Last $147.36 USD
Change Today +0.58 / 0.40%
Volume 255.4K
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Company Description

Contact Info

5 Riverwalk

Citywest Business Campus

Dublin, 24


Phone: 353 1 429 7700


FDA in 2010 for the long-term treatment of patients with Type 1 Gaucher disease. The EMA approved the marketing authorization for the use of VPRIV in 2010. VPRIV was authorized as an orphan medicine through the Centralized Procedure in Europe with approximately 10 years market exclusivity from 2010. As of December 31, 2012 VPRIV was approved in 40 countries. FIRAZYR (icatibant) FIRAZYR is a peptide-based therapeutic developed for the symptomatic treatment of acute attacks of Hereditary Angioedema (HAE). HAE is a debilitating and potentially life-threatening genetic disease characterized by unpredictable recurring swelling attacks in the hands, feet, face, larynx, or abdomen. The disease is estimated to affect approximately 1 in 50,000 individuals (Bowen et al, 2008). In 2008 the EMA granted marketing authorization throughout the EU for the use of FIRAZYR for the symptomatic treatment of acute attacks of HAE, and in 2011 approved FIRAZYR for self-administration after training in subcutaneous injection technique by a healthcare professional. In 2011 the FDA granted marketing approval for FIRAZYR in the U.S. for treatment of acute attacks of HAE in adults aged 18 and older and, after injection training, patients may self-administer FIRAZYR. FIRAZYR has been granted orphan drug exclusivity by both the FDA and the EMA, providing it with up to 7 and 10 years market exclusivity in the U.S. and EU, respectively. As of December 31, 2012 FIRAZYR was approved in 38 countries. RM DERMAGRAFT DERMAGRAFT is a bio-engineered skin substitute that assists in restoring damaged tissue. DERMAGRAFT is indicated for use in the treatment of full-thickness Diabetic Foot Ulcers (DFUs) approximately six weeks in duration, which extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure. DERMAGRAFT was approved by the FDA in 2001 as a Class III medical device for the treatment of DFUs and was approved by Health Canada as a Class IV medical device for the treatment of DFUs in 2012. DERMAGRAFT is also approved for the treatment of DFUs in Israel, Mexico and Malaysia and the company is exploring commercialization opportunities for those countries. Royalties Received from Other Products Antiviral products The company receives royalties on antiviral products based on certain of the company’s patents licensed to GlaxoSmithKline. These antiviral products are for Human Immunodeficiency Virus (HIV) and Hepatitis B virus. In the U.S., 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. From the third quarter of 2012, the company 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 in 2003. Bayer launched FOSRENOL in Japan in 2009. Shire 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 SP Treatments for Behavioral Health INTUNIV for the treatment of ADHD in Canada: In 2011 Shire submitted a New Drug Submission (NDS) seeking the approval in Canada for INTUNIV for the treatment of ADHD in children and adolescents aged 6 to 17. Health Canada accepted the NDS for screening in 2011. VYVANSE for the treatment of ADHD in the U.S.: In 2012, the FDA accepted the filing for review of a supplemental New Drug Application (sNDA) for VYVANSE (lisdexamfetamine dimesylate (LDX)) Capsules, (scheduled as CII) seeking approval as a maintenance treatment in children and adolescents ages 6 to 17 years with ADHD. The FDA has issued a Prescription Drug User Fee Act (PDUFA) action date of April 29, 2013. INTUNIV for the treatment of ADHD in the EU: INTUNIV for the treatment of ADHD in children aged 6 to 17 in the EU is in Phase 3 development. LDX for the treatment of inadequate response in MDD: A Phase 3 clinical program to assess the efficacy and safety of LDX as adjunctive t


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Valuation SHPG Industry Range
Price/Earnings 20.4x
Price/Sales 5.6x
Price/Book 5.1x
Price/Cash Flow 43.5x
TEV/Sales 5.9x

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