It looks like Ironshore Pharmaceuticals is back in business.
Seven months after the company shuttered its commercial ops as its new drug application for a reformulation of methylphenidate to treat ADHD drifted into limbo, the company says that it was green-lighted by the FDA. And now it’s announced $143 million in financing to launch the drug, to be marketed as Jornay.
There’s nothing new about its drug, methylphenidate. That’s the active ingredient in Ritalin and other generic stimulants used to treat ADHD. Ironshore developed this version of the drug using some delayed-release tech that it hopes will distinguish it from the crowd.
Word on this comes from the company, which refers to Jornay as a “blockbuster drug.” The FDA has yet to put this NDA on the annual list it maintains, but the approval letter was dated August 10.
Morgan Stanley helped the company sell $143 million in senior secured notes for the launch, which rolls out in the first half of next year.
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