UNITED STATES
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) July 21, 1997
EMISPHERE TECHNOLOGIES, INC.
(Exact name of registrant as specified in its charter)
DELAWARE 1-10615 13-3306985
(State or jurisdiction (Commission File (I.R.S. Employer
of incorporation or Number) Identification
organization) Number)
15 Skyline Drive
Hawthorne, New York 10532
(Address of principal (Zip Code)
executive offices)
Registrant's telephone number, including area code (914) 347-2220
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
Certain statements in this Form 8-K constitute "forward-looking
statements" within the meaning of the Private Securities Litigation Reform
Act of 1995 (the "Reform Act"). Such forward-looking statements involve
known and unknown risks, uncertainties and other factors which may cause
the actual results, performance or achievements of the Company, or industry
results, to be materially different from any future results, performance,
or achievements expressed or implied by such forward-looking statements.
Such factors include, among others, the following: uncertainties related
to future test results and viability of the Company's product candidates,
which are in the early stages of development; the need to obtain regulatory
approval for the Company's product candidates; the Company's dependence on
partnerships with pharmaceutical and other companies to develop manufacture
and commercialize products using the Company's drug delivery technologies;
the Company's dependence on the success of its joint venture with Elan
Corporation plc ("Elan") for the development and commercialization of an
oral heparin product and its strategic alliance with Eli Lilly and Company
("Lilly") for the development and commercialization of certain of Lilly's
therapeutic proteins; the risk of technological obsolescence and risks
associated with the Company's highly competitive industry; the Company's
dependence on patents and proprietary rights; the Company's absence of
profitable operations and need for additional capital; the Company's
dependence on others to manufacture the Company's chemical compounds; the
risk of product liability and policy limits of product liability insurance;
potential liability for human clinical trials; the Company's dependence on
key personnel and the quality, judgment and strategic decisions of
management and other personnel; uncertain availability of third-party
reimbursement for commercial medical products; general business and
economic conditions; and other factors referenced in the Company's Annual
Report on Form 10-K for the fiscal year ended July 31, 1996 and other
periodic filings with the Securities and Exchange Commission.
Item 5. Other Events.
Recent Developments
On July 14, 1997 Emisphere Technologies, Inc. announced, on behalf of
its joint venture with Elan Corporation plc ("Elan"), the successful
completion of a Phase I clinical trial demonstrating oral delivery of
clinically relevant levels of the macromolecule heparin in a formulated
liquid preparation. The trial consisted of five arms, four of which were
with a fixed amount of the Company's carrier and escalating doses of
heparin, each administered as a drink in a 30-ml (two tablespoon) solution.
The fifth arm was a subcutaneous administration of heparin alone. All
formulations were well-tolerated by the eight subjects in the study, and
none of the subjects reported any treatment-related gastrointestinal
effects or other adverse experiences. Moreover, preliminary analysis of
the trial results provided evidence of the oral delivery of clinically
relevant levels of heparin, as measured by blood clotting time (activated
partial thromboplastin time, or APTT). Dose-dependent increases in
clotting times for the oral heparin were observed, and were well within the
therapeutic range for heparin.
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The Elan joint venture, which has exhausted the funds previously
committed by Elan, will require the commitment of additional funds by Elan
and the Company, on a 50-50 basis, to continue its efforts with respect to
the development of oral formulations of heparin products.
The Company has thirteen (13) issued U.S. patents and forty-three
pending U.S. patent applications, seven (7) of which have been allowed by
the U.S. Patent and Trademark Office. The seven allowed applications
include, without limitation, an application directed to a method for
transporting biologically active agents across cell membranes or lipid
bilayers.
In 1992, the Company filed an application to reissue one of its
granted U.S. patents on proteinoid based drug delivery systems in an
attempt to obtain certain broader patent claims to which the Company
believed it was entitled. The United States Patent and Trademark Office
("USPTO") Examiner rejected the claims of the Company's reissue
application, and the Company appealed from the rejection to the USPTO Board
of Appeals and Interferences. In a May 1997 decision, the Board of Appeals
and Interferences reversed the rejection by the USPTO Examiner of the
Company's reissue patent application. In the absence of further action by
the USPTO, it is anticipated that the Company's reissue application will be
granted.
The Company has entered into a ten-year noncancelable lease for new
office and laboratory space commencing August 1997. The annual minimum
rental is to be approximately $1,300,000. Build-out costs for this space,
net of amounts to be paid by the landlord, are expected to total
approximately $6,000,000.
The Company is a defendant in a third-party action relating to a
personal injury lawsuit brought by a former employee of the Company against
the manufacturer of a piece of laboratory glassware. The Company believes
that it is adequately protected by worker's compensation and general
liability insurance and intends to defend the action vigorously.
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.
EMISPHERE TECHNOLOGIES, INC.
By: /s/ Michael M. Goldberg
Date: July 21, 1997 Michael M. Goldberg, M.D.
Chairman of the Board and
Chief Executive Officer
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