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Last $12.75 USD
Change Today +0.07 / 0.55%
Volume 466.8K
RPTP On Other Exchanges
Symbol
Exchange
Frankfurt
As of 8:10 PM 09/4/15 All times are local (Market data is delayed by at least 15 minutes).
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Company Description

Contact Info

7 Hamilton Landing

Suite 100

Novato, CA 94949

United States

Phone: 415-408-6200

Fax: 415-382-8002

Raptor Pharmaceutical Corp., a biopharmaceutical company, focuses on developing and commercializing transformative treatments for people affected by rare and debilitating diseases. Marketed Product PROCYSBI The company’s product, PROCYSBI (cysteamine bitartrate) delayed-release capsules (PROCYSBI), received marketing approval from the U.S. Food and Drug Administration (FDA) in 2013 for the management of nephropathic cystinosis in adults and children six years and older. PROCYSBI is an approved therapy for the management of nephropathic cystinosis, a rare, life-threatening metabolic lysosomal storage disorder that causes the toxic accumulation of cystine in all cells, tissues and organs in the body. PROCYSBI capsules contain cysteamine bitartrate in the form of microspheronized beads that are individually coated to create delayed and extended-release properties, allowing patients to maintain consistent therapeutic systemic drug levels over a 12-hour dosing period. Randomized controlled clinical trials and extended treatment with PROCYSBI therapy demonstrated consistent cystine depletion as monitored by levels of the biomarker (and surrogate marker), white blood cell cystine. In Europe, PROCYSBI gastro-resistant hard capsules of cysteamine (as mercaptamine bitartrate) received a marketing authorization in 2013 from the European Commission as an orphan medicinal product for the management of proven nephropathic cystinosis in the European Union (EU). The EU marketing authorization allows the company to commercialize PROCYSBI in the 28 Member States of the EU plus Norway, Liechtenstein and Iceland (which are not EU Member States but are part of the European Economic Area). PROCYSBI received 7 and 10 years of market exclusivity due to its designation as an orphan drug in the United States and the EU, respectively. The company achieved first commercial sales of PROCYSBI in the United States in 2013 and in the EU, primarily in Germany, in 2014. RP103 Clinical Development RP103, enteric-coated delayed-release cysteamine bitartrate, is being evaluated as a treatment for Huntington’s disease. Centre Hospitalier Universitaire d'Angers, France, is conducting the Phase 2/3 clinical trial of RP103. RP103 as a Treatment for Non-alcoholic Steatohepatitis (NASH) in Children: In 2012, the company announced the dosing of the first patient in a Phase 2b clinical trial – Cysteamine Bitartrate Delayed-Release for the Treatment of Non-alcoholic Fatty Liver Disease in Children, which is evaluating the safety and efficacy of RP103 as a potential treatment of NASH in children. The clinical trial is being conducted under a cooperative research and development agreement with the National Institute of Diabetes and Digestive and Kidney Diseases, part of the National Institutes of Health. RP103 as a Treatment for Mitochondrial Disorders, including Leigh Syndrome: In 2014, the company initiated a Phase 2 study in the United States designed to evaluate the safety, tolerability and efficacy of RP103 as a potential treatment for Leigh syndrome and other mitochondrial disorders. RP103 potentially increases mitochondrial glutathione, which might act as a scavenging agent of reactive oxygen species and thereby reduce the mitochondrial oxidative stress typically associated with these disorders. Other Clinical-Stage Product Candidates Convivia for ALDH2 Deficiency The company is developing Convivia, its proprietary oral formulation of 4-methylpyrazole for the potential treatment of acetaldehyde toxicity resulting from ALDH2 deficiency, an inherited metabolic disorder affecting a material percent of East Asian populations. The company has an agreement with Uni Pharma Co., Ltd. (Uni Pharma), pursuant to which the company granted Uni Pharma a license under its intellectual property portfolio relating to Convivia, including method of use (MOU) and formulation patents. Under this agreement, Uni Pharma is responsible for clinical development, registration and commercialization of Convivia in Taiwan. Preclinical Product Candidates The company’s preclinical programs include its cysteamine dioxygenase (ADO) program to improve tre

 

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