Emisphere (NASDAQ:EMIS) is an emerging bio-pharma company specializing in the development of a drug delivery technology platform for the oral administration of therapeutic compounds which are either poorly absorbed or must be given through alternative routes such as injections.
On 6/1/09, EMIS announced that Novartis (NYSE:NVS) and Nordic Bioscience have completed recruitment for the planned second multi-center Phase 3 study exploring the safety and efficacy of an oral formulation of salmon calcitonin using Emisphere's proprietary Eligen Technology to treat patients with osteoarthritis of the knee. This study, which is intended to be used to support a FDA regulatory approval filing in the U.S., includes more than 900 patients between the ages of 51-80 with a medical history and symptoms of knee osteoarthritis. The study is being conducted in Europe and the U.S., as well as other countries, and is a two year study.
Oral calcitonin is also being investigated using Eligen Technology in a Phase 3 study for osteoporosis. Both indications for the compound are in Phase 3 development with over 6,000 patients enrolled in three clinical studies. The osteoporosis trial is a three year trial initiated in February 2007 and the two year osteoarthritis trial beginning in May 2007 with the second two year trial for osteoarthritis initiated in June 2008.
On 5/26/09, EMIS announced data from a clinical study designed to assess the effect of oral administration of two peptides (GLP-1 and PYY3-36) utilizing Emisphere's Eligen Technology on appetite suppression. The randomized, double-blind, placebo-controlled trial was conducted in 16 normal weight males between the ages of 18-40. The study concluded that these orally administered peptides, when delivered with Emisphere's SNAC carrier, were rapidly absorbed from the gastrointestinal tract, leading to concentrations several times higher than endogenous hormone levels achieved after a standard test meal.
Specifically, results showed that oral GLP-1 (2 mg tablet) alone and the combination of oral GLP-1 (2 mg tablet) plus PYY3-36 (1 mg tablet) induced a significant reduction in calorie intake although there was no synergistic effect when the two peptides were used in combination. The data was encouraging and will warrant further investigation in clinical trials for appetite suppression and the results further validate the Company's Eligen Technology and SNAC carrier's ability to improve the oral absorption of peptides.
In June 2008, EMIS announced an exclusive deal with Novo Nordisk (NYSE:NVO) to develop and commercialize oral formulations of the latter's proprietary GLP-1 receptor agonists for the potential treatment of Type 2 diabetes. Previously conducted clinical trials have confirmed that the Company's SNAC drug delivery technology allows for the safe and rapid oral absorption of GLP-1.
On 5/21/09, EMIS received a $500,000 milestone payment from MannKind (NASDAQ:MNKD) in connection with that Company's recent FDA filing and acceptance of a NDA for Afresa as an inhaled, ultra rapid-acting insulin. In early 2008, EMIS sold the rights to certain drug delivery patents to MNKD for an initial payment of $1.5M, and an additional payment of $500,000 remains to be paid to EMIS no later than 10/5/10.
In early May, EMIS reported 1Q09 financial results, which included a net loss of $5.1M and an operating loss of $4.7M compared to a net loss of $3.9M and an operating loss of $6.5M in the year-ago periods.
