with SBS who are dependent on parenteral support. GATTEX was approved by the FDA in 2012. REVESTIVE was approved in the EU in 2012. As of December 31, 2015, GATTEX/REVESTIVE was launched in the U.S., Canada, Sweden, Germany, Norway, and France. NATPARA/NATPAR NATPARA (parathyroid hormone) for injection is indicated as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism (HPT). NATPARA was approved by the FDA in January 2015. NATPARA has been granted orphan drug exclusivity by the FDA. The EMA granted orphan drug designation for NATPAR in 2014. Treatments for Other Therapeutic Areas FOSRENOL FOSRENOL is a phosphate binder that is indicated for use in patients with end-stage renal disease (stage 5) receiving dialysis, and is also indicated in the EU for the treatment of adult patients with chronic kidney disease 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. Formulated as a chewable tablet, FOSRENOL is available in 500mg, 750mg and 1,000mg dosage strengths. The FDA approved the 500mg dosage strength in 2004 and the 750mg and 1,000 mg dosage strengths were approved in 2005. In 2009, FOSRENOL was launched in Japan. An oral powder formulation was approved and made available in certain European countries in 2012 and was approved in the U.S. in 2014. As of December 31, 2015, FOSRENOL was approved in 51 countries. In addition, the company has various other less material marketed products for the treatment of Neuroscience conditions (EQUASYM and BUCCOLAM), GI diseases (RESOLOR) and other TAs (PLENADREN). Recently Acquired Product Following completion of the acquisition of Dyax Corp. (Dyax) in January 2016, the company obtained KALBITOR. KALBITOR KALBITOR is a plasma kallikrein (pKal) inhibitor for the treatment of acute attacks of HAE in patients 12 years of age and older. It is administered subcutaneously. It is available in the U.S. It was approved by the FDA in 2009. Royalties Received From Other Products Cinacalcet HCI Following the acquisition of NPS Pharmaceuticals Inc. (NPS Pharma) in 2015, the company receives royalties arising from NPS Pharma’s collaborations with Amgen Inc. (Amgen), Janssen Pharmaceuticals N.V. and Kyowa Hakko Kirin. Amgen markets cinacalcet HCI as SENSIPAR in the U.S. and as MIMPARA in the EU; Janssen Pharmaceuticals N.V. markets tapentadol as Nucynta in the U.S.; and Kyowa Hakko Kirin markets cinacalcet HCI as REGPARA in Japan, Hong Kong, Malaysia, Macau, Singapore and Taiwan. The company is entitled to royalties from the relevant net sales of these products. Antiviral Products The company receives royalties on antiviral products based on certain of the company’s patents licensed to GSK. These antiviral products are for human immunodeficiency virus and Hepatitis B virus. In the U.S., royalty terms expire at various periods through to 2018. ADHD ADDERALL XR The company receives royalties from Impax’s sales of its authorized generic version of ADDERALL XR. The company also receives royalties from Actavis’ sales of their generic version of ADDERALL XR. INTUNIV From December 1, 2014, the company received royalties from Actavis’ sales of its generic version of INTUNIV, for 180 days from launch. Hyperphosphatemia FOSRENOL The company licensed the rights to FOSRENOL in Japan to Bayer in 2003. Bayer launched FOSRENOL in Japan in 2009. The company receives royalties from Bayer’s sales of FOSRENOL in Japan. In addition, the company has licensed the rights to certain other products to third parties and receives royalties on third party sales. Following the acquisition of Dyax, the company has acquired rights to future milestones and royalties from Dyax’s Licensing and Research Funded Porftolio, including royalties arising from relevant net sales of Lilly’s CYRAMZA. Products under Development The company focuses its development resources on projects in various TAs, including rare diseases, neuroscience, ophthalmics, hematology, and gastrointestinal (GI); and focuses its early develo
(SHPG:Consolidated Issue Listed on NASDAQ Global Select )
Citywest Business Campus
Dublin, D24 TW13
Phone: 353 1 429 7700
Fax: 353 1 429 7701www.shire.com
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