The Journal of Clinical Pharmacology recently reported population pharmacokinetic (PK) modeling and dosing simulations based on data from Hyperion Therapeutics, Inc.’s (HPTX) four phase II and phase III studies. The studies enrolled patients suffering from urea cycle disorders (UCDs) aged between 2 months and 72 years.
Hyperion described the differences in absorption rate and pharmacokinetic profiles of its two approved drugs, Ravicti and Buphenyl, in UCD patients, in the final model. Buphenyl is approved in the US for the treatment of UCD. Ravicti is approved in the US 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.
Data from the final model revealed that phenylbutyric acid is absorbed slowly in patients treated with Ravicti compared to those treated with Buphenyl. Moreover, patients under Ravicti also showed less fluctuation in blood metabolite levels compared to those under Buphenyl.
We remind investors that earlier this month Hyperion acquired global rights to Buphenyl tablets and powder from Ucyclyd Pharma Inc., a subsidiary of Valeant Pharmaceuticals (VRX).
Last year, Hyperion had acquired worldwide rights to 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.
Hyperion currently carries a Zacks Rank #3 (Hold). Currently, companies like Santarus, Inc. (SNTS) and Jazz Pharmaceuticals (JAZZ) look well positioned with a Zacks Rank #1 (Strong Buy).
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