Oral 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 gastric 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.

Eligen® is designed to overcome these hurdles with a patented formulation that delivers B12 more efficiently and rapidly with peak concentrations of B12 into the bloodstream within just 30 minutes - a significant improvement over the 6.8 hours absorption time of standard B12 tablets. The enhanced bioavailability ensures the achievement of optimum B12 blood levels.

Emisphere is developing an oral formulation of Eligen® B12 (1000 mcg) for use by B12 deficient individuals. During the fourth quarter 2010, we completed a clinical trial which demonstrated that both oral Eligen® B12 (1000 mcg) and injectable B12 (current standard of care) can efficiently and quickly restore normal Vitamin B12 levels in deficient individuals. The manuscripts summarizing the results from that clinical trial have been published in both the March and July 2011 edition of the journal Clinical Therapeutics (Volume 33, pages 358-371 and Volume 22, pages 934-945). We also conducted market research to help assess the potential commercial opportunity for our potential Eligen® B12 (1000 mcg) product. Currently, we are evaluating the results of our clinical trials and market research and exploring alternative development and commercialization options with the purpose of maximizing the commercial and health benefits potential of our Eligen® B12 asset.