Profile: Shire PLC (SHPG.OQ)
21 May 2013
Shire plc (Shire), incorporated on January 28, 2008, is a specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit and hyperactivity disorder (ADHD), gastrointestinal (GI) diseases, human genetic therapies (HGT) and regenerative medicine (RM), as well as opportunities in other therapeutic areas. As of December 31, 2012, the Company’s products included VYVANSE/VENVANSE (lisdexamfetamine dimesylate), ADDERALL XR (mixed salts of a single-entity amphetamine), INTUNIV (extended release guanfacine), EQUASYM (methylphenidate hydrochloride) modified release (XL), LIALDA (mesalamine)/ MEZAVANT(mesalazine), PENTASA (mesalamine), RESOLOR (prucalopride), FOSRENOL (lanthanum carbonate), XAGRID (anagrelide hydrochloride), REPLAGAL (agalsidase alfa), ELAPRASE (idursulfase), VPRIV (velaglucerase alfa), FIRAZYR (icatibant) and DERMAGRAFT(Human Fibroblast-Derived Dermal Substitute). As of December 31, 2012, the Company’s products under development included INTUNIV (extended release guanfacine), VYVANSE/VENVANSE (lisdexamfetamine dimesylate), INTUNIV, Guanfacine Carrier Wave, LIALDA (mesalamine)/MEZAVANT (mesalazine), RESOLOR (prucalopride), RESOLOR (prucalopride), SPD 557(M0003), XAGRID, VYVANSE (lisdexamfetamine dimesylate), REPLAGAL (agalsidase alfa), HGT-4510, HGT-2310, HGT-1410, HGT-1110, HGT-3010, and DERMAGRAFT. On January 31, 2012, the United States Food and Drug Administration approved VYVANSE for the maintenance treatment of ADHD in adults. In March 2013, it announced the acquisition Of Premacure AB.
VYVANSE is a New Chemical Entity (NCE) and is the pro-drug stimulant for the treatment of ADHD, where the amino acid l-lysine is linked to d-amphetamine. VYVANSE is therapeutically inactive until metabolized in the body. The United States Food and Drug Administration approved VYVANSE as a once-daily treatment for children aged 6 to 12 with ADHD in February 2007, for adults in April 2008 and for adolescents aged 13 to 17 in November 2010. VYVANSE is available in the United States in six dosage strengths: 20 milligram, 30 milligram, 40 milligram, 50 milligram, 60 milligram and 70 milligram. Health Canada approved VYVANSE for the treatment of ADHD in pediatric patients aged 6 to 12 in February 2009, and for adolescents and adults in November 2010. In April 2012, ANVISA, the Brazilian health authority, granted marketing authorization approval for lisdexamfetamine dimesylate for the treatment of ADHD in children aged 6-12.
ADDERALL XR is an extended release treatment for ADHD, which uses MICROTROL drug delivery technology and is designed to provide once-daily dosing. It is available in 5 milligram, 10 milligram, 15 milligram, 20 milligram, 25 milligram and 30 milligram capsules and can be administered either as a capsule or sprinkled on soft food. The United States Food and Drug Administration has approved ADDERALL XR as a once-daily treatment for children aged 6 to 12 with ADHD, for adults in and for adolescents aged 13 to 17. Teva Pharmaceutical Industries, Ltd. (Teva) and Impax Laboratories, Inc. (Impax) commenced commercial shipment of their authorized generic versions of ADDERALL XR in April and October 2009, respectively. Shire receives royalties from Impax’s sales of authorized generic ADDERALL XR.
INTUNIV is a selective alpha-2A receptor agonist indicated for the treatment of ADHD. Alpha-2A-adrenoceptors strengthen working memory networks by inhibiting cAMP-HCN channel signalling in the prefrontal cortex (Cell. 2007; 129:397-410). INTUNIV is non-scheduled and has no known potential for abuse or dependence. The United States Food and Drug Administration approved INTUNIV in September 2009, as a once-daily monotherapy treatment of ADHD in children and adolescents aged 6 to 17. It is available in 1 milligram, 2 milligram, 3 milligram and 4 milligram tablets.
Shire has acquired from UCB the worldwide rights (excluding the United States, Canada and Barbados) to EQUASYM (methylphenidate hydrochloride) IR and XL for the treatment of ADHD in children and adolescents aged 6 to 18. At December 31, 2012,EQUASYM XL was commercially available in 10 countries in 10mg, 20mg and 30mg strengths. EQUASYM XL is marketed in Mexico and South Korea under the trade name METADATE CD.
LIALDA is indicated for the induction ofmild to moderately active UC and for the maintenance of remission of UC. The addition of the indication for maintenance of remission of ulcerative colitis was approved by Health Canada in February 2011, and by the United States Food and Drug Administration in July 2011. LIALDA is once-daily oral formulation of mesalamine indicated for the induction and maintenance of remission. As of December 31, 2012, LIALDA/MEZAVANT (this product is marketed outside the United States as MEZAVANT) was commercially available in 19 countries either directly or through distributor arrangements.
