Shares of Questcor Pharmaceuticals (NASDAQ:QCOR) are under pressure Friday, down 10% in morning trading on news that unknown drug company Cerium Pharmaceuticals has received Orphan Drug status from the FDA for its synthetic ACTH product, Synacthen Depot for Infantile Spasms (IS). Questcor’s H.P. Acthar Gel (Acthar) is a naturally-produced ACTH product and is indicated for IS among other conditions, therefore, investors are sensitive to this issue on the belief that Synacthen Depot could represent “generic” competition to Acthar. This news today is a significant buying opportunity for several reasons: 1) Synacthen Depot is known to contain benzyl alcohol which has been implicated in infant toxicity (various articles here). As a result, FDA approval for a product containing this ingredient in infants is highly unlikely. 2) H.P. Acthar Gel already has Orphan Drug status in IS and this exclusivity expires in 2017. The chance that FDA would overrule Acthar’s Orphan Drug exclusivity is very slim, so even if Synacthen Depot was an actual threat, gaining market approval in the U.S. before 2017 is unlikely. 3) IS is only a small portion of Acthar sales anyway; other indications are driving growth. Because “off-label” use is so heavily scrutinized with Acthar, Synacthen would have trouble getting used anywhere besides its FDA approved indication, if approved. 4) Who is Cerium Pharmaceuticals? See link here for the location of this company. (Perhaps someone’s home office in Maryland?) We see little to no threat from Synacthen Depot, hence investors can step into QCOR and take advantage of today’s weakness. We wouldn’t be surprised to see the stock regain all of its losses from this morning’s downturn.
