deficient alpha-galactosidase A with an active enzyme to ameliorate certain clinical manifestations of Fabry disease. As of December 31, 2015, REPLAGAL was approved in 53 countries excluding the U.S. ELAPRASE ELAPRASE is a treatment for Hunter syndrome (also known as Mucopolysaccharidosis Type II or MPS II). Hunter syndrome is a rare, inherited genetic disorder mainly affecting males that interferes with the body's ability to break down and recycle waste substances called mucopolysaccharides, also known as glycosaminoglycans or GAGs. In patients with Hunter syndrome, cumulative build-up of GAGs in cells throughout the body interferes with the way certain tissues and organs function, leading to severe clinical complications and early mortality. ELAPRASE was approved by the FDA in 2006 and granted marketing authorization by the European Medicines Agency (EMA) in 2007 for the long term treatment of patients with Hunter syndrome. ELAPRASE has been granted orphan drug exclusivity by both the FDA and the EMA. ELAPRASE also benefits from the 12 years of data exclusivity from the date of grant of registration given to innovator biologics in the U.S. under the Patient Protection and Affordable Care Act (ACA). ELAPRASE received approval from the Ministry of Health Labour and Welfare in Japan in 2007. As part of an agreement with Genzyme, Genzyme manages the sales and distribution of ELAPRASE in Japan, as well as certain other countries in the Asia Pacific region. As of December 31, 2015, ELAPRASE was approved in 64 countries. VPRIV VPRIV is a treatment for Type 1 Gaucher disease. Gaucher disease is a rare, inherited genetic disorder, which results in a deficiency of the lysosomal enzyme beta-glucocerebrosidase. This enzymatic deficiency causes an accumulation of glucocerebroside, primarily in macrophages called Gaucher cells in the liver, spleen, bone marrow, and other organs. The accumulation of glucocerebrosidase in Gaucher cells in the liver and spleen leads to organomegaly. VPRIV was approved by the FDA in 2010 for the long term treatment of patients with Type 1 Gaucher disease. The EMA approved the marketing authorization for the use of VPRIV in 2010. VPRIV has been granted orphan drug status in the EU with approximately 10 year’s market exclusivity from August 2010. VPRIV also benefits from the 12 years of data exclusivity in the U.S. from the date of grant of registration given to innovator biologics under the ACA. As of December 31, 2015, VPRIV was approved in 51 countries. FIRAZYR FIRAZYR is a peptide-based therapeutic developed for the symptomatic treatment of acute attacks of hereditary angioedema (HAE). HAE is a debilitating and potentially life-threatening genetic disease characterized by unpredictable recurring swelling attacks in the hands, feet, face, larynx, or abdomen. In 2008, the EMA granted marketing authorization throughout the EU for the use of FIRAZYR for the symptomatic treatment of acute attacks of HAE, and in 2011 approved FIRAZYR for self-administration after training in subcutaneous injection technique by a healthcare professional. In 2011, the FDA granted marketing approval for FIRAZYR in the U.S. for treatment of acute attacks of HAE in adults aged 18 and older and, after injection training, patients might self-administer FIRAZYR. FIRAZYR has been granted orphan drug exclusivity by both the FDA and the EMA, providing it with approximately 7 and 10 years market exclusivity in the U.S. and EU, respectively, from the date of the grant of the relevant marketing authorization. As of December 31, 2015, FIRAZYR was approved in 44 countries. CINRYZE CINRYZE is a C1 esterase inhibitor therapy for routine prophylaxis against HAE, also known as C1 inhibitor (C1-INH) deficiency. CINRYZE is marketed and sold in the U.S. for routine prophylaxis against HAE attacks in adolescent and adult patients with HAE. CINRYZE has been granted orphan drug exclusivity by the FDA. As of December 31, 2015, CINRYZE was approved in 36 countries. GATTEX/REVESTIVE GATTEX/REVESTIVE (teduglutide (rDNA origin)) for injection is the first prescription medicine for the long-term treatment of adults
shire plc-adr (SHPG:NASDAQ GS)
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Phone: 353 1 429 7700
Fax: 353 1 429 7701www.shire.com
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