The US Food and Drug Administration (FDA) recently approved
ViroPharma Incorporated
's (
VPHM
) supplement to the Cinryze Biologics License Application (BLA) for
industrial scale manufacturing changes. ViroPharma expects to
complete labeling of earlier produced vials, six weeks before
entering the market.
Notably, ViroPharma submitted a prior approval supplement (PAS)
in the second quarter of 2010. The PAS involved this industrial
scale manufacturing project to increase Cinryze production
capabilities. In respond to this, the FDA issued a complete
response letter (CRL) in October 2010 requesting additional
information from the pre-approval inspection and review of the
technical process. In February 2012, the FDA issued another CRL
regarding this.
The approval of the supplement for industrial scale production
will ensure that enough Cinryze is available for prophylactic use
for patients with HAE.
We note that Cinryze (intravenous formulation - IV) is approved
both in the US and Europe. In the US, the drug is approved for
routine prophylaxis against angioedema attacks in adolescent and
adult patients with hereditary angioedema (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. As per company sources, there are
around 6,500 people in the US and around 10,000 people in the EU
suffering from HAE.
ViroPharma also received bad news recently on a study of
Cinryze. Earlier this month, the FDA stated that the phase II study
evaluating the combination of subcutaneous Cinryze and
Halozyme Therapeutics'
(
HALO
) recombinant human hyaluronidase enzyme (rHuPH20) should be put on
temporary clinical hold.
The FDA's Center for Biologics Evaluation and Research (CBER)
division 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.
The US regulatory body also mentioned that the problems are not
specific to Cinryze and ViroPharma can continue evaluating its
subcutaneous administration of Cinryze without rHuPH20. ViroPharma
intends to inform European regulatory authorities of the FDA's
action.
The biopharma company has also decided to postpone its
enrollment process in Europe for the phase II combination study of
Cinryze and rHuPH20 until the FDA provides an update on the safety
of the latter. We believe that the study halt is a major set back
for the company.
ViroPharma recorded Cinryze sales of $68 million in the first
quarter of 2012.
Our Recommendation
We believe that the approval of the industrial scale
manufacturing expansion process can be a major growth driver for
ViroPharma. Though the halting of the combination study of Cinryze
and rHuPH20 will keep the company concerned. We currently have a
Neutral recommendation on ViroPharma. The stock carries a Zacks #3
Rank (Hold rating) in the short run.
ViroPharma will be reporting its second quarter financial
results on August 9, 2012. We are expecting net sales of $104
million for the second quarter.
HALOZYME THERA (HALO): Free Stock Analysis
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VIROPHARMA (VPHM): Free Stock Analysis Report
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