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Last $84.39 USD
Change Today -0.53 / -0.63%
Volume 100.0
SHPGF On Other Exchanges
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As of 8:10 PM 04/24/15 All times are local (Market data is delayed by at least 15 minutes).

shire plc (SHPGF) Snapshot

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52 Week High
09/29/14 - $87.45
52 Week Low
10/15/14 - $52.99
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Current Stock Chart for SHIRE PLC (SHPGF)

shire plc (SHPGF) 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/ ELVANSE/ TYVENSE/ ELVANS E VUXEN/ADUVANZ; INTUNIV, an alpha-2A receptor agonist; EQUASYM, a methylphenidate hydrochloride; and ADDERALL XR, an extended release treatment for ADHD. The company also provides BUCCOLAM for epilepsy treatment; PENTASA and LIALDA/MEZAVANT for ulcerative colitis treatment; and RESOLOR, a 5-HT4 receptor agonist that is used for the treatment of chronic constipation in women. In addition, it offers 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 and CINRYZE C1 esterase inhibitor for the treatment of hereditary angioedema. Further, the company provides FOSRENOL, a phosphate binder for use in end-stage renal disease receiving dialysis; XAGRID that is used for the reduction of elevated platelet counts in at-risk essential thrombocythemia patients; and PLENADREN for the treatment of adrenal insufficiency. Additionally, it licenses its patented antiviral products for human immunodeficiency virus and hepatitis B virus. The company also focuses on the development of resources projects in various therapeutic areas, including rare diseases, neuroscience, ophthalmics, hematology, and gastrointestinal disorders; and early development projects primarily on rare diseases. Shire plc markets its products through wholesalers and pharmacies. The company has research collaboration with ArmaGen Technologies Inc., Santaris Pharma A/S, and Sangamo. Shire plc was founded in 1986 and is based in Dublin, Ireland.

5,016 Employees
Last Reported Date: 02/24/15
Founded in 1986

shire plc (SHPGF) Top Compensated Officers

Managing Director, Chief Executive Officer an...
Total Annual Compensation: $3.6M
Compensation as of Fiscal Year 2014.

shire plc (SHPGF) Key Developments

FDA Accepts Filing the New Drug Application for Shire's Lifitegrast and Grants Priority Review Designation

Shire plc announced that the United States Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for lifitegrast and granted a Priority Review designation. Lifitegrast is an investigational treatment for dry eye disease in adults and, if approved, has the potential to be the first treatment indicated to address both signs and symptoms of the disease. The FDA is expected to provide a decision on October 25, 2015, based on the Prescription Drug User Fee Act V action date. The FDA grants Priority Review designation to drugs that have the potential to provide significant improvements in the safety or effectiveness for the treatment, diagnosis or prevention of a serious disease. Drugs with Priority Review designation have an accelerated review target of eight months, instead of the standard of 12 months.

Shire plc Reports Topline Results from Phase 2 IMAGO Study

Shire plc announced that the 13-week Phase 2 IMAGO trial of its investigational compound SHP625 (LUM001) did not meet the primary or secondary endpoints in the study of 20 pediatric patients with Alagille syndrome (ALGS), a rare, life-threatening genetic disorder that presents with chronic cholestasis (accumulation of bile acids in the liver) and severe pruritus (itching). The primary endpoint was the change from baseline in serum bile acid levels as compared to placebo. The secondary endpoint of pruritus was assessed using the novel ItchRO™ instrument. Mean serum bile acid levels and pruritus at the end of the study were lower in both SHP625 and placebo treated groups as compared to baseline. However, in a post-hoc analysis, a positive correlation between changes from baseline in serum bile acid levels and pruritis was observed in the SHP625 treated group. The number of patients in the placebo treated group was too small to make an accurate assessment of this relationship. There were no treatment emergent serious adverse events in this study. As expected, the most common adverse events were diarrhea and abdominal pain, which were more frequent with SHP625 than with placebo. In addition to IMAGO, two larger placebo-controlled phase 2 studies in ALGS are in progress, one of which has pruritus as the primary endpoint. SHP625 is also being studied in progressive familial intrahepatic cholestasis, primary biliary cirrhosis and primary sclerosing cholangitis.

Shire plc Announces Clear Regulatory Path Forward for SHP465, an Investigational Treatment for Adults with ADHD

Shire plc announced that it has reached an agreement with the U.S. Food and Drug Administration on a clear regulatory path for SHP465 (triple-bead mixed amphetamine salts - MAS), an investigational oral stimulant medication being evaluated as a potential treatment for Attention-Deficit/Hyperactivity Disorder (ADHD) in adults. The company has agreed with the FDA to conduct a short-term efficacy and safety study in pediatric patients with ADHD (ages 6-17). While Shire intends to pursue an adult indication, the FDA is requesting this additional pediatric data to better understand the potential effects of SHP465 on children with ADHD in the event of use in this population. The company anticipates the clinical trial's first patient, first visit to take place in August 2015, with study completion targeted by the last quarter of 2016. Shire then expects to submit to the FDA by second quarter 2017 a Class 2 resubmission for approval of SHP465 as a treatment for ADHD in adults, which typically entails a 6-month review. Pending FDA approval, Shire anticipates launching the medicine in the second half of 2017. This update follows Shire's announcement on October 9, 2014, that it was engaging the FDA to determine the parameters of clinical data requirements in order to submit the Class 2 resubmission. Adult patients with ADHD represent the fastest growing segment of the overall ADHD patient population. Data from IMS Health (a global healthcare information and technology firm) suggest that about 10% of adult patients are adding an immediate release medicine to their extended release medicine, most often to gain a longer duration of treatment effect. SHP465 demonstrated a statistically significant difference versus placebo at 16 hours post dosing, with onset of action starting 4 hours post dosing, as measured by the Permanent Product Measure of Performance (PERMP). Common adverse reactions in SHP465 registration trials (incidence =5% and at a rate twice placebo) in adults were: insomnia, decreased appetite, dry mouth, decreased weight, heart rate increased, and dysmenorrhea. These adverse events are generally known to be associated with the use of amphetamine products. There are patents supporting Shire's overall ADHD franchise in the U.S. that extend to 2029. With a launch planned for the second half of 2017, Shire expects that SHP465, following FDA approval, will have three years of Hatch-Waxman exclusivity and at least three patents listed in the FDA Orange Book expiring as late as May 2029. Vyvanse (lisdexamfetamine dimesylate), which has patents expiring in 2023, is a prescription medicine used for the treatment of ADHD in patients 6 years and above and for the treatment of moderate to severe Binge Eating Disorder (B.E.D.) in adults. Vyvanse is not for weight loss. It is not known if Vyvanse is safe and effective for the treatment of obesity. Shire announced on June 12, 2014 that it has agreed to a Written Request by the FDA to conduct pediatric clinical studies to investigate the potential use of Vyvanse for the treatment of ADHD in preschool-age children, ages 4 to 5. Upon FDA confirmation of a timely submission and review of data that adheres to the requirements of the Written Request, Shire will be entitled to the benefits of the Best Pharmaceuticals for Children Act, including a six-month extension to the exclusivity afforded by Shire's patents for Vyvanse.


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