Positive Data on Shire's Firazyr - Analyst Blog

Shire plc (SHPGY) recently announced that it met its goals in the FAST 3 trial that was conducted with its hereditary angioedema (HAE) treatment, Firazyr. Hereditary angioedema is a rare genetic disease characterized by acute swelling of the hands, feet, face and larynx. Firazyr is an injectable drug that helps reduce the inflammation. FAST-3 was a randomized, double-blind, placebo controlled multicenter trial where Firazyr was administered by subcutaneous injection in 88 patients with acute attacks of HAE.

Top-line data from the trial demonstrated that patients who took Firazyr experienced a 50% reduction in the individual and combined cutaneous and abdominal HAE symptoms after a median time of 2 hours. In comparison, patients on placebo suffered a median time of 19.8 hours before their symptoms eased. Moreover, patients on Firazyr also experienced a 30% reduction in the primary symptom after 1.5 hours as compared to 18.5 hours for placebo. Overall, Firazyr, consistent with earlier studies, was noted to be well tolerated.

At present, Firazyr is approved in the European Union for the symptomatic treatment of acute attacks of HAE in adults. The company conducted the FAST 3 trial to support the filing of a New Drug Application (NDA) with the US Food and Drug Administration (FDA).

Firazyr received a non-approvable letter in the US in 2008 following mixed results from two phase III trials (FAST 1 and FAST 2). As a consequence, the company was required to conduct the FAST 3 study for approval. The company plans to file a complete response with the FDA in early 2011.

We currently have a Neutral recommendation on Shire, which is supported by a Zacks #3 Rank (short-term Hold rating). We believe the positive data on Firazyr could help the candidate gain approval in late 2011. Shire needs to expand its pipeline in order to maintain growth beyond 2015, as there are very few projects to be launched thereafter.