UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
-------------------
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): December 4, 1997
IMCLONE SYSTEMS INCORPORATED
(Exact Name of Registrant as Specified in its Charter)
Delaware 0-19612 04-2834797
(State or other Jurisdiction (Commission (IRS Employer Identification
of Incorporation) File Number) Number)
180 Varick Street, New York, New York 10014
(Address of Principal Executive Offices) (Zip Code)
(212) 645-1405
Registrant's telephone number, including area code
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ITEM 5. OTHER EVENTS
On December 4, 1997, ImClone Systems Incorporated ("ImClone") and Merck
KGaA, Darmstadt, Germany announced that the two companies are signing a
co-marketing agreement for BEC2, ImClone's therapeutic cancer vaccine. The
agreement amends and expands their 1990 agreement for the development and
marketing of BEC2. Under the terms of the agreement, Merck KGaA and ImClone will
continue to develop BEC2 for the U.S. and international markets with the intent
upon registration of establishing separate ethical oncology sales forces for the
co-marketing of BEC2 in North America. Merck KGaA will continue to hold an
exclusive royalty bearing license to market BEC2 outside North America. Merck
KGaA will also be responsible for funding the clinical development of BEC2
worldwide for a single indication, expenses for which had earlier been shared by
the parties. It is the intent of the parties that ImClone will be the
manufacturer of the product worldwide. The agreement calls for $15 million in
milestone fees beyond those previously established under the 1990 agreement. In
addition, Merck KGaA has agreed to purchase immediately $40 million of ImClone
convertible preferred stock. In the first two years, up to one-quarter of the
total preferred stock may be converted into ImClone common stock at a price of
$12.50 per share. In subsequent years, Merck KGaA has the option to convert
additional preferred shares at varying prices related to the then market price
of ImClone common stock.
The amendment modifies the 1990 Research and License Agreement between
ImClone and Merck KGaA to develop therapeutic cancer vaccines, including BEC2,
for the use in small cell lung carcinoma and malignant melanoma. In May 1996,
ImClone announced the extension and modification of the collaboration including
additional license fees and milestone payments. BEC2 is a proprietary
anti-idiotypic monoclonal antibody designed to mimic GD3, a glycolipid
(ganglioside) antigen which is found on the surface of a number of tumor cells,
including small cell lung cancer (SCLC), melanoma and a variety of soft tissue
sarcomas. BEC2 is intended to elicit a cancer-fighting immune response in
patients with these tumor cells.
On May 19, 1997, at the 33rd American Society of Clinical Oncology Annual
Meeting, ImClone and Merck KGaA reported data from its pilot study investigating
the effects of BEC2 treatment among 15 patients with small cell lung cancer. The
data from the study conducted at Memorial Sloan-Kettering Cancer Center (MSKCC)
in New York supports previously reported clinical results that the compound
significantly increased survival for patients with small cell lung cancer.
Except for the historical information contained herein, the matters
discussed herein include forward-looking statements. Actual results may differ
materially from those predicted in such forward-looking statements due to the
risks and uncertainties inherent in ImClone's business, including, without
limitation, risks and uncertainties in obtaining and maintaining regulatory
approval, market acceptance of and continuing demand for ImClone's products, the
impact of competitive products and pricing, and ImClone's ability to obtain
additional financing to support its operations and achieve its objectives.
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SIGNATURES
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 thereunto duly authorized.
IMCLONE SYSTEMS INCORPORATED
Date: December 9, 1997 By:/s/ John B. Landes
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John B. Landes
Vice President,
Business Development
and General Counsel
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