DNDN: Surges 200% on Positive Results from Ph 3 Trial of PROVENGE(R)

Shares of Dendreon Corporation (DNDN) surged 200% in early trading on Tuesday after the Company announced that the pivotal Phase 3 IMPACT study of PROVENGE(R) (sipuleucel-T) in men with advanced prostate cancer met its primary endpoint of improving overall survival compared to a placebo control. The magnitude of the survival difference observed in the intent to treat population resulted in the study successfully achieving the pre-specified level of statistical significance defined by the study's design.

PROVENGE is Dendreon's investigational product candidate for men with advanced prostate cancer and may represent the first in a new class of active cellular immunotherapies specifically designed to engage the patient's own immune system against cancer.

Dr. Mitchell H. Gold, president and CEO of Dendreon, commented in a conference call this morning, "This is a historic day for patients, the industry, memebers of the scientific community and certainly for Dendreon. Until PROVENGE, harnessing the immune system to fight cancer has been elusive. Today's data validates the potential of this approach in a large Phase 3 randomized, controlled clinical trial theta confirms the results that we observed in previous studies."

He continued, "We have achieved a major milestone to potentially help the many prostate cancer patients that currently have few appealing treatment options."

Dr. Gold explained, " We intend to seek licensure of PROVENGE in Q4 of this year. We will be preparing our manufacturing, sales and marketing operations to insure that we are well positoned to successfully launch PROVENGE."

He concluded, "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."

Merriman upgraded DNDN today to Neutral from Sell. According to the firm's view, "Dendreon continues to be one of the more controversial stocks in the biotechnology sector. After a long wait for the Phase III IMPACT study the company has posted statistically significant survival data and the company is now expected to file an amendment to Provenge's BLA. While the Dendreon story was too risky in our belief, we feel it is a great win for the company and more importantly the immunotherapy space, which has seen countless failures and Dendreon's data should reinvigorate the space."

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