Emisphere Technologies has announced US commercial availability of Eligen B12, the first and only once-daily oral prescription medical food tablet shown to normalise B12 levels without the need for an injection.
Eligen B12 is indicated for the dietary management of patients who have a medically-diagnosed vitamin B12 deficiency, associated with a disease or condition that cannot be managed by a modification of the normal diet alone.
Eligen B12 is the first product to market using advanced Eligen Technology, which uses a carrier, salcaprozate sodium (SNAC) to guide B12 through the gastric lining and directly into the bloodstream independent of intrinsic factor, a protein made in the stomach that normally facilitates B12 absorption.
The groundbreaking technology may have potential applications across a range of diseases and conditions, including diabetes and women’s health needs.
Eligen Technology is being used to develop oral formulations of insulin and GLP-1 receptor agonists.
Emisphere CEO Alan L Rubino said: "Eligen B12, the first of multiple products in development that use Eligen Technology, fills a significant gap in the B12 treatment landscape, offering prescription strength B12 that is clinically proven to normalize B12 levels without the need for an injection.
"This type of practical innovation is the backbone of our commercial expansion, one that can address a number of existing unmet medical needs, while having a meaningful impact on the lives of patients."
Medical B12 deficiency is a serious medical problem that, if left untreated, can cause irreversible damage to nerve cells and other comorbidities. It can occur with a range of conditions in which there is an impaired capacity to absorb vitamin B12, including pernicious anaemia, Crohn’s and celiac disease.
Long term use of proton pump inhibitors (PPIs), a commonly used treatment to reduce acid in the stomach, can impair the body’s ability to absorb B12.
UC Davis Health System Medical Diagnostics Outreach Laboratory medical director Ralph Green said: "Most people, even those who are at highest risk like the elderly and folks with gastrointestinal problems, aren’t aware of the detrimental effects that a deficiency in vitamin B12 can have on their overall health."
"B12 deficiency is often overlooked, yet early detection and management is crucial because if untreated, it can lead to permanent nerve damage and serious neurological problems, such as memory loss and even dementia."
The launch of Eligen B12 marks a turning point for Emisphere as it advances into a well-calculated commercial expansion strategy.
Eligen B12’s commercialisation has been precisely implemented through a fully integrated and comprehensive go-to-market strategy that includes a nationally deployed field force, a full-scale retail pharmacy roll-out, a highly targeted advertising and promotional campaign and a sophisticated medical education component.