Buphenyl is approved by the US Food and Drug Administration (FDA) to treat urea cycle disorders (UCD).
As per the restated collaboration agreement with Ucyclyd, entered into in Mar 2012, Hyperion was given an option to purchase all of Ucyclyd's worldwide rights to Buphenyl and Ammonul. A net amount of $11 million was paid to Hyperion; this reflects $32 million due to Hyperion on account of Ucyclyd retaining its rights to Ammonul, $19 million due to Ucyclyd for the purchase of rights to Buphenyl and a $2 million inventory adjustment due to Ucyclyd.
Last year, Hyperion had acquired worldwide rights to another drug, Ravicti, from Ucyclyd for an upfront payment of $6 million, future payments based upon the achievement of regulatory milestones in indications other than UCD, sales milestones, and mid-to-high single-digit royalties on global net sales of Ravicti.
Ravicti received FDA approval in Feb 2013 for the use as a nitrogen-binding agent for chronic management of adult and pediatric UCD patients more than two years of age who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. Ravicti completed a phase II study for the treatment of hepatic encephalopathy (HE) in Apr 2012.
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