The Journal of Clinical Pharmacology recently reported
population pharmacokinetic (PK) modeling and dosing simulations
based on data from
Hyperion Therapeutics, Inc.
) four phase II and phase III studies. The studies enrolled
patients suffering from urea cycle disorders (UCDs) aged between
2 months and 72 years.
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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
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,
) look well positioned with a Zacks Rank #1 (Strong Buy).