Profile: Shire PLC (SHPG.OQ)
24 May 2017
Shire plc, incorporated on January 28, 2008, is a biotech company focused on serving people with rare diseases and other specialized conditions. The Company's segment is engaged in research, development, licensing, manufacturing, marketing, distribution and sale of specialist medicines. The Company focuses its development resources on projects in various therapeutic areas (TAs), including Neuroscience, Ophthalmology, Hematology, Oncology, Immunology, Gastrointestinal (GI)/Metabolic/Endocrinology Diseases. The Company's Hematology products include ADVATE (Antihemophilic Factor (Recombinant)), ADYNOVATE/ADYNOVI (Antihemophilic Factor (Recombinant), PEGylated), RIXUBIS (Coagulation Factor IX (Recombinant)), VONVENDI (von Willebrand factor (Recombinant)) and FEIBA (Anti-Inhibitor Coagulant Complex). Its Genetic Diseases products include CINRYZE (C1 esterase inhibitor (human)), FIRAZYR (icatibant), ELAPRASE (idursulfase), REPLAGAL (agalsidase alfa) and VPRIV (velaglucerase alfa). Its Neuroscience products include VYVANSE/VENVANSE/ELVANSE/TYVENSE/VUXEN/ADUVANZ (lisdexamfetamine dimesylate) and ADDERALL XR (mixed salts of a single-entity amphetamine).
The Company's Immunology products include GAMMAGARD LIQUID/KIOVIG (Immune globulin intravenous (Human)), GAMMAGARD S/D (Immune globulin intravenous (Human)), GAMMAGARD S/D (Immune globulin intravenous (Human)), CUVITRU(Immune Globulin Subcutaneous (Human)) and FLEXBUMIN (Albumin (Human)). Its Internal Medicine products include LIALDA (mesalamine)/MEZAVANT (mesalamine), GATTEX/REVESTIVE (teduglutide(rDNA origin)) and NATPARA (parathyroid hormone). Its Oncology products include ONCASPAR (pegasapragase) and ONYVIDE (pegylated liposomal formulation of irinotecan). Its Ophthalmology products include XIIDRA (lifitegrast ophthalmic solution) 5%. It offers a range of marketed products in the Immunology portfolio, including SUBCUVIA for primary immunodeficiency, ARALAST NP and GLASSIA NP for emphysema due to severe hereditary deficiency of alpha1- antitrypsin, CEPROTIN for congenital protein C deficiency and BUMINATE for hypovolemia and hypoalbuminemia.
The Company's ADVATE (Antihemophilic Factor (Recombinant)) is a recombinant factor VIII (rFVIII) therapy. ADVATE is a recombinant antihemophilic factor indicated for use in adults and children with hemophilia A (congenital factor VIII deficiency) for control and prevention of bleeding episodes, perioperative management and routine prophylaxis to prevent or reduce the frequency of bleeding episodes. Its ADYNOVATE/ADYNOVI is an extended half-life rFVIII treatment for hemophilia A based on ADVATE. ADYNOVATE/ADYNOVI uses the same manufacturing process as ADVATE and adds a proven technology, PEGylation. Its RIXUBIS is an injectable medicine used to replace ulcerative colitis (U.C.) clotting factor IX that is missing in people with hemophilia B. Its FEIBA (Anti-Inhibitor Coagulant Complex) is a plasma-based inhibitor bypass therapy, and is an inhibitor management therapy and is the only marketed bypassing agent approved for prophylactic use. FEIBA is indicated for use in hemophilia A and hemophilia B patients with inhibitors for control of spontaneous bleeding episodes, to cover surgical interventions and routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
The Company's VONVENDI is a recombinant von Willebrand factor (VWF) and is used to replace the VWF the body is missing in von Willebrand disease. VONVENDI can also be given independent of recombinant Factor VIII (rFVIII), based on patient need. CINRYZE is a C1 esterase inhibitor therapy for routine prophylaxis against Hereditary Angioedema (HAE) attacks, 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. FIRAZYR is a peptide-based therapeutic developed for the symptomatic treatment of acute attacks of HAE. ELAPRASE is an enzyme replacement treatment for Hunter syndrome (also known as Mucopolysaccharidosis Type II or MPS II). REPLAGAL is an enzyme replacement marketed for the treatment of Fabry disease outside of the United States. REPLAGAL is a fully human alpha-galactosidase A protein made in a human cell line is designed to replace the deficient alpha-galactosidase A with an active enzyme to ameliorate certain clinical manifestations of Fabry disease.
