The clock is ticking on Provenge; Dendreon Corp. ($DNDN)

Dendreon Corp. (NASDAQ:DNDN) is a biotechnology company focused on targeting cancer and transforming lives through the discovery, development, commercialization, and manufacturing of novel therapeutics that may significantly improve cancer treatment options for patients. Dendreon's first product, PROVENGE® (sipuleucel-T), is the first autologous cellular immunotherapy to receive FDA approval for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer. 

A North America Equity Research report by JP Morgan released last week evalutes the impact of the Independent Data Monitoring Committee's unanimous recommendation to unblind "the Phase 3 trial of Zytiga in pre-chemo metastatic castration-resistant prostate cancer (mCRPC) patients – the market currently served by DNDN’s Provenge." 

The report states:

"Ultimately we believe CRPC patients are likely to receive several drugs (including DNDN’s Provenge and JNJ’s Zytiga) during the course of their disease (as none of them are “cures”) and note that DNDN is currently conducting a sequencing trial with Provenge and Zytiga (data expected later this year). Today’s news doesn’t impact our valuation as this development was already built into our assumptions. While our overall view is unchanged, we believe the clock is ticking on DNDN to cement use of Provenge into CRPC treatment practice before approval of other drugs in the pre-chemo setting."

Read the full report below. 

JP Morgan Dendreon Report

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Dendrion ($DNDN): J&J unblinds Zytiga trial in chemo-naive CRPC

Johnson & Johnson (NYSE:JNJ) unblinded the Phase III COU-AA-302 trial in chemotherapy-naive castration-resistant prostate cancer after Zytiga plus prednisone showed "evidence of clinical benefit" on the co-primary endpoints of radiographic progression-free survival (PFS) and overall survival (OS) vs. prednisone alone. J&J based the decision on the recommendation of an independent DMC, which conducted an interim analysis. Details of the analysis were not disclosed. The trial enrolled 1,088 chemotherapy-naive patients with asymptomatic or mildly asymptomatic metastatic CRPC.

Zytiga is approved in the U.S. in combination with prednisone to treat patients with metastatic CRPC who have received prior chemotherapy containing docetaxel. Next half, J&J plans to submit an sNDA to FDA, as well as worldwide regulatory applications, for Zytiga to treat men with metastatic CRPC who have not yet received chemotherapy. J&J gained Zytiga through its 2009 acquisition of Cougar Biotechnology Inc., which received rights to the product from BTG in 2004. BTG was up 15.30 to 365p on Thursday. Zytiga is an inhibitor of steroidal enzyme 17 alpha-hydroxylase/C17, 20 lyase (CYP17).

Zytiga would be a potential competitor to Provenge sipuleucel-T, which is marketed by Dendreon Corp. (NASDAQ:DNDN) for asymptomatic or minimally symptomatic metastatic CRPC. Dendreon fell as much as 17% on Thursday before closing off 7%, or $0.76, to $10.11. Provenge consists of autologous dendritic cells loaded with a fusion protein of prostatic acid phosphatase and an immunostimulatory cytokine

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