A popular way to trade biotechs with upcoming PDUFA dates is to play the run-up or buy them well in advance of the decision date and sell them shortly before the FDA’s decision. Here are 3 stocks that are not overextended with ample room for upside.
Corcept Therapeutics (CORT) has a PDUFA date on 2/17/12 for Corlux for Cushing's Syndrome. Cushing's Syndrome results from prolonged exposure of the body's tissues to high levels of the hormone cortisol generated by tumors. Cushing's Syndrome is an orphan indication, which most commonly affects adults aged 20 to 50. An estimated 20,000 people in the United States have Cushing's Syndrome, with more than 3,000 newly diagnosed patients each year.
The NDA submission for Corlux is based on a Phase 3 study for which data was released in June. The data demonstrated that refractory Cushing's Syndrome patients receiving Corlux experienced significant clinical and metabolic improvements over baseline measurements.
Fifty Cushing's Syndrome patients were enrolled in the study. Forty-three had Cushing's disease (pituitary tumor), of which 42 had prior surgery, four patients had ectopic ACTH-producing tumors and three had adrenal cancer. All patients were included in the analysis for safety. Forty-six of the patients completed at least 30 days of treatment and were included in the modified intent to treat group (mITT) for the efficacy analysis. Thirty-four patients completed the study.
Statistically significant improvement in the primary endpoint was achieved for the glucose intolerant group and the hypertensive group. Whether included in the glucose intolerant group or the hypertension group for the purpose of evaluating the primary endpoints, patients were evaluated as a single group on the key secondary endpoint of "global clinical improvement" as determined by an independent data review board's evaluation of eight clinical areas (glucose, blood pressure, lipids, weight and body composition, appearance, strength, bone, psychiatric and quality of life measures). A statistically significant improvement was achieved in the key secondary endpoint with a response rate of 87% (p < 0.000001).
Corlux was well tolerated in the Phase 3 study and consistent with the safety profile of Corlux’s active ingredient, mifepristone. The stock was last trading at $3.81, in between the $3.50-5.00 range it has traded in since last October.
pSivida (PSDV) has a PDUFA date on 11/12/11 for Iluvien for the treatment of diabetic macular edema (DME). DME, the primary cause of vision loss associated with diabetic retinopathy, is a disease affecting the macula, the part of the retina responsible for central vision. The Wisconsin Epidemiologic Study of Diabetic Retinopathy found that over a 10-year period approximately 19% of people with diabetes studied were diagnosed with DME. As the population of people with diabetes increases, Alimera expects the annual incidence of diagnosed DME to increase, as well.
pSivida’s partner Alimera (ALIM) conducted two 36-month, Phase 3 pivotal clinical trials (collectively known as the FAME Study) for Iluvien involving 956 patients in sites across the United States, Canada, Europe and India to assess the efficacy and safety of Iluvien with two doses of the corticosteroid fluocinolone acetonide, a high and low dose, for the treatment of DME. The primary efficacy endpoint for the FAME Study was the difference in the percentage of patients whose best corrected visual acuity improved by 15 or more letters from baseline on the ETDRS eye chart at month 24 between the treatment and control groups. The study concluded in October 2010 with the final patient visit at the three-year data point. Alimera prepared the analyses of the data from the FAME Study.
Pfizer (PFE) owns 9% of the company. The stock was last trading at $5.05, near its 2011 highs, but still below the $7 a share the stock reached right before previous PDUFA date at the end of 2010 when the company received a Complete Response Letter from the FDA.
SuperGen (SUPG) has a PDUFA date on 3/6/12 for Dacogen (decitabine) for acute myeloid leukemia (AML). In 2008, there were slightly more than 13,000 new cases of AML reported and nearly 9,000 deaths in the United States.
The NDA for Dacogen is based on the Phase III randomized open-label, multi-center trial (DACO-016) comparing Dacogen versus patient’s choice with physician’s advice of either supportive care or low-dose cytarabine in patients 65 years and older with newly diagnosed de novo or secondary AML and with poor- or intermediate-risk cytogenetics.
The full results of the trial were released on June 6 at the ASCO annual meeting. The data demonstrated a clinical improvement in overall survival in older patients with newly diagnosed de novo or secondary acute myeloid leukemia. The primary endpoint of the study was overall survival. The analysis at the protocol-specified cutoff with 396 (81.6%) deaths demonstrated an increase of greater than 50% in median overall survival in patients taking decitabine (7.7 months for decitabine patients compared to 5.0 months for patients in the comparator arm), HR=0.85, 95% CI: 0.69, 1.04, p=0.108. An updated unplanned analysis of more mature survival data with additional one year of patient follow up and 446 (92%) deaths confirmed this trend for improved overall survival (HR=0.82; 95% CI: 0.68, 0.99; nominal p=0.037). Adverse events were consistent with the known decitabine safety profile and without major differences between the treatment arms.
The stock was last trading at $3.01, right around in the middle of its 2011 $2.60-$3.20 range.