On Wednesday, Corcept Therapeutics Inc. (NASDAQ:CORT
) reported positive results
from their Phase III trial in Cushing’s Syndrome for their drug, Corlux. The company also announced that they expect to file a New Drug Application (NDA) sometime in Q1 2011 and will seek a six-month priority review. Despite the positive results and outlook, the stock has continued a downward trend, maybe in part to lack of safety and secondary endpoint data. This data should be coming over the next 1-2 months. While that data wasn’t there, we still think Corcept could offer appreciable gains in 2011.
Their Phase III study evaluated the response of two patient groups receiving Corlux; those patients who were glucose intolerant and those who were hypertensive. Corcept saw statistically significant improvements in the primary endpoint for both groups, with 60% responding in the glucose intolerant group and 43% in the hypertensive group. Corlux was well-tolerated and appears to offer these patients some hope. Note that 90% of the patients who completed the Phase III study opted to enter the long-term extension study. Data on the secondary endpoint (global clinical improvement) is expected to be available in the first quarter of 2011. For orphan diseases like Cushing’s, secondary endpoints are very important and if Corlux still demonstrates efficacy, it will lower the regulatory risk and make their program much more attractive.
“We remain on track to submit a New Drug Application to the FDA for Corlux in Cushing’s Syndrome by the end of the first quarter of 2011 and continue to work toward our goal of making Corlux available to patients with this severe disease,” Joseph Belanoff, M.D., chief executive officer of Corcept said.
Corlux was granted orphan drug designation by the FDA for the treatment of endogenous Cushing's Syndrome in 2007. With Orphan Drug Designation, Corcept will have seven years of marketing exclusivity from the date of drug approval and other economic benefits that will help them out a great deal. Reuters reported
that Corlux could see $230 to $300 million in peak sales of Corlux, based on estimates from Global Hunter Securities' Kimberly Lee and Stifel Nicolaus' Annabel Samimy. Corcept will also be able to charge a premium for Corlux and has little competition, since Novartis’ (NYSE:NVS) drug had some serious metabolic side effects that will likely end that program. Safety data wasn’t available with the topline results, but it’s positive to hear that most “of the serious adverse events reported in the study were not related to Corlux treatment, as determined by the clinical investigators.” We will have to wait and see the complete safety analysis until then.
CORT has a shelf registration statement to raise up to $100 million, which we think could come sometime after the NDA is filed, in order to support commercialization activities in Cushing's. However, the shelf may not be needed if they can find a European partner over the next few months. We will be watching this in the hopes of positive news like a partnership and the secondary endpoint/completed safety data.
Disclosure: No position
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