Hyperion Therapeutics (FRA:0HY) Quality Rank

Hyperion Therapeutics Inc., was incorporated in Delaware on November 1, 2006. The Company completed its initial public offering on July 2012. It is a commercial biopharmaceutical company, engaged in the development and commercialization of novel therapeutics to treat disorders in the areas of orphan diseases and hepatology. Its products, RAVICTI (glycerol phenylbutyrate) Oral liquid, BUPHENYL and AMMONAPS (sodium phenylbutyrate) Tablets and Powder, are designed to lower ammonia in the blood. The Company has developed RAVICTI to treat urea cycle disorders including 7 of the 8 prevalent UCD subtypes, and is developing glycerol phenylbutyrate, the active pharmaceutical ingredient in RAVICTI, to treat hepatic encephalopathy. RAVICTI is indicated for use as a nitrogen-binding agent for chronic management of adult and pediatric patients above 2 years of age with urea cycle disorders who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. It distributes RAVICTI through two specialty pharmacies with a single dedicated call center responsible for interfacing with patients, physicians and payors. BUPHENYL is indicated in all patients with neonatal-onset deficiency (complete enzymatic deficiency, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease (partial enzymatic deficiency, presenting after the first month of life) who have a history of hyperammonemic encephalopathy. The Company faces competition from established pharmaceutical and biotechnology companies, as well as from academic institutions, government agencies and private and public research institutions, among others, which may in the future develop products to treat UCD or HE. The Company is subject to numerous federal, state and local laws relating to such matters as safe working conditions, manufacturing practices, environmental protection, fire hazard control, and disposal of hazardous or potentially hazardous substances.