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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
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Date of Report: November 23, 1998
ERGO SCIENCE CORPORATION
(Exact name of registrant as specified in its charter)
Delaware 0-24936 04-3271667
(State or other jurisdiction of (Commission (I.R.S. Employer
incorporation or organization) File Number) Identification Number)
Charlestown Navy Yard
100 First Avenue, Fourth Floor
Charlestown, Massachusetts 02129
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (617) 241-6800
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(Former name or former address, if changed since last report)
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ITEM 5. Other Events
On November 23, 1998, Ergo Science Corporation (the "Company") publicly
disseminated a press release announcing that it had received a letter from
the Division of Metabolic and Endocrine Drug Products at the U.S. Food and
Drug Administration that its New Drug Application for ERGOSET-Registered
Trademark- tablets for the treatment of Type 2 diabetes is not approvable,
citing the overall benefit to risk ratio.
Reference is made to the Company's press release dated November 23, 1998
filed as Exhibit 99.1 hereto and incorporated by reference herein.
ITEM 7. Financial Statements, Proforma Financial Information and Exhibits
(a) Financial Statements
None.
(b) Proforma Financial Information
None.
(c) Exhibits
99.1 Press Release dated November 23, 1998
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) 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.
ERGO SCIENCE CORPORATION
By: /s/ Francis M. Ferrara, Jr.
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Francis M. Ferrara, Jr.
Controller (principal accounting officer)
Date: December 1, 1998
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Exhibit 99.1
For Immediate Release
ERGO SCIENCE ANNOUNCES DECISION FROM FDA ON TYPE 2 DIABETES PRODUCT
Contact: Lisa V. DeScenza
Corporate Communications &
Investor Relations Specialist
(617) 241-6824 (Direct Line) [email protected] (E-Mail)
(617) 241-8822 (Fax) http://www.ergo.com (Web Site)
BOSTON, November 23, 1998 - Ergo Science Corporation (Nasdaq: ERGO)
today announced that it has received a letter from the Division of Metabolic
and Endocrine Drug Products at the U.S. Food and Drug Administration (FDA)
that its New Drug Application for ERGOSET-Registered Trademark- tablets for
the treatment of Type 2 diabetes is not approvable, citing the overall
benefit to risk ratio.
In response to the announcement, Ronald H. Abrahams, Ph.D., Chairman
and Chief Executive Officer of Ergo Science stated, "We are disappointed with
the letter from the Division and disagree with their position. We continue to
believe that the data demonstrate that ERGOSET-Registered Trademark- tablets
are safe and effective and, therefore, approvable, in accordance with FDA
regulations and our previous understandings with the Division. During the
next several weeks, we will be evaluating our options with respect to the
letter from the Division, including the possibility of appealing the letter
within the Center for Drug Evaluation and Research."
At September 30, 1998, Ergo Science reported $37M in cash, cash
equivalents and short-term investments.
Ergo Science Background
Ergo Science Corporation is a biopharmaceutical company developing
novel treatments for metabolic and immune system disorders.
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This discussion contains forward-looking statements. Forward-looking
statements reflect Ergo Science's current views with respect to future
events. Actual results may vary materially and adversely from those
anticipated, believed, assumed, estimated or otherwise indicated. Important
factors that could cause actual results to differ materially include, without
limitation, (1) there can be no assurance that ERGOSET-Registered Trademark-
tablets will receive approval from FDA or that Ergo Science will be able to
submit clinical trial results in the future that will produce an approval by
the FDA of ERGOSET-Registered Trademark- tablets, (2) there can be no
assurance that Ergo Science will have sufficient capital to complete any
additional trials undertaken, (3) data obtained from clinical trials are
subject to varying interpretations, and there can be no assurance that the
FDA (or an FDA panel of experts) will agree with Ergo Science's assessment of
future clinical trial results, (4) uncertainty related to the scientific
development of a new medical therapy, (5) competition in the anti-diabetic
and anti-obesity markets is intense; other products have been
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recently approved for these indications and other companies are developing
competing products, (6) the need for additional funding, (7) there can be no
assurance that Ergo Science's formulation of bromocriptine mesylate, if approved
for commercial marketing, will be successful in the marketplace, or that Ergo
Science will receive any profits from its sale, (8) if approved for commercial
marketing, Johnson & Johnson, and not Ergo Science, is responsible for
manufacturing and the timing and implementation of marketing Ergo Science's
formulation of bromocriptine mesylate (9) there can be no assurance that Ergo
Science will achieve any of the objectives required for milestone payments by
Johnson & Johnson, (10) Johnson & Johnson has the right to terminate the
collaboration at any time subject to the possibility of paying penalties in
certain circumstances, and (11) the uncertainty relating to patent protection in
the pharmaceutical and biotechnology industries. Further information and
additional important factors are set forth in reports and other filings of Ergo
Science with the Securities and Exchange Commission, including, without
limitation, the 1997 Annual Report on Form 10-K, generally under the section
entitled "Risk Factors." Ergo Science does not undertake to update any
forward-looking statement that may be made from time to time by or on behalf of
Ergo Science.
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