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As filed with the Securities and Exchange Commission on March 1, 1999.
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)
MARCH 1, 1999 (FEBRUARY 25, 1999)
MEDAREX, INC.
(Exact name of registrant as specified in its charter)
NEW JERSEY 0-19312 22-2822175
(State of other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification No.)
1545 ROUTE 22 EAST, ANNANDALE, NEW JERSEY 08801-0953
(Address of Principal Executive Offices)
Registrant's telephone number, including area code: (908) 713-6001
NOT APPLICABLE
(Former name or former address, if changed since last report)
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MEDAREX, INC.
TABLE OF CONTENTS
FOR
CURRENT REPORT ON FORM 8-K
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<S> <C> <C>
Item 5. Other Events.......................................... 3
Item 7. Financial Statements and Exhibits..................... 3
Signature ...................................................... 4
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2
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ITEM 5. OTHER EVENTS.
On February 25, 1999, Medarex, Inc., a New Jersey corporation ("Medarex")
announced that it had reacquired the worldwide rights to its MDX-210 anti-HER-2
cancer product. Certain commercial rights to MDX-210 were previously held by
Ciba-Geigy, Limited, which subsequently became part of Novartis Pharma AG, which
has elected not to participate further in the development of the product. In
addition, Medarex announced certain results of Phase II trials of MDX-210 in
hormone refractory prostate cancer patients.
The press release with respect to this announcement is filed herewith as
Exhibit 99.1.
This Current Report on Form 8-K contains "forward-looking statements"
within the meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended, which represent
Medarex's expectations or beliefs concerning future events. Forward-looking
statements involve known and unknown risks and uncertainties and are indicated
by words such as "anticipates", "expects", "believes", "plans", "could" and
similar words and phrases. These risks and uncertainties include, but are not
limited to, uncertainties regarding the receipt of future payments, the
continuation of business partnerships, the progress of ongoing clinical trials,
development of new business opportunities and other risks that may be detailed
from time to time in Medarex's periodic reports and registration statements
filed with the Securities and Exchange Commission.
ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS.
(c) Exhibits. The following material is filed as an exhibit to this
Current Report on Form 8-K:
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<CAPTION>
Exhibit
Number Description of Exhibit
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<S> <C>
99.1 Press release dated February 25, 1999.
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3
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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 hereunto duly authorized.
MEDAREX, INC.
Registrant
Date: March 1, 1999 By: /s/ Michael A. Appelbaum
------------------------
Michael A. Appelbaum
Executive Vice President -
Finance and Administration,
Secretary, Treasurer and
Chief Financial Officer
4
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EXHIBIT INDEX
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<CAPTION>
Exhibit Page
Number Description Number
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99.1 Press release dated February 25, 1999.
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EXHIBIT 99.1
MEDAREX .......news release
- --------------------------------------------------------------------------------
1545 Route 22 East, P.O. Box 953 Annandale, NJ 08801 Tel. (908) 713-6001
Fax (908) 713-6002
For Immediate Release Contact:
Donald L. Drakeman Kimberly Hofman
President and CEO Middleberg + Associates
Medarex, Inc. for Media Inquiries
908-713-6001 212-888-6610 ext. 544
www.medarex.com [email protected]
--------------- ------------------
MEDAREX REACQUIRES WORLDWIDE RIGHTS
TO MDX-210 CANCER PRODUCT
ANNANDALE, NJ; FEBRUARY 25, 1999 - Medarex, Inc. (NASDAQ: MEDX) announced today
that it has reacquired the worldwide rights to its MDX-210 anti-HER2 cancer
product. Certain commercial rights to MDX-210 were previously held by Ciba-
Geigy, Limited, which subsequently became part of Novartis, which has elected
not to participate further in the development of the product.
In Phase II trials of MDX-210 in hormone refractory prostate cancer patients,
89% of the patients experienced a reduction in the rate at which their PSA
levels were rising, and 65% of the patients experienced a reduction in PSA
levels. PSA is a biochemical marker associated with disease progression and
death. In some cases, PSA levels have been reduced over 250 days.
Additionally, over a quarter of the patients evaluated for quality of life
reported a significant reduction in average pain levels following treatment.
"Several potential corporate partners have approached us about the MDX-210
product based upon the promising Phase II results announced in late 1998," said
Donald L. Drakeman, President of Medarex. "We will be exploring our partnering
options as we move MDX-210 towards Phase III trials. In the meantime, we look
forward to continuing our global licensing arrangement with Novartis involving
Medarex's HuMAb Mouse/TM/ technology."
Medarex's HuMAb-Mouse technology produces high affinity human antibodies to a
target antigen in months. Initial expectations are that, under Medarex's
arrangement with Novartis, total fees to Medarex, including technology access
fees, license fees and milestone payments, could exceed $50 million, exclusive
of royalties. Novartis' scientists have already begun use of the HuMAb-Mouse
technology and have developed an initial product candidate with an affinity of
10/10/.
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MDX-210 is a Bispecific antibody that targets the HER-2 receptor. HER-2 is a
protein found in excess on the surface of certain cancer cells, including
prostate, kidney, colon and breast. Bispecific antibodies are Target-Trigger
combinations. One arm of the Bispecific activates and guides immune system
killer cells, and the other targets the disease cells.
Patients in the Phase II trials were pre-treated with GM-CSF (granulocyte
monocyte colony stimulating factor) which increases production and
differentiation of certain white blood cells, such as granulocytes, monocytes,
macrophages, and eosinophils. This was followed by administration of the anti-
cancer Bispecific antibody MDX-210, which is designed to trigger the killing
function of immune cells against the targeted cancer cells. Results of Phase II
trials of this product were presented at the American Society of Clinical
Oncology 1998 Annual Meeting and at the 1998 International Antibody Engineering
Conference.
Medarex is a biopharmaceutical company developing monoclonal antibody-based
therapeutics to fight cancer and other life-threatening and debilitating
diseases. The Company has developed a broad platform of patented technologies
for antibody discovery and development, including the HuMAb-Mouse/TM/ system for
the creation of high-affinity human antibodies; Bispecific antibodies, which
enhance and direct the body's own immune system to fight disease; and
immunotoxin technology. Medarex has seven products in clinical development for
the treatment of cancer and leukemia, autoimmune diseases and ophthalmic
conditions. For more information about the company visit the website at
www.medarex.com.
Certain statements in this press release consist of forward-looking statements
that involve risks and uncertainties including, but not limited to,
uncertainties regarding the progress of on-going clinical trials and the
continuation of business partnerships. Actual results, events or performance
may differ materially.