The Company's VPRIV is an enzyme replacement treatment for Type I Gaucher disease. VYVANSE is a 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. VYVANSE is approved and marketed in certain European countries, Australia, Canada and Latin America under a variety of trade names VYVANSE/VENVANSE/ELVANSE/TYVENSE/VUXEN/ADUVANZ. ADDERALL XR is an extended release treatment for ADHD and is designed to provide once-daily dosing. ADDERALL XR is available in five milligram (mg), 10 mg, 15 mg, 20 mg, 25 mg and 30 mg dosage strengths. Its GAMMAGARD LIQUID (Immune Globulin Intravenous (Human)) is a liquid formulation of the antibody-replacement therapy immunoglobulin product. GAMMAGARD S/D (Immune Globulin Intravenous (Human)) is indicated for the treatment of Primary immunodeficiencies (PID) in patients two years old and older. GAMMAGARD S/D is also indicated for prevention of bacterial infections in hypogammaglobulinemia and/or recurrent bacterial infections associated with B-cell chronic lymphocytic leukemia (CLL), treatment of adult patients with chronic idiopathic thrombocytopenic purpura (ITP) to increase platelet count and to prevent and/or control bleeding, and prevention of coronary artery aneurysms associated with Kawasaki Syndrome in pediatric patients.
The Company's HYQVIA (Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase) is a product consisting of human normal immunoglobulin (IG) and recombinant human hyaluronidase (licensed from Halozyme). The IG provides the therapeutic effect and the recombinant human hyaluronidase facilitates the dispersion and absorption of the IG administered subcutaneously, increasing its bioavailability. CUVITRU is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Solution indicated as replacement therapy for primary humoral immunodeficiency in adult and pediatric patients two years of age and older. FLEXBUMIN (Albumin (Human)) is available as a 5% and 25% solution. Both products are indicated for hypovolemia, hypoalbuminemia due to general causes and burns, and for use during cardiopulmonary bypass surgery as a component of the pump prime.
The Company's ONCASPAR (pegaspargase) is approved in the United States and European Union as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of patients with Acute lymphoblastic leukemia (ALL). ONIVYDE (pegylated liposomal formulation of irinotecan) is approved in the United States and European Union in combination with fluorouracil (5-FU) and leucovorin (LV), for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. XIIDRA (lifitegrast ophthalmic solution) 5%, is used for the treatment of the signs and symptoms of dry eye disease. 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 competes with Pfizer, SOBI, Bayer, CSL, Bayer, Biogen, Octapharma, DDAVP (desmopressin), Novo Nordisk, Pharmstandard, LFB Group, Genzyme, Protalix, Actelion, Isu Abxis, CSL Behring, Pharming Group N.V., BERINERT, Sangamo, JCR and REGENXBIO, Biocryst, Pharming, Janssen, Rhodes, Arbor, Novartis, Medice, Lilly, Sunovion Pharmaceuticals, Takeda Pharmaceuticals, Ironshore Pharmaceuticals, Highland Therapeutics, Grifol, Biotest, Kendrion, BPL, Allergan, Tillots, Valeant, Ferring Pharmaceutical, Dr. Falk, Faes Farma, Recordati S.p.A, Mylan, Zydus, Samsung, Bioepis, Amgen, Roche, J&J, Abbvie, EMD/Serono, Emmaus LifeSciences, Zealand Pharma, Naia Ltd, EnteraBio, Chugai, Astra Zenaca, Taiho, Eleison, Jazz, Erytech and RegeneRx.
Hampshire Intl Business Park, Ch
BASINGSTOKE RG24 8EP
Company Web Links
- BRIEF-Xenetic Biosciences receives update from Shire's Phase 1/2 study evaluating SHP656 in development as long-acting treatment for Hemophilia A
- Shire's swelling disorder drug moves closer to U.S. approval
- UPDATE 3-Shire's swelling disorder drug moves closer to U.S. approval
- BRIEF-Shire expects to file potential EU marketing submission for lanadelumab in H1 2018
- BRIEF-Shire's angioedema drug succeeds in late-stage study