Recently, Shire plc (SHPGY) announced that the European Commission (EC) has approved a change in the label of its drug Firazyr. Firazyr is approved for treating patients suffering from hereditary angioedema (HAE). HAE is a rare genetic disease characterized by acute swelling of the hands, feet, face and larynx.
Following the approval of the label change by the European regulatory authorities, the label for Shire’s drug will include self-administration after training in subcutaneous injection technique by doctor. Firazyr will be marketed with the revised label in all the 27 member states of the European Union in addition to Iceland, Liechtenstein and Norway.
The update to Firazyr’s label was approved based on data from a late stage study. The study evaluated the safety, local tolerability, convenience and effectiveness of the self-administration of Firazyr for symptomatic therapy following acute HAE attacks. The study evaluated patients who are Firazyr naive in addition to non-naive HAE patients.
We note that Firazyr is the first and only medication approved in Europe for self-administration in patients suffering from acute type I and type II HAE. Firazyr is currently approved in 37 nations worldwide, including the members of the EU.
We note that Shire made some progress regarding the approval of the drug in the US. Late last month, Shire submitted a response to the not approvable letter issued by the US Food and Drug Administration (FDA) for Firazyr. The letter was issued by the US regulatory body in 2008. Shire is looking to get the drug approved in the US for treating acute HAE.
Boost for Shire’s ADHD franchise
Shire’s attention deficit hyperactivity disorder (ADHD) franchise received a boost recently with the FDA approving Intuniv (guanfacine) as a combination therapy for treating children and adolescents (aged between 13 to 17 years) suffering from ADHD. ADHD refers to a psychiatric behavioral disorder. The disease gives way to lack of attention and often results in impulsiveness and hyperactivity.
Intuniv is already approved as a monotherapy. The current approval allows the ADHD drug to be marketed in the US as adjunctive therapy to stimulants. The approval for the additional indication is based on positive results from a 9-week placebo-controlled study which evaluated the efficacy of Intuniv as a combination therapy.
The label expansion of Intuniv is a shot in the arm for Shire’s ADHD portfolio. The ADHD market is lucrative and is projected to reach approximately $3.88 billion by 2017. Apart from Shire, the market includes players such as Eli Lilly & Company (LLY), Novartis (NVS) and Johnson & Johnson (JNJ).
Our Recommendation
We currently have a Neutral recommendation on Shire, which is supported by a Zacks #3 Rank (short-term Hold rating). Longer term, we believe that Shire needs to expand its pipeline in order to maintain growth beyond 2015, as there are very few projects to be launched thereafter.
JOHNSON & JOHNS (JNJ): Free Stock Analysis Report
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SHIRE PLC-ADR (SHPGY): Free Stock Analysis Report
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