Questcor Pharmaceuticals said today it acquired rights to develop Synacthen® (tetracosactide) and Synacthen Depot in the U.S. from Novartis Pharma and parent company Novartis, in a deal that could net up-to-$135 million-plus for the Swiss-based pharma giant.
Synacthen is a synthetic 24 amino acid melanocortin receptor agonist approved for use in Europe for several autoimmune and inflammatory conditions. Synacthen Depot is a depot formulation of Synacthen.
Questcor has paid Novartis $60 million in up-front cash, and has agreed to pay at least $75 million over “several” years, as well as undisclosed potential milestone payments prior to FDA approval. Upon FDA approval of Synacthen in the U.S., Questcor will pay Novartis another undisclosed milestone payment as well as royalties based on net sales in the U.S.
The deal expands Questor’s offerings for autoimmune and inflammatory disorders beyond its current main product H.P Acthar® Gel (repository corticotropin injection). The naturally derived formulation of adrenocorticotropic hormones is indicated for acute exacerbations of multiple sclerosis (MS) in adults, and as monotherapy for the treatment of infantile spasms (IS) in infants and children under two years of age. Acthar gel is also indicated to induce a diuresis or a remission of proteinuria in nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus, as well as for treatment of several other diseases and disorders.
"We intend to develop and seek FDA approval for Synacthen and are committed to developing this product not only in conditions different than Acthar but also in conditions where Synacthen would potentially provide a clinical benefit over Acthar." Questcor CSO David Young, Pharm.D., Ph.D, said in a statement.
Until now, Questcor has sought to expand the indications for which Acthar could be used. During the first quarter, the company’s net sales zoomed 41% year-over-year to $135.1 million. Questcor said April 30 the increase was driven by expanded usage of Acthar by nephrologists in nephrotic syndrome (NS), and by rheumatologists in dermatomyositis, polymyositis, systemic lupus erythematosus, and rheumatoid arthritis.
The gel continued to be prescribed by neurologists for MS exacerbations and IS, while the number of MS-related Acthar prescriptions fell from the fourth quarter of 2012, according to Questcor.
Under the deal, Questcor must pursue FDA approval, then commercialize Synacthen in the U.S., at which point Questcor will immediately take over U.S. rights to the drug. In addition, Questcor will also take over rights in over three dozen countries outside the U.S., subject to closing conditions that must be satisfied within two years.
"This key acquisition provides an opportunity to initiate our presence in more than three dozen international markets, giving us an opportunity to reinvigorate Synacthen in these markets and providing us a platform for potential international growth," Don M. Bailey, Questcor’s president and CEO, said in the statement.