New Treatment Category for Cancer-Autologous Cellular Immunotherapy
The FDA cleared the first therapeutic vaccine for cancer with Dendreon’s Provenge (R)(Sipuleucel-T), an individualized treatment approach for advanced prostate cancer (CRPC). CRPC is asymptomatic or minimally symptomatic, metastatic,castrate-resistant (hormone refractory) prostate cancer.Provenge takes the patient’s own immune cells and infuses them back thereby priming the immune system in order to generate a T-cell response against specific tumor associated antigens. Dendreon is also developing active cellular therapies (ACI’s) for a variety of other cancers. Provenge targets a specific antigen for an immune response, prostatic acid phosphatase (PAP), which is expressed on most prostate cancers.
Three Phase 3 studies were presented to the FDA to support licensure. The pivotal study was the Phase 3 IMPACT trial , a 512 -patient , multi-center., randomized, double blind, placebo controlled study that evaluated men with asymptomatic or minimally symptomatic metastatic CRPC.Provenge extended median survival beyond two- years demonstrating a median improvement of 4.1 months compared to the control group. Risks of death was reduced by 22.5%. The post marketing requirement will be a registry of about 1500 patients to further evaluate a small potential safety signal of cerebrovascular events which were observed in 3,5% of patients in the Provenge arm of the study.
In 2007,The FDA rejected Provenge despite a unanimous vote in favor of treatment.
The Company has already mobilized the Provenge product launch with three manufacturing facilities, 70 field sales and support, with 50 clinics offering the product (all clinics involved in the clinical trial); 70 percent of these sites are for oncology and 30% for urology by specialty. Initial capability in the NJ facility will be for 2000 patients but at only 25% plant capacity. Pricing will be a total of about $93k($31k per infusion) per patient including three infusions over one month. Treatment will begin almost immediately.Only nominal other costs are expected. According to the Company on their conference call these patient costs are comparable to other cancer drugs. The Company will meet with CMS to coordinate reimbursement codes (J) as Medicare and other insurance reimbursement is expected.
The Company does not yet have a major pharma partner but it is expected that other major biotech companies like Celgene will collaborate with Dendreon on their respective cancer technologies utilizing Dendreon’s ACI technology. A priority for the Company is to pursue regulatory approval in major countries outside the US. During the conference call today (4/29/10) a point was made that the likelihood of generic competition would be more difficult due to IP and the unique delivery system of autologous therapy.
Dendreon has been working on this product and technology for 15 years with an investment of close to $1B. In Q4 2009 the Company raised $409.5M bringing the total cash position to $630M.Dendreon received stock upgrades from analysts at Canaccord Adams, JPMorgan and Robert W.Baird. The stock was downgraded by Citigroup on April 14,2010.
The stock traded up 15% to $45.50 prior to being halted. The Spyder ETF with symbol XBI up 3% , has not been halted and has a 4% exposure to Dendreon (DNDN). After the conference call at 3:45 EDT,the stock traded in the fifty range up 27% for the day. The market cap is $6.8B. One year ago the stock traded in the teens.