Profile: Shire PLC (SHPG.OQ)
Shire plc, incorporated on January 28, 2008, is a biotech company. The Company, along with its subsidiaries, is engaged in developing and marketing medicines for patients with rare diseases and other select conditions. The Company operates in the segment of research, development, licensing, manufacturing, marketing, distribution and sale of specialist medicines. The Company's products include VYVANSE/VENVANSE/ELVANSE/TYVENSE/ELVANSE VUXEN/ADUVANZ (lisdexamfetamine dimesylate), ADDERALL XR (mixed salts of a single-entity amphetamine), INTUNIV (extended release guanfacine), LIALDA (mesalamine)/MEZAVANT(mesalazine), PENTASA (mesalamine), REPLAGAL (agalsidase alfa), ELAPRASE (idursulfase), VPRIV (velaglucerase alfa), FIRAZYR (icatibant), CINRYZE C1 esterase inhibitor (human), GATTEX/REVESTIVE, NATPARA/NATPAR, FOSRENOL (lanthanum carbonate) and KALBITOR.
The Company focuses its development resources on projects in various therapeutic areas (TAs), including rare diseases, neuroscience, ophthalmics, hematology and gastrointestinal (GI), and focuses its early development projects primarily on rare diseases. The Company also offers ADVATE Antihemophilic Factor (Recombinant); ADYNOVATE Antihemophilic Factor (Recombinant), PEGylated; ARALAST NP Alpha1-Proteinase Inhibitor (Human); BEBULIN Factor IX Complex; BUMINATE 5% Albumin (Human), USP, 5% Solution; BUMINATE 25% Albumin (Human), USP, 25% Solution; CEPROTIN Protein C Concentrate (Human); GAMMAGARD S/D Immune Globulin Intravenous (Human), IgA less than 1 ug/mL in a 5% solution; GLASSIA Alpha1-Proteinase Inhibitor (Human) and ONCASPAR pegaspargase.
The Company's VYVANSE is a pro-drug stimulant for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), where the amino acid l-lysine is linked to d-amphetamine. VYVANSE is therapeutically inactive until metabolized in the body. The Food and Drug Administration (FDA) has approved VYVANSE as a once-daily treatment for children aged 6 to 12 with ADHD, for adults and for adolescents aged 13 to 17. VYVANSE is available in the United States in a range of dosage strengths, including approximately 10 milligrams (mg), 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg. VYVANSE was approved by Health Canada for the treatment of ADHD in pediatric patients aged 6 to 12, for adolescents and adults. VENVANSE is also granted marketing authorization by ANVISA, the Brazilian health authority, for the treatment of ADHD in children aged 6-12.
The Company's ELVANSE is indicated as part of a treatment program for ADHD in children approximately six years of age and over when response to previous methylphenidate treatment is considered clinically inadequate. The product has also been approved and launched in Switzerland.
The Company's ELVANSE ADULT is indicated as part of a treatment program for ADHD in adults. The product has been approved and launched in the United Kingdom, Sweden and Denmark.
The Company's ADDERALL XR is an extended release treatment for ADHD, which uses MICROTROL drug delivery technology and is designed to provide once-daily dosing. The Company's ADDERALL XR is available in approximately five mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg capsules. The FDA has approved ADDERALL XR as a once-daily treatment for children aged 6 to 12 with ADHD, for adults and for adolescents aged 13 to 17.
The Company's INTUNIV is a selective alpha-2A receptor agonist indicated for the treatment of ADHD. It is available in approximately one mg, two mg, three mg and four mg tablets.
The Company's LIALDA is indicated in the United States and Canada for the induction of remission in patients with mild to moderately active Ulcerative Colitis (UC) and for the maintenance of remission of UC. LIALDA is a once-daily oral formulation of mesalamine indicated for the induction and maintenance of remission.
PENTASA controlled release capsules are marketed by the Company in the United States and are indicated for the induction of remission and for the treatment of patients with mild to moderately active UC. 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 approximately 250 mg and 500 mg capsules.
The Company's REPLAGAL is marketed for the treatment of Fabry disease outside of the United States. REPLAGAL is a human alpha-galactosidase. REPLAGAL is approved in approximately 50 countries, excluding the United States.
The Company's ELAPRASE is a treatment for Hunter syndrome (also known as Mucopolysaccharidosis Type II or MPS II). ELAPRASE is approved in approximately 60 countries.
The Company's VPRIV is a treatment for Type I Gaucher disease. VPRIV is approved in over 50 countries.
The Company's FIRAZYR is a peptide-based therapeutic developed for the symptomatic treatment of acute attacks of Hereditary Angioedema (HAE). Its FIRAZYR is approved in approximately 40 countries.
The Company's 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 United States for routine prophylaxis against HAE attacks in adolescent and adult patients with HAE. The CINRYZE is approved in 40 countries.
The Company's GATTEX/REVESTIVE for injection is a prescription medicine for the long-term treatment of adults with short bowel syndrome (SBS). Its GATTEX/REVESTIVE is launched in the United States, Canada, Sweden, Germany, Norway and France.
The Company's NATPARA (parathyroid hormone) for injection is indicated as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism (HPT). The Company's NATPARA has been granted orphan drug by the FDA.
The Company's FOSRENOL is a phosphate binder that is indicated for use in patients with end-stage renal disease (stage 5) receiving dialysis. The Company's FOSRENOL is also indicated in the EU for the treatment of adult patients with Chronic kidney disease (CKD) who are not on dialysis. Formulated as a chewable tablet, FOSRENOL is available in approximately 500 mg, 750 mg and 1,000 mg dosage strengths. FOSRENOL has been launched in Japan, as well as an oral powder formulation was approved and made available in certain European countries and in the United States. Its FOSRENOL is approved in over 50 countries.
The Company's KALBITOR is a plasma kallikrein (pKal) inhibitor for the treatment of acute attacks of HAE in patients of approximately 12 years of age. The Company's KALBITOR product is available in the United States.
The Company competes with Janssen, Rhodes, Arbor, Pfizer Inc., Janssen-Cilag, Novartis AG, Medice Arzneimittel Putter GmbH & Co. KG, Eli Lilly and Company, Targacept, Otsuka Pharmaceutical Co., Ltd., Purdue, Alcobra, Teva, Theravance, Euthymics, Neuroderm, Durect Pharma, Tris, Neos, Supernus Pharmaceuticals, Inc., Sunovion Pharmaceuticals, Takeda Pharmaceuticals, Ironshore Pharmaceuticals/Highland Therapeutics, Allergan, Tillots, Valeant, Ferring Pharmaceutical, Dr. Falk, Faes Farma, Recordati S.p.A, Genzyme Corporation, Amicus, Protalix, JCR Pharmaceuticals Co. Ltd, Isu-Abxis, Actelion Pharmaceuticals, Ltd., Greenovation, Korean Green Cross Corporation, CSL Behring GmbH, Pharming Group N.V., EMD/Serono, Emmaus LifeSciences, Zealand Pharma, Naia Ltd., EnteraBio and Chugai.
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