News

CAMBRIDGE, Mass., Aug 08, 2002 /PRNewsire-FirstCall via Comtex/ -- ImmunoGen, Inc. (Nasdaq: IMGN) today announced financial results for the three and twelve months ended June 30, 2002. For the three-month period, the Company reported a net loss of $4.4 million, or $0.11 per basic and diluted share, compared to a net loss of $3.3 million, or $0.09 per basic and diluted share, in the same quarter last year. For the twelve month period ended June 30, 2002, the Company reported a net loss of $14.6 million, or $0.37 per basic and diluted share, compared to a net loss before the cumulative effect of a change in accounting principle of $9.6 million, or $0.26 per basic and diluted share, in the same period last year. The net loss for the twelve months ended June 30, 2001 reflects the Company's adoption of Staff Accounting Bulletin No. 101, "Revenue Recognition in Financial Statements," retroactive to July 1, 2000, which resulted in a cumulative effect of a change in accounting principle charge of $5.7 million, or $0.16 per share. Net loss including the cumulative effect of a change in accounting principle for the twelve months ended June 30, 2001 was $15.3 million or $0.42 per basic and diluted share.

Revenue for the twelve months ended June 30, 2002 was $5.9 million as compared to revenue of $4.5 million for the same period last year. Revenues for the fiscal year included $1.7 million of previously deferred revenue related to payments made pursuant to existing collaborative agreements as well as payments associated with a new collaboration with Boehringer Ingelheim.

Also included in revenues for the twelve-month period ended June 30, 2002 was $3.5 million of clinical material reimbursements related to the manufacture of clinical material under certain collaboration agreements.

Total operating expenses for the fiscal year ended June 30, 2002 were $26.4 million as compared to $20.3 million last year. Included in total operating expenses for the twelve-month period ended June 30, 2002 was research and development expense totaling $17.7 million, as compared to research and development expense of $15.2 million last year. Included in research and development expense for the twelve months ended June 30, 2002 are costs associated with the development of the internal product pipeline, support of the collaborators and charges recorded in the third quarter related to valuation allowances the Company established to record inventory and prepaid assets at their estimated realizable value. The increase in total operating expenses also included $3.3 million of costs related to clinical materials made on behalf of the collaborators as compared to $0.6 million for the fiscal year ended June 30, 2001.

As of June 30, 2002, ImmunoGen had approximately $137.8 million in cash, cash equivalents and marketable securities.

Mitchel Sayare, Ph.D., Chairman and CEO, commented, "In recent months, we have made important announcements about cantuzumab mertansine - a Tumor- Activated Prodrug (TAP) product being studied in colorectal, pancreatic and certain non-small-cell lung cancers - and our relationship with GlaxoSmithKline. In three Phase I studies, cantuzumab mertansine has been found to be well tolerated and we've been able to collect important information on dosing schedules. The product has also shown evidence of biological activity. The next step for cantuzumab mertansine is to advance it into Phase II. Depending upon the outcome of our ongoing negotiations with GlaxoSmithKline, we will either bring this product to Phase II with GlaxoSmithKline, or we will move it forward ourselves or with the help of a future partner."

Dr. Sayare continued, "In addition to our work on cantuzumab mertansine, a lot of progress has been made on other programs. Earlier today, we announced that British Biotech has initiated the planned second Phase I trial for huN901-DM1/BB-10901, which is being studied for the treatment of small-cell lung cancer and other cancers of neuroendocrine origin. This study evaluates a different dosing schedule - dosing the product daily for three days - than the study currently underway in the U.S. to determine the best dosing regimen for use in efficacy studies with the product. In addition to achievements with our clinical-stage products, there are important activities underway at our partners related to their programs. For example, Trastuzumab-DM1 is in preclinical studies at Genentech. We have made excellent progress on our own pipeline products and recently presented important data on our highly potent, proprietary taxane derivatives that are available for use with our own or partners' antibodies."

Update on Cantuzumab Mertansine

Data from all three cantuzumab mertansine Phase I studies have now been presented. In aggregate, the Phase I program for cantuzumab mertansine found the product to be well tolerated and identified its maximum tolerated dose under different dosing schedules. While Phase I studies are not designed to assess efficacy, evidence of biological activity has been reported for the product.

