IDPH--Positive preliminary results for pivotal trial of ID Message Board

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Biotech / Medical : IDPH--Positive preliminary results for pivotal trial of ID

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To: Roudy who wrote (46)	12/26/1996 7:20:00 PM
From: Brad C. Dunlap	of 1762

Hi Don, I had a chance to review Coulter Pharmaceuticals preliminary prospectus. Some of the key points are as folllows. They do not expect to file their NDA[new drug application] until the second half of 1998 assuming all goes well. Their results from previous studies look very positive as previously discussed. Apparently there has been new legislation ruling on acceptable amounts of body radiation/isolation requirements, and as a result of less stringent requirements Coulter believes that certain patients will be able to be treated in an outpatient settings. However, the individual states could have the final say in this matter. This certainly appears as if their stretching reallity to be cost competitive with Idec. They also must complete a phase III/IV study, identical to their recently released phase I/II. They state that this is required assuming accelerated approval and this will be a post approval study while the product will be available in the public market. This appears to be a bit odd, and my immediate thoughts were that the FDA required the additional study to clarify potential toxicities. However, the prospectus does not mention any hint of these concerns. They also state that to date there has been no unlabled monoclonal antibodies that have been successful against cancer. Obviously, this paragraph will have to be removed due to C2B8 successfully completing the FDA trials. Coulter has initiated a small study using their antibody as an unlabled monclonal without the iodine-131 for informative reasons and the study will not quallify for approval. This should be interesting and I would be surprised if this study showed efficacy remotely close to C2B8. Major questions in regard to manufacturing[especially in regards to attaching the iodine-131 to the antibody] and marketing. These are just a few of many points but my overall feel is that Idec will have a good 1 1/2 year head start in marketing C2B8. Afterwords, YB28 is the product that will compete against the radiolabled antibodies.

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