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: Brad C. Dunlap who wrote (556)	4/10/1997 8:37:00 PM
From: Miljenko Zuanic	of 1762

>>Hi Bennett, it could get real interesting and especially with something with such huge potential as CE9.1. Here is an interesting point. About 1 1/2 yrs ago smithkline started to build a plant to specifically manufacture CE9.1 upon mkt approval. Now I'm sure they had a back-up use for this plant in case something were to go wrong with CE9.1 in the clinicals. Smithkline has now started to manufacture a second plant to manufacture CE9.1 which is a real vote of confidence and it also shows that they're looking at large potential demand in the sense that one plant wasn't going to meet their estimated demand. My understanding is that the cost of this second facility is greater then the cost of the entire phase III clinical. I heard the president of Immunex in an interview in which he stated their phase III for RA would cost them around $35 million. Idec/smithkline with the different dosages and many additional patients in their phase III should be considerably greater in cost then the $35 million that immunex is incurring.<< Brad, May I ask you what is your source for this information? Building two plant for monoclonal antibody manufacture(CE9.1) is economically non-sense. Processes are very complicate and equipment very expensive. More logical will be to expand current plant, unless it was only pilot-plant, which is not likely. Building the plant is long process, as are the clinical trials. They do not need all finance at once, as they sold 1/2 of their IDPH holding. Also, SmithKline has enough cash to support RA trials. Reasons for their action are something else, IMO. mz

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