Category Archives: SGLT2i

Janssen Diabetes VP Moves to Vertex

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.

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Diabetes Takes a Backseat During Part II Drug Pricing Hearing

Today, the Senate Finance Committee held the second drug pricing hearing of 2019 (Drug Pricing in America: A Prescription for Change, Part II). Part I was held on January 29, 2019. While the Part I drug pricing hearing spent much time discussing insulin pricing, diabetes-specifically was hardly mentioned. When a specific drug was mentioned, it was most often AbbVie’s Humira. Below, FENIX provides diabetes-related highlights and insights from the hearing.

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Farxiga eGFR Cutoff Lowered; Positive Brilinta T2DM Data

AstraZeneca’s Farxiga franchise labels (Farxiga and Xigduo) have been updated to reduce the eGFR cutoff from 60 to 45 mL/min/1.73m2. Additionally, AZ announced positive topline results from the Brilinta Ph3 THEMIS study in patients with established CAD and T2DM. Below, FENIX provides insight into the lower Farxiga eGFR as well as thoughts on AZ’s strengthening CV protection market position.

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Farxiga LCM and Litigation Update; AZ Q4 ’18 Earnings Summary

AstraZeneca hosted its Q4 ’18 earnings call and provided a brief update on its diabetes business including Farxiga LCM initiatives (T2DM CVOT, T1DM, HF, and CKD). Of note, as part of AZ’s business reorganization, MedImmune has been fully integrated including the dissolution of the MedImmune name. Below, FENIX provides highlights and insights from the earnings call including thoughts the generic dapa patent dispute, PDUFA projections for Farxiga T1DM and DERIVE CKD, and AZ’s dual agonist from MedImmune.

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Could Teva Generic Dapa Be Para III? Teva Receives Tentative FDA Approval

Earlier this week, FDA tentatively approved Teva’s generic version of Farxiga. Below, FENIX provides evidence suggesting Teva filed its generic dapa via Paragraph III as well as thoughts on potential generic dapa launch timings, particularly Zydus.

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Sanofi Discontinues 2 Dual-Agonist Programs; Q4 ’18 Earnings Update

Today, Sanofi hosted its Q4 ’19 earnings call, provided updates to its diabetes business, and disclosed that it discontinued SAR425899 (GLP-1/GCGR) and SAR438335 (GLP-1/GIP) for the treatment of obesity in T2DM and T2DM, respectively. Of note, Sanofi’s CEO will be testifying at the February 26, 2019 Senate Committee hearing on drug pricing. Below, FENIX provides highlights from the call as well as thoughts on Sanofi’s position in diabetes, obesity, and NASH.

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No REWIND PRV Mentioned; Lilly Q4 ’18 Earnings Update

Lilly hosted its Q4 ’18 earnings call and provided brief updates to its diabetes business including its REWIND outlook, Jardiance tailwinds, URLi regulatory filing, and CAROLINA topline results. Of note, Lilly discontinued development of the Ph2 DACRA-042 compound from KeyBioscience. Below, FENIX provides highlights and analysis from the call.

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Dapa T1DM Positive CHMP Opinion for AZ

AZ received a positive CHMP opinion for dapagliflozin in T1DM and confirmed that dapa T1DM is under review by FDA. The company will likely discuss the positive CHMP opinion and US filing during its Q4 ’18 earnings call on February 14. Below, FENIX provides thoughts on a dapa T1DM indication in the context of the recent sotagliflozin FDA adcom.

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Merck Q4 ’18 Earnings Update

Merck held its Q4 ‘18 earnings call and briefly discussed its diabetes portfolio. Of note, Merck’s earnings press release highlighted the recent in-licensing of NGM313, renamed MK-3655 (monoclonal antibody agonist of the β-Klotho/FGFR1c receptor), which is being evaluated in T2DM and NASH. Additionally, senior management announced that the company will hold an investor event on June 20, 2019 to provide an update on Merck’s strategic progress and its plans for the future. Below are highlights from the call.

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JNJ Q4 ’18 Earnings Update

JNJ hosted its Q4 ’18 earnings call (press release) and briefly discussed financial results for its Invokana franchise. Of note, the recent Invokana CV indication listed on a single slide, but was not discussed during prepared remarks or Q&A (see previous FENIX insight). Below, FENIX provides financial highlights for Invokana and perspective on the ongoing CV indication launch.

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