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Hyperion Therapeutics Completes Phase 2 Data Analysis and Schedules End of Phase 2 Meeting With FDA for HPN-100 in the Chronic Treatment of Urea Cycle Disorders
Date:11/12/2008

SOUTH SAN FRANCISCO, Calif., Nov. 12 /PRNewswire/ -- Hyperion Therapeutics, Inc. today reported completion of data analysis for its Phase 2 clinical trial designed to evaluate the safety, tolerability and ammonia scavenging effects of HPN-100 versus BUPHENYL(R) (sodium phenylbutyrate), the current standard of care in patients with urea cycle disorders. Data from the trial will be presented at an upcoming medical conference.

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"We are encouraged by this trial and the potential to develop a new therapy for patients with urea cycle disorders," said Dr. Bruce Scharschmidt, Senior Vice President and Chief Medical Officer of Hyperion Therapeutics, Inc. "Based on the results, we plan to meet with the Food and Drug Administration in early 2009 to discuss our Phase 3 development program."

"We are pleased with the progress of the HPN-100 clinical program," said Cindy LeMons, Executive Director of the National Urea Cycle Disorders Foundation (NUCDF). "The urea cycle disorder community encourages the development of treatment alternatives."

Hyperion and Ucyclyd Pharma, Inc., a subsidiary of Medicis Pharmaceutical Corporation, entered into a collaboration agreement for HPN-100 in August 2007. Under the terms of the agreement, Hyperion is conducting ongoing research and development of HPN-100 for urea cycle disorders, hepatic encephalopathy, and other forms of hyperammonemia.

About Urea Cycle Disorder

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.
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SOURCE Hyperion Therapeutics, Inc.
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