option for appropriately trained patients. CINRYZE has been granted orphan drug exclusivity by the FDA, providing it with up to 7 years market exclusivity in the United States from 2008. Treatments for Other Therapeutic Areas FOSRENOL FOSRENOL is a phosphate binder that is indicated for use in end-stage renal disease (stage 5) receiving dialysis and, from 2009, is also indicated in the EU for the treatment of adult patients with CKD who are not on dialysis with serum phosphate > 1.78 mmol/L (5.5 mg/dL) in which a low phosphate diet alone is insufficient to control serum phosphate levels. XAGRID Myeloproliferative disorders (MPD), including essential thrombocythemia (ET), are a group of diseases in which one or more blood cell types are overproduced. XAGRID is marketed in Europe for the reduction of elevated platelet counts in at-risk ET patients. In the United States, anagrelide hydrochloride is sold by the company under the trade name AGRYLIN for the treatment of thrombocythemia secondary to a MPD. Generic versions of AGRYLIN are available in the United States market. Royalties Received From Other Products Antiviral Products The company receives royalties on antiviral products based on certain of its patents licensed to GSK. These antiviral products are for Human Immunodeficiency Virus (HIV) and Hepatitis B virus. In the United States, royalty terms expire between 2014 and 2018. ADHD ADDERALL XR The company receives royalties from Impax’s sales of its authorized generic version of ADDERALL XR. In 2012, Shire also started receiving royalties from Actavis’ sales of their generic version of ADDERALL XR. Hyperphosphatemia FOSRENOL The company licensed the rights to FOSRENOL in Japan to Bayer. Bayer launched FOSRENOL in Japan in 2009. The company receives royalties from Bayer’s sales of FOSRENOL in Japan. Other royalties The company has licensed the rights to certain other products to third parties and receives royalties on third party sales. Products under Development The company focuses its development resources on projects in various therapeutic areas, including neuroscience, rare diseases, ophthalmology, hematology and gastrointestinal, and focuses its early development projects on rare diseases. In 2013, the company’s total research and development expenditure included $933.4 million. Products in Registration as at December 31, 2013 FIRAZYR for the treatment of Acute Angiotensin Converting Enzyme Inhibitor-Induced Angioedema (ACE-I A) in Europe: In 2012, the company submitted a supplemental Marketing Authorization Application (MAA), to the EMA seeking approval for FIRAZYR for the treatment of ACE-I AE in Europe. XAGRID for the treatment of essential thrombocythaemia in Japan: In 2013, the company submitted a marketing authorisation to the Ministry of Health, Labour and Welfare (MHLW) in Japan, seeking approval for XAGRID in adult essential thrombocythaemia patients treated with cytoreductive therapy who have become intolerant to their therapy or whose platelet counts have not been reduced to an acceptable level. VPRIV for the treatment of Gaucher disease in Japan: In 2013, the company submitted a Marketing Authorisation to the Ministry of Health, Labour and Welfare (MHLW) in Japan, seeking approval for VPRIV for the treatment of adult and paediatric patients with Gaucher disease. Products in Clinical Development as at December 31, 2013 Phase 3 Lisdexamfetamine dimesylate (LDX) for the treatment of inadequate response in major depressive disorder (MDD): In 2014, the company announced results from two pivotal Phase 3 investigational studies evaluating the efficacy and safety of LDX versus placebo as an adjunctive treatment for MDD in adults who inadequately responded to antidepressant monotherapy with a selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors. LDX for the treatment of Binge Eating Disorder (BED): In 2013, the company reported top-line results from two identically designed randomized placebo-controlled Phase 3 studies evaluating the efficacy and safety of LDX versus placebo in adults with BED.
shire plc-adr (SHPG:NASDAQ GS)
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Phone: 353 1 429 7700
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