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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C.20549
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FORM 8-K
CURRENT REPORT
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PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
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Date of Report (Date of earliest event reported): May 5, 2000
IMMUNOGEN, INC.
(Exact name of registrant as specified in its Charter)
Massachusetts 0-17999 04-2726691
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(State or Other Jurisdiction (Commission (IRS Employer
of Incorporation File Number) Identification No.)
333 Providence Highway, Norwood, Massachusetts 02062
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (781) 769-4242
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ITEM 5. OTHER EVENTS
On May 4, 2000, ImmunoGen, Inc. and British Biotech plc announced a license
agreement to develop and commercialize ImmunoGen's huN901-DM1 tumor- activated
prodrug (TAP) for treatment of small-cell lung cancer (SCLC). British Biotech
has been granted the exclusive right to develop and commercialize huN901-DM1 in
the European Union and Japan. ImmunoGen retains the rights to commercialize
huN901-DM1 in the United States and the rest of the world, as well as the right
to manufacture the product worldwide. British Biotech paid an upfront fee of
$1.5 million for its territorial rights. Under the agreement, British Biotech is
responsible for conducting the clinical trials necessary to achieve regulatory
approval in the US, EU and Japan. ImmunoGen is responsible for the remaining
preclinical development, and will be reimbursed for manufacturing the product
for clinical trials. It is anticipated that a Phase I clinical trial will start
in the fourth quarter of this year. Upon regulatory approval of the product for
marketing in the US, ImmunoGen will pay British Biotech a one-time milestone
payment. ImmunoGen will receive royalties on sales of huN901-DM1 in the EU and
Japan.
The press release announcing the exclusive license agreement is incorporated
herein by reference and filed as exhibit 99.1 hereto.
ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS
(C) Exhibits.
99.1 The Registrant's Press Release dated May 5, 2000.
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned hereto duly authorized.
ImmunoGen, Inc.
(Registrant)
Date: May 5, 2000 /s/Kathleen A. Carroll
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Kathleen A. Carroll
Vice President, Finance and
Administration, and principal
financial officer
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EXHIBIT INDEX
Exhibit Sequential
Number Description Page Number(s)
99.1 The Registrant's Press Release
dated May 5, 2000 5
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Exhibit 99.1
CONTACT: Mitchel Sayare, Ph.D.
Chairman and CEO
ImmunoGen, Inc.
(781) 769-4242
www.immunogen.com
FOR IMMEDIATE RELEASE
ImmunoGen, Inc. and British Biotech plc Enter Collaboration to Develop and
Commercialize huN901-DM1 for the Treatment of Small-Cell Lung Cancer
CAMBRIDGE, MA and OXFORD, England, May 5, 2000 - ImmunoGen, Inc. (Nasdaq:
IMGN) and British Biotech plc (LSE: BBG) today announced a license
agreement to develop and commercialize ImmunoGen's huN901-DM1
tumor-activated prodrug (TAP) for treatment of small-cell lung cancer
(SCLC).
British Biotech has been granted the exclusive right to develop and
commercialize huN901-DM1 in the European Union and Japan. ImmunoGen retains
the rights to commercialize huN901-DM1 in the United States and the rest of
the world, as well as the right to manufacture the product worldwide.
British Biotech paid an upfront fee of $1.5 million for its territorial
rights.
Under the agreement, British Biotech is responsible for conducting the
clinical trials necessary to achieve regulatory approval in the US, EU and
Japan. ImmunoGen is responsible for the remaining preclinical development,
and will be reimbursed for manufacturing the product for clinical trials.
It is anticipated that a Phase I clinical trial will start in the fourth
quarter of this year. Upon regulatory approval of the product for marketing
in the US, ImmunoGen will pay British Biotech a one-time milestone payment.
ImmunoGen will receive royalties on sales of huN901-DM1 in the EU and
Japan.
"This innovative collaboration allows us to benefit from British Biotech's
clinical development capabilities while retaining rights in the US," said
Mitchel Sayare, Ph.D., Chairman and CEO of ImmunoGen, Inc. "We look forward
to collaborating with British Biotech, one of only a few companies who have
experience in conducting clinical trials in SCLC. We believe their unique
experience in this disease, coupled with their enthusiasm for this product,
will enable us to aggressively advance the development of huN901-DM1 to the
marketplace."
Dr. Elliot Goldstein, Chief Executive of British Biotech, commented, "This
collaboration broadens our approach to the treatment of cancer beyond the
area of metalloenzyme inhibition. Innovative deal terms, combined with our
clinical development and regulatory capabilities, have enabled us to obtain
the commercialization rights to a novel anti-cancer agent in Europe and
Japan. We are delighted to be working with ImmunoGen to undertake the
worldwide development of huN901-DM1."
huN901-DM1 is a tumor-activated prodrug consisting of a humanized
monoclonal antibody (huN901) targeting SCLC cells, coupled with a highly
potent cytotoxic agent (DM1), a maytansine derivative. In preclinical
studies, huN901-DM1 eradicated SCLC tumors. In the same studies, cisplatin
and etoposide, drugs used in current SCLC treatment, produced only
temporary interruption of tumor growth.
SCLC accounts for approximately 25% of all lung cancer cases. Currently,
there are few treatment options for patients who have relapsed or are
refractory to chemotherapy. Median survival for such patients is less than
a year.
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 most advanced TAP, huC242-DM1/SB-408075,
designed to treat colorectal and pancreatic cancer, has been licensed to
SmithKline Beecham and is in a Phase I/II human clinical study. In addition
to its maytansinoid platform of TAPs, the Company is working on other
proprietary TAP platforms comprising agents, such as taxanes, which exert
cell-killing activity via different mechanisms of action.
British Biotech is a development-stage pharmaceutical company which is
building a portfolio of products for the treatment of cancer, infection and
inflammation. These opportunities will be generated from in-house research
and development and by acquisition from, and collaboration with, outside
parties. British Biotech currently has four products in development. Its
lead product, marimastat, a matrix metalloproteinase inhibitor, is in Phase
III development for the treatment of cancer and has been licensed worldwide
to Schering Plough Corporation except for Japan and the Far East where it
has been licensed to Tanabe Seiyaku Co., Ltd.
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 ability to secure future funding; 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.
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