In advance of ADA 2018 beginning June 21, FENIX has conducted a comprehensive analysis of new and recent promotional materials obtained at AACE 2018. Notably, this was the first major conference opportunity for Novo to promote both Ozempic and the Tresiba DEVOTE label update.
Insulet has announced FDA 510(k) clearance of its next generation handheld personal diabetes manager (PDM) called “Omnipod DASH.” Below, FENIX provides insight into the DASH system including Insulet’s decision to give DASH away at no cost.
Currently, there are multiple ongoing, label-enabling HF CVOTs in the SGLT2i class for Jardiance, Farxiga, and Zynquista (sotagliflozin), along with other studies exploring surrogate endpoints, biomarkers, and mechanisms of action. FENIX has created a tale-of-the-tape summary of the SGLT2i HF CVOTs along with a projected timeline for filings and launches. In summary, it is believed that AZ’s DAPA-HF CVOT has a high probability of stopping early for overwhelming efficacy and thus creating a priority review scenario to leap AZ ahead of BI/LLY by 6-12 months in this important LCM opportunity. Below is a summary of the rationale and hypothesis comparing the different development approaches by SGLT2i sponsors to improve clinical outcomes in HF patients.
Recently, we’ve noticed that Dexcom has started a TV campaign for its new G6 CGM system. Interestingly, the DTC campaign was initiated prior to the June 4th product launch. Although there were a few TV commercials for G5 Mobile, we expect the TV reach to be much broader for the G6 launch. In summary, the ad theme centers on knowledge being a superpower in T1DM that can lead to better glycemic management without being inconvenient. Below, FENIX summarizes the key messages and imagery in the new G6 commercials.
Zealand reported completion of the second Ph3 dasiglucagon pivotal trial for the treatment of severe hypoglycemia, slightly ahead of previous guidance. Results of the trial, which included 156 T1DM subjects, are now anticipated in Q3 2018.
Xeris Pharmaceuticals has filed with the SEC for a $75M IPO under the ticker XERS. Of note, the S1 IPO registration document states FDA filing of G-Pen is anticipated in Q3 ’18, which is later than previously stated by Xeris (late Q2 ’18).
AZ hosted their Q1 ’18 earnings call and briefly discussed their diabetes portfolio, with a particular focus on Farxiga, including H2 ‘18 readout of the DECLARE CVOT and planned H2 ’18 US filing in T1DM.
Zealand hosted its Q1 ‘18 earnings call and provided updates on its diabetes portfolio including dasiglucagon. Additionally, Zealand discussed the potential of a priority review voucher (PRV) for dasiglucagon in congenital hyperinsulinism (CHI).
Dexcom hosted its Q1 ’18 earnings call and provided updates on its recently approved G6 CGM as well as pipeline initiatives. Of note, Dexcom has initiated a limited launch of the G6 CGM and it plans a larger rollout prior to ADA in June 2018. Below are highlights from the call.
Biocon has reportedly received 7 Form 483 observations from FDA for its Bangalore facility. According to the report, the Bangalore facility observations are “largely procedural and aimed at continuous improvement.”