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DNDN or Dendreon, Seattle based biotechnology company DNDN or Dendreon:

DNDN or Dendreon is a Seattle based biotechnology company. 

DNDN or Dendreon 's leading product candidate, Sipuleucel-T 

known as Provenge during drug trials, is an immunotherapy 

for prostate cancer. Provenge sipuleucel-T consists of autologous 

reimplanted dendritic cells complexed with the PAP antigen and GM-CSF.

In his February 18, 2005 column in Forbes magazine, Dr. Scott Gottlieb, 

who later served as a top policy maker with the FDA until early 2007, 

argued for Provenge approval: That 4.5-month increase in survival is almost 

double the 2.5-month benefit shown in clinical trials of Taxotere, a drug that 

is the next best thing for patients like those in the Provenge trial whose cancer 

has spread beyond the prostate gland and is no longer being controlled by hormonal therapy.

In 2006, DNDN or Dendreon  built a manufacturing facility in Morris Plains, New Jersey 

to accommodate Provenge production in anticipation of possible FDA approval in 2007, 

as well as for production for a Phase III trial, IMPACT previously known as D9902B.

In January 2007, the FDA accepted Dendreon 's Biologics License Application filing for 

Provenge, with an FDA decision due by May 15, 2007.

The Food and Drug Administration FDA Office of Cellular, Tissue and Gene Therapies Advisory 

Committee on March 29, 2007 voted 17-0 that Provenge is reasonably safe and 13-4 that the 

trial data showed substantial evidence that it is effective.

The FDA has a set a PDUFA date of May 15, 2007 as its deadline to decide whether or not 

to grant approval to Provenge. 

The FDA is not bound to accept the recommendation of the advisory committee.

On May 9, 2007 DNDN or Dendreon dropped to just over $7 per share when the company 

received a letter from the FDA demanding more results and information before approval. 

The Seattle Times reported that layoffs are likely and quoted an industry analyst as 

saying that DNDN or Dendreon will probably lay off half of its current workforce of 250.

Dr. Mark Thornton described this in the annals of cancer immunotherapy as Black Wednesday 

as, within an eight-hour period the FDA succeeded in killing not one but two safe, promising 

therapies - Provenge, and also Junovan for Osteosarcoma treatment, with this decision being 

criticised as motivated by Cancer Industry derailment of potential threats to its profits.

On December 13, 2007 three US congressmen, Mike Michaud (D-Maine), Dan Burton (R-Indiana) 

and Tim Ryan (D-Ohio), requested a probe into the FDA's delay in approving Provenge 

and conflicts of interest held by certain advisory committee members.

On March 12, 2008 the FDA said they would accept results a year early, boosting the stock 

price 10%.