Part of the biotechnology hubs of north western and north eastern USA, the Dendreon Corporation head office is located in Seattle, WA, with a second location in NJ. Dendreon, originally named Activated Cell Therapy Inc. was founded in 1992 by scientists from the Fred Hutchinson Cancer Research Center. The company became publicly traded in 2000 under the Nasdaq symbol: DNDN.
Dendreon has focussed its research objectives on finding a means to control and enhance immune system responses to various types of cancer. It is an industry leader in the development of a new approach to cancer treatment, known as Active Cellular Immunotherapies (ACIs). The company portfolio consists of a mixture of ACI, monoclonal antibody and small molecule pharmaceuticals.
Dendreon's specialty is tailor-made vaccines containing antigens developed using cells taken directly from patients. Their goal is to turn the immune system back on, or turn it up, with a specific immune response that is long-lasting, against a particular cancer. Two cancer vaccines at the forefront of Dendreon's product line made headlines in 2007: Lapuleucel-T (Neuvenge), for breast cancer, and Sipuleucel-T (PROvenge), for prostate cancer. PROvenge is designed to treat asymptomatic, metastatic, androgen-independent prostate cancer, also known as hormone-refractory prostate cancer (HRPCa).
As of August 2007, Dendreon had a total of six new drugs in its pipeline. Sipuleucel-T was the most advanced, having completed two Phase III trials already, and with more underway. Two Phase I clinical trials had been completed using Lapuleucel-T (breast, ovarian, colon cancer). The other drugs in the pipeline were: Trp-p8 (lung, breast, prostate, colon), CEA (breast, lung, colon), CA-9 (kidney, colon, cervical) and Anti-Serine Protease (multiple cancers).
In January 2007, PROvenge was granted a priority review by the US FDA, the company's future appeared bright, and stock prices were rising. However, the review, completed in May 2007, did not deliver the anticipated result. In an article by Forbes.com, it was reported that the FDA requested more clinical data. If the trials that are currently underway are successful, they might provide the necessary information to convince the FDA that the drug extends the life expectancy for men with an otherwise grim prognosis. However, Forbes predicted that, with full data not expected until 2010, and if the company has to wait that long for approval, it would have to do some financial reorganizing. In fact, in a press release on August 1, 2007, Dendreon announced a Convertible Senior Subordinated Notes offering designed to raise funds for completion of the commercialization process and in preparation for production of PROvenge.
Upon the FDA's May 2007 announcement, Dendreon shares plunged in value by nearly 65%, after having more than doubled in preceding months. According to some reports, clinical test results were rejected by the FDA because reports of the success of the drug were based on shrinkage of tumour cells or other factors not directly related to actual longevity of the patients. Patient survival data, now required to complete the FDA review, will take much longer to assess and report. The clinical trials were also too small to be convincing to cancer experts and the FDA panel.
Despite the FDA's decision, Dendreon stock continues to fluctuate amid daily rumours surrounding approval of its key cancer-treatment products. Controversy surrounds the company in the form of a bioethical debate over whether the drug should be approved because those suffering the disease want it, or not approved in order to facilitate collection of more accurate clinical data using proper controls. Organizations representing sufferers of HRPCa are angry and the FDA has been sued for withholding approval of the drug. Amid rumours of layoffs and the demise of the company, Dendreon's website still touts PROvenge as “nearing commercialization” and says little else on the topic.
Sources:
Matthew Herper. Dendreon’s Dilemma. Forbes.com May 9, 2007.Pharmaceutical-technology.com. Dendreon Vaccine Plant, USA.
Washington Biotechnology and Biomedical Association. Washington BioHistory, 2004.
