August 4, 2017
By Alex Keown, Breaking News Staff


STAINES-UPON-THAMES, United Kingdom – Specialty pharmaceutical company Mallinckrodt plc (MNK) struck a deal to acquire privately-held InfaCare, a Pennsylvania-based company focused on therapies for neonatal and pediatric patients

Mallinckrodt will fork over up to $425 million for InfaCare’s stannsoporfin, a heme oxygenase inhibitor, used to treat elevated bilirubin levels that can cause severe jaundice in infants. According to terms of the deal, Mallinckrodt will pay $80 million in upfront monies, and up to $345 million in milestone payments. In late July 2016, the U.S. Food and Drug Administration accepted InfaCare’s New Drug Application for stannsoporfin. In December 2016, the FDA also granted stannsoporfin its Fast Track designation, which is expected to accelerate review of the therapy. The FDA is expected to review the drug in the first half of 2018.

Jaundice is fairly common in newborns, but severe jaundice, the highly elevated bilirubin levels, can be threatening. If a baby develops severe jaundice, there is a risk of bilirubin passing into the brain, a syndrome called acute bilirubin encephalopathy. Prompt treatment is needed. Persistent, high levels of bilirubin in the brain can progress to kernicterus, a rare condition associated with severe and permanent brain damage. Symptoms include poor feeding, shrill cry, muscle rigidity, markedly arched back with a backwards hyperextension of the neck, seizures, and stupor or coma. Complications may also include hearing loss and death.

There are approximately 750,000 cases of jaundice each year in term babies in the United States. Of those, Mallinckrodt estimates there are 70,000 to 125,000 cases of severe jaundice. Severe jaundice requires extended or recurrent treatment, with costs estimated to be approximately $5,000 per patient, according to Mallinckrodt.

Trial data shows that stannsoporfin reduced the potential for developing severe jaundice. Data showed stannsoporfin inhibited bilirubin production. The drug also had a strong safety profile compared to placebo. If approved, this proprietary therapy is expected to be the first and only pharmacologic treatment indicated for treatment of newborns at risk for developing severe infantile jaundice in the U.S., Mallinckrodt said in its announcement.

Dan Burns, president and chief executive officer of InfaCare, said stannsoporfin has the potential to help thousands of infants whose severe jaundice is unresolved by current treatments.

“Severe hyperbilirubinemia can result in serious complications in infants, including brain damage and, rarely, death,” Steven Romano, Mallinckrodt’s chief scientific officer, said in a statement. “We look forward to bringing this much-needed treatment option to babies at greatest risk for the consequences of this condition.”

Being absorbed by Mallinckrodt will provide InfaCare with a greater reach for its products, Burns said in a statement. Mallinckrodt estimates that the number of severe jaundice cases in term babies globally is between 150,000 and 275,000 per year. In addition to seeking regulatory approval in the United States, Mallinckrodt intends to seek approval in other global markets.

Shares of Mallinckrodt are up this morning, trading at $42.15 as of 11:32 a.m.



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