BASEL (dpa-AFX) - Emisphere Technologies Inc. (EMIS.OB) announced today that Novartis Pharma AG (NVS) has informed the Company that it will not pursue further clinical development of the investigational drug SMC021 or oral calcitonin being studied by Nordic Bioscience as a treatment option in two indications, osteoarthritis or OA and for post-menopausal osteoporosis or OP and that it will not seek regulatory submission for SMC021 in OA or OP indications. Nordic Bioscience is the exclusive license partner of Novartis.
Novartis advised the Company that its decision to stop the clinical program of SMC021 in both indications was based on analysis and evaluation of data from three Phase III clinical trials that showed that while SMC021 displayed a favorable safety profile, it failed to meet key efficacy endpoints in all three trials.
Emisphere stated that it will need to further analyze and evaluate the data from the three studies in osteoporosis and osteoarthritis in order to understand the results and determine next steps.
Emisphere noted that its other development programs are continuing with Novo Nordisk A/S using Emisphere's Eligen Technology to develop and commercialize oral formulations of Novo Nordisk's insulins and GLP-1 receptor agonists, with a potential GLP-1 drug currently in a Phase I clinical trial; and with the Company's internally developed oral formulation of Eligen B12 (1000 mcg.) for use by B12 deficient individuals undergoing evaluation of regulatory and commercial development options.
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