In late June 2002, ImmunoGen announced that GlaxoSmithKline had elected not to advance cantuzumab mertansine into Phase II under the present terms of the license agreement. The announcement noted that ImmunoGen plans to renegotiate the agreement with GlaxoSmithKline. Should ImmunoGen determine that it is not in the Company's best interests to enter into a revised agreement with GlaxoSmithKline, rights to the product would be returned to ImmunoGen and the Company would be free to develop and re-license the product as the Company considers most appropriate. ImmunoGen owns the IND for cantuzumab mertansine and has rights to the data from the clinical studies conducted.

Cantuzumab mertansine is a TAP product created by conjugating the cytotoxic agent DM1 with the humanized monoclonal antibody C242. The huC242 antibody targets the CanAg receptor found on the surface of a number of types of cancer cells, including colorectal, pancreatic, gastric, and certain non- small-cell lung cancers. In early 1999, the Company licensed development and commercialization rights for cantuzumab mertansine to SmithKline Beecham.

Update on huN901-DM1/BB-10901

The first clinical data on huN901-DM1/BB-10901 were presented at the 2002 Annual Meeting of the American Society of Clinical Oncology (ASCO). The presentation included data on the product's pharmacokinetics and tolerability; initial evidence of biological activity was also presented. Subsequent to the ASCO meeting, the dose level under evaluation has been increased to 75 mg/m2 per week.

Earlier today, ImmunoGen and British Biotech announced the initiation of a second Phase I study of huN901-DM1/BB-10901 in which the product will be dosed daily for three successive days followed by an eighteen-day follow-up period. The study is being conducted in the United Kingdom by leading cancer clinicians and is expected to be completed by mid-2003, although such timing is dependent on the rate of patient recruitment and the extent of dose escalation.

huN901-DM1/BB-10901 is a TAP product in development for the treatment of small-cell lung cancer and other cancers of neuroendocrine origin. British Biotech acquired rights to develop and commercialize the product for Europe and Japan under an agreement with ImmunoGen entered into in May 2000. ImmunoGen retained commercialization rights for the U.S. and the rest of the world.

Update on Other ImmunoGen Programs

ImmunoGen continues to make progress with other programs in the Company's pipeline, including huMy9-6-DM1 and its IGF1 receptor program. The Company also continues to work with other companies - Genentech, Millennium, Boehringer Ingelheim, Abgenix - that have established partnerships with ImmunoGen related to the use of the Company's TAP technology with their antibodies.

In June 2002, the Company announced that its taxane derivatives have shown greater activity in vitro than Taxol^® (paclitaxel). The Company's derivatives were shown to be up to 55 times more potent than Taxol even with the molecular modification necessary for delivery using monoclonal antibodies. The Company's taxane derivatives also include a derivative that is over 200 times more potent than Taxol in cancer cell lines that are multi-drug resistant.

About ImmunoGen, Inc.

ImmunoGen, Inc. develops innovative biopharmaceuticals for the treatment of cancer. The Company's TAP technology couples highly potent cytotoxic agents with tumor-targeting antibodies to create effective new treatments for cancer with minimal damage to normal tissue. Two TAP products developed by ImmunoGen are in clinical trials - cantuzumab mertansine and huN901-DM1/BB-10901; the former is licensed to GlaxoSmithKline, the latter is licensed to British Biotech in certain territories. Several companies are developing TAP products comprised of ImmunoGen's TAP technology and the partner's antibody - Genentech (Trastuzumab-DM1), Millennium (MLN591DM1) and Boehringer Ingelheim (bivatuzumab mertansine). ImmunoGen also has multi-target agreements with Genentech, Abgenix, and Millennium.

This press release includes forward-looking statements based on management's current expectations. Factors that could cause future results to differ materially from such expectations include, but are not limited to: the success of the Company's research strategy; the applicability of the discoveries made therein; the difficulties inherent in the development of pharmaceuticals, including uncertainties as to the timing and results of preclinical studies; delayed achievements of milestones; reliance on collaborators; uncertainty as to whether the Company's potential products will succeed in entering human clinical trials and uncertainty as to the results of such trials; uncertainty as to whether adequate reimbursement for these products will exist from the government, private healthcare insurers and third-party payors; the uncertainties as to the extent of future government regulation of the pharmaceutical business; and other factors described in ImmunoGen's periodic filings with the Securities and Exchange Commission.

Taxol^® is a registered trademark of Bristol-Myers Squibb Company.