The acquisition brings two products to Retrophin that have been approved by the US Food and Drug Administration (FDA). Chenodal (chenodeoxycholic acid — a synthetic bile acid also known as chenodiol) is indicated for patients suffering from gallstones in whom surgery poses an unacceptable health risk due to disease or advanced age.
Vecamyl (mecamylamine HCI tablets) is indicated for the management of moderately severe to severe essential hypertension and uncomplicated cases of malignant hypertension.
Retrophin intends to pursue US regulatory approval for Chenodal in cerebrotendinous xanthomatosis (CTX). CTX is a rare inborn error of bile acid metabolism that often causes chronic diarrhea in infants and cataracts in childhood or adolescence and ultimately neurodegeneration caused by the buildup of cholestanol in the brain.
Chenodeoxycholic acid is the standard of care for CTX, and the FDA granted it orphan drug designation for CTX in March 2010.
Retrophin founder and CEO Martin Shkreli noted that the acquisition of Manchester Pharmaceuticals is a transformative event for Retrophin, as the company is now a commercial company with two FDA-approved products on the market.
"We also look forward to raising awareness of CTX, a rare, underdiagnosed and severe disease that is treated with chenodeoxycholic acid. Early diagnosis of CTX is essential, as many patients have permanent neurological damage that could be avoided if the disease is detected early. As such, we are building a team of medical science liaisons who will help educate physicians about CTX," Shkreli added.