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.
Pancreatic insufficiency or intestinal malabsorption may result in reduced or absent digestion of RAVICTI and/or absorption of phenylbutyrate and reduced control of plasma ammonia. Monitor ammonia levels closely in these patients.
Most common adverse reactions in 10% or more of patients are: diarrhea, flatulence, headache, nausea, vomiting, fatigue, decreased appetite, HA, dizziness, headache, upper abdominal (stomach) pain and rash.
Corticosteroids, valproic acid, or haloperidol may increase plasma ammonia levels; monitor ammonia levels closely when used concomitantly with RAVICTI. Probenecid may affect renal excretion of metabolites of RAVICTI including PAGN and PAA.
The use of RAVICTI in pregnant women may cause fetal harm. Breastfeeding is not recommended during RAVICTI treatment.
Please see full Prescribing Information for RAVICTI at www.hyperiontx.com.
About Hyperion Therapeutics
Hyperion Therapeutics, Inc. is a commercial stage biopharmaceutical company committed to developing and delivering life-changing treatments for orphan diseases and hepatology.
To the extent that statements contained in this press release are not descriptions of historical facts regarding Hyperion, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements contained in this press release include statements regarding expectations about Valeant's intention to retain AMMONUL as well as the timing of the closing of the transaction. Hyperion undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties relating to the business of the company in general, see Hyperion's Annual Report on Form 10-K/A filed with the Securities and Exchange Commission on February 26, 2013, and any subsequent filings with the Securities and Exchange Commission.