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To: Gary Mohilner who wrote (4629)12/10/2003 11:41:17 PM
From: Greg Rich
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Nice little uptrend over this past month. Some strength even in the teeth of this little biotech correction these past few days. Volume not bad either. Accumulation???

Endeavor to persevere,

greg

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To: Greg Rich who wrote (4630)12/11/2003 2:14:06 PM
From: Gary Mohilner
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Greg, it's doubtful that the partnership Mitch had once mentioned will happen this year, but I suppose anything's possible. I do believe the news from MLNM is very positive, and while I don't know when, I believe the Milestone for starting the Phase II Trial which could be a Pivotal Trial should be substantial.

We've yet to see a Phase II Milestone Payment, but I'm guessing it will be about $10 million, that should get some attention. To me the question is, do the current trials have to complete, or has the FDA's acceptance of Fast Track already established the protocol for the Phase II Trial. I would guess that a 30 day delay is built into the actual milestone payment, as it was in the original SKB agreement, but I certainly don't know that's a fact.

Gary

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To: Gary Mohilner who wrote (4629)12/12/2003 11:25:36 AM
From: RJMC
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This may help in understanding the fast track designation.

Bob M.

fda.gov 

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To: RJMC who wrote (4632)12/12/2003 5:48:44 PM
From: Gary Mohilner
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Thanks Bob,

It seems to me that someone ought to be able to sit down and combine all the various regulations into a single regulation, and if they seriously got down to basics they could do it in less than 10 pages.

The information is certainly very useful, and looking through it, you can probably make a case for Fast Tracking virtually every drug that's intended to benefit patients that have potentially terminal diseases.

It's certainly worth skimming through, and it probably would answer many of our questions in the future, if we refer back to it.

Thanks again,

Gary

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To: Gary Mohilner who wrote (4633)12/15/2003 4:14:34 PM
From: Gary Mohilner
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It's interesting to note that when Fast Track approval occurs, trials continue anyway. MLNM's Velcade was in Phase III Trials after approval, the trial has been terminated as the results were clearly positive, and the FDA thought it was wrong to withhold the drug from the control group.

Let's hope that we get similar results with the Fast Track Trial that MLNM plans with their TAP drug.

Gary

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To: j.d.robbins who started this subject12/16/2003 3:32:05 PM
From: Gary Mohilner
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It's amazing how well the Max Pain theory works. This Friday closes out the options for December, so the MM's are already positioning IMGN to close at or near $5. Let's hope we rally after that, and close the year strong.

Speaking of that, Merry Christmas, Happy Channuka, and Happy New Year's to all.

I'll probably say it again, but while on a percentage basis this hasn't been a bad year for IMGN investors, lets hope that next year is far better. I'm not expecting new all time high's, but significant double digits are certainly possible as the technology's validated.

Gary

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To: j.d.robbins who started this subject12/30/2003 6:39:04 PM
From: Gary Mohilner
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It looks like once again we've managed not to be invited to the JP Morgan Healthcare Conference. The good news is all of our major partners have been invited, so something could come of that. It would be nice if MLNM spoke about their plans for Fast Track with their TAP drug.

Frankly, with the exception of the AVE Partnership and the MLNM Fast Track, 2003 has almost been the year that wasn't there for IMGN. Sure, we've spoken at a few conferences, but I can't remember any new clinical data being presented in spite of the fact that three drugs have been in trial through the year.

The good news is 2004 should see more information. Drugs should advance into Phase II Trials, and we should see some data, especially from MLNM, who's drug is in Fast Track. Furthermore, the Vernalis situation should be resolved one way or the other.

At this point I'm more concerned with N901-DM1 getting into a combined trial with Taxol or one of the other Taxanes then I am about whether it's with or without Vernalis. I believe IMGN should commit to running this trial, though they may not be able to do so publicly as Vernalis probably has a say in anything that is to be released about the drug. Frankly, this is the pipeline drug that could still be a blockbuster, but it won't be by itself based on trial results to date. Preclinical results combined with Taxol were spectacular, if they were even close to that in humans this drug would become the immediate Gold Standard for SCLC.

2004 could have its disappointments, but I believe it will truly be positive for IMGN on balance, and I think we'll be back in double digits again by the end of the year.

Happy New Year's all,

Gary

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To: Gary Mohilner who wrote (4636)12/31/2003 12:31:23 AM
From: RJMC
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2004 should at least be more eventful (either positive or negative) than 2003. At least we can expect to see some trial results for the new drugs in the coming year. I didn't expect to hear too much from Immunogen this year but was at least pleased to see a major pharma who still was willing to provide some significant funding to Immunogen.

Let's cross our fingers and ring in the New Year in hopes for a good one!

Bob M.

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To: RJMC who wrote (4637)12/31/2003 3:59:05 PM
From: Gary Mohilner
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Bob, you're certainly right about 2004, it should have many more events. I hope the Vernalis situation is resolved sooner, rather than later, but it's been pointed out to me that the Phase II Trial was still accepting applicants when last we heard, that could mean it has substantially longer to go.

