News

CAMBRIDGE, Mass., Nov. 8 /PRNewswire/ -- ImmunoGen, Inc. (Nasdaq: IMGN) today announced financial results for the first quarter ended September 30, 2001. For the three-month period, the Company reported a net loss of $1,593,000, or $0.04 per share, compared to a net loss before the cumulative effect of a change in accounting principle of $1,979,000, or $0.06 per share, in the same quarter last year. The net loss for the quarter ended September 30, 2000 is prior to the Company's adoption of Staff Accounting Bulletin No. 101, "Revenue Recognition in Financial Statements" (SAB 101), retroactive to July 1, 2000, which resulted in a cumulative effect of a change in accounting principle charge of $5,734,000, or $0.17 per share. Net loss including the cumulative effect of a change in accounting principle for the quarter ended September 30, 2000 was $7,713,000 or $0.23 per share.

Mitchel Sayare, Chairman and CEO commented, "The announcements of a new pre-clinical product candidate, huMy9-6-DM1 and a new class of effector molecules, taxanes, are consistent with the promises we've made to develop our internal product pipeline and demonstrate our ability to deliver on those promises. We have been able to fund this development through our financing and business development activities. We have a strong balance sheet with over $152,000,000 in cash and marketable securities, and we have five corporate partners developing TAP products. We expect that their progress will generate additional cash flow for ImmunoGen in the form of milestones and royalties."

ImmunoGen Recent Highlights

Corporate Collaborations

• ImmunoGen announced that Trastuzumab-DM1 (Herceptin^® conjugated to DM1) caused complete tumor regression in HER2 positive xenograft models in mice. In addition, Trastuzumab-DM1 demonstrated superior anti-tumor activity when compared to Herceptin (Trastuzumab) alone. Genentech, the U.S. marketer of Herceptin (Trastuzumab), is developing Trastuzumab-DM1. Genentech plans to submit an Investigational New Drug application for the product candidate to the U.S. Food and Drug Administration (FDA) in 2002.

• Raven Biotechnologies delivered the first in a series of candidate monoclonal antibodies for evaluation by ImmunoGen. Under the agreement, Raven is employing its unique platform to simultaneously discover cell surface targets and antibodies to those targets useful in the treatment of ovarian cancer. ImmunoGen has North American and European commercialization rights to any resulting products.

Product Development

• ImmunoGen introduced a new product candidate for acute myelogenous leukemia. My9-6-DM1, a tumor-activated prodrug (TAP), showed robust anti-human-tumor activity in studies conducted in mice. My9-6-DM1 is a TAP produced by linking the monoclonal antibody My9-6, which targets myeloid leukemia cells, with DM1. Complete elimination of human tumor xenografts was seen in mice treated with My9-6-DM1. No recurrence or toxicity was observed during the first 100 days of the study. The Company is humanizing the My9-6 monoclonal antibody component using its patented resurfacing technology so that development of this TAP as a therapeutic agent can begin.

• ImmunoGen reported that data from its taxane-based TAP platform showed exceptional anti-tumor activity in mice. The results demonstrated that taxane-based TAPs completely eradicated human tumor xenografts in mice at doses that were non-toxic. Histopathology results 75 days after tumor implantation showed no evidence of tumor. In comparison, doxorubicin, the "naked" antibody alone, and the combination of "naked" antibody and doxorubicin only slowed tumor growth. Taxane-based TAPs achieved these results at half the dosage level of doxorubicin at its maximum dosage level.

Clinical Trial Progress

• ImmunoGen announced very favorable safety data from the initial 27 patients enrolled in a human clinical trial of its TAP, huC242-DM1/SB-408075, which is being conducted at the University of Chicago. The study is designed to characterize the safety and pharmacokinetic profile and determine the maximum tolerated dose and dose-limiting toxicities of huC242-DM1/SB-408075 when administered weekly.

• The reported results were from patients with various forms of cancer: colorectal (18 patients), pancreatic (4 patients), unknown primary (3 patients), non-small-cell lung (1 patient) and peritoneal cancer (1 patient). Patient enrollment in the study is continuing to include a total of 48 evaluable patients. Additional patients are being dosed at 115 mg/m2 administered weekly.

• All patients treated had advanced disease refractory to standard therapy. Patients had received a median of two prior chemotherapy regimens.

• Patients were treated with huC242-DM1/SB-408075 at doses ranging from 40 mg/m2 to 138 mg/m2. The maximum tolerated dose was determined to be 115 mg/m2. Dose-limiting toxicities were fatigue and asymptomatic, reversible elevation of liver enzymes.

• Promising evidence of anti-tumor activity was observed. One patient, diagnosed with diffuse peritoneal disease and producing massive ascites, experienced complete resolution of ascites production. It was also observed that this patient had no evidence of disease progression after 42 weeks. A patient with pancreatic cancer had persistent, stable disease for 24 weeks. Another patient with advanced adenocarcinoma of unknown primary origin experienced a 66% reduction in total tumor mass after five weeks of treatment, although the disease eventually progressed.

About ImmunoGen, Inc.

ImmunoGen, Inc. develops innovative biopharmaceuticals, primarily for cancer treatment. The Company has created potent tumor-activated prodrugs, consisting of drugs coupled to monoclonal antibodies for delivery to and destruction of cancer cells. The Company has collaborative arrangements with GlaxoSmithKline, Genentech, Abgenix, Millennium Pharmaceuticals, British Biotech, MorphoSys, Avalon Pharmaceuticals, and Raven Biotechnologies.

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; and the uncertainties as to the extent of future government regulation of the pharmaceutical business.