Questcor Pharmaceuticals, announced that the transaction acquiring rights to Synacthen and Synacthen depot from Novartis Pharma AG and Novartis AG in certain countries outside the US. has now closed. Available in more than forty countries for multiple indications, Synacthen (tetracosactide) is a synthetic 24 amino acid melanocortin peptide. Synacthen depot is a depot formulation of Synacthen. The products are approved outside the US. for multiple indications, including certain autoimmune and inflammatory conditions as well as for diagnostic use, but have never been developed or approved for patients in the US Questcor is presently engaged in pre-clinical development for Synacthen in the US.
"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," said Steve Cartt, Chief Operating Officer of Questcor.
"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," continued Mr. Cartt. "Importantly, we are also currently conducting a pre-clinical evaluation of Synacthen for the US. market, with the goal of working with the FDA to eventually make it available to US. patients."
Under the terms of the transaction agreements, Questcor will have the right to develop, market, manufacture, distribute, sell and commercialize Synacthen in all countries worldwide except for 13 European countries in which Novartis has previously granted rights to another third party. This process will involve the transfer to Questcor of individual marketing authorizations in more than forty countries outside the US. With the first transfer expected to take place mid-2014, Questcor anticipates that the marketing authorisations for Synacthen currently held by Novartis will be transferred to Questcor on or before the end of 2016.
Synacthen and Synacthen Depot are available in more than forty countries to treat a number of conditions including some rheumatoid diseases, ulcerative colitis, chronic skin conditions not responsive to corticosteroids, Bell's palsy, acute exacerbations in patients suffering from multiple sclerosis and periarteritis nodosa. Synacthen and Synacthen Depot are also used as a diagnostic test for adrenal insufficiency. Synacthen and Synacthen Depot are not approved in the US.
Questcor Pharmaceuticals, Inc. is a biopharmaceutical company focused on the treatment of patients with serious, difficult-to-treat autoimmune and inflammatory disorders. Questcor also provides specialty contract manufacturing services to the global pharmaceutical industry through its wholly-owned subsidiary BioVectra Inc.