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Volume 23.0
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shire plc-adr (SP2) Details

Shire plc, a biopharmaceutical company, together with its subsidiaries, researches, develops, licenses, manufactures, markets, distributes, and sells pharmaceutical products. It offers various products for the treatment of attention deficit hyperactivity disorder (ADHD), including VYVANSE/VENVANSE, a pro-drug stimulant; ELVANSE/TYVENSE; INTUNIV, an alpha-2A receptor agonist; EQUASYM, a methylphenidate hydrochloride; and ADDERALL XR, an extended release treatment for ADHD. The company also provides PENTASA and LIALDA/MEZAVANT for ulcerative colitis treatment; and RESOLOR, a 5-HT4 receptor agonist for oral symptomatic treatment of chronic constipation in women. In addition, it offers FOSRENOL, a phosphate binder for use in end-stage renal disease receiving dialysis; and XAGRID for the reduction of elevated platelet counts in at-risk essential thrombocythemia patients, as well as for the treatment of thrombocythemia. Further, the company provides REPLAGAL for the treatment of Fabry disease; ELAPRASE for the treatment of hunter syndrome; VPRIV for the treatment of type 1 Gaucher disease; and FIRAZYR for the symptomatic treatment of acute attacks of hereditary angioedema. Additionally, it offers FOSRENOL for the treatment of hyperphosphatemia in end stage renal disease; XAGRID for the reduction of elevated platelet counts; and CINRYZE, a C1 esterase inhibitor therapy for routine prophylaxis against hereditary angioedema. The company also licenses its patented antiviral products for human immunodeficiency virus and hepatitis B virus. Shire plc markets its products directly to government hospitals, clinics, pharmacies, and other agencies; and through wholesalers and distributors. The company sells its products in North America, the United Kingdom, the Republic of Ireland, and internationally. Shire plc has research collaboration with Santaris Pharma A/S. The company was founded in 1986 and is headquartered in Dublin, Ireland.

5,338 Employees
Last Reported Date: 02/24/14
Founded in 1986

shire plc-adr (SP2) Top Compensated Officers

Chief Executive Officer, Managing Director an...
Total Annual Compensation: $2.7M
Compensation as of Fiscal Year 2013.

shire plc-adr (SP2) Key Developments

Shire Presents at 14th Annual Biotech in Europe Forum for Global Partnering & Investment, Sep-30-2014 09:00 AM

Shire Presents at 14th Annual Biotech in Europe Forum for Global Partnering & Investment, Sep-30-2014 09:00 AM. Venue: Congress Center Basel, MCH Messe Schweiz (Basel) AG, CH-4005 Basel, Switzerland. Speakers: David Colpman, Former Head of Global Business Development at Shire.

The Department of Justice Orders Shire to Pay $56.5 Million Fine

The Department of Justice announced that Shire PLC will pay $56.5 million to settle allegations it broke the law in promoting five drugs, including its attention deficit disorder drugs Adderall XR and Vyvanse. According to a whistle-blower lawsuit, Shire said ADHD patients who took Adderall XR would be "indistinguishable" from people who don't have the condition. It also suggested that the drug would prevent patients from getting bad grades, losing their jobs, engaging in criminal behavior, getting into traffic accidents, and acquiring sexually transmitted diseases. Shire is also alleged to have marketed Adderall XR as a treatment for conduct disorder even though it did not have approval to do so. Shire is alleged to have said Vyvanse would also help prevent car accidents, divorce, arrests, and unemployment. It also allegedly said Vyvanse and its Daytrana patch were less likely to be abused than other medications. The government also said Shire marketed Lialda, a treatment for ulcerative colitis, for the prevention of co-lorectal cancer. The Justice Department said the claims made by Shire representatives are not backed by evidence from clinical trials. The allegations cover activities from January 2004 to September 2010. Shire confirmed it had agreed to settle the investigation and also said it will make an additional payment of $2.9 million to the state of Louisiana to resolve allegations it violated state law. The company did not acknowledge any wrongdoing. Shire PLC will pay $35.7 million to the federal government and $20.8 million to state Medicaid programs.

Shire plc Announces FDA Acceptance for Filing with Priority Review of Supplemental New Drug Application for Vyvanse Capsules (CII) for Adults with Binge Eating Disorder

Shire plc announced that the US Food and Drug Administration (FDA) has accepted for filing with priority review a supplemental New Drug Application (sNDA) for Vyvanse(R) (lisdexamfetamine dimesylate) Capsules (CII) as a treatment for adults with binge eating disorder (BED). The FDA is expected to provide a decision in February 2015, based on the anticipated Prescription Drug User Fee Act (PDUFA) action date. Vyvanse is a prescription medicine currently only approved for Attention-Deficit/Hyperactivity Disorder (ADHD). Vyvanse should only be used to treat ADHD. Vyvanse is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep in a safe place to prevent misuse and abuse. Selling or sharing Vyvanse may harm others and is illegal. Shire is seeking approval for Vyvanse as a treatment option for adults with BED based on the results of two identically designed randomized placebo-controlled Phase 3 studies evaluating the efficacy and safety of Vyvanse versus placebo.


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