Per the terms of the transaction, Shire will purchasePremacure for an upfront payment as well as certain contingent payments dependentupon the achievement of pre-established development and commercial milestones.No financial terms were disclosed.
The transaction provides Shire with a foothold inneonatology, a new field for the company, while continuing to bolster itsportfolio of therapies and therapeutics for rare diseases.
"The acquisition of Premacure by Shire further underscoresthe potential to change the long-term outlook for preterm infants with ROP andtheir families," Jan Borg, founding CEO of Premacure, said in a press releaseregarding the transaction. "We are excited that this program will become partof the innovative pipeline at Shire and believe that their experience andresources may accelerate the development of a product that seeks to preventsome of the devastating long-term consequences of ROP."
In normal gestation, developing fetuses are dependent oncertain growth factors from their mothers' serum, and full-term babies canproduce those factors on their own. In preterm babies (born before 31 weeks),however, being separated prematurely from the maternal circulation causes themto lose specific growth factors, such as insulin-like growth factor 1 (IGF-1),whose loss is implicated in lifelong complications such as ROP,bronchopulmonary dysplasia, intraventricular hemorrhage, necrotizingenterocolitis and impaired brain chronic. According to Premacure's website,"Chronic complications following premature birth are present in up to 70percent of these neonates." Given that the company reports that some 54,000 and87,000 premature infants are born in the European Union and United Statesrespectively each year, finding a way to compensate for IGF-1 deficiency inpremature infants is critical.
Premacure is currently developing Premiplex (IGF-I/IGFBP-3),a preventative treatment with IGF-1. In a Phase I clinical trial, Premiplex wasshown to increase levels of IGF-1 to within physiological levels ("equivalentto in utero," according to Premacure) andto be safe and well tolerated in preterm infants. A Phase II safety and efficacyclinical trial has begun in Sweden to continue evaluating the treatment, andfollowing the transaction, Shire HGT will take over administration of thestudy.
"ROP is a devastating eye disorder that can severely impactpreterm infants for the rest of their lives," Dr. Flemming Ornskov, CEO designate for Shire, commented in a statement. "This investigational proteinhas the potential to provide a first-in-class treatment that may minimize thedevelopment and impact of complications arising from ROP. We will build on thework that Premacure has done and will apply Shire's proven ability indeveloping protein replacement therapies for rare disorders to bring thismuch-needed therapy to the market."