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.
Adocia released its Q4 ’18 earnings results, but did not have an associated webcast. Below, FENIX provides highlights from the earnings press release including 2019 pipeline activities, and thoughts on how Adocia could enter the US and EU markets.
Yesterday, Zafgen hosted its Q4 ’18 earnings call and discussed its pathway to have FDA remove the clinical hold on ZGN-1061, its novel MetAP2 inhibitor for the treatment of T2DM. Additionally, Zafgen disclosed it has discontinued development of ZGN-1258 for the development of Prader-Willi Syndrome due to unforeseen findings in rat toxicity studies. Below are highlights and insights from the call.
In AstraZeneca’s press release regarding presentations at ACC 2019, Joris Silon was listed as the company’s new SVP of the CV, renal, and metabolism (CVRM) group. Recall, in October 2018, Novo announced that Ludovic Helfgott, previous head of AZ’s CVRM business, would be joining Novo as of April 3, 2019. According to Silon’s LinkedIn profile, he took the new position as of December 2018. Below, FENIX provides thoughts on Silon’s appointment to head AZ’s CVRM group as well as the headwinds and tailwinds that he faces.
AnTolRx, a privately held biotech company, announced Pfizer has exercised its option to license AnTolRx’s antigen-specific immunotherapy for T1DM. According to the press release, AnTolRx will receive an up-front payment and is eligible for milestone and royalty payments. The specific financial terms were not disclosed. Below, FENIX provides thoughts on the AnTolRx opportunity in the context of other T1DM immunotherapies in development.
Glooko announced it is removing the subscription fee for its data management platform. Previously, users who did not have coverage through their insurance or employers were required to pay a fee to access the platform. Additionally, the Glooko/Senseonics data integration appears to be complete. Now, users can directly sync Eversense data to the Glooko platform via the Senseonics Cloud. Below, FENIX provides thoughts on Glooko’s new business model as well as insight into how the integration with Eversense likely benefits Senseonics more than Glooko.
As of February 2019, Janssen’s VP and Franchise Medical Leader for the metabolism business, Gary Meininger (pictured below), has left Janssen and is now the SVP and Head of Pipeline Development for Vertex Pharmaceuticals. Prior to his ~9 years at Janssen, Meininger spent 8 years at Merck as a director of Merck Research Laboratories. Below, FENIX provides brief thoughts on Meininger’s departure.