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Hyperion Therapeutics Exercises Option To Acquire Rights To BUPHENYL(R) And AMMONUL(R)

SOUTH SAN FRANCISCO, Calif., May 2, 2013 (GLOBE NEWSWIRE) -- Hyperion Therapeutics, Inc. (Nasdaq:HPTX) today announced the exercise of its option to acquire BUPHENYL®(sodium phenylbutyrate) Tablets and Powder, an FDA approved therapy for the chronic management of the most prevalent urea cycle disorders (UCD), and AMMONUL® (sodium phenylacetate and sodium benzoate) Injection 10%/10%, a hospital based product used to treat UCD patients in hyperammonemic crisis, from Valeant Pharmaceuticals International, Inc. (NYSE:VRX) (TSX:VRX).  

As a result of a March 2012 agreement between Hyperion and Medicis Pharmaceutical Corporation, now a subsidiary of Valeant, Valeant has 20 days to formally notify Hyperion whether it intends to retain rights to AMMONUL.  If Valeant elects not to retain AMMONUL, Hyperion is obligated to pay $22 million to Valeant; if Valeant elects to retain AMMONUL, Valeant must pay Hyperion $13 million. The transaction is expected to close by May 29, 2013 subject to satisfaction of any closing conditions.

According to Donald J. Santel, Hyperion's chief executive officer, "RAVICTI™ remains the cornerstone of our commercial plan. We are confident that either one or both of these therapies represent important opportunities for Hyperion to serve the UCD community. "

Please see full Prescribing Information for:

BUPHENYL at http://ureacycle.com/buphenyl.aspx

AMMONUL at http://www.ureacycle.com/ammonul.aspx

RAVICTI Indications, Usage and Safety Information

RAVICTI is indicated for use as a nitrogen-binding agent for chronic management of adult and pediatric patients ≥ two years of age with UCD that cannot be managed by dietary protein restriction and/or amino acid supplementation alone. RAVICTI must be used with dietary protein restriction and in some cases, dietary supplements (e.g. essential amino acids, arginine, citrulline, protein-free calorie supplements).

Limitations of Use:

  • RAVICTI is not indicated for the treatment of acute hyperammonemia (HA) in patients with UCD because more rapidly acting interventions are essential to reduce plasma ammonia levels.
  • The safety and efficacy of RAVICTI for the treatment of N-acetylglutamate synthase (NAGS) deficiency has not been established.

RAVICTI is Contraindicated in Patients:

  • Less than two months of age. Children less than two months of age may have immature pancreatic exocrine function which could impair hydrolysis of RAVICTI, leading to impaired absorption of phenylbutyrate and HA.
  • With known hypersensitivity to phenylbutyrate. Signs of hypersensitivity include wheezing, shortness of breath, coughing, low blood pressure, flushing, nausea and rash.

The major metabolite of RAVICTI, PAA, is associated with neurotoxicity at levels ≥ 500 μg/mL. If symptoms of vomiting, nausea, headache, drowsiness, or confusion are present in the absence of high ammonia or other intercurrent illnesses, reduce the RAVICTI dosage.

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