PENTASA controlled release capsules are approved in the United States (marketed by Shire in the United States and by Ferring outside of the United States) and indicated for the induction of remission and for the treatment of patients with mild to moderately active ulcerative colitis. PENTASA is an ethylcellulose-coated, controlled release capsule formulation designed to release therapeutic quantities of mesalamine throughout the gastrointestinal tract. PENTASA is available in the United States in 250 milligram and 500 milligram capsules.
RESOLOR (prucalopride), a 5-HT4 receptor agonists that stimulates gastrointestinal motility and acts primarily on different parts of the lower gastrointestinal tract (enterokinetic). In October 2009, RESOLOR was approved by the EMA throughout the European Union as a once daily oral treatment for symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief. In July 2010, Swissmedic granted RESOLOR marketing authorization in Switzerland for the treatment of idiopathic chronic constipation in adults. RESOLOR is available in milligram and 2 milligram dose strengths, both for once-daily dosing. At December 31, 2012, RESOLOR was available in six European Union countries. Formulated as a chewable tablet, FOSRENOL is available in 500 milligram, 750 milligram and 1,000 milligram dosage strengths.
XAGRID (anagrelide hydrochloride) is marketed in Europe for the reduction of elevated platelet counts in at-risk ET patients. XAGRID has been granted orphan drug status in the European Union. In the United States, anagrelide hydrochloride is sold by the Company under the name AGRYLIN for the treatment of thrombocythemia secondary to a MPD.
REPLAGAL is for the treatment of Fabry disease. Fabry disease is a genetic disorder resulting from a deficiency in the activity of the lysosomal enzyme alpha-galactosidase A, which is involved in the breakdown of fats. REPLAGAL is a human alpha-galactosidase A protein made in human cells that replaces the deficient alpha-galactosidase A with an active enzyme to ameliorate certain clinical manifestations of Fabry disease. At December 31, 2012, REPLAGAL was approved in 46 countries.
ELAPRASE is a treatment for Hunter syndrome (also known as Mucopolysaccharidosis Type II or MPS II). Hunter syndrome is a 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 (GAGs). ELAPRASE was approved by the United States Food and Drug Administration and granted marketing authorization by the EMA for the long term treatment of patients with Hunter syndrome. ELAPRASE has been granted orphan drug by both the United States Food and Drug Administration and the EMA. ELAPRASE received approval from the Ministry of Health, Labour and Welfare in Japan. At December 31, 2012, ELAPRASE was approved in 51 countries.
VPRIV is a treatment for Type 1 Gaucher disease. Gaucher disease is an inherited genetic disorder, which results in a deficiency of the lysosomal enzyme beta-glucocerebrosidase. VPRIV was approved by the United States Food and Drug Administration in February 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 August 2010. VPRIV was authorized as an orphan medicine through the Centralised Procedure in Europe. At December 31, 2012, VPRIV was approved in 38 countries.
FIRAZYR is a peptide-based therapeutic developed for the symptomatic treatment of acute attacks of HAE. In July 2008 the EMA granted marketing authorization throughout the European Union for the use of FIRAZYR for the symptomatic treatment of acute attacks of HAE, and in May 2011 approved FIRAZYR for self-administration after training in subcutaneous injection technique by a healthcare professional. In August 2011, the United States Food and Drug Administration granted marketing approval for FIRAZYR in the United States for treatment of acute attacks of HAE in adults aged 18 and older. After injection training, patients may self-administer FIRAZYR. FIRAZYR has been granted orphan drug by both the United States Food and Drug Administration and the EMA. At December 31, 2012, FIRAZYR was approved in 38 countries globally.
DERMAGRAFT is a bio-engineered skin substitute that assists in restoring damaged tissue. DERMAGRAFT is indicated for use in the treatment of full-thickness Diabetic foot ulcers (DFU) greater than six weeks in duration, which extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure. DERMAGRAFT is approved by the United States Food and Drug Administration as a Class III medical device for the treatment of DFUs. DERMAGRAFT is also approved for the treatment of DFUs in South Africa, Israel and Singapore.
The Company competes with Shionogi & Co., Ltd., Janssen-Cilag, Novartis, Medice, Eli Lilly, Warner Chilcott, Synergy Pharmaceuticals, Inc., ARYx Therapeutics, Theravance, Inc., Sucampo Pharmaceuticals, Inc., Albireo, Actelion Ltd., Protalix BioTherapeutics Inc, Genzyme, CSL Behring, Pharming Group N.V., ViroPharma, Dyax Corporation, Organogenesis, Healthpoint, Soluble System, KCI, Smith & Nephew, Aurobindo and Apotex.
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