Company to Present Results Today During Presentation at Rodman and Renshaw
Healthcare Conference
* Patients Across Three Dose Groups of Oral Insulin with Stable Hemoglobin
A1c (HbA1c) Levels at Baseline Experienced Mean Decrease in HbA1c
* Highest Dose of Oral Insulin Shown To Be Statistically Significant Versus
Placebo in Decrease of HbA1c in Patients with Baseline of 8.0% and Above
* Webcast of Presentation Today at 11:40 a.m. EST on Company Website
TARRYTOWN, N.Y., Nov. 8 /PRNewswire-FirstCall/ -- Emisphere
Technologies, Inc. ("Emisphere", Nasdaq: EMIS) announced today additional
results from its 90-day, Phase 2 study of its oral insulin product
utilizing the Company's eligen(R) oral delivery technology.
Among all the patients, those on the high dose of oral insulin (10mg
QID) had the most profound effect on HbA1c reduction:
* In patients with HbA1c levels at baseline between 7% and 8.9%, a
decrease of 0.1% was seen in patients on oral insulin, versus an
increase of 0.05% on placebo.
* In patients with HbA1c levels of 7.5% to 8.9%, a decrease of 0.22% was
seen in patients on oral insulin, versus an increase of 0.075% on
placebo.
* In patients with HbA1c levels of 8.0% to 8.9%, a statistically
significant decrease of 0.74% was observed in patients on oral insulin,
while no change (0.00%) was observed in patients on placebo (n=17,
p=0.03)
In order for an efficacy determination to be made one requires a
meaningful baseline measure. For efficacy evaluation purposes all patients
whose screening to baseline HbA1c changed no more than 0.3% absolute were
included in the efficacy database. For the safety evaluation all patients
were included.
Also seen in these patients was a reduction of other glycemic
parameters, such as fasting blood glucose, fructosamine and proinsulin,
supporting that it was Emisphere's high-dose oral insulin product that was
responsible for the drop in patients' HbA1c levels.
When further evaluating patients in the high dose oral insulin group, 2
of the 10 patients experienced a significant drop in HbA1c to 7% or lower
while none of the placebo patients achieved this level of control. These
patients both had HbA1c levels at baseline of 8.1%, and at day 90 had HbA1c
levels of 7.0% and 6.0%, respectively. Patients with HbA1c levels of 7.0%
or greater are classified as inadequately controlled diabetics.
In the high dose group, 4 out of the 10 patients experienced a decrease
greater than or equal to 1% in HbA1c, while no patients in the placebo
group experienced this magnitude of a drop, and 6 out of the 10 patients in
the high dose group achieved a decrease greater than or equal to 0.7% in
HbA1c vs. none in the placebo group.
Please see data slides related to today's announcement on the investor
relations portion of Emisphere's website at http://www.emisphere.com/ir.asp.
"An in-depth analysis of our Phase 2 clinical data shows the potential
of Emisphere's oral insulin product to be beneficial and practical in a
diverse population of Type II diabetics," said Michael M. Goldberg, M.D.,
Chairman and CEO of Emisphere Technologies. "The study met the Company's
expectations that we could demonstrate the oral administration of insulin
using our technology for 90 days, eliminate the key safety concerns
associated with the administration of insulin and patient monitoring, and
achieve statistical significance with a particular dose in a small Phase 2
trial. We believe these results will allow us to effectively pursue a
partner for the drug."
Enrollment Criteria
Patients enrolled in the trial were first observed for three weeks, and
the variability of their HbA1c levels was monitored over this time. They
were all on a fixed dose of a single oral agent, metformin, to treat their
diabetes. The inclusion criteria for patients was a baseline HbA1c level of
7.0% - 9.5%.
During the initial monitoring stage, the three-week period between
screening and baseline where there was no change in their treatment regimen
and which was pre- randomization (n=91), patients' HbA1c changed by as much
as 1.2%. Evaluated in the efficacy endpoint in this clinical study were
data from patients whose HbA1c levels did not change by more than 0.3%
during the three week period.
The four arms of the study consisted of three doses of oral insulin
(10mg four times daily, 10mg twice a day and 5mg four times daily) and
placebo. There were 35 patients enrolled in each oral insulin arm of the
trial, and 36 in placebo.
Emisphere's oral insulin product demonstrated an encouraging safety
profile. During the study, there were no statistically significant
differences in hypoglycemic events, serious adverse events, or insulin
antibody formation for our oral insulin product compared to placebo. The
patients on high dose oral insulin saw no difference in weight and
experienced no nighttime hypoglycemic events.
Webcast Information
Michael M. Goldberg, M.D. will present these results today during
Emisphere's presentation at the Rodman and Renshaw Healthcare Conference at
11:40 a.m. EST, and will also discuss these results when the Company holds
its third quarter earnings results conference call on Thursday, November 9,
2006 at 10:00 a.m. EST. Investors may access the presentations within the
investor relations portion of the Company's website at
http://www.emisphere.com/ir.asp.
About Diabetes
According to statistics provided by the World Health Organization and
the American Diabetes Association, approximately 177 million people
worldwide are afflicted by diabetes, with approximately 18 million of those
afflicted residing in the United States. Nearly one-third of all
individuals in the United States suffering from diabetes are unaware that
they have this chronic disease. Type 2 diabetics account for approximately
90-95% of diabetes cases. According to the publicly filed annual reports of
leading insulin manufacturers, worldwide sales of insulin were
approximately $5.6 billion in 2004. Currently, there are no approved
insulin therapies in oral form.
About EMISPHERE(R) Oral Insulin
Emisphere's oral insulin mimics the natural physiology of insulin
release, by targeting the liver prior to being distributed to the
peripheral circulation, so that both the timing and location of naturally
secreted (endogenous) insulin release are replicated. Orally delivered
insulin, with the appropriate clinical attributes, may provide for an
effective diabetes therapy with fewer side-effects as compared to existing
therapies, and may be useful in halting the progression of early stage
diabetes.
About the eligen(R) Technology
Emisphere's broad-based oral drug delivery technology platform, known
as the eligen(R) technology, is based on the use of proprietary, synthetic
chemical compounds, known as EMISPHERE(R) delivery agents, or "carriers".
These molecules facilitate or enable the transport of the therapeutic
macromolecules across biological membranes such as those of the
gastrointestinal tract, and exert their desired pharmacological effect.
Emisphere's eligen(R) technology makes it possible to orally deliver a
therapeutic molecule without altering its chemical form or biological
integrity.
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 16, 2006.
SOURCE Emisphere Technologies, Inc.
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Related links:
http://www.emisphere.com
http://www.emisphere.com/ir.asp
CONTACT:
Stewart Siskind, Investor Relations,
+1-914-785-4742, at Emisphere Technologies, Inc.; Dan Budwick,
+1-212-477-9007 ext. 14, BMC Communications, for Emisphere
Technologies, Inc.
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