Dendreon Conference Call - Final.

Original Source: FD (FAIR DISCLOSURE) WIRE

OPERATOR: (OPERATOR INSTRUCTIONS). I would like to welcome you to the Dendreon conference call. Now, I will turn the meeting over to Ms. Monique Greer, Senior Director of Corporate Communications. Ma'am you may begin.

MONIQUE GREER, SENIOR DIRECTOR, CORPORATE COMMUNICATIONS, DENDREON CORPORATION: Good morning and thanks for joining us for today's conference call. Before we begin, I would like to remind you that during the call we will be making forward-looking statements that are subject to risks and uncertainties that may cause the actual results to differ from the results discussed in the forward-looking statements. Reference to these risks and uncertainties is made in today's press release and are disclosed in detail in our most recent 10-Q and other public disclosure filings with the US Securities and Exchange Commission. I will now like to turn the call over to Dr. Mitchell Gold, President and Chief Executive Officer.

DR. MITCHELL GOLD, PRESIDENT & CEO, DENDREON CORPORATION: Good morning everyone, and thank for joining us. In addition to Monique, with me today is Rob Hershberg, our Senior Vice President and Chief Medical Officer. The purpose of the call today is to review the press release that was issued this morning regarding the Final Survival Analysis in the completed D9901 Phase III study of Provenge. As you might guess, we are very encouraged by these data.

I would like to start this morning by thanking the clinical investigators, nurses, and patients who participated in this important study. Please keep in mind that due to the scientific and clinical relevance of this new and exciting information, the principal investigators will be submitting it for presentation and for subsequent publication in a peer reviewed medical journal. As you know, the guidelines for these scientific meetings and publications are strict with respect to data disclosure and therefore we will not be able to get into any specifics regarding the data until that time.

What we can say is that the results of the pre-specified 36-month final followup of the patients in the D9901 study show there is a statistically significant survival benefit for patients who received Provenge in the overall intent-to-treat population, as well as with Gleason less than or equal to 7 patient population. In addition, at 36 months, the percentage of patients alive in the Provenge-treated group is substantially greater than the percentage of patients alive who received placebo regardless of their Gleason score. As a result of these new data, Provenge may have a broader market reach than we previously anticipated. For those of you on the call who are new to the Company, let me briefly review some of the more recent history of Provenge.

D9901 is our first Phase III trial of Provenge, which is an investigational immunotherapy directed against prostatic acid phosphatase or PAP. D9901 enrolled 127 patients with metastatic, asymptomatic, androgen-independent prostate cancer and the last patient was enrolled in the trial in October of 2001. In August of 2002, the intent-to-treat analysis for progression of D9901 comparing the Provenge-treated group to the placebo group indicated a benefit as measured by a delay in disease progression that closely reached, but did not achieve statistical significance. Importantly, the results of the D9901 study reveal that men with androgen-independent prostate cancer with a Gleason score of 7 or less significantly benefited from Provenge treatment showing a 2.2 fold delay in disease progression.

Provenge also showed similar results, but claimed that onset of cancer-related pain in both of these groups. Based on these results, we, and our clinical investigators, designed and are currently conducting a pivotal Phase III trial D9902B under a Special Protocol Assessment agreement with the FDA. This trial further evaluates Provenge in men with prostate cancer with a Gleason score of 7 or less. In January of this year, we released interim survival data from the D9901 study that indicated that Provenge may confer a survival advantage in men with androgen-independent prostate cancer with Gleason 7 or less tumors. With Gleason 7 or less tumors. It was prespecified in the D9901 protocol that we fellow all patient for 3 years for survival. And the last patient was enrolled in this study in October of 2001.

We are pleased to announce this morning that the final 36 months follow-up data showed that treatment with Provenge resulted in statistically significant survival benefit in the Intent-treat-group, which is defined as all 127 patients randomized in the study regardless of their Gleason score. To put this in context, this survival benefit is greater than that observed in any published Phase III study in late-stage prostate cancer. These data indicate for the first time the potential broad applicability of Provenge in the patient population. It fills upon earlier evidence that this drug works and how it may potentially impact survival in prostate cancer. We believe these data continue to support what we have believed all along. Provenge has the potential to fundamentally change the treatment of advanced prostate cancer with a targeted therapy that is well tolerated. And by definition, this could represent the first step, sort of paradigm shift in the way traditions think about treating cancer with immunotherapy…