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): June 3, 1997
IMCLONE SYSTEMS INCORPORATED
(Exact Name of Registrant as Specified in its Charter)
Delaware 0-19612 04-2834797
(State or other Jurisdiction (Commission File (IRS Employer Identification
of Incorporation) 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 June 3, 1997, ImClone Systems Incorporated ("ImClone" or the "Company")
announced that it has received a milestone payment of $500,000 from corporate
partner Merck KGaA. This payment results from the achievement of a pilot-scale
manufacturing run for BEC-2, ImClone's lead therapeutic compound for the
treatment of small cell lung cancer. This achievement also triggers the first in
a series of eight quarterly support payments, which will total $4.7 million. The
meeting of further milestones attached to the development and registration of
the product worldwide can result in additional payments to ImClone totaling $6.5
million.
On May 19, 1997, at the 33rd American Society of Clinical Oncology annual
meeting, ImClone reported data from its pilot study investigating the effects of
BEC-2 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. Based on these
findings pivotal Phase III multi-national clinical trials for BEC-2 are intended
to be initiated in the fourth quarter of this year.
Under the terms of the collaboration with Merck for BEC-2, ImClone will
retain marketing rights in North America, and Merck has the marketing rights for
all therapeutic indications outside North America. ImClone will also be entitled
to royalty payments based upon all product sales outside of North America. In
addition, Merck is responsible for 60 percent of the development costs in the
United States, Europe, Australia and New Zealand and 100 percent of the
development costs in all other territories. It is the intent of the parties that
ImClone be the manufacturer of the product Worldwide.
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 the Company's business, including, without
limitation, risks and uncertainties in obtaining and maintaining regulatory
approval, market acceptance of and continuing demand for the Company's products,
the impact of competitive products and pricing, and the Company's ability to
obtain additional financing to support its operations.
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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: June 6, 1997 /s/John B. Landes
John B. Landes
Vice President,
Business Development
and General Counsel
