From looking at the action on Dendreon Corp. (DNDN) shares today, you'd think the company found a cure to cancer. Well . . . not quite, but it may have definitely made a milestone when it comes to cancer therapy. Dendreon reported this morning that its experimental prostate cancer treatment, the therapeutic vaccine Provenge, was significantly successful in prolonging patient survival. This may clear the way for the long-awaited regulatory approval for the drug.
The active immunotherapy drug is different from standard chemotherapy as it aims to train the patient's own immune system to attack the cancer. Provenge is produced from a patient's white blood cells and tumor proteins, administered when the disease no longer responds to hormone blockers (the standard treatment). Not only does it have fewer side effects than chemo, it may be a more precise way to attack cancer rather than flooding the body with poison. While it's called a therapeutic vaccine, it does not prevent the disease, but treats it once the patient is already ill. Provenge is now the first of its kind to prolong survival in cancer patients.
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There is some concern over the lack of detail, as Dendreon only said it met the main study goal of improving survival, or a 22 percent reduction in the risk of death. The Seattle-based company will present more detailed results from the Impact study on April 28 at the American Urological Association's annual meeting in Chicago. But to relieve any concerns perhaps, Mitchell Gold, M.D., president and chief executive officer of Dendreon, said the "Results are unambiguous. It was a clear hit on overall survival."
"The positive results from this landmark study provide confirmatory evidence demonstrating that treatment with PROVENGE may prolong survival," Gold said. "The successful outcome from the Phase 3 IMPACT study provides validation of the long-pursued goal of harnessing the human immune system against a patient's own cancer," he continued, and added, "We have achieved a major milestone to potentially help the many prostate cancer patients that currently have few appealing treatment options."
This brought to light much angst against the FDA, after the agency rejected the treatment in May 2007 due to concerns over the goals of the study, despite voting in its favor two months earlier. It highlighted the debate over speed of access to experimental drugs for patients who need them versus society's responsibility and benefit as a whole.
Back to Dendreon: it plans to submit additional information to the FDA in the fourth quarter as part of its new drug application, meaning approval could come within six months -- by mid 2010. Still, with its earlier rejection and public outcry, the FDA may feel pressured to approve it sooner.
This may not be all that Dendreon could have to offer. Gold said "Provenge may also be leveraged to develop similar products to treat breast, colon, bladder, kidney, and multiple other forms of cancer. We will be evaluating a more comprehensive development plan to expand our cancer immunotherapy product pipeline."
Provenge has blockbuster potential if it is approved for marketing, with some analysts estimating that sales may reach $1 billion a year, providing both top line and bottom line growth for Dendreon in the coming years.
Shares of Dendreon tripled earlier today as they soared to $22.10 from the previous close of $7.30. By noon they traded up about 130 percent to around $17 a share.
But as happy as shareholders may be, the real winners -- if the drug lives up to expectations -- are the cancer patients.