Company Receives Written Guidance from the FDA
TARRYTOWN, N.Y., Nov. 7 /PRNewswire-FirstCall/ -- Emisphere Technologies,
Inc. (Nasdaq: EMIS) today announced that it has received written guidance from
the U.S. Food and Drug Administration (the "FDA") regarding the Company's
planned Phase III trial with oral heparin. The planned trial is designed to
determine the safety and efficacy of oral heparin versus titrated Coumadin(R)
(sodium warfarin) for the prevention of venous thromboembolism ("VTE")
following elective total hip replacement.
The trial will be a randomized double blind, non-inferiority, multi-center
study with the primary endpoint to prevent VTE, which consists of deep venous
thrombosis ("DVT"), objectively confirmed by ultrasound, pulmonary embolism
and death. The two arm study will compare 30 days of dosing, three times per
day, of two Emisphere oral heparin capsules, to 30 days of dosing, once per
day, of oral titrated Coumadin(R). The expected enrollment for the trial is
approximately 2100 patients (including an allowance for non-evaluable
patients), with 1050 patients per arm. An independent Data and Safety
Monitoring Committee ("DSMC") will be charged with periodically reviewing the
trial for safety. Emisphere plans to initiate the study in the first half of
2006.
"We believe we have made important progress with the FDA in terms of
defining a Phase III clinical strategy with our oral heparin program. Based
on discussions and correspondence with the FDA over the past year, we are
confident that our trial design will assist us in demonstrating the safety and
efficacy of our oral heparin product. Our trial design incorporates the use
of ultrasound as the primary event detection technique, which should enable
rapid enrollment in the trial at high quality U.S. clinical sites," said
Michael M. Goldberg, M.D., Chairman and Chief Executive Officer. "We have
worked with our Steering Committee on the trial design and the members of that
committee - Samuel Z. Goldhaber, MD, Cardiovascular Division, Brigham and
Women's Hospital; Professor Ajay Kakkar, BSc, MBBS (Hons), PhD, FRCS,
Institute of Cancer, Barts, The London School of Medicine, and Professor
Russel D. Hull, MBBS, MSc, FRCPC, University of Calgary - will remain closely
involved with us throughout the trial."
"Also, we have been working with the FDA to demonstrate our belief that
heparin, when given orally using our technology, is unaltered as compared to
heparin delivered by injection. Those results will be available shortly. Once
available, we will discuss the data with the FDA to determine if these data
can accelerate our product registration. In addition, we intend to pursue a
Special Protocol Assessment with the FDA for the Phase III trial, further
decreasing the regulatory and clinical development risk associated with late
stage drug development," Goldberg concluded.
Dr. Goldhaber remarked: "Prevention and treatment of VTE will be well
served by the introduction of a safe and effective, fixed dose, oral agent,
and I am delighted to be working with Emisphere on this study."
Patients undergoing hip replacement surgery are treated prophylactically
with heparin, low molecular weight heparin, pneumatic compression devices in
combination with aspirin, or oral anticoagulants like Coumadin(R). Warfarin is
used by many physicians as it is the only approved oral agent in the U.S. for
the indication of DVT prophylaxis. Various injected heparins are also used by
many physicians due to their fixed dose, no monitoring dosing regimen. We
believe that there is an unmet medical need for a safe and effective fixed-
dose, oral anticoagulant that can be administered without monitoring and that,
therefore, such an anticoagulant would be clinically beneficial, patient
friendly and potentially cost-effective.
Currently, heparin is not administered orally because it is not absorbed
from the gastrointestinal tract due to its size, poor lipid solubility, and
ionic repulsion from the negatively charged epithelial tissue. Emisphere's
proprietary compound Sodium N-[8(-2-hydroxybenzoy l) amino] caprylate (SNAC)
is a delivery agent that can be combined with heparin to mediate its
gastrointestinal absorption by a passive transcellular process, without
apparent damage to intestinal epithelium.
About Deep Vein Thrombosis
Deep vein thrombosis 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 (called emboli) and become lodged
in the blood vessels of the lung causing pulmonary embolism.
Thromboembolic events kill more people 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 VTE.
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, 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 29, 2004.
SOURCE Emisphere Technologies, Inc.
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Related links:
http://www.emisphere.com
CONTACT:
Gillian Racine, Investor Relations of
Emisphere Technologies, Inc., +1-914-785-4742; or Media, Dan
Budwick of BMC Communications for Emisphere Technologies, Inc.,
+1-212-477-9007 ext. 14
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