June 29, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Lexington, Massachusetts - Shire announced positive topline results today from its clinical trial of SHP465-306 in attention deficit/hyperactivity disorder (ADHD).
The trial looked at 275 adults between the ages of 18 and 55 with ADHD. The study showed both doses of the drug, 12.5mg and 37.5mg, worked better than placebo. Side effects included decreased appetite, dry mouth, insomnia, headache, anxiety, irritability and bruxism (grinding of the teeth). They were generally mild to moderate.
“ADHD affects adults in multiple ways and, therefore, physicians need additional treatment options,” said Matthew Brams, clinical assistant professor at Baylor College of Medicine and principal investigator in the study, in a statement. “Based upon this study’s findings, and pending the U.S. FDA’s review, SHP465 may provide a promising treatment option for physicians and patients alike.”
About 4.4 percent of adults in the U.S. have ADHD, which comes to approximately 10.5 million adults. It is marked by a persistent pattern of inattention and/or hyperactivity-impulsivity that is bad enough that it causes problems with functionality or development.
Shire also markets two other drugs for ADHD, Vynase and Intuniv. The company indicates it is on schedule for FDA approval in the second half of 2017. If approved, SHP465 would protect its ADHD franchise up to 2029. The company indicates that after approval, it would have three years of Hatch-Waxman exclusivity, with at least three patents in the FDA Orange Book.
This most recent study, 306, is now part of 16 clinical studies that have evaluated more than 1,600 people in the SHP465 program.
The company recently completed its acquisition of Bannockburn, Illinois-based Baxalta . That deal began in July 2015, when Shire approached Baxalta about an acquisition. Baxalta had just spun off from Baxter International on July 1, 2015. It declined the offer, but in early August, Shire went public with its bid in hopes of pressuring the Baxalta board and shareholders into considering the acquisition.
The deal officially closed on June 3, 2016. The merged companies employ over 22,000 people in more than 100 countries. It has projected compound annual top-line growth in the double digits, and expects to pass $20 billion in annual revenue by 2020. The merged companies have more than 50 programs in clinical development across all stages.
In addition, Shire cut the ribbon for new global corporate headquarters in Lexington, Massachusetts this week. Located at 95 Hayden Avenue, the 200,000-square-foot building will house more than 800 employees.
Shire plans to file a Class 2 Resubmission of the New Drug Application (NDA) to the FDA by the end of the year for SHP465.
“Shire has been working to fully understand the needs of adult patients with ADHD so we can help physicians and their patients optimally manage the disorder,” said Philip Vickers, head of research and development at Shire in a statement. “We are excited that SHP465, when taking into account the broader clinical development program and multiple dosing strengths, has the potential to benefit adult patients with ADHD.”
Shire popped at the news, and is currently trading for $180.28. On March 16, shares traded for $152.40.
