- Emisphere has issued patents with claims directed to pulmonary delivery
of peptides
- Pre-clinical data demonstrates high bioavailability
- Favorable safety profile
- Pulmonary delivery of insulin in combination with Emisphere carrier
reduces the up-regulation of immune response genes
- Second generation inhaled insulin formulations demonstrating promise in
clinical studies
TARRYTOWN, NY, April 12 /PRNewswire-FirstCall/ -- Emisphere
Technologies, Inc. (Nasdaq: EMIS) today announced that the U.S. Patent and
Trademark Office has granted an additional patent to Emisphere regarding
the pulmonary delivery of proteins, using Emisphere's eligen(R) technology.
Emisphere received U.S. Patent number 6,991,798 with claims directed to the
pulmonary delivery of peptides. In addition, foreign Patent Number
2001273153, granted in March, provides Emisphere with additional patent
protection for pulmonary delivery of peptides. Thus far in 2006, three
patents have been granted to Emisphere containing language and/or claims
affording patent protection for the pulmonary delivery of proteins,
bringing the total of U.S. patents owned by Emisphere to nine, with
additional applications concerning pulmonary routes of administration in
progress.
The Company also announced that it has generated promising preclinical
data from studies conducted by Emisphere and its academic collaborators
demonstrating that the bioavailability of insulin via pulmonary delivery
with an eligen(R) carrier was approximately two fold higher than pulmonary
dosing of insulin alone, and had a bioavailability greater than 70% when
compared to subcutaneous dosing. The preclinical results demonstrated that
the product showed rapid absorption kinetics with an onset of action (Tmax)
in less than 5 minutes. Moreover, as described in a recently published
article*, gene microarray analyses of mRNA showed that pulmonary delivery
of insulin in combination with the Emisphere carrier reduces the
up-regulation of immune response genes, potentially ameliorating certain
concerns related to long term dosing of insulin to the lung.
"While we remain completely focused on developing oral forms of insulin
using our eligen(R) technology, and look forward to our Phase 2 oral
insulin results later this year, for those companies interested in
improving the pulmonary delivery of insulin, Emisphere's eligen(R)
technology could provide a unique advantage of high bioavailability with
the potential to reduce the undesirable side effects from chronic
administration of insulin to the lungs," said Michael M. Goldberg M.D.,
Chairman and CEO of Emisphere Technologies, Inc. "We believe our
intellectual property in improved transport of proteins, such as insulin
across biological membranes, including in the GI tract and lung, is quite
broad. With the recent approval of a first generation product of inhaled
insulin and the emerging clinical data base with second generation inhaled
insulin formulations, Emisphere has a strong intellectual property estate
in next generation pulmonary delivery using a system that has demonstrated
activity and the potential to improve the safety profile over existing
products with the added benefit of formulation flexibility as either a dry
powder or liquid."
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 drugs that are not currently available
or have poor bioavailability in oral form, 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 .
* "Response of the Lung to Pulmonary Insulin Dosing in the Rat Model and
Effects of Changes in Formulation." T. Cooper Woods, Ph.D., Bin Zhang,
M.S., Frank Mercogliano, B.S., and Steven M. Dinh, Sc.D. Diabetes
Technology & Therapeutics, Volume 7, Number 3, 2005.
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:
Investor Relations: Stewart Siskind of
Emisphere Technologies, Inc. +1-914-785-4790, Info@Emisphere.com;
Media: Dan Budwick of BMC Communications, +1-212-477-9007 ext.14,
for Emisphere Technologies
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