto Rico)

ViroPharma And Halozyme Provide Update On Clinical Development Of Subcutaneous Cinryze® (C1 Esterase Inhibitor [Human]) With Recombinant Human Hyaluronidase (rHuPH20)

Sep 21, 2012 | www.viropharma.com

EXTON, Pa. and SAN DIEGO, Sept. 21, 2012 /PRNewswire/ – ViroPharma Incorporated (Nasdaq: VPHM) and Halozyme Therapeutics, Inc. (Nasdaq: HALO) announced today that the U.S. Food & Drug Administration (FDA) has provided guidance enabling ViroPharma to resume clinical studies of the subcutaneous administration of Cinryze in combination with rHuPH20. The FDA informed ViroPharma that based upon their ongoing assessment, the FDA believes the potential safety signals regarding antibodies to rHuPH20 that were detected in the clinical development program of another company’s product are limited to that specific program. According to Halozyme, the detected antibodies were non-neutralizing and not associated with any clinical adverse events. The FDA has advised ViroPharma to amend the study protocol, allowing for increased laboratory sampling to monitor rHuPH20 antibody levels, and keep the Agency informed of elevated antibody levels during the treatment phase of the study.

ViroPharma intends to provide additional commentary on next steps and timing at ViroPharma’s analyst day event scheduled to begin at 9:00 A.M. E.T. today.  To access the webcast of ViroPharma’s analyst day, please visit www.viropharma.com.

About Cinryze® (C1 esterase inhibitor [human])
Cinryze is a highly purified, pasteurized and nanofiltered plasma-derived C1 esterase inhibitor product.  In the U.S., Cinryze is approved by the FDA for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE.  In the E.U., the product is approved by the EMA for the treatment and pre-procedure prevention of angioedema attacks in adults and adolescents with hereditary angioedema (HAE), and routine prevention of angioedema attacks in adults and adolescents with severe and recurrent attacks of hereditary angioedema (HAE), who are intolerant to or insufficiently protected by oral prevention treatments or patients who are inadequately managed with repeated acute treatment. Cinryze is for intravenous use only.