Cumberland books $77.8m quarterly profit on Apotex gain as ifetroban heads to FDA

Cumberland Pharmaceuticals reported third-quarter net income of $77.8m on 10 November, crediting the result to the gain from its $100m transaction with Apotex, which completed on 1 July. The material available does not include revenue, operating results or a breakdown of the gain, so the underlying trading picture is not clear.

The same update set out the company's plan for ifetroban, which it intends to put before the US Food and Drug Administration as a treatment for cardiomyopathy in Duchenne muscular dystrophy. Cumberland said it had reached this point after meeting the agency before filing, and that the FDA has agreed to a rolling review of the application. No submission dates or approval timetable were given.

By way of context, rolling review lets a sponsor hand over finished parts of an application in stages instead of delivering a single complete package, which can let the agency begin assessing data earlier. Whether that shortens the overall path to a decision for ifetroban has not been stated.

Cumberland also released top-line results from ASSIST-SSc, a Phase 2a study of ifetroban in systemic sclerosis. The company said none of the serious adverse events seen were judged related to the drug. Efficacy findings were not provided, so the data say little yet about the commercial case in that second indication.