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To: jopawa who wrote (2395)10/8/1999 2:46:00 PM
From: HandsOn  Read Replies (1) | Respond to of 2782
 
Thanks for the heads up, probably mention GERN also Monday.



To: jopawa who wrote (2395)10/10/1999 9:24:00 PM
From: pat w.  Read Replies (1) | Respond to of 2782
 
Posted Monday, October 04, 1999 at 09:30 AM EST

by Jim McCamant
Medical Technology Stock Letter

ImmunoGen (NasdaqNM:IMGN · 2 9/32) announced that the FDA has accepted their investigational new drug (IND) application for C242-DMI for the treatment of colorectal and pancreatic cancer. This means that IMGN is now cleared to start human clinical testing, which the company has indicated will begin later this year. In conjunction with the acceptance of the IND, SmithKline Beecham (SB), IMGN's development partner for C242-DMI, will make a $4 million milestone payment to IMGN. This is a big deal for a company with the market cap the size of IMGN's. It is also a big deal that the FDA approved the study of C242-DMI in pancreatic cancer patients along with colorectal cancer patients, because studying in pancreatic cancer will likely lead to a faster approval of the drug. The reason for this is that for diseases like pancreatic cancer, where there are currently little in the way of effective therapeutics, the FDA will often approve the drug based on positive Phase II results. Therefore, IMGN could possibly get approval for pancreatic, continue the trials for colorectal, and then use the therapy off-label for colorectal until the trials finish up and the label gets expanded.

This is clearly good news, both the size of the milestone payment and the fact that pancreatic cancer patients will be included. Granted, IMGN has a sizable road ahead to eventual FDA approval, but this is another event which signifies progress, and we are very comfortable holding our positions, and even adding where appropriate. As a side note, IMGN will not make an announcement at the time the trial is initiated, but rather, when the next milestone is received from SB, which is dependent upon a certain undisclosed number of patients having been enrolled in the trial. We also anticipate one or two licensing deals, possibly by year-end, which will incorporate IMGN's technology with other companies' antibodies. To reflect this obvious progress at the company, we are raising our current buy limit.

IMGN is now a buy under $4.

Source: Medical Technology Stock Letter, P.O. Box 40460, Berkeley, CA 94704




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