Hyperion Therapeutics, Inc. today announced that it has acquired worldwide rights to the investigational drug Ravicti™ (glycerol phenylbutyrate) from Ucyclyd Pharma, Inc., a wholly owned subsidiary of Medicis Pharmaceutical Corporation (NYSE: MRX). Terms of the deal were not disclosed. In connection with the acquisition announced today, Hyperion also entered into an amended and restated collaboration agreement with Ucyclyd pursuant to which Hyperion retains an option to acquire, in the first half of 2013 for a pre-negotiated price, worldwide rights for BUPHENYL® and, subject to certain conditions, AMMONUL®.
Under terms of a previous collaboration agreement with Ucyclyd Pharma, Hyperion has been developing Ravicti for two orphan diseases: urea cycle disorders and episodic hepatic encephalopathy. A New Drug Application (NDA) for the use of Ravicti as adjunctive therapy for the chronic management of urea cycle disorders in patients six years of age and older was recently accepted for filing by the FDA and is currently under review. The FDA action date under the Prescription Drug User Fee Act (PDUFA) is October 23, 2012. Hyperion has completed enrollment in a phase II study in patients with cirrhosis and episodic hepatic encephalopathy. Results from that study are expected to be available late in the second quarter of this year.
Source: Hyperion Therapeutics, Inc.