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Hyperion Therapeutics Announces Results for Phase II Study in Urea Cycle Disorders
Date:3/30/2009

ere two SAEs related to hyperammonemia; both occurred during 100% BUPHENYL treatment. No SAEs occurred during 100% HPN-100 treatment. Ammonia values were ~30% lower on HPN-100 assessed as TNAUC over 24 hours [mean (SD) = 38.4 (19.6) versus 26.1 (10.3) umol/L), Cmax = 79.1 (40.1) versus 56.3 (27.9) umol/L, or the percentage of normal values: 58% vs. 72%]. Differences in ammonia values were not statistically significant.

"We are very pleased with the study results and our recent end of phase II meeting with the Food and Drug Administration," said Don Santel, Chief Executive Officer of Hyperion Therapeutics. "We are currently finalizing our phase III study protocol in consultation with the Agency and are eager to further explore the potential of HPN-100 for the treatment of urea cycle disorders."

About Urea Cycle Disorders

Urea cycle disorders are inherited, inborn errors of metabolism present in an estimated 1 in 10,000 births in the United States. Patients with urea cycle disorders are deficient in one of the key enzymes that comprise the urea cycle, the body's primary vehicle for removing ammonia, a potent neurotoxin, from the bloodstream. Onset may occur at any age depending on the severity of the disorder. Left untreated, urea cycle disorders can cause dangerously heightened levels of ammonia in the bloodstream (hyperammonemia) resulting in brain damage, coma, and/or death.

About HPN-100

HPN-100 is a pro-drug of phenylbutyrate and a pre-pro-drug of phenylacetic acid, the active moiety of BUPHENYL(R), the only therapy currently FDA-approved as adjunctive therapy for the chronic management of patients with the most prevalent urea cycle deficiencies including those related to carbamylphosphate synthetase, ornithine transcarbamylase and argininosuccinic acid synthetase. HPN-100, which is dosed orally in liquid form, provides an alternative pathway to the urea cycle for the disposal of waste nit
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SOURCE Hyperion Therapeutics, Inc.
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