Lilly hosted its Q1 ’18 earnings call (press release) and provided updates on its diabetes business unit. Of note, Lilly affirmed REWIND (Trulicity CVOT) topline readout is anticipated in early Q4 ’18 with full results at ADA 2019. Below are highlights from the call.
Sanofi announced that Elias Zerhouni, the company’s Head of Global R&D, is retiring and will be succeeded by John Reed, the former Global Head of Roche Pharma Research & Early Development.
Mylan hosted its Investor Day and provided updates on biosimilar Lantus and Novolog, as well as disclosing for the first time its intentions to develop biosimilar versions of Toujeo, Victoza, and Saxenda. Below, FENIX provides analysis and market implications for each of the biosimilar programs.
Two new clinical trials for Lilly’s ultra-rapid-acting insulin lispro (LY900014; also called ultra-rapid lispro or “URLi” pronounced “early” [ur-lee] by Lilly at ATTD 2018), have been observed on CT.gov including a Ph1 H2H PK trial vs. Novo’s Fiasp and a Ph3 study in pumps called PRONTO-Pump.
During Day 2 of JPM, presentations ranged across both diabetes drug (Sanofi, Lilly, Lexicon, and Mylan) and device manufacturers (Dexcom, Insulet, and Roche), although Mylan and Roche did not discuss their diabetes portfolios. Below, find key takeaways from JPM followed by more in-depth coverage.
Sanofi has reportedly announced a round of 400 layoffs for the diabetes and cardiovascular business unit sales team. In a separate news release, it was also announced that Sanofi has appointed Dominique Carouge, former VP of Administration & Management for Global R&D, as a new EVP Head of Business Transformation.
Lilly disclosed major announcements about its diabetes connected care strategy, including intentions to develop an in-house automated insulin-delivery (AID) device as well as a wireless smart pen injection device. As a part of this endeavor, Lilly has engaged in collaborations with Deka R&D Corp., CGM-manufacturer Dexcom, and acquired Montreal-based algorithm startup Class AP. In light of these developments, Lilly has indicated plans to initiate trials by YE 2017 and has suggested it will take 2-3 years for these new devices to reach the market.
An ADA abstract titled “A Novel Formulation of Insulin Lispro Containing Citrate and Treprostinil Shows Faster Absorption and Improved Postprandial Glucose Excursions vs. Humalog in Patients with T1DM” will be presented by Lilly at the General Poster Session on June 10, 2017.
MannKind held its Q1 2017 earnings call and provided updates on commercial and clinical activities for Afrezza.
MannKind Corporation and One Drop are entering into a collaborative agreement that would extend One Drop’s subscription service and digital health platform through the addition of Afrezza as a rapid-acting insulin offering integrated in-app with Bluetooth technology.