AZ has begun actively promoting Bydureon BCise, the new autoinjector device which became available in US pharmacies in January 2018. Below, FENIX has conducted a launch analysis in the context of the broader GLP-1RA market including assessment of prescription data trends.
Novo Nordisk began actively promoting Ozempic (sc QW semaglutide) in the field in early February 2018, two months after the December 2017 approval. Below, FENIX has conducted a launch analysis, including thoughts on promotional materials, sampling strategy, and early insights from NRx trends.
J&J announced it has received an offer from Platinum Equity to purchase LifeScan for $2.1B. According to the press release, the acceptance period for the offer ends June 15, 2018 with closing of the deal to occur by YE ’18. Below, FENIX provides insight on the potential opportunity that Platinum Equity may see for the LifeScan business.
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.
AstraZeneca recently announced the European Medicines Agency has accepted the Forxiga application for the treatment of T1DM. Of note, AZ filed with 52-week DEPICT-1 data but only 24-week data from DEPICT-2. FDA filing for Farxiga in T1DM remains projected for H2 ’18.
Dexcom hosted its Q4 ’17 earnings call and provided updates to its CGM business. Of note, Dexcom disclosed that while they are working with FDA on not requiring calibrations for G6, it will still allow calibrations if the user chooses. Below are highlights from the call.
Lexicon hosted its Q4 ’17 earnings call and provided updates on its T1DM and T2DM sotagliflozin development programs. Interestingly, Lexicon disclosed they plan to file sotagliflozin in T1DM in the US and EU in the coming weeks, which is more specific than previously projected (H1 ’18).
Biocon has reported that FDA issued a form 483 with six observations for its Malaysian facility. Recall, this facility is primarily responsible for the manufacturing of insulins including its biosimilar glargine. Biocon did not provide further details into the FDA observations.
In light of the recent journal publication of PRECISE II, the US pivotal IDE trial for Senseonics’s Eversense implantable CGM, FENIX has conducted a comparative analysis vs. Abbott Freestyle Libre and Dexcom G5 Mobile, with a particular focus on sensor accuracy across glucose ranges.