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CPX erhält "Orphan Drug Status"
Dieser Status sichert dem Hersteller für 10 Jahre nach der Zulassung des Medikaments die exklusive Vermarktung (neben einigen anderen Bevorzugungen). Sciclone, der Entwickler von CPX schätzt den Markt für CPX in Europa und den USA, jeweils auf 300 Mill. US$. SCICLONE'S CPX RECEIVES ORPHAN DRUG STATUS IN EUROPE FOR CYSTIC FIBROSIS San Mateo, CA, May 22, 2001 - SciClone Pharmaceuticals (Nasdaq: SCLN) today announced that CPX, the Company's protein-repair therapy for the treatment of cystic fibrosis (CF), has been granted Orphan Drug Status throughout the European Union (EU). CPX currently is in phase 2 clinical trials in the U.S., where it already has been granted Orphan Drug Status by the U.S. Food and Drug Administration. "Orphan Drug Status for CPX in the EU as well as the in the U.S., significantly adds to our proprietary position in the world's major cystic fibrosis markets," said Donald R. Sellers, SciClone's President and Chief Executive Officer. "This significantly complements our cystic fibrosis program intellectual property position around the world, which already includes patents on CPX and DAX. Orphan Drug policy in the EU, which was recently legislated, grants ten years of marketing exclusivity upon approval (compared to seven years in the U.S.), assistance in protocol design for clinical trials and a reduction in marketing application fees. In the U.S., there also are certain tax benefits for an Orphan Drug. Cystic fibrosis is the most common fatal genetic disease among Caucasians. With around 70,000 cases worldwide, it affects approximately 30,000 children and young adults in the U.S. and approximately 30,000 in Europe. There is no cure for the underlying abnormal protein defects (caused by a mutated gene), and the median survival age for CF patients is 31 years. Current treatments address only the symptoms of the disease, primarily the bacterial lung infections that are the most common cause of death in CF patients. Cystic fibrosis is caused by a defect in the Cystic Fibrosis transmembrane regulator (CFTR) protein. Normally, the CFTR protein transports chloride ions across the membrane of epithelial cells lining several organs in the body such as the lungs and the pancreas. The most debilitating consequence of the defective CFTR protein occurs in the lungs of cystic fibrosis patients where it causes the production of abnormally thick, sticky mucus that clogs the airways and leads to fatal lung infections. In preclinical studies sponsored by the National Institutes of Health, CPX repaired the two basic CFTR protein-associated defects that cause cystic fibrosis in most patients: (1) it improved the impaired chloride ion transport and (2) it enabled the defective CFTR to reach the epithelial cell membrane (a process called "trafficking"). SciClone believes that its new improved formulation of CPX has the potential to prevent the serious complications of cystic fibrosis, including the production of abnormal mucus. SciClone Pharmaceuticals is a global specialty pharmaceutical company that develops and commercializes novel medicines for the treatment of a broad range of the world's most serious diseases. In addition to cystic fibrosis, the Company is currently targeting hepatitis C, liver cancer, malignant melanoma, hepatitis B, HIV and drug-resistant tuberculosis and cystic fibrosis. Press releases and corporate information from SciClone Pharmaceuticals are available on the Internet at www.sciclone.com or by calling the Company's Investor Relations Department at 800/724-2566. SciClone's Common Stock is listed on The Nasdaq National MarketŪ under the symbol SCLN. Contact: Ruth Koh, Investor Relations 650-358-3437
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