) recently announced that the Scottish regulatory body has approved
its epilepsy drug, Buccolam to be used as a treatment for
prolonged, acute, convulsive seizures in infants, toddlers,
children and adolescents, aged 3 months to less than 18 years.
Earlier, in December last year, ViroPharma had announced the
launch of Buccolam, in the United Kingdom for the same indication.
In September 2011, the European Commission had granted Buccolam a
Centralized Pediatric Use Marketing Authorization (PUMA) for the
PUMA is a new type of centralized marketing authorization
procedure for medicines that are already authorized, but are no
longer covered by intellectual property rights. Also,
PUMA-authorized drugs are exclusively developed for children.
Buccolam became a part of ViroPharma's portfolio following the
acquisition of Auralis Limited in May 2010.
We note that ViroPharma was in the news earlier this month when
the US Food and Drug Administration (FDA) issued a complete
response letter (
) for Cinryze's industrial scale manufacturing facility.
The regulatory body made three comments related to a portion of
the cleaning validation for industrial scale manufacturing, of
which only one requires additional unplanned activity. ViroPharma
does not expect this activity to take much time to complete.
The FDA also said that it has not finished reviewing the
company's January 2012 updated responses in relation to the
observations specific to the September 2011 inspection of the
Cinryze is one of the leading products at ViroPharma. The
company markets the drug worldwide in the intravenous form as a
treatment for routine prophylaxis against angioedema attacks in
adolescent and adult patients with hereditary angioedema (
ViroPharma undertook an expansion of the production capacity for
Cinryze in 2009. In early 2010, the company submitted the Cinryze
industrial scale manufacturing Prior Approval Supplement (PAS) to
the FDA. In October 2010, the regulatory body issued a CRL, asking
for additional information on observations from the pre-approval
inspection and review of the technical processes. In October 2011,
ViroPharma submitted its response to the CRL.
We currently have an Outperform recommendation on ViroPharma.
The stock carries a Zacks #2 Rank (Buy rating) in the
): Free Stock Analysis Report
To read this article on Zacks.com click here.