Results Show that Heparin Delivered Orally Using Emisphere's eligen(R)
Technology is Identical to Heparin Delivered by Injection Based on all
Analytical Methods Utilized
TARRYTOWN, N.Y., March 31 /PRNewswire-FirstCall/ -- Emisphere
Technologies, Inc. (Nasdaq: EMIS) today announced results of a clinical study
designed to compare heparin administered in the Company's proprietary oral
formulation to heparin administered by the two standard methods of injection.
The purpose of the study was to demonstrate that heparin's molecular
configuration when delivered by the oral route using the Emisphere's eligen(R)
technology is unaltered as compared to heparin when administered by either the
subcutaneous or intravenous routes of administration. The results show that
heparin delivered orally utilizing Emisphere's eligen(R) drug delivery
technology, is chemically identical to heparin delivered by injection. The
study was conducted as a result of discussions with the U.S. Food and Drug
Administration ("FDA") regarding potential expedited registration pathways for
oral heparin.
Previous studies have repeatedly demonstrated that Emisphere's oral
heparin formulation can elevate the key parameters of anticoagulation (aptt,
anti-Factor Xa, Anti-Factor IIa and TFPI) similar to injectable heparin. The
data from the recently completed study is expected to support a claim that
heparin is unchanged by the oral route of administration using Emisphere's
eligen(R) technology.
"Our data confirms that the eligen(R) technology makes it possible to
deliver heparin to the blood stream in an oral formulation," commented Robert
J. Linhardt, Ph.D., Professor of Chemistry and Chemical Biology at the
Rensselaer Polytechnic Institute. "The data show that heparin delivered to
the blood in an oral formulation has the same molecular properties as native
heparin (naturally occurring heparin) and heparin delivered by injection. We
look forward to submitting these results to peer reviewed publications with
additional data in the near term."
Professor Shaker A. Mousa, PhD and Chairman of Pharmaceutical Research
Institute Albany College of Pharmacy who conducted the pharmacodynamic
component of the study, commented, "the fact that oral heparin delivers the
full range of heparin molecules is important, not only because it faithfully
reproduces the injectable heparin, but also because it provides an oral agent
that can take full advantage of the pleiotropic properties of heparin, many of
which reside exclusively on the higher molecular weight fractions of
unfractionated heparin."
Michael M. Goldberg, M.D., Chairman and Chief Executive Officer of
Emisphere, stated, "We are very excited by these results and quite impressed
with the capabilities of Professors Linhardt and Mousa. We will be submitting
their report to the FDA in the near future, at which time we will discuss ways
to utilize the findings of the study to expedite the registration process for
oral heparin. The detailed results of this study will be made available thru
publication and presentation at scientific meetings."
About Oral Heparin
Emisphere's lead product candidate is oral heparin, an
antithrombotic/anticoagulant used to prevent deep vein thrombosis following
surgery. Deep vein thrombosis (DVT) is a condition in which a blood clot
(thrombus) develops in deep veins of the body, most often in the deep veins of
the legs, either above the knee or below it. While this condition itself is
not life- threatening, the blood clot can break free and become lodged in the
blood vessels of the lung causing a pulmonary embolism (PE).
Thromboembolic events are responsible for more deaths in the U.S. than
AIDS, breast cancer, and highway fatalities combined. Every year,
approximately 2 million Americans are affected by deep vein thrombosis, and
approximately 600,000 experience pulmonary embolisms. For up to 200,000 of
those with PE, the blood clot in the lung proves fatal. Approximately 600,000
people with DVT are hospitalized and about 60,000 die each year in the U.S. as
a result of thromboembolic events.
There are approximately 350,000 patients who undergo total hip replacement
surgery in the U.S. each year. In addition, anticoagulant therapy is
prescribed for total knee replacement (estimates are U.S. 350,000 patients),
DVT treatment (estimates are U.S. 600,000 patients), atrial fibrillation
(estimates are U.S. 1.5 million patients), and a number of other indications.
The prevalence of DVT and PE in knee and hip replacement patients has been
well documented. Patients who undergo total hip replacement are at a high
risk of developing VTE which includes DVT and PE.
About Emisphere Technologies, Inc.
Emisphere Technologies, Inc. is a biopharmaceutical company pioneering the
oral delivery of otherwise injectable drugs. Emisphere's business strategy is
to develop oral forms of injectable drugs, either alone or with corporate
partners, by applying its proprietary eligen(R) technology to those drugs or
licensing its eligen(R) technology to partners who typically apply it directly
to their marketed drugs. Emisphere's eligen(R) technology has enabled the
oral delivery of proteins, peptides, macromolecules and charged organics.
Emisphere and its partners have advanced oral formulations or prototypes of
salmon calcitonin, heparin, insulin, parathyroid hormone, human growth hormone
and cromolyn sodium into clinical trials. Emisphere has strategic alliances
with world-leading pharmaceutical companies. For further information, please
visit http://www.emisphere.com.
Safe Harbor Statement Regarding Forward-looking Statements
The statements in this release and oral statements made by representatives
of Emisphere relating to matters that are not historical facts (including
without limitation those regarding the timing or potential outcomes of
research collaborations or clinical trials, any market that might develop for
any of Emisphere's product candidates and the sufficiency of Emisphere's cash
and other capital resources) are forward-looking statements that involve risks
and uncertainties, including, but not limited to, the likelihood that future
research will prove successful, the likelihood that any product in the
research pipeline will receive regulatory approval in the United States or
abroad, the ability of Emisphere and/or its partners to develop, manufacture
and commercialize products using Emisphere's drug delivery technology,
Emisphere's ability to fund such efforts with or without partners, and other
risks and uncertainties detailed in Emisphere's filings with the Securities
and Exchange Commission (the "SEC"), including those factors discussed under
the caption "Risk Factors" in Emisphere's Annual Report on Form 10-K (file no.
1-10615) filed on March 16, 2006.
SOURCE Emisphere Technologies, Inc.
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Related links:
http://www.emisphere.com
CONTACT:
Investors: Stewart Siskind of Emisphere
Technologies, Inc., +1-914-785-4742; or Media: Dan Budwick of BMC
Communications, +1-212-477-9007, ext. 14, for Emisphere
Technologies, Inc.
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