ViroPharma (VPHM) 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 HAE.
As of now, Cinryze is not approved for use in children. Cinryze is also not approved to treat HAE attacks or for procedural prophylaxis.
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 attractive is Valeant Pharmaceuticals (VRX) which carries a Zacks Rank #1 (Strong Buy).