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STOCKHOLM, Sweden and SOUTH SAN FRANCISCO, Calif., Oct. 1, 2013 (GLOBE NEWSWIRE) -- Swedish Orphan Biovitrum AB (publ) (Sobi) (STO:SOBI) and Hyperion Therapeutics, Inc., (Nasdaq:HPTX) announced today that Sobi has been granted the exclusive rights by Hyperion to distribute RAVICTI (glycerol phenylbutyrate) Oral Liquid on a named patient basis for the chronic treatment of Urea Cycle Disorders (UCD) in the Middle East. Under the agreement, Sobi receives the rights to provide RAVICTI in Saudi Arabia, Oman, United Arab Emirates, Jordan, Kuwait, Qatar and Bahrain. Financial details were not disclosed.
"We are proud of this partnership with Hyperion and RAVICTI is a perfect fit with our existing UCD business and the capabilities within our Genetics Therapeutic Area," said Geoffrey McDonough, President and CEO at Sobi. "We believe the recent FDA approval of RAVICTI can allow us to provide access for this important therapy in the Middle East."
UCD patients lack enzymes or transporters necessary for the conversion of ammonia to urea and experience heightened levels of ammonia in the bloodstream. Left untreated, UCDs can result in neurological damage, coma, and/or death. Approved by the Food and Drug Administration on February 1, 2013, RAVICTI is an oral medication used for the long-term management of high blood levels of ammonia.
In short term clinical studies involving more than 70 UCD patients ages two years and older, RAVICTI was safe and efficacious based on 24-hour ammonia profiles. In addition in long-term follow up studies, patients on RAVICTI maintained average fasting ammonia levels below the upper limit of normal.
In the United States, RAVICTI is indicated for use as a nitrogen-binding agent for chronic management of adult and pediatric patients ≥ 2 years of age with UCDs who 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). RAVICTI is not indicated for the treatment of acute hyperammonemia in patients with UCDs 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. The use of RAVICTI in patients < 2 months of age is contraindicated.