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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 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): February 9, 1999
ENTREMED, INC.
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(Exact name of issuer as specified in charter)
Delaware 0-26713 58-1959440
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(State or other jurisdiction (Commission File Number) (I.R.S. Employer
of incorporation) Identification No.)
Suite 200
9610 Medical Center Drive
Rockville, Maryland
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(Address of principal executive offices)
20850
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(Zip code)
(301) 217-9858
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(Registrant's telephone number, including area code)
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Item 5. Other Events
On February 9, 1999, EntreMed, Inc. ("EntreMed") and Bristol-Myers
Squibb Company ("BMS") agreed to modify the research agreement between the two
companies regarding Angiostatin(R) protein, an antiangiogenic molecule under
study as a potential cancer therapy. Such modifications include the following:
1. EntreMed will assume all responsibility (financial and operational)
for preclinical, pharmaceutical development and clinical work on Angiostatin(R)
protein. BMS has agreed to provide EntreMed with advice on structuring its
clinical program but otherwise will have no direct involvement with the
development of the Angiostatin(R) protein.
2. Upon completion of Phase II proof of principle trial(s) (safety and
efficacy) of Angiostatin(R) protein, except as described below, BMS will have
the option to review all of EntreMed's data and exercise an option to reacquire
further development and marketing rights to the product. If it does so, it will
pay EntreMed a $1 million option exercise fee and the financial terms applicable
to commercialization will remain the same as those in the existing research
agreement, except that EntreMed's worldwide royalty will be substantially
increased and will not be subject to any offsets.
3. If a third party wishes to step into BMS's former position (i.e.,
fund and/or conduct development of Angiostatin(R) protein and commercialize it
upon approval) on terms satisfactory to EntreMed or EntreMed decides to proceed
with the development and/or commercialization of Angiostatin(R) protein without
a corporate partner, in either case prior to the occurrence of proof of
principle and BMS's exercise of its option, BMS's option will be terminated
effective with the signing of EntreMed's deal with such third party or its
giving of written notice to BMS that it intends to proceed without a corporate
partner.
4. BMS's current rights of first offer/refusal with respect to products
or technology arising out of EntreMed's agreement with Children's Hospital has
terminated, including those rights with respect to Endostatin(TM).
5. BMS will be licensed, on a royalty free basis, to conduct further
internal research with regard to the Angiostatin(R) protein and will exchange
with EntreMed any data it obtains on the Angiostatin(R) molecule per se. This
license will continue for a minimum of one year and thereafter until the
termination of BMS's option as described above.
6. BMS will retain its equity interest in EntreMed but has agreed to
certain restrictions on its ability to sell its interest. These restrictions
will prevent BMS from selling its full interest in EntreMed until at least
December 1, 2001, without EntreMed's consent.
7. The semi-annual research support payment due June 5, 1999 to
EntreMed from BMS will be prorated to cover the period from June 5 to August 9,
1999 and will be the final research payment under the agreement. All patent and
related costs incurred by EntreMed prior to August 9, 1999 will be reimbursed to
EntreMed by BMS.
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On February 9, 1999, EntreMed and BMS issued a joint press release
relating to the foregoing modifications, a copy of which is included as an
exhibit to this report.
Item 7. Financial Statements, Pro Forma Financial Information and Exhibits
(c) Exhibits
99.1 Text of Press Release, dated February 9, 1999.
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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 hereunto duly authorized.
ENTREMED, INC.
(Registrant)
/s/ John W. Holaday
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John W. Holaday, Ph.D.
President and Chief Executive Officer
Date: February 11, 1999
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EXHIBIT INDEX
Exhibit No. Description Sequential Page No.
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99.1 Text of Press Release,
dated February 9, 1999
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Exhibit 99.1
EntreMed Logo
EntreMed, Inc.
9610 Medical Center Drive
Suite 200
Rockville, MD 20850
301.217.9858
fax 301.217.9594
(BW) (MD-ENTREMED) (ENMD) Bristol-Myers Squibb and EntreMed Modify
Research Agreement
Health & Medical Writers
PRINCETON, N.J. and ROCKVILLE, Md.--(BW HealthWire)--Feb. 9,
1999--Bristol-Myers Squibb Company (NYSE:BMY) and EntreMed Inc. (NASDAQ:ENMD)
announced today a modification of the research agreement between the two
companies regarding Angiostatin(R) protein, an antiangiogenic molecule under
study as a potential cancer therapy.
Under the new terms, EntreMed will assume immediately from
Bristol-Myers Squibb responsibility for all future preclinical and clinical work
on the Angiostatin molecule. Bristol-Myers Squibb will have the option to
reassume development and marketing rights for Angiostatin protein once clinical
proof of principal has been demonstrated.
"At this time, Angiostatin protein in its present form does not meet
our criteria for molecules that advance to clinical trials," said Robert A.
Kramer, Ph.D., vice president, Oncology Drug Discovery for Bristol-Myers Squibb.
"We have chosen to direct our resources to other programs in our broad oncology
pipeline. We continue, however, to view antiangiogenesis as an important and
viable target in the spectrum of oncology research. Our internal discovery
programs that cover a range of antiangiogenesis targets will continue at full
strength."
Dr. John W. Holaday, chairman, president, and chief executive officer
of EntreMed, stated, "EntreMed has been working on a parallel track with BMS for
the production of Angiostatin protein since 1995 using the Pichia pastoris yeast
recombinant expression system. EntreMed currently uses the Pichia pastoris yeast
expression system for GMP production of Endostatin(TM) protein. EntreMed's
development plan for Angiostatin will include scale-up GMP manufacturing of the
protein for clinical trials and submission of an Investigational New Drug (IND)
application this year."
Currently, Bristol-Myers Squibb continues and extensive program to
discover and develop antiangiogenic small molecules. Additionally, Bristol-Myers
Squibb has a broad portfolio of discovery and development programs that
encompass most major oncology targets.
Among these are oncogene signaling pathways and the development of
cancer vaccines, matrix metalloproteinase inhibitors, second-generation
taxane-like molecules, novel chemotherapeutic agents, and hormonal therapies.
Bristol-Myers Squibb is a diversified worldwide health and personal
care company whose principal businesses are pharmaceuticals, consumer products,
nutritionals, and medical devices. It is a leading maker of innovative therapies
for cardiovascular, metabolic and infectious diseases, central nervous system
and dermatological disorders, and cancer.
The Company is a leader in consumer medicines, orthopaedic devices,
ostomy care, wound management, nutritional supplements, infant formulas, and
hair and skin care products.
Rockville based EntreMed Inc., The Angiogenesis Company(TM), is a
leader in the field of antiangiogenesis research, which involves the
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inhibition of abnormal blood vessel growth recently associated with a broad
range of diseases.
The Company's strategy is to accelerate development of its core
technologies through collaborations and sponsored research programs with
university medical departments, research companies and government laboratories.
For further information, please visit the EntreMed web site at www.entremed.com.
Statements herein regarding EntreMed that are not descriptions of
historical facts are forward-looking and subject to risk and uncertainties.
Actual results could differ materially from those currently anticipated
due to a number of factors, including those set forth in the Company's
Securities and Exchange commission filings under "Risk Factors," including risks
relating to the early stage of products under development; uncertainties
relating to clinical trials; dependence on third parties; future capital needs;
and risks relating to the commercialization, if any, of the Company's proposed
products (such as marketing, safety, regulatory, patent, product liability,
supply, competition and other risks).
CONTACT: Bristol Myers Squibb
Peggy Ballman
609/818-3015
or
EntreMed Inc.
Mary P. Sundeen
301/738-2490
