InfaCare Pharmaceutical

InfaCare Pharmaceutical Corporation was a specialty pharmaceutical company focused on developing and commercializing products for the neonatal and pediatric population. Founded in 2001 by Robert Vukovich, the Pennsylvania-based firm directed its efforts towards addressing unmet medical needs in newborns. The company's operations were centered around its lead drug candidate, stannsoporfin, a first-in-class heme oxygenase inhibitor.

The core of InfaCare's business was the clinical development of stannsoporfin (brand name Stanate) for the treatment of neonatal hyperbilirubinemia, commonly known as infant jaundice. This condition, resulting from high levels of bilirubin, can lead to severe neurological damage if not effectively managed. Stannsoporfin's mechanism of action involves inhibiting the production of bilirubin, offering a preventative pharmacological approach rather than treatments like phototherapy or exchange transfusions, which only address the issue after bilirubin levels have already risen. The product was designed to be administered as a single intramuscular injection to newborns at risk, potentially reducing the need for more invasive procedures.

Throughout its history, InfaCare was a venture-capital-backed entity, raising a total of $78.2 million over 14 funding rounds from investors including Longitude Capital, Healthcare Ventures, and Atlas Venture. A significant milestone was the completion of its Phase IIB clinical trial for stannsoporfin in 2016, after which the company reached an agreement with the U.S. Food and Drug Administration (FDA) to file a New Drug Application (NDA) based on the existing data.

In August 2017, Mallinckrodt plc entered into an agreement to acquire InfaCare, a deal that was finalized in September 2017. The transaction involved an upfront payment of $80 million, with up to $345 million in potential future payments contingent on regulatory and sales milestones. However, the development of stannsoporfin faced a major setback in May 2018 when an FDA advisory committee voted overwhelmingly against its approval, citing insufficient efficacy and safety data. This was followed by the FDA issuing a complete response letter in August 2018, formally rejecting the drug's application.

Keywords: InfaCare Pharmaceutical, stannsoporfin, neonatal hyperbilirubinemia, infant jaundice, pediatric pharmaceuticals, heme oxygenase inhibitor, bilirubin, Mallinckrodt, Robert Vukovich, neonatal care, drug development, venture capital, clinical trials, FDA submission, pharmaceutical acquisition, Stanate, pediatrics, newborn health, Trevose Pennsylvania, Longitude Capital, Healthcare Ventures