Emisphere recently provided its 2Q16 update in a call led by CEO Dr. Alan Rubino. As in previous quarters, Emisphere continued to highlight Novo Nordisk’s use of its Eligen SNAC carrier technology to facilitate delivery of its oral formulation of GLP-1 agonist semaglutide. The company once again reiterated the scale and scope of Novo Nordisk’s phase 3 PIONEER development program for oral semaglutide, consisting of 10 trials initiating throughout 2016. We have not heard any updates on the progress of the PIONEER program since Novo Nordisk’s 1Q16 update, when the company shared that the PIONEER 3 head-to-head trial of oral semaglutide against Merck’s DPP-4 inhibitor Januvia (sitagliptin) had initiated (expected completion in Marck 2018). According to ClinicalTrials.gov, two additional trials – PIONEER 2 (head-to-head vs. Lilly/BI’s SGLT-2 inhibitor Jardiance [empagliflozin]) and PIONEER 4 (head-to-head vs. Novo Nordisk’s flagship GLP-1 agonist Victoza [liraglutide]) – began recruiting participants in August 2016, with expected completion dates of March 2018 and April 2018, respectively. PIONEER 5 (in patients with moderate renal impairment) and PIONEER 7 (flexible dose trial of oral semaglutide against sitagliptin) will both initiate in September 2016, with expected completion in January 2018 and March 2018, respectively. The cardiovascular outcomes trial PIONEER 6 is expected to initiate in October 2016, according to ClinicalTrials.gov, a slight delay from the previous expected initiation date of July 2016 (completion expected in March 2018). Emisphere management also reiterated Novo Nordisk’s commitment to developing oral products through Emisphere technology, as demonstrated by the expanded licensing partnership with Novo Nordisk to develop four novel oral formulations. Novo Nordisk and the success of oral semaglutide will be critical to Emisphere’s future prospects, though it’s clear that Emisphere needs Novo Nordisk much more than the reverse.
-- by Helen Gao and Kelly Close