Personally I'd like a statement from IMGN that trials won't be delayed regardless of the outcome of the talks, but even if true they probably can't say it without the okay of Vernalis.

It should be an interesting year, I look forward to information from MLNM and BI. It's funny that the last drug to start trials could be the first approved, but it's very possible with MLNM's Fast Track authorized.

Have a Happy New Years,

Gary

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To: j.d.robbins who started this subject1/8/2004 7:17:56 AM
From: nigel bates
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ImmunoGen, Inc. to Advance its Lead Product Candidates Cantuzumab Mertansine and huN901-DM1 into its Own Proof-of-Concept Studies
Thursday January 8, 6:30 am ET

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 8, 2004--ImmunoGen, Inc. (Nasdaq: IMGN - News)
* ImmunoGen to Advance Cantuzumab Mertansine into Phase II Testing and Regain Control of huN901-DM1 from Vernalis

ImmunoGen, Inc. (Nasdaq: IMGN - News), a biotechnology company that develops targeted anticancer products, announced today that the Company will advance both of its clinical stage Tumor-Activated Prodrug (TAP) compounds - cantuzumab mertansine and huN901-DM1 - into proof-of-concept trials managed by ImmunoGen.

ImmunoGen will advance cantuzumab mertansine into Phase II proof-of-concept studies. Previously, the Company had indicated its intention to advance the compound into the next stages of clinical testing with a partner. ImmunoGen's collaboration with Aventis has enabled the Company to retain the rights to cantuzumab mertansine and advance the compound into Phase II testing on its own.

Additionally, ImmunoGen will take over future development of huN901-DM1 from Vernalis (formerly British Biotech). Vernalis will continue the two huN901-DM1 clinical studies currently underway, but has now relinquished its rights to the product. ImmunoGen is preparing to initiate its own clinical trial with huN901-DM1 in the United States.

Mitchel Sayare, Ph.D., Chairman and CEO, commented, "Both of these compounds have the potential to become significant anticancer products. Now that we have the partnership with Aventis in place - and the funding it provides - we can advance these compounds into well-designed proof-of-concept studies. This decision will have little impact on our burn rate over the next six months, but is expected to result in some increase in our burn rate in our fiscal year ending June 30, 2005."

ImmunoGen's TAP technology uses a tumor-targeting antibody to deliver a highly potent cell-killing agent specifically to cancer cells. In addition to cantuzumab mertansine and huN901-DM1, two partner-developed TAP compounds have advanced into clinical testing.

Cantuzumab Mertansine

ImmunoGen developed cantuzumab mertansine for the treatment of cancers that express CanAg, such as colon, pancreatic, gastric, other abdominal cancers, and many non-small-cell lung cancers. Cantuzumab mertansine is composed of ImmunoGen's huC242 antibody, to target the compound to CanAg-positive cancer cells, and DM1, to kill the targeted cancer cells. ImmunoGen developed the potent cell-killing agent DM1 specifically for antibody-guided delivery to cancer cells.

In Phase I studies cantuzumab mertansine was found to be well tolerated, evidence of anticancer activity was reported, and essential dosing information was obtained. The next step is for the compound to be evaluated in patients with specific types of CanAg-expressing cancers in Phase II trials. Initiation of cantuzumab mertansine proof-of-concept trials requires production of clinical materials. Due to the time required for the various steps in the production process (e.g., antibody production and release; release of final conjugated product), patient dosing is expected to begin in 12 to 18 months. During this time, ImmunoGen will finalize its study plans, reconfirm that the compound's formulation is optimized, and complete protocol development and study center preparation.

huN901-DM1

huN901-DM1 is composed of ImmunoGen's huN901 antibody, which targets CD56, and DM1. This compound was developed by ImmunoGen for the treatment of CD56-expressing cancers such as small-cell lung cancer and cancers of neuroendocrine origin. CD56 also is expressed in multiple myeloma and acute myeloid leukemia malignancies.

In May 2000 ImmunoGen licensed to British Biotech the rights to develop and commercialize huN901-DM1 for Europe and Japan; British Biotech also was responsible for developing the product for marketing approval in the U.S. In 2003, British Biotech merged with RiboTargets, Ltd. and the combined entity subsequently merged with Vernalis Group plc to become Vernalis plc. As a result of these changes, ImmunoGen and Vernalis have renegotiated their agreement on huN901-DM1. ImmunoGen will take over future development of the compound. Vernalis, which has agreed to relinquish its rights to the product, will complete the U.K. Phase I clinical study of huN901-DM1 currently underway and will continue the U.S. Phase I/II study until June 30, 2004. If the U.S. Phase I/II study is not completed as of that date, ImmunoGen will assume responsibility for it.

ImmunoGen is preparing to initiate its own huN901-DM1 proof-of-concept study in the U.S. The Company intends to study the compound in CD56-expressing hematologic malignancies (multiple myeloma and/or acute myeloid leukemia) as strong interest has been expressed by clinicians to test the compound in these cancers. Study initiation is expected in 2004.

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