Questcor Acquires Global Rights To Novartis' Synacthen

Questcor Pharmaceuticals announced that it has closed the transaction to acquire global rights to Synacthen and Synacthen Depot from Novartis Pharma AG and Novartis AG in specific countries outside the U.S.

Synacthen and Synacthen Depot are approved in over 40 countries outside the U.S. for the treatment of several conditions, including certain rheumatoid diseases, Bell’s palsy, acute exacerbations in multiple sclerosis and periarteritis nodosa, ulcerative colitis, and chronic skin conditions unresponsive to corticosteroids. The drugs are also used to diagnose adrenal insufficiency. Neither drug is approved by the U.S. Food and Drug Administration (FDA).

Steve Cartt, COO of Questcor, said, “As a leader in melanocortin peptide therapeutics, we now have the opportunity with Synacthen to expand our commercial presence to more than forty international markets and develop a new potential platform for international growth in this important emerging field of medicine.”

Under the terms of the agreement, Questcor gains the right to develop, manufacture, and commercialize Synacthen in all countries around the world, with the exception of 13 EU countries in which Novartis has already handed rights over to another third party. Individual marketing authorizations will be transferred to Questcor, with the first transaction expected to occur in the middle of the year. All Novartis-held marketing authorizations for Synacthen in over 40 countries are expected to be transferred to Questcor on or before the end of 2016.

The company says that it is pursuing pre-clinical development for Synacthen in the U.S., where it was never developed or approved for U.S. patient use. “With the international team that we now have in place, the closing of this transaction positions us to begin the process of reinvigorating this important therapeutic in international markets. Importantly, we are also currently conducting a pre-clinical evaluation of Synacthen for the U.S. market, with the goal of working with the FDA to eventually make it available to U.S. patients,” said COO Cartt.