Category Archives: SGLT2i

New Lilly Academic Collaboration to Help Compete with Novo/Oxford

Lilly and the Indiana Bioscience Research Institute (in collaboration with Indiana University School of Medicine) have partnered to create the “Lilly Diabetes Center of Excellence” (LDCE). According to the press release, the LDCE will support “cutting-edge research in diabetes, diabetic complications, and related metabolic disorders.” Lilly’s decision to create the LDCE appears to be (at least in part) driven by a need to keep up with Novo’s collaboration with The University of Oxford. Below, FENIX provides thoughts on the LDCE including a comparison with a similar program between Novo and University of Oxford.

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CREDENCE and CANVAS Filing Update & Implications

J&J hosted its pharmaceutical business review and provided a brief update on its diabetes business. J&J disclosed its intention to file CREDENCE in “2019”, which is later than initially projected by FENIX (late Q3 ’18 / early Q4 ’18). There was no discussion in the prepared remarks on the US review of CANVAS/R. Below, FENIX discusses a hypothesis where delaying the CREDENCE filing to 2019 could signal the CANVAS FDA discussions are going well and Invokana is likely to receive a CV protection indication.

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Sanofi Restructures GBUs; Stefan Oelrich Moves to Bayer

Less than 3 years after reorganizing the company into 5 Global Business Units (GBUs), Sanofi is once again restructuring the organization. Now, Sanofi is creating Primary Care and China & Emerging Markets GBUs, which will replace the Diabetes and Cardiovascular (DCV) and General Medicines & Emerging Markets (GEM) GBUs. As part of the transition, Stefan Oelrich, head of the DCV business, is leaving Sanofi to join Bayer’s Board of Management and lead its Pharmaceuticals Division. The transition is set to take effect by the beginning of 2019. Below, FENIX provides thoughts Sanofi’s reorganization with insight on the potential impact on its diabetes business.

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DECLARE Confirmed @ AHA on Sat Nov 10

The full results presentation for DECLARE has been confirmed as a late-breaker at AHA. In a recent AHA online planner posting, captured below, DECLARE will be presented on Saturday November 10 at 345pm CST by TIMI’s Stephen Wiviott. Javed Butler, the PI on the Jardiance EMPEROR-HF trials, has been invited as the discussant for DECLARE

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FENIX Analysis: Triplet SGLT2i+DPP-IVi+MET FDCs

A Ph1 CT.gov record evaluating a new triplet FDC of empa+lina+met XR has been observed. Below, FENIX provides further details on potential triplet FDC filings and analysis, including pricing, based on read-through from the SGLT2i+DPP-IVi FDC market.

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New FDA SGLT2i Warning For Rare Genital Infections

FDA issued a warning for the risk of a rare genital infection (necrotizing fasciitis of the perineum aka Fournier’s gangrene) with the use of SGLT2 inhibitors. FDA is also requiring label updates for the class. According to the FDA’s warning letter, there have been 12 cases (7 males and 5 females) of Fournier’s gangrene from March 2013 to May 2018.

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Thoughts on Merck’s Digital Diabetes App

Merck and its partner Healthy Interactions launched a newly updated unbranded digital diabetes app called Map4health. Previously, the app was available with fewer features under the name “Conversation Map.” Interestingly, the platform can be used by both patients and HCPs; however, Merck and Healthy Interactions are primarily marketing the platform to HCPs with the intent to drive patient uptake through HCP recommendations. Below, FENIX provides an overview of the app features as well as thoughts on the program.

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Thoughts on New Dapa HF CVOT (DELIVER)

Late last week, AZ announced a new HF CVOT for Farxiga named DELIVER. Curiously enough, the news was not seen on any global newswires. Below, FENIX provides its thoughts on the trial, including the checkered past of Scott Solomon and the choice of him as PI on DELIVER.

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