The official announcement will be on April 28th at the American Urological Association meeting in Chicago, but we have some preliminary information beginning to appear and a quite a few investors getting aroused. This has been an up and down development project for the drug, unlike any other we have seen. It has politics, it has causes, promoters, and a number of other elements.
There have been a number of drug failures in this category, but the big desire for the drug to be a success is to extend the life of those suffering from prostate cancer, as the treatment is much easier tolerated than conventional chemotherapy according to reports. The Dendreon CEO has called the outcome of the phase 3 trials a success. When submitted to the FDA, there’s still the 6 month process for approval to occur. The company may also look at this type of therapy for developing treatment for other types of cancer. The price for the drug will not be cheap as other biotech drugs run into a lot of money too for patients.
Provenge works with the body’s natural immune defenses to recognize cancer cells as foreign invaders, like a virus, and destroy them. In 2007 it was expected that the FDA would approve the drug, but further studies were requested, so it was back to clinical tests for more information. A related story about the investors at stake can be read here. Consumer groups were outraged at the denial and death threats followed to 2 of the individuals on the advisory committee. If you missed the fireworks, this page gives a good summary of events. The money side with investors truly contributed to the drama substantially as well as those wanting and needing the drug. There was even a court case filed against the FDA from the consumer groups which was thrown out of court. Care To Live was the most active consumer group and even had marches on Washington over the matter.
The Wall Street Journal reports the shares once again are up. Back in 2007, even the CEO cashed in many of his shares due to the price rising based on the anticipated approval by the FDA, so again, this story has the drama, science and everything else you might want to throw in there and with the last years of events, I sure hope it is a success, especially if it leads to treatment for other types of cancer as well. BD
[[Updated]] Dendreon has been vindicated. The Seattle biotech company, after living through years of controversy about whether its experimental drug helps prostate cancer patients live longer, said today that a clinical trial of 512 men now shows that the treatment can help prolong life with minimal side effects. Shares skyrocketed by more than $12, rising above $20 a share after the opening bell.
The trial, called Impact, randomly assigned men to get either the company’s experimental immune-boosting therapy, Provenge, or a placebo. The study found that men who took Provenge had a lower risk of death than those in the control group—the company needed to show at least a 22 percent improvement on that measure. Side effects were consistent with what was seen in previous trials—fever and chills that lasted a couple days. Dendreon (NASDAQ: DNDN) will now pull together this new information to update its application with the FDA in the fourth quarter, in the hopes of bringing this new drug to the U.S. market. Full data are expected to be announced at 2:20 pm Central time on April 28 at the American Urological Association meeting in Chicago.
The finding is a watershed moment for the field of cancer immunotherapy, sometimes called cancer vaccines, in which researchers try to stimulate the immune system to fight cancer cells like a virus. If Dendreon can win FDA approval, it will be the first company in this field to do so.
Dendreon will wrap up some final remaining questions FDA has about its manufacturing processes at a factory in New Jersey, and get ready to start pumping out commercial product after the FDA completes its six-month review of the company’s amended application.
Related Reading for Prostate Cancer