Pervasis will receive an upfront payment, plus potential post-closing milestone payments that are dependent on Shire's achievement of certain clinical development, regulatory and sales targets.
The assets bring to Shire a new cell-based technology platform (endothelial cell technology) and lead program Vascugel, an acute vascular repair technology focused on improving hemodialysis access for patients with end-stage renal disease (ESRD). The acquisition also complements Shire’s purchase of Advanced BioHealing in 2011, strengthening the company’s portfolio of regenerative medicine therapies. Furthermore, it leverages many of Shire’s existing capabilities, including specialized marketing, cell-based manufacturing, unique reimbursement and outpatient call point.
Shire will initially focus on completing a phase II program to address maturation and maintenance of arteriovenous (AV) access for hemodialysis patients, which will instruct a future development pathway.
"There are currently no approved therapies that directly target the underlying physiological processes associated with the creation of AV access sites in hemodialysis patients, including inflammation, thrombosis, and restenosis,” said Kevin Rakin, president, regenerative medicine, Shire. “We believe Vascugel has the potential to enhance the rate of blood vessel repair while also providing for increased maintenance of the access site for a prolonged period of time as compared to current treatments.”
The closing of the acquisition is subject to ancillary conditions.