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Provenge

Valeant Pharmaceuticals International, Inc.

Drug Names(s): APC 8015, sipuleucel-T

Description: Provenge is a procedure by which autologous dendritic cells from patients are processed and antigen loaded with prostatic acid phosphatase (PAP) fused with GMCSF. PAP is expressed in approximately 95% of prostate cancer cells. The activated and antigen loaded dendritic cells are then injected back into the patient intravenously to stimulate the patients own immune system to kill off the PAP-expressing cancer cells.

Further Background on Provenge

Processing of Dendritic Cells for Vaccine Production:
Dendreon harvests dendritic cells from the blood of patients.  Blood drawn from patients is subject to a common process called leukapheresis (separation of white blood cells).   Immature blood dendritic cells are separated from the remaining white blood cell population using the Company’s proprietary technology.  The immature dendritic cells are then cultured in serum-free and cytokine-free media with the antigen delivery cassette for forty hours.   This incubation yields activated dendritic cells, which are then tested for various quality control tests that include sterility and ability to induce a potent immune response.  The activated dendritic cells are then ready to be infused back in the patient. The entire process takes less than three days.

The collection of blood can be done at any standard blood collection center.  Patient blood is shipped to one of several dendritic cell-processing centers around the country. The cell-processing centers have been established at Dendreon's headquarters in Seattle (WA), Dendreon’s Satellite facility in Mountain View (CA), The Mayo Clinic in Rochester (MN), The American Red Cross in Philadelphia (PA), Progenitor Cell Therapy in Hackensack (NJ), and in Tokyo, Japan in conjunction with Kirin Brewery.  After processing, the dendritic cell vaccine is shipped back for infusion into patients in an outpatient procedure that lasts thirty minutes.

Deal Structure: Revenue splits for this drug are BioMedTracker estimates.

Dendreon and GlaxoSmithKline
In September 2010, Dendreon entered into a Development and Supply Agreement with GlaxoSmithKline. The agreement covers the commercial production and supply of the antigen used in the manufacture of Provenge (sipuleucel-T). The term of the agreement is through December 31, 2015, unless earlier terminated pursuant to the terms of the agreement, and provides Dendreon an option to request one or more two-year extensions to the then expiring term.

In September 2011, Dendreon provided written notice to GlaxoSmithKline (GSK) that the Company is terminating the Development and Supply Agreement upon sixty days written notice, as required by the Agreement. Termination of the Agreement was due to unforeseen delays and implementation difficulties in achieving the commercial purpose of the Agreement. Dendreon may continue to pay GSK a fee of $2 million per month for each of...See full deal structure in Biomedtracker


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