Wednesday, March 13, 2013

Shire Acquires Sweden based biotech company Premacure AB

Shire plc (LSE: SHP, NASDAQ: SHPG), has acquired Premacure AB of Uppsala, Sweden, a privately held biotechnology company developing a protein replacement therapy, currently in Phase II development,  for the prevention of retinopathy of prematurity (ROP). ROP is a rare and potentially blinding eye disorder that primarily affects premature infants and is one of the most common causes of visual loss in childhood. Currently, only symptomatic treatment is available for ROP. Shire will purchase Premacure for an upfront payment and certain contingent payments based on the achievement of pre-specified development and commercial milestones. This acquisition underscores and expands Shire’s commitment to bringing innovative therapies to patients with rare disorders worldwide.



During normal gestation, the developing fetus is reliant on certain growth factors from the maternal serum; full term babies can produce these growth factors on their own. In preterm infants (born before 31 weeks of gestation), the early separation from the maternal circulation results in a loss of specific growth factors, such as insulin-like growth factor 1 (IGF-1), that are believed to result in lifelong complications, including ROP.

This acquisition allows Shire HGT to enter a new therapeutic area – neonatology – while maintaining its focus on developing novel therapies for the treatment of rare diseases with high unmet medical need. With the acquisition of Premacure, Shire HGT will continue the ongoing Phase II study, the primary goal of which is to restore the IGF-1 levels in the preterm infant to those found during normal in utero development. 

Premacure initiated the clinical development of the preventative treatment with a formulation of recombinant human IGF-1 combined with a recombinant version of its naturally occurring binding protein, insulin-like growth factor-1 binding protein-3 (IFGBP3).
A Phase I clinical trial was conducted and results showed that the levels of IGF-1 were increased to within physiological levels and that administration of the investigational protein to preterm infants is generally well tolerated. A Phase II, safety and efficacy multi-centre clinical trial has started in Sweden and is on-going.