) recently announced that the US Food and Drug Administration (FDA)
has advised the company and its partner,
), to put the phase II study evaluating the combination
subcutaneous Cinryze (C1 esterase inhibitor [human]) and
recombinant human hyaluronidase enzyme (rHuPH20) on temporary
The Center for Biologics Evaluation and Research (CBER) division
of the FDA informed the companies that the US regulatory body is
assessing the potential risk of the long-term effect of
anti-rHuPH20 non-neutralizing antibodies associated with the use of
Halozyme's rHuPH20. The FDA detected some risks pertaining to
rHuPH20 in a separate study without Cinryze.
Halozyme informed ViroPharma that it must first provide results
from additional pre-clinical studies to the CBER before they can
resume the on-hold combination study. The US regulatory body also
mentioned that the problem does not specify Cinryze and ViroPharma
can continue evaluating subcutaneous administration of Cinryze
ViroPharma has decided to inform the European regulatory
authorities of the FDA's action. The company has also decided to
postpone its enrollment process in Europe for the phase II
combination study of Cinryze and rHuPH20, until the FDA confirms
the safety of the latter.
Following the FDA's decision, ViroPharma is set to commence a
phase II study, evaluating the safety and efficacy of two different
doses of the subcutaneous administration of Cinryze as a
stand-alone therapy. The US regulatory body cleared ViroPharma's
Investigational New Drug (IND) application for the stand-alone
therapy of Cinryze in 2011.
ViroPharma recently announced positive results from an open
label prophylaxis study of Cinryze in patients suffering from
hereditary angioedema (HAE).
We note that Cinryze is approved both in the US and Europe. In
the US the drug is approved as intravenous (IV) administration for
routine prophylaxis against angioedema attacks in adolescent and
adult patients with HAE. In Europe it is approved for routine
prevention, pre-procedure prevention and acute treatment of
angioedema attacks in adolescent and adult patients with HAE.
We currently have a Neutral recommendation on ViroPharma. The
stock carries a Zacks #3 Rank (Hold rating) in the short run.
HALOZYME THERA (HALO): Free Stock Analysis
VIROPHARMA (VPHM): Free Stock Analysis Report
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