Mallinckrodt has acquired InfaCare in a deal worth up to $425 million. InfaCare’s developmental product stannsoporfin, a heme oxygenase inhibitor, is under investigation for its potential to reduce the production of bilirubin, the elevation of which can contribute to serious consequences in infants.

In July 2016 InfaCare and the U.S. FDA reached agreement that a new drug application (NDA) could be filed for stannsoporfin after a positive Phase 2(b) trial as its pivotal study and data from a second positive Phase 2(b) trial. This allowance reflects the medical need in infants at risk of developing severe jaundice. There are also challenges in conducting controlled trials in this population.

In December 2016 the FDA also granted stannsoporfin its Fast Track designation. Approval is anticipated in the first half of 2018. Post-approval commitments required by the FDA would include conducting trials in pre-term infants less than 35 weeks gestational age as part of the pediatric requirements. If approved, the drug will have durability both as a new chemical entity and through its intellectual property which is valid until 2032.

“We believe stannsoporfin has the potential to significantly alter the treatment paradigm for infants with this condition which, if unchecked, can have devastating impact to the patient,” said Mark Trudeau, chief executive officer and president, Mallinckrodt. “The addition of this highly durable, unique developmental asset to our growing hospital business is an excellent example of Mallinckrodt’s investment strategy.”

InfaCare’s founder and chairman, Robert Vukovich, said, “A number of years ago we recognized the potential medical importance of stannsoporfin and the role it would play in treating severe neonatal jaundice and the potential serious neurological consequences of elevated bilirubin levels in newborns. Stannsoporfin is a breakthrough therapy and I am delighted to see that, with this transaction, the dream we have had to successfully develop this drug is coming to fruition, and we look forward to making it available for clinical use.”