CEDAR KNOLLS, N.J., Nov 02, 2009 (BUSINESS WIRE) -- Emisphere Technologies,
Inc. (OTC BB:EMIS) today announced that interim data from an ongoing study
demonstrated its high-dose oral Eligen(R) B12 (1000mcg) performed as well as or
better than B12 injections in individuals with Vitamin B12 deficiency. Normal
levels of serum B12 and active B12 were achieved by 100 percent of those study
participants who have currently taken Eligen(R) B12 (1000mcg) 15 days into the
90-day study when the first blood samples were taken.
As part of an interim analysis in this randomized, multi-center study, levels of
serum B12, active B12, homocysteine and methyl malonic acid were measured on day
15, at which point a total of 18 participants (8 on IM injection and 10 on oral)
had received either five 1000mcg intramuscular injections of Vitamin B12 or once
daily tablets of oral Eligen(R) B12 (1000mcg). Study subjects taking Eligen(R)
B12 also saw a marked decrease in homocysteine, which is a known risk factor for
cardiovascular disease.
"We are excited and encouraged by the speed with which the individuals in the
oral Eligen(R) B12 group were able to reach normal levels of serum B12 and
active B12," said Michael V. Novinski, President and Chief Executive Officer,
Emisphere Technologies. "We believe these interim results illustrate the
enormous potential of the Eligen(R) Technology, which we look forward to
applying to other poorly absorbed nutrients."
"These interim data with high-dose oral Eligen(R) B12 open up a real potential
for replacing an injection with an oral, which has never been done before with
B12 due to challenges with absorption and bioavailability," said Dr. Michael
Rothkopf, Director of Atlantic Health's Metabolic Medicine and Weight Control
Center in Morristown, NJ and an investigator in the study. "Availability of a
needle free but highly efficacious B12 product would be a significant benefit
for the millions of individuals under medical supervision for B12 deficiency."
This clinical study with Eligen(R) B12 (1000mcg) is expected to be completed
within the first half of 2010. Upon completion of this study the high dose
Eligen(R) B12 product (1000 mcg) should compete directly with the standard high
dose B12 injection currently administered to millions of individuals under
medical supervision for B12 deficiency. It is estimated that between 30 and 40
million high dose injections of B12 are given each year in the U.S. alone and
over 250 million such injections are given worldwide.
Emisphere's Eligen(R) B12 product (1000mcg) is planned to be available in 2010.
Oral Eligen(R) B12 and the foregoing statements have not been evaluated by the
Food and Drug Administration. Oral Eligen(R) B12 is not intended to diagnose,
treat, cure, or prevent any disease.
About Vitamin B12
Vitamin B12 is necessary for the formation and maturation of red blood cells and
for the synthesis of DNA. It is also necessary for normal nerve function and
assists in the body's immune system. B12 deficiency is a major health concern
that can lead to anemia, fatigue, weakness, loss of appetite, neurological
changes, confusion and dementia.
Unlike most vitamins, B12 is stored in the liver until it is needed by the body.
Vitamin B12 is adequately absorbed in the bodies of healthy people, but many
older people lose their natural ability to absorb the nutrient. Younger
individuals may also have difficulty absorbing B12 as a result of taking certain
medications or chemotherapy. Those at highest risk for B12 deficiency include
anyone over age 60, those with GI tract disorders such as Crohn's Disease,
Irritable Bowel Syndrome or Celiac Disease, individuals who have had bypass
surgery, those undergoing chronic therapy with absorption-altering drugs,
alcoholics and vegetarians/vegans. It is estimated that between 30 and 40
million high-dose injections of B12 are given each year in the U.S. alone and
that more than 250 million such injections are given worldwide.
About Emisphere Technologies, Inc.
Emisphere is a biopharmaceutical company that focuses on a unique and improved
delivery of therapeutic molecules or nutritional supplements using its
proprietary Eligen(R) Technology. The Eligen(R) Technology can be applied to the
oral route of administration as well as other delivery pathways such as buccal,
rectal, inhalation, intra-vaginal or transdermal. The company's website is
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 for the fiscal year ended December 31,
2008, filed on March 16, 2009, and as amended on Form 10-K/A as filed on April
30, 2009, and our Quarterly Report on Form 10-Q for the quarter ended March 31,
2009, filed on May 7, 2009, and as amended on Form 10-Q/A ,as filed on October
21, 2009, and our Quarterly Report on Form 10-Q for the quarter ended June 30,
2009, filed on August 10, 2009, and as amended on Form 10-Q/A, as filed on
October 21, 2009.
SOURCE: Emisphere Technologies, Inc.
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