) recently announced that
The Journal of Pediatrics
published data in an article on Jan 14, 2013, which demonstrated
that key product Cinryze (C1 esterase inhibitor [human]) is
useful in providing relief from the symptoms of hereditary
angioedema (HAE) attacks in pediatric patients. Cinryze also
helped reduce the rate of attacks.
We note that Cinryze is approved in the US 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
As of now, Cinryze is not approved for use in children.
Cinryze is also not approved to treat HAE attacks or for
A study was conducted on four patients in the age group of
9-17 years who completed the pivotal prophylaxis trial. It was
observed that HAE attacks reduced by almost two folds in these
children when they were given Cinryze for prophylaxis as compared
to the time period when they were given placebo.
We remind investors that in Nov 2012, ViroPharma had presented
promising data on Cinryze from a post marketing study that
evaluated the safety, tolerability and efficacy of Cinryze in
escalating doses in patients with HAE who did not show sufficient
treatment benefit with 1000 units every 3 or 4 days.
The data was presented at the American College of Allergy,
Asthma and Immunology's (ACAAI) annual congress.
Meanwhile, ViroPharma expects sales from Cinryze to come
around $321 million in 2012, towards the lower end of its
previously announced guidance of $320 million - $335 million.
Approximately $311 to $312 million of total Cinryze sales was
attributed to actual patient demand while an increase in channel
inventories accounted for the remainder. Cinryze sales are
expected in the range of $390 million - $400 million in North
America in 2013.
Although the prospects for Cinryze look bright for ViroPharma,
we remain concerned about the company's dependence primarily on
Cinryze for growth.
We have a Neutral recommendation on ViroPharma, which carries
a Zacks Rank #3 (Hold). A pharma stock which currently looks
) which carries a Zacks Rank #1 (Strong Buy).
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