Shire plc and its subsidiaries engage in the research, development, licensing, manufacturing, marketing, distribution and sale of specialist medicines to meet unmet patient needs. Marketed Products Treatments for Neuroscience Attention deficit hyperactivity disorder (ADHD) is a chronic neurobehavioral disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable level of development. Standard treatments include educational approaches, psychological therapies that might include behavior modification, and/or medication. VYVANSE VYVANSE is the pro-drug stimulant for the treatment of ADHD, where the amino acid l-lysine is linked to d-amphetamine. VYVANSE is therapeutically inactive until metabolized in the body. The U.S. Food and Drug Administration (FDA) approved VYVANSE as a once-daily treatment for children aged 6 to 12 with ADHD in 2007, for adults in 2008, and for adolescents aged 13 to 17 in 2010. In addition, VYVANSE became the first drug in its class to be approved by the FDA for maintenance treatment, having been approved both as a maintenance treatment in adults with ADHD in 2012, and as a maintenance treatment in pediatrics and adolescents aged 6 to 17 in 2013. VYVANSE is available in the U.S. in seven dosage strengths, such as 10mg, 20mg, 30mg, 40mg, 50mg, 60mg, and 70mg. VYVANSE was approved by Health Canada for the treatment of ADHD in pediatric patients aged 6 to 12 in 2009, for adolescents and adults in 2010, and was launched in Canada in 2010 for pediatric patients and 2011 for adolescents and adults. VENVANSE was granted marketing authorization by ANVISA, the Brazilian health authority, for the treatment of ADHD in children aged 6 to12 and launched in 2011 and launched for adolescents and adults in 2013. ELVANSE/TYVENSE received a positive outcome from the European Decentralised Procedure in 2012. ELVANSE is indicated as part of a treatment program for ADHD in children six years of age and over when response to previous methylphenidate treatment is considered clinically inadequate. The product has been approved and launched in eight countries through the European Decentralised Procedure (the U.K., Germany, Sweden, Spain, Norway, Finland, Denmark and Ireland). The product has also been approved and launched in Switzerland. ELVANSE ADULT/ELVANSE VUXEN/ADUVANZ received a positive outcome from the European Decentralised Procedure in January 2015. ELVANSE ADULT is indicated as part of a treatment programme for ADHD in adults taking into consideration the profile of the patient, including a thorough assessment of the severity and chronicity of the patient’s symptoms, the potential for abuse, misuse or diversion and clinical response to any previous pharmacotherapies for the treatment of ADHD. The product has been approved and launched in the U.K., Sweden and Denmark. The product has also been approved and launched in Switzerland. VYVANSE was also approved in the U.S. in January 2015 as the first and only treatment of moderate to severe binge eating disorder in adults. Binge eating disorder is defined as recurring episodes (more than once weekly), for approximately three months, of consuming a large amount of food in a short time, compared with others. ADDERALL XR ADDERALL XR is an extended release treatment for ADHD, which uses MICROTROL drug delivery technology and is designed to provide once-daily dosing. It is available in 5mg, 10mg, 15mg, 20mg, 25mg and 30mg capsules. The FDA approved ADDERALL XR as a once-daily treatment for children aged 6 to 12 with ADHD in 2001, for adults in 2004, and for adolescents aged 13 to 17 in 2005. Teva Pharmaceutical Industries, Ltd. and Impax Laboratories, Inc. (Impax) commenced commercial shipment of their authorized generic versions of ADDERALL XR in 2009. The company receives royalties from Impax’s sales of authorized generic ADDERALL XR. From 2012, the company also started receiving royalties from Actavis Elizabeth LLC and Actavis Inc.’s (collectively ‘Actavis’) sales of its generic version of ADDERALL XR.
shire plc-adr (SHPG:NASDAQ GS)
Citywest Business Campus
Dublin, D24 TW13
Phone: 353 1 429 7700
Fax: 353 1 429 7701www.shire.com
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