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Biotech / Medical : Millennium Pharmaceuticals, Inc. (MLNM) -- Ignore unavailable to you. Want to Upgrade?

To: Ian@SI who wrote (2003)	1/6/2004 9:35:03 AM
From: Extra Pale	Read Replies (1) \| Respond to of 3044

(from yahoo board) Adam Feuerstein Millennium Pharma halts Velcade colon cancer study 1/06/04 08:44 AM ET Breaking news: Millennium Pharmaceuticals (MLNM-Nasdaq) has halted a study of its cancer drug Velcade in colon cancer patients, raising questions about the drug's ability to treat solid tumors. A Millennium spokeswoman confirms that the phase 2 Velcade study in colon cancer has been stopped, but she says the reason is for a pre-planned interim efficacy analysis. Results of this analysis will be made public next week when the company presents at the J.P. Morgan healthcare conference. But sources knowledgeable with this study tell me that, in fact, Velcade has proven to be ineffective as a colon cancer treatment. In other words, the study failed, which is why it was halted. Velcade is approved for multiple myeloma, a cancer of the blood, and is doing well commercially in this indication. But in order for Velcade to achieve blockbuster status, it must be approved and used in solid tumors like cancers of the colon, lung, etc. Millennium has been conducting a variety of early- and mid-stage studies of Velcade in solid tumors, of which the colon cancer study was one.

To: Ian@SI who wrote (2003)	1/6/2004 10:32:01 AM
From: Icebrg	Read Replies (3) \| Respond to of 3044

Ian >> Since when were Ph IIs designed to evaluate efficacy?>> That should be one of the prime objectives of a solid phase II design. Millennium has for about a year told us that they are looking for signals with regard to which (if any) additional cancers they should take into phase III. They cannot do so without having an idea about where there is efficacy to be found and where there is none. (It would be interesting to know whether this was a single-agent study or not). These studies are however not powered to prove beyond any doubt that there is efficacy. Only that there might very well be some. Erik