Mallinckrodt To Acquire InfaCare Pharmaceutical Corporation And Stannsoporfin, Its Proprietary Therapy In Late-Stage Development For Treatment Of Newborns At Risk For Developing Severe Jaundice

Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, and InfaCare Pharmaceutical Corporation today announced that they have entered into an agreement under which Mallinckrodt will acquire InfaCare, a privately held specialty pharmaceutical company focused on development and commercialization of proprietary pharmaceuticals for neonatal and pediatric patient populations. 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. Food and Drug Administration (FDA) reached agreement that a New Drug Application (NDA) could be filed for stannsoporfin using the totality of the drug's data package, including:

a positive Phase 2(b) trial as its pivotal study, and
data from a second positive Phase 2(b) trial, with
no additional studies required pre-approval.

This allowance reflects the medical need in infants at risk of developing severe jaundice. There are also challenges in conducting controlled trials in this fragile population.

In December 2016 the FDA also granted stannsoporfin its Fast Track designation, a process designed to facilitate development and expedite the review of drugs to treat serious conditions and fill an unmet medical need1. Fast Track status allows for a "rolling" NDA data submission that has recently begun, and 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 substantial durability both as a new chemical entity2 and through its intellectual property which is valid until 20323.

"Severe hyperbilirubinemia can result in serious complications in infants, including brain damage and, rarely, death," said Steven Romano, MD, Chief Scientific Officer and Executive Vice President of Mallinckrodt. "We look forward to bringing this much-needed treatment option to babies at greatest risk for the consequences of this condition."

"We believe stannsoporfin has the potential to help thousands of infants whose severe jaundice is unresolved by current treatments," said Dan Burns, President and Chief Executive Officer, InfaCare. "We're also excited by the additional development capability and commercial reach that can be gained by becoming part of Mallinckrodt. Together I'm confident we can successfully bring this important treatment to market."