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
Date of Report (Date of earliest event reported): February 17, 2000
EMISPHERE TECHNOLOGIES, INC.
(Exact name of registrant as specified in its charter)
Delaware 1-10615 13-3306985
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(State or other (Commission (IRS Employer
jurisdiction of File No.) Identification No.)
incorporation)
765 Old Saw Mill River Road, Tarrytown, New York 10591
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (914) 347-2220
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Item 5. Other Events.
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On February 17, 2000, Emisphere Technologies, Inc. (the "Company")
announced that Novartis Pharma AG ("Novartis") agreed to execute its option to
acquire an exclusive license to develop and commercialize oral calcitonin, a
drug used in the treatment of osteoporosis.
Attached as Exhibit 99.1 and incorporated herein by reference is the
Company's press release, dated February 17, 2000.
Item 7. Financial Statements and Exhibits.
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(c) Exhibits:
Exhibit number Description of Exhibit
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99.1 Press release dated February 17, 2000
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Signatures
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Pursuant to the requirements of the Securities Exchange Act of 1934, as
amended, the Registrant has duly caused this report to be signed on its behalf
by the undersigned thereunto duly authorized.
Date: February 17, 2000
EMISPHERE TECHNOLOGIES, INC.
/s/ Charles H. Abdalian
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Name: Chalres H. Abdalian, Jr.
Title: Vice President, Chief Finaicial
Officer and Secretary
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EXHIBIT INDEX
Exhibit number Description of Exhibit
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99.1 Press Releases dated February 17, 2000
Exhibit 99.1
Emisphere Technologies, Inc.
Charles H. Abdalian, Jr.
Chief Financial Officer
(914) 785-4763
or
Morgen-Walke Associates, Inc
Investor Relations: Jill Meleski
Press Contact: Gregory Tiberend
(212) 850-5600
NOT FOR IMMEDIATE RELEASE
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NOVARTIS PHARMA AG AND EMISPHERE TECHNOLOGIES AGREE TO EXECUTE
ORAL CALCITONIN LICENSE AGREEMENT
Tarrytown, NY, FEBRUARY 17, 2000 --- Emisphere Technologies, Inc. (NASDAQ: EMIS)
today announced that Novartis had agreed to execute its option to acquire an
exclusive license to develop and commercialize oral calcitonin, a drug used for
the treatment of osteoporosis. Oral calcitonin will utilize Emisphere's
proprietary drug delivery technology. The license agreement follows the
successful completion of a two-year feasibility program culminating with a human
study.
Under the terms of the agreement, Emisphere will receive royalties on product
sales, an up-front fee and potential milestone payments. In exchange, Novartis
will receive exclusive worldwide rights to develop and to commercialize, in
conjunction with Emisphere, oral salmon calcitonin. Novartis will be responsible
for clinical development, marketing, and commercialization.
"Oral calcitonin will be an important addition to our development portfolio. We
are excited about the opportunity to have Novartis, a world leading developer of
pharmaceuticals, commercializing an oral protein product using our technology.
An oral calcitonin would have an immediate impact on the quality of life for
patients worldwide who currently use this drug in the treatment of osteoporosis.
This license agreement demonstrates Novartis'continued commitment to Emisphere's
oral drug delivery approach," said Lewis H. Bender, Senior Vice President,
Business Development at Emisphere.
The Novartis and Emisphere research collaboration began in 1997. A Phase I study
in healthy human subjects was conducted by Novartis in the fall of 1999.
Recently released study results indicated that therapeutic blood levels of
salmon calcitonin were achieved using a solid dosage formulation.
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Michael M. Goldberg, M.D., Chairman and Chief Executive Officer of Emisphere
Technologies commented, "We are excited to be working with Novartis and pleased
that they have committed to the clinical development of our first oral protein
product. This license further validates our technology platform for oral
macromolecule delivery."
Salmon calcitonin is a synthetic version of a natural hormone that inhibits bone
resorption. It is traditionally administrated as an injection or nasal spray.
Calcitonin is used in the treatment of osteoporosis, which is a disease that
causes bones to become fragile and, as a result, more likely to break.
Osteporosis affects more than 28 million people in the United States and over
200 million people world wide, with a higher incidence in women. Annual
worldwide sales of salmon calcitonin are estimated to be in excess of $800
million.
Emisphere Technologies, Inc. is a biopharmaceutical company specializing in the
oral delivery of therapeutic macromolecules and other compounds that are not
currently deliverable by oral means. The Company has two drugs, including
calcitonin, in human clinical trials using its unique carrier technology and, in
addition to Novartis, has strategic alliances and ongoing feasibility studies
with several pharmaceutical and biotechnology companies, including Eli Lilly &
Co. Further information about Emisphere can be found at www.emisphere.com.
The statements in this release and oral statements made by representatives of
the Company relating to matters that are not historical facts (including without
limitation those regarding the timing or potential outcomes of clinical trials
and any market that might develop for any of the Company's product candidates)
are forward-looking statements that involve risks and uncertainties, including,
but not limited to, the likelihood that any product in the research pipeline can
receive regulatory approval in the United States or abroad, the ability of
Emisphere and/or its partners to develop, manufacture and commercialize products
using the Company's drug delivery technology, Emisphere's ability to fund such
efforts with or without partners, and other risks and uncertainties detailed in
the Company's Securities and Exchange Commission filings.
