ROSELAND, N.J., Feb. 20, 2015 (GLOBE NEWSWIRE) -- Emisphere Technologies, Inc. (OTCBB:EMIS) today highlighted positive Phase 2 data from Eligen® licensee Novo Nordisk pertaining to OG217SC, the oral formulation of semaglutide, a long-acting human GLP-1 analogue that stimulates insulin and suppresses glucagon secretion in a glucose-dependent manner. OG217SC is provided in a tablet formulation with an absorption-enhancing excipient, SNAC. SNAC is included in the Eligen® Carrier Concept.
Novo Nordisk today announced that it has successfully completed the phase 2 trial for OG217SC, investigating dose range, escalation, efficacy and safety of once-daily oral semaglutide compared with oral placebo or once-weekly subcutaneously administered semaglutide in around 600 people with type 2 diabetes treated for 26 weeks. Results of the study are available on Novo Nordisk's website. Based on these results, Novo Nordisk announced that it will initiate consultations with regulatory authorities subsequent to which a decision of whether to progress OG217SC into phase 3 development will be made.
"There are many challenges in developing an oral formulation of GLP-1, in particular obtaining adequate bioavailability," stated Alan L. Rubino, Emisphere's President and Chief Executive Officer. "OG217SC addresses some of these key challenges by utilizing Emisphere's Eligen® Technology to facilitate absorption from the gastrointestinal tract, overcoming major obstacles to effective oral delivery such as drug degradation and poor absorption."
Under its GLP-1 License Agreement, Novo Nordisk is working to develop and commercialize oral formulations of its proprietary GLP-1 receptor agonists in combination with Emisphere carriers. Under the GLP-1 License Agreement, Emisphere could receive additional contingent product development and sales milestone payments and would also be entitled to receive royalties in the event Novo Nordisk commercializes products developed under such Agreement. Under the GLP-1 License Agreement, Novo Nordisk is responsible for the development and commercialization of the products.
About semaglutide and OG217SC
Semaglutide is a long-acting human GLP-1 analogue that stimulates insulin and suppresses glucagon secretion in a glucose-dependent manner. The molecule is in development for once-weekly subcutaneous use and for once-daily oral administration for the treatment of type 2 diabetes. The oral formulation, OG217SC, is provided in a tablet formulation with an absorption-enhancing excipient, SNAC. SNAC is included in the Eligen® Carrier Concept. The Eligen® technology is licensed from Emisphere Technologies, Inc.
Semaglutide and OG217SC are Novo Nordisk product candidates.
Emisphere Technologies, Inc. is a specialty pharmaceutical company preparing to commence commercial operations. The Company is currently preparing to launch its first prescription product, oral Eligen B12™, in the U.S. Beyond Eligen B12™, the Company utilizes its proprietary Eligen® Technology to create 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 www.emisphere.com.
Safe Harbor Statement Regarding Forward-looking Statements
The statements in this release or oral statements made by representatives of Emisphere relating to matters that are not historical facts are forward-looking statements that involve risks and uncertainties, including, but not limited to, the success of the Company's commercialization initiatives, the sufficiency of the Company's cash position, the Company's ability to enter into strategic partnerships, the Company's ability to capture market share for any potential products, the Company's ability and/or that of its partners to develop, manufacture and commercialize products using Emisphere's drug delivery technology, and other risks and uncertainties detailed in Emisphere's filings with the Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" identified in the documents Emisphere has filed, or will file, with the Securities and Exchange Commission ("SEC"). Copies of Emisphere's filings with the SEC may be obtained from the SEC Internet site at http://www.sec.gov. Emisphere expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Emisphere's expectations with regard thereto or any change in events, conditions, or circumstances on which any such statements are based.
Alan L. Rubino, CEO 973.532.8000 Michael R. Garone, CFO 973.532.8005
- See more at: http://globenewswire.com/news-release/2015/02/20/708501/10121198/en/Emisphere-Highlights-Positive-Phase-2-OG217SC-Data-From-Eligen-R-Licensee-Novo-Nordisk.html#sthash.APSfBCuE.zwcwZ2Ud.dpuf