Mallinckrodt snaps up pediatric jaundice drug
- Shelling out $80 million upfront and another $345 million in possible milestone payments, Mallinckrodt has bought up pediatric specialist InfaCare Pharmaceutical to get its hands on the heme oxygenase inhibitor stannsoporfin.
- Stannsoporfin has fast track status for the treatment of severe jaundice in high-risk newborns, and InfaCare has applied for approval in the U.S. under a rolling New Drug Application process. Approval is expected in the first half of 2018.
- The acquisition will be dilutive to adjusted diluted earnings per share by $0.15 to $0.20 for 2017 and modestly higher in 2018. The transaction will close in the second half of 2017. It's not yet clear what the impact will be on InfaCare's staff or headquarters.
Stannsoporfin is InfaCare Pharmaceutical's sole clinical stage product. Acquiring the company will not only give Mallinckrodt access to a near-market drug but will also diversify its portfolio.
Mallinckrodt's existing sales organization already visits neonatal centers across the U.S. for sales of Inomax nitric oxide gas for inhalation and will add stannsoporfin to this portfolio. According to both companies, if stannsoporfin makes it to the market, it will be the first and only pharmacologic option to treat jaundice, also known as infantile hyperbilirubinemia, in at-risk newborns.
"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, CEO and president of Mallinckrodt. "The addition of this highly durable, unique developmental asset to our growing hospital business is an excellent example of Mallinckrodt's investment strategy."
Jaundice affects around 750,000 babies born in the U.S. each year. The most common form of treatment is phototherapy, but some babies have jaundice that is resistant, and prolonged or severe jaundice can lead to chronic bilirubin encephalopathy (kernicterus), including fever, seizures, brain damage, hearing loss and death. Other treatments include exchange transfusion or intravenous immunoglobulin infusions (IVIG), but according to Mallinckrodt, stannsoporfin's single injection will make treatment simpler and less time-consuming.
In July 2016, the Food and Drug Administration agreed that InfaCare could submit stannsoporfin for approval under a rolling NDA, based on results from two Phase 2b trials. InfaCare will need to carry out studies in pre-term infants at less than 32 weeks gestational age.
- Mallinckrodt Statement
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