Celgene Corporation (NASDAQ:CELG) announced that results from a multicenter, randomized, placebo-controlled phase II trial (BCT-001) of apremilast (Otezla®) in patients with Behçet’s disease were published in the April 16 issue of The New England Journal of Medicine. Behçet’s disease is a rare, chronic inflammatory disorder characterized by recurrent oral and genital ulcers, which are considered a hallmark of the disease. Joint inflammation and recurrent skin and eye lesions may also occur.
“Painful oral ulcers due to Behçet’s disease are the hallmark of the condition and can have a significant impact on the lives of many patients. Currently used drugs for this condition may not control oral or genital ulcers in some patients or have potential adverse events that may limit their use,” said Gulen Hatemi, M.D., Associate Professor, Cerrahpasa Medical School, Istanbul, Turkey. “The publication of these phase II data in The New England Journal of Medicine is critical to disseminating the findings to the healthcare professional community, to keep them informed of the latest developments in research on this rare, chronic disease.”
Findings from this study, including the primary endpoint (reduction in mean number of oral ulcers following 12 weeks of treatment), were initially presented at the European League against Rheumatism (EULAR) and the American College of Rheumatology (ACR) annual meetings in 2013 (P < 0.001). In addition to the previously reported results, the publication includes findings that the median (min, max) number of oral ulcers was also reduced following 12 weeks of treatment with apremilast compared with placebo (0.0 (0, 6) vs. 2.0 (0, 13), respectively).
Findings from the full 24-week treatment phase were also included in the publication. After 12 weeks, patients in the placebo group were crossed over to apremilast treatment, and those in the apremilast arm continued treatment. For those treated with apremilast for the full 24 weeks, the decrease in the mean number of oral ulcers was evident by week 2 (0.3 at week 2 vs. 2.7 at baseline) and this decrease was sustained through week 24 (0.6). In the placebo arm, the mean number of oral ulcers was 2.9 at baseline and 1.7 at week 2. At week 24, following 12 weeks of apremilast treatment, the mean number of oral ulcers in the placebo group was 0.4.
A decrease in pain associated with oral ulcers paralleled this decrease in ulcers over time. Mean pain scores, measured using a visual analog scale, decreased from 54.3 at baseline to 12.0 at week 2 and 9.7 at week 24. In the placebo arm, pain scores were 51.7 at baseline and 29.8 at week 2. At week 24, following 12 weeks of apremilast treatment, mean pain score in this group was 9.7.
Apremilast also significantly improved several measures of disease activity and quality of life at week 12. Mean change from baseline at week 12 was significantly better for scores on the Behçet’s disease current activity form (-1.5 with apremilast vs. -0.1 for placebo; P < 0.001), the Behçet’s syndrome activity scale (-21.2 vs. -6.0, respectively; P < 0.001), the Behçet’s disease quality of life instrument (-4.5 vs. -1.6; P=0.040), and the short form 36 version 2 physical component summary (4.7 vs. -1.7; P=0.001). No significant improvement was seen in the short form 36 version 2 mental component summary (2.0 vs. 1.6; P=NS).
The safety and tolerability data for apremilast observed in this study were consistent with previously reported data from six other phase III studies of apremilast in psoriatic arthritis or plaque psoriasis. The percentages of patients who developed at least one adverse event (AE) during the placebo-controlled phase were comparable between apremilast (85.5 percent) and placebo (80.4 percent). Serious AEs occurred in two patients receiving apremilast and none receiving placebo. AEs leading to drug discontinuation occurred in four patients receiving apremilast and none receiving placebo. Nausea, vomiting and diarrhea were more common with apremilast compared with placebo.
“Celgene is dedicated to investigating and delivering to patients new treatment options for rare, chronic inflammatory disorders such as Behçet’s disease,” said Scott Smith, President, Celgene Inflammation & Immunology. “Based on these phase II results, Celgene has filed with regulatory authorities in Turkey and has initiated a global phase III trial of OTEZLA in this debilitating disease.”
These results are from an investigational phase II study. Apremilast is not approved for the treatment of patients with Behçet’s disease in any country. (Original Source)
Shares of Celgene closed today at $118.39, up $2.61 or 2.25%. CELG has a 1-year high of $129.06 and a 1-year low of $66.85. The stock’s 50-day moving average is $119.00 and its 200-day moving average is $112.28.
On the ratings front, Celgene has been the subject of a number of recent research reports. In a report issued on March 31, Citigroup analyst Yaron Werber maintained a Buy rating on CELG, with a price target of $143, which implies an upside of 21.0% from current levels. Separately, on March 25, Canaccord Genuity’s John Newman reiterated a Buy rating on the stock and has a price target of $156.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Yaron Werber and John Newman have a total average return of 27.2% and 15.9% respectively. Werber has a success rate of 79.7% and is ranked #81 out of 3574 analysts, while Newman has a success rate of 63.5% and is ranked #260.
In total, one research analyst has assigned a Hold rating and 6 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $118.23 which is 27.2% above where the stock opened today.
Celgene Corp is a biopharmaceutical company. It is engaged in the discovery, development and commercialization of therapies designed to treat cancer and immune-inflammatory related diseases.