Shire is buying substantially all the assets of Pervasis Therapeutics with an eye on the firm’s endothelial cell-based technology. Shire will provide Pervasis with an up-front payment plus milestone fees linked to Shire’s achievement of certain clinical development, regulatory, and sales targets.
Pervasis’ lead candidate, Vascugel®, is being investigated in two mid-stage studies for its ability to enhance blood-vessel repair and promote vascular health. Shire says that it will initially focus on completing a Phase II program in end-stage renal disease (ESRD) patients to address maturation and maintenance of arteriovenous (AV) access for hemodialysis patients.
“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,” Shire’s regenerative medicine president, Kevin Rakin, remarks. “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.”
Shire notes that results from that study will instruct future development, but for now it will focus on the Phase II program investigating the potential of Vascugel to improve AV access. Pervasis was studying Vascugel in a Phase I trial in coronary artery bypass grafting and in the preclinical phase in peripheral bypass grafting. Vascugel utilizes adult allogeneic endothelial cells embedded into a polymer matrix and is placed on the outside of the blood vessel at the AV access site during the surgical intervention to create the access. Vascugel has received orphan product designation from the FDA and EMA.
Shire also points out that there is a strong strategic fit with its existing product, Dermagraft, which is indicated for diabetic foot ulcers. Diabetes is the global leading cause of ESRD and accounts for approximately 40% of ESRD patients treated in the U.S., the company explains. Diabetic patients on dialysis have a greater risk of developing a diabetic foot ulcer than diabetics not receiving dialysis treatment, the firm adds.
Additionally, the acquisition complements its purchase of Advanced BioHealing. In May 2011, Shire paid $750 million for the company to use it as a foundation for establishing a regenerative medicine unit.
“This acquisition marks a very important step for Shire in building a regenerative medicine business focused on tissue repair and regeneration,” Rakin adds.