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Biotech / Medical : Cell Genesys (CEGE)

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To: Londo who wrote (1060)	11/17/2000 11:26:31 PM
From: cliff28	Read Replies (1) of 1298

Fair challenge. I will see what examples I can dig up. My statement was more general as I have been away from my research job for a couple of years. I attended several FDA approval meetings with that position and listened to usually four compounds presented at each hearing. Each time (I was dealing with oncology/hematology products at the time) there were a couple of products presented that treated neoplasms which had no current effective treatment. The panel would make several strong challenges and seem doubtful but, in the end, approve the product as they saw the potential benefit as outweighing the risk. i.e. the patients would die with no treatment so these products were a reasonable step up. Post-market surveillance was most likely required. I have found that products seem to have a lower hurdle when satisfying an unmet need with life threatening diseases which makes intuitive sense. As I said, I have been away from the area for several years but could probably find some examples in a few days. I currently work in a therapeutic area that deals with non-life threatening diseases so I have to go back a few years or look for recent examples. You could probably find examples yourself by looking back in cancer or HIV to products that were breakthrough at the time. Non-Hodgkin's lymphoma is a good area (one of the products I saw was in this area) or looking along HIV therapeutic (protease inhibitors, 3TC) for initial launches of the first in class compounds. Another area where you will find expedited approvals is in the area of diseases of limited scope (SCIDs, hairy cell leukemia, T-cell lymphomas) where the number of patients is small and companies receive orphan drug status with approval. Also note that 51% of drugs uses by oncologists are off-label. Some pharmaceutical companies will pursue, say, pancreatic cancer looking for a quicker approval with lower hurdles and hope to have their product used in larger disease states such as non-small cell lung cancer. CEGE may pursue that tactic. Ligand Pharmaceuticals has a couple of products (Targretin Capsules) which were approved for a type of skin melanoma but there is data supporting its use in lung cancer. Their sales have not taken off but it is an example from the top of my head. I do not know approval time for Targretin (or even if I am spelling the drug name right!) so cannot comment as to if going after an unmet need saved them time or scrutiny on the way to market.

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