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The new apple of Shire’s eye
April 2013
by Kelsey Kaustinen  |  Email the author


LEXINGTON, Mass.—In keeping with its dedication to growth as a provider of therapies for rare disorders, Shire PLC has acquired Uppsala, Sweden-based Premacure AB, a privately held biotechnology company developing a protein replacement therapy for the rare eye disorder retinopathy of prematurity (ROP). Though no financial details were disclosed, the transaction includes an upfront payment as well as additional potential payments contingent on the achievement of pre-arranged development and commercial milestones.  
"ROP is a devastating eye disorder that can severely impact preterm infants for the rest of their lives," Dr. Flemming Ornskov, CEO-designate for Shire, said in a press release. "This investigational protein has the potential to provide a first-in-class treatment that may minimize the development and impact of complications arising from ROP. We will build on the work that Premacure has done and will apply Shire's proven ability in developing protein replacement therapies for rare disorders to bring this much-needed therapy to the market."  
During normal gestation, a fetus receives necessary growth factors from the maternal serum, and full-term babies can produce said factors on their own. Preterm infants, however, lose specific growth factors such as insulin-like growth factor 1 (IGF-1), which supports childhood growth and development, as a result of early separation from their mothers. The lack of growth factors like IGF-1 is linked to lifelong complications such as ROP, bronchopulmonary dysplasia, intraventricular hemorrhage, necrotizing enterocolitis and impaired brain growth, according to Premacure's website, and "chronic complications following premature birth are present in up to 70 percent of these neonates."  
According to current estimates, roughly 54,000 premature infants are born in the European Union each year, and 87,000 in the United States, and of those numbers, approximately 14,000 to 16,000 preterm infants in the United States present with some degree of ROP. For anywhere between 1,100 and 1,500 of those infants, ROP is severe enough to require medical treatment, and some 400 to 600 infants become legally blind. ROP primarily affects preterm infants born before 31 weeks of gestation, and the smaller an infant is at birth, the higher its chances of developing ROP, which usually develops in both eyes and is one of the leading causes of childhood vision loss.  
At present, only symptomatic treatment exists for ROP. However, administering IGF-1 to premature infants to compensate for the loss of the maternal source has been shown to establish a physiological level of the hormone similar to that seen in utero.  
Premacure's treatment—which it is developing under the brand name Premiplex—began with a formulation of IGF-1 combined with a recombinant version of insulin-like growth factor-1 binding protein-3, IGF-1's naturally occurring binding protein. In a Phase I clinical trial, the investigational protein was shown to be generally well tolerated in preterm infants, and IGF-1 levels were increased to within physiological levels. The current multicenter Phase II clinical trial to determine safety and efficacy is ongoing, and Shire HGT will continue the study following the acquisition.  
Jessica Cotrone, senior director of corporate communications for Shire HGT, comments that Shire is "always looking to partner or acquire companies who have life-altering therapies and are looking for a global development and commercial partner. Taking all of this into consideration, Premacure was the right strategic fit for us."  
The transaction complements Shire's existing expertise in protein replacement, she adds, and is "aligned with Shire's focus on the orphan disease space, meeting the needs of the specialist physician and pursuing innovative treatment options in areas of high unmet need that deliver value for patients, physicians and the healthcare community." In addition, it allows Shire to expand its footprint into the field of neonatology.
"The acquisition of Premacure by Shire further underscores the potential to change the long-term outlook for preterm infants with ROP and their families," said Jan Borg, founding CEO of Premacure, in a statement. "We are excited that this program will become part of the innovative pipeline at Shire and believe that their experience and resources may accelerate the development of a product that seeks to prevent some of the devastating long-term consequences of ROP."
Code: E041306



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