Tag Archives: Diabetes

New Bydureon label update: EXSCEL now in US label

Earlier this week, the Bydureon franchise label was updated to include 3 major changes: 1) CV safety data from EXSCEL, 2) a worse label restriction at an eGFR <45, up from <30, and 3) inclusion of acute gallbladder disease under warnings. Below, FENIX provides an analysis on the updated Bydureon label in comparison to the SUSTAIN-6 CV data from the Ozempic label, and why AZ may be able to infer in their field promotion that EXSCEL was superior despite the trial’s miss.

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Biocorp/DreaMed Partnership; Abbott Libre and Valeritas V-Go RWE

Three diabetes device-related press releases were observed today including a new Biocorp/DreaMed partnership, as well as Abbott Libre and Valeritas V-Go patch pump RWE, presented at ATTD 2019. Below, FENIX provides an overview of the news as well as thoughts on how the Biocorp/DreaMed partnership appears to favor DreaMed.

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Connected Pens: New Novo and Abbott Partnership for Data Integration

Today, Abbott and Novo Nordisk announced a non-exclusive partnership to integrate insulin dosing data from Novo’s connected insulin pens into Abbott’s digital health tools compatible with the FreeStyle Libre system. Below, FENIX provides insights into the Novo/Abbott partnership.

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Connected Pens: Novo Expanded Capability with Glooko; Biocorp/AgaMatrix Partnership

Prior to the start of the 2019 ATTD conference, two diabetes technology-related press releases have been observed. First, Glooko announced that its cloud-storage platform will integrate with Novo Nordisk’s connected pens and Dexcom’s G6 CGM. Second, Biocorp and AgaMatrix entered into a partnership for the distribution of Biocorp’s wraparound connected pen device now called “Mallya” (formerly Easylog). Below, FENIX provides insight into the respective news including thoughts on why the remote upload feature is critical for Novo.

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Medtronic Receives Breakthrough Device Designation; CY Q4 ’18 (FY Q3 ’19) Earnings Update

Medtronic hosted its CY Q4 ’18 (FY Q3 ’19) earnings call and provided brief updates to its diabetes device pipeline and commercial activities. Of note, Medtronic also announced that FDA granted Breakthrough Device Designation for its Personalized Closed Loop (PCL) insulin pump system (Breakthrough Devices Program Guidance was finalized in December 2018). Below, FENIX provides highlights from the earnings call as well as perspective why Medtronic chose to pursue Breakthrough Device Designation.

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Merck Files 12 Lawsuits Over Generic Januvia/Janumet Filings

On February 13, 2019, Merck filed 12 lawsuits in the Wilmington, Delaware Federal Court claiming patent infringement on Merck’s Januvia franchise. Defendants include Teva, Sandoz, Mylan, Watson, Zydus, Sun, Wockhardt, Macleods, Apotex, Torrent, Anchen, and Alvogen Pine Brook. Below, FENIX provides thoughts on the lawsuits and potential insight into when generic Januvia could enter the US market.

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Thoughts on iPump Special Controls

Yesterday, FDA approved the first interoperable pump through the de novo pathway and created a new pump category called “alternate controller enabled” (ACE) infusion pump. With the approval of the new class, FDA established “special controls” that must be met in order to qualify as an ACE pump, similar to Dexcom’s G6 iCGM approval in March 2018. Below, FENIX provides analysis and summary of these controls as well as thoughts on how achievable the ACE special controls are compared to the iCGM special controls.

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New iPump Pathway: Tandem t:slim X2 Approved as First Interoperable Pump

Today, FDA approved an interoperable version of Tandem’s t:slim X2 pump under the de novo pathway for a new insulin pump class called “alternate controller enabled” or ACE. Tandem has not yet issued a press release. This designation allows for the pump to be used with different components of an integrated insulin delivery system (e.g. CGM) with future iterations using the streamlined 510(k) process. As part of the approval, FDA has created special controls to meet the standard for ACE designation (similar to how FDA approved iCGM with special controls). Below, FENIX provides thoughts on the ACE category and implications to pump, CGM, and algorithm companies.

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CAROLINA CVOT Neutral; No Impact to OAD Market

BI/Lilly announced that the CAROLINA CVOT met the primary endpoint of non-inferiority on 3P-MACE vs. glimepiride. Full results from the study are scheduled to be presented on June 10 at the ADA conference. Below, FENIX provides thoughts on CAROLINA and how OAD market dynamics are unlikely to be affected, continuing the slow decline of SU volume share.

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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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