14 major news items were observed over the past 2 days including Provention Bio’s teplizumab, dasiglucagon pivotal data, DECLARE and EMPA-REG subanalyses, Afrezza pediatric and fixed titration data, Tandem and Insulet hybrid-closed loop data, and more. Below, FENIX provides context and analysis for the announcements.
Medtronic hosted its annual ADA investor event and provided updates to its diabetes business including a pipeline roadmap over the next 24 months (download slides here). The event appeared to have many of the same themes from the 2018 event with a large focus on competing externally (previous FENIX insight). However, this is believed to be the first time that Medtronic has specifically called out pump and CGM competitors (Tandem and Dexcom), and for the first time, Medtronic management was wearing prototype Synergy CGMs at the event. Below, FENIX provides highlights and insights from the call.
Today, seven major new items were observed across Sanofi, Dexcom/Companion Medical, Xeris, Senseonics, Zealand/Beta Bionics, vTv, and Adocia. Below, FENIX provides context and analysis for the announcements.
Ahead of the ADA 2019 conference start, a series of diabetes-device related press releases have been observed including Companion Medical, Glooko, DreaMed, Roche, CeQur, and Virta Health. Below, FENIX provides context and analysis for the announcements.
JDRF has appointed Aaron Kowalski (pictured below, Twitter @aaronjkowalski) as the new President and CEO. Previously, Kowalski served as the Chief Mission Officer. He is succeeding Derek Rapp who stepped down in October 2018 after serving as CEO for ~5 years. Below, FENIX provides brief thoughts on Kowalski’s appointment.
Today, the Senate Finance Committee held its third hearing on drug pricing titled “Drug Pricing in America: A Prescription for Change, Part III” which focused particularly on the role of PBMs. As predicted, the PBMs largely tried to deflect attention back onto pharmaceutical manufacturers. Key themes from the hearing include: 1) PBMs blame outdated MPD legislation, PBMs do not set list prices, and PBMs do not want to provide as much transparency as manufacturers do. Below, FENIX provides highlights and insights from the hearing.
Sanofi is reportedly set to lay off an undisclosed number of diabetes US sales reps starting in June 2019. Below, FENIX provides thoughts on the new layoffs in the context of increasing US pricing pressures on Sanofi’s insulin franchise as well as the recent sotagliflozin CRL.
Diamyd Medical, the developer of the Diamyd T1DM vaccine, announced its 2019 and 2020 development and regulatory strategy. The company believes it can file for Conditional Marketing Authorization in Europe by the end of 2020 followed by the initiation of a global Ph3 study in the US and EU. Below, FENIX provides thoughts and insight into the Diamyd platform.
FENIX has observed a new teplizumab pivotal Ph3 trial (PROTECT) on CT.gov. Teplizumab is an anti-CD3 monoclonal antibody being studied for new-onset T1DM. Of note, the initiation of this pivotal trial is earlier than the previous guidance from Provention Bio (previously late 2019). Below, FENIX provides thoughts on this new trial in the context of the failed Ph2/3 PROTÉGÉ study for teplizumab when the compound was under the control of Macrogenics.
Fractyl, a Massachusetts-based medical technology company, announced the appointments of former Sanofi diabetes VP Margaret Borys as Chief Commercial Officer and former Intercept SVP Juan Carlos Lopez-Talavera as Chief Medical Officer. Below, FENIX provides thoughts on the appointments.