Horizon Pharma plc HZNP announced that the European Commission (EC) has cleared Ravicti (glycerol phenylbutyrate) oral liquid as an adjunctive therapy for chronic management of six subtypes of urea cycle disorders (UCDs) in adults and pediatric patients aged two months and older. The company will now focus on launching the drug on a country-by-country basis.
The favorable EC decision was largely expected as the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency had recommended a centralized marketing authorization for Ravicti in Sep 2015.
Ravicti enjoys orphan drug status in the EU and stands to benefit from a period of 10 years of regulatory data/market protection with a possibility of extension to 11 years and a period of 10 years of orphan market exclusivity concurrently applied to each of the six approved sub-types of UCDs.
We note that Ravicti is already available in the U.S. for chronic management of UCDs in adult and pediatric patients aged 2 years or older. Ravicti was added to Horizon Pharma’s portfolio in May 2015 after the company acquired Hyperion Therapeutics.
The approval of Ravicti in the EU is a huge win for Horizon Pharma. Ravicti is the first product by the company to receive centralized marketing authorization in the EU.
Currently, Horizon carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Anika Therapeutics Inc. ANIK, Actelion Ltd. ALIOF and Baxalta Incorporated BXLT. While Anika and Baxalta sport a Zacks Rank #1 (Strong Buy), Actelion carries a Zacks Rank #2 (Buy).
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