The US Food and Drug Administration (FDA) recently informed
) that the company may continue with its clinical studies of the
subcutaneous administration of Cinryze in combination with its
) recombinant human hyaluronidase enzyme (rHuPH20).
In early August, this year the FDA had advised ViroPharma and
Halozyme to put a phase II study evaluating the combination of
subcutaneous Cinryze and rHuPH20 on temporary clinical hold.
At that time, the US regulatory body had mentioned that the
problem does not specify Cinryze and ViroPharma can continue
evaluating the subcutaneous administration of Cinryze without
rHuPH20. We note that the FDA detected some risks rHuPH20 in a
separate study without Cinryze.
In the recent update, ViroPharma said that the US regulatory
body believes that the potential safety concerns of the antibodies
to rHuPH20 were limited to the clinical program in which they were
detected. Halozyme believes the detected antibodies are
non-neutralizing in nature. Halozyme further stated that the
antibodies were not associated with any adverse events during the
The FDA has asked ViroPharma to modify the trial protocol for
the combination. The US regulatory body asked the company to
monitor antibody levels and update the agency about elevated
antibody levels during the study.
Though ViroPharma did not provide any information regarding its
plans in Europe in its recent press release, the company had
earlier decided to inform the European regulatory authorities of
the FDA's action to put the clinical trial on temporary hold. The
company had also decided to postpone its enrollment process in
Europe for the phase II combination study of Cinryze and rHuPH20,
until the FDA confirmed the safety of the latter.
We currently have a Neutral recommendation on ViroPharma. The
stock carries a Zacks #3 Rank (Hold rating) in the short run. We
view the news as positive for the stock and the shares reacted
favorably for the company. We expect that Cinryze sales will be
benefited with the label expansion.
HALOZYME THERA (HALO): Free Stock Analysis
VIROPHARMA (VPHM): Free Stock Analysis Report
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