Mallinckrodt plc, a leading global specialty pharmaceutical company, announced it closed the acquisition of InfaCare Pharmaceutical Corporation, a privately held specialty pharmaceutical company focused on development and commercialization of proprietary pharmaceuticals for neonatal and pediatric patient populations. If approved, InfaCare's developmental product stannsoporfin is expected to become the first and only pharmacologic option indicated for treatment of neonates at risk for developing severe hyperbilirubinemia, or severe jaundice.
"The addition of stannsoporfin further expands and diversifies Mallinckrodt's pediatric pipeline, and will add strength and breadth to our specialty brands business," said Mark Trudeau, chief executive officer at Mallinckrodt. "There is an urgent need for therapies to treat thousands of infants at risk for serious illness or death due to severe jaundice, and Mallinckrodt is committed to bringing stannsoporfin to this population as quickly and efficiently as possible."
Mallinckrodt has made an upfront payment of $80 million, with additional payments of up to $345 million dependent on regulatory and sales milestones. Mallinckrodt expects the acquisition to be dilutive to adjusted diluted earnings per share by $0.15 to $0.20 for 2017 and modestly higher in 2018. Guidance on the impact of the acquisition to the company's GAAP diluted earnings per share has not been provided due to the inherent difficulty of forecasting the timing or amount of items that would be included in calculating such impact.
In the US, the total number of term births is estimated at 3.7 million per year and, of those, approximately 750,000 infants are treated for jaundice. Of those treated, a significant number may be unresponsive to phototherapy – the current standard of care – even with extended and repeated courses of the treatment and face the risk of developing severe jaundice prior to discharge. A small percentage of full-term infants may experience elevated bilirubin levels after discharge and be at risk of severe jaundice, requiring hospital readmission. It is anticipated stannsoporfin could reduce the incidence of readmission. The combined potential patient treatments required annually in the US for severe jaundice is approximately 70,000 to 125,000.
Stannsoporfin, a heme oxygenase inhibitor, is under investigation for its potential to reduce the production of bilirubin. If approved, stannsoporfin is expected to be a highly effective therapy used for near- and full-term infants at risk of developing complications associated with severe jaundice. This new treatment option may reduce the number of newborns advancing to bilirubin levels requiring more intrusive, less specific therapies, most often blood exchange transfusion and less frequently intravenous immunoglobululin infusions (IVIG), both of which have a more complex and lengthy administration than stannsoporfin's single injection. Stannsoporfin, if approved, may also decrease the risks associated with other treatments (e.g., bilirubin rebound) and the risk of prolonged and/or severe bilirubin elevation, which can impact central nervous system development.
Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical products and therapies.