All eyes are on Dendreon Corporation (DNDN) today and their shares have been halted ahead of their meeting with the FDA. Their shares were trading at $5.22, so what’s the big deal about anyway?
After spending 10 years and $400 million to develop and test its prostate cancer drug, Seattle-based Dendreon today faces the next-to-last hurdle.
An advisory panel for the U.S. Food and Drug Administration will decide whether to recommend approval of the drug, Provenge, evaluating whether the drug is both safe and
effective. So what’s to gain? Money baby, lots of money.
The Good:
- Dendreon is the only Seattle biotech company with a potential blockbuster drug, meaning that analysts project annual sales could reach $1 Billion.
- It’s the first treatment of its kind against cancer and one of the only drugs targeting late-stage prostate cancer patients .
- Provenge’s side effects, including fever and chills, are generally fewer than chemotherapy drugs
The Bad:
- There is conflicting data from Dendreon’s clinical trials. One study of 127 patients with advanced, metastatic prostate cancer did not meet its goal, which was to delay the time toward progression of the disease.
- Two clinical trials didn’t achieve their stated goal of delaying the disease’s progress, but a long-term statistical analysis suggests that patients receiving the treatment lived longer than others.
- The company is enrolling patients for a final study that won’t produce results until 2010. The FDA might request to see that data before approving the drug.
Dendreon shares have climbed 41% in the last 5 days and experts are saying their drug has a 50/50 chance of getting the green light from the FDA. Gentlemen, place your bets.
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