New Dendreon Competition Is Not Really Competition (DNDN, SNY)
Dendreon Corp. (NASDAQ: DNDN) is holding up rather well considering that competition from its prostate cancer drug market may be higher than before. The FDA has approved a competing product called Jevtana (cabazitaxel) from Sanofi-Aventis (NYSE: SNY).
Jevtana is a chemotherapy drug used in combination with the steroid prednisone to treat men with prostate cancer. The release from the FDA noted that Jevtana is the first treatment for advanced, hormone-refractory, prostate cancer that has worsened during or after treatment with docetaxel, a commonly used drug for advanced prostate cancer.
The approval came after a priority drug review and before the September 30, 2010 deadline.
Jevtana’s safety and effectiveness was established in a 755-patient study and all had previously received docetaxel. The study was designed to measure overall survival in men who received Jevtana in combination with prednisone compared with those who received the chemotherapy drug, mitoxantrone, in combination with prednisone. The median overall survival for patients receiving the Jevtana regimen was 15.1 months compared with 12.7 months for those who received the mitoxantrone regimen. You can see the updated Dendreon survival data on PROVENGE here.
PROVENGE from Dendreon is designed to stimulate a patient’s immune system, using a patient’s immune cells to a protein that functions as a prostate cancer-associated antigen, to target prostate cancer cells.
The thing to consider here is rather simple for now. Dendreon’s PROVENGE is not as simple (none really are) but the demand is far greater for PROVENGE today than what can be delivered. The centers who participated in the Dendreon studies are getting first call for this, and based upon two separate discussions with personal contacts with family members who have prostate cancer it is being issued effectively on a lottery basis right now. Dendreon is in the process of manufacturing more facilities and it has secured more supplies to assist it in making more and more PROVENGE treatments.
Dendreon closed at $40.59 earlier this week and the shares were at $39.57 the day before this Jevtana was approved. Dendreon closed at $38.46 yesterday and shares are down less than 0.2% today at $38.40. Is this competition in the classical sense of competition? Yes, of course? Will it likely have any impact at all on any demand for PROVENGE over the ramp-up time of the next 18 to 24 months? Absolutely not. Even if some decide to go for Javtana right now and pull their name from the PROVENGE waiting list, there are many many patients who will step in to fill their slot.
JON C. OGG