Sector: Medical Devicew
Mallinckrodt announced its InfaCare addition for $425 million
The company gains a therapy for treating jaundice in infants with the acquisition. Jaundice, also known as infantile hyperbilirubinemia, affects as many as 750,000 infants born in the US each year. While it is a common condition in newborns, if traditional treatments are ineffective, severe jaundice can lead to permanent neurological damage (brain damage) and death in rare cases. Jaundice occurs when there are higher than normal levels of bilirubin in the blood. In newborns is occurs due to accelerated breakdown of red blood cells and can lead to severe bilirubin levels. At these high levels, there is a risk that the bilirubin can enter the brain, a condition referred to as acute bilirubin encephalopathy. Immediate treatment is required to prevent progression to kernicterus, a rare condition associated with severe and permanent brain damage.
A new drug developed by InfaCare, a privately held specialty pharmaceutical company focused on development and commercialization of proprietary pharmaceuticals for neonatal and pediatric patient populations, will now be pursued by specialty pharma company Mallinckrodt following its acquisition of InfaCare. The deal involves an upfront payment to InfaCare of $80 million and up to $345 million in regulatory and sales milestones payments.
InfaCare’s New Drug Application (NDA) for stannsoporfin was accepted by FDA in July 2016 based on the results of tow Phase II(b) trials. FDA also granted stannsoporfin its Fast Track designation. Approval of the drug is expected in the first half of 2018.
If approved, Mallinckrodt expects stannsoporfin to “be a highly effective therapy used for near- and full-term infants at risk of developing complications associated with severe jaundice,” potentially “reduce the number of newborns advancing to bilirubin levels requiring more intrusive, less specific therapies” and possibly “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.”
The acquisition of InfaCare and stannsoporfin expands Mallinckrodt’s pediatric offerings, diversifying its hospital portfolio pipeline with this differentiated, highly durable product, according to the company, which estimates there are 150,000 to 275,000 annually babies worldwide that could benefit from the drug. “The addition of this highly durable, unique developmental asset to our growing hospital business is an excellent example of Mallinckrodt’s investment strategy,” said Trudeau.