Emisphere Development Update

3/20/19

ROSELAND, N.J., March 20, 2019 (GLOBE NEWSWIRE) -- Novo Nordisk announced today it has submitted two New Drug Applications to the US Food and Drug Administration for oral semaglutide, a once-daily oral formulation of the long-acting GLP-1 analog utilizing Emisphere Technologies, Inc.’s (OTCBB: EMIS) proprietary Eligen® SNAC Carrier Technology.

An NDA was submitted for oral semaglutide seeking approval for an indication for the treatment of adults with type 2 diabetes. A priority review voucher has been applied to the NDA, leading to an anticipated review time of six months from the submission date, according to standard FDA review timelines.

A second NDA was submitted for oral semaglutide seeking approval for a cardiovascular risk reduction indication in adults with type 2 diabetes. The NDA for an oral semaglutide cardiovascular risk reduction indication has an anticipated 10-month review time from the submission date, according to standard FDA review timelines.

A copy of Novo Nordisk’s announcement can be viewed at the following link:
https://www.novonordisk.com/media/news-details.2239031.html

About Emisphere

Emisphere Technologies, Inc. is a drug delivery company that utilizes its proprietary Eligen® Technology to develop new oral formulations of therapeutic agents. Emisphere is currently partnered with global pharmaceutical companies for the development of new orally delivered therapeutics. For more information, please visit the company’s website at www.emisphere.com.

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