Category Archives: Topics

Nemaura enters into multiple non-binding agreements for sugarBEAT; Mylan wins over Sanofi in Lantus patent litigation

A series of diabetes-related news has been observed including an announcement that Nemaura has entered into multiple non-binding agreements for its sugarBEAT CGM (press release) as well as the US District Court ruling favorably for Mylan/Biocon’s bs-glargine over Sanofi’s Lantus (press release). Below, FENIX provides brief thoughts on these announcements in the context of the recent news from Nemaura and the potential launch of Mylan/Biocon’s bs-glargine.

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Intarcia CRL’d again, multiple outlets reporting

Multiple outlets are reporting that Intarcia has received a second CRL for ITCA-650 (see Boston Business Journal and STAT News for articles). FENIX has not seen an official company press release but will continue to monitor.

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Thoughts on FDA’s New Draft Guidance for T2DM Trials

FDA announced it has issued a new draft guidance titled “Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control” (download draft guidance here). Of note, this new draft guidance replaces two other FDA guidance documents – the famous Dec 2008 CV risk guidance and a Feb 2008 draft guidance. The new draft guidance provides recommendations on the size and nature of the safety databases needed to improve glycemic control in T2DM patients. Below, FENIX provides a brief overview of the FDA’s new draft guidance and its implications including a favors/disfavors analysis on specific market players.

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Intarcia PDUFA passes without update

It has been observed that Intarcia’s March 9 PDUFA date for ITCA-650 has passed. To the best of FENIX’s knowledge, there has been no company announcement from Intarcia and no new NDA database entries seen in an Orange Book search. Recall, after receiving a Sept 2017 CRL, Intarcia re-filed the ITCA-650 NDA on or around September 9, 2019, with a subsequent acceptance announcement on October 8, 2019 (previous FENIX insight). FENIX will provide analysis and market implications once a company announcement is made from Intarcia.

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New dapa HF study (DICTATE-AHF) in T2DM patients with acute decompensated heart failure

Last week, a Ph3 dapagliflozin trial (DICTATE-AHF) in T2DM patients with acute decompensated heart failure (ADHF) was observed on CT.gov. Of note, the study is assessing the decongesting effects of dapagliflozin and protocolized diuretic therapy in ADHF patients. Below, FENIX provides thoughts on this new trial in the context of other SGLT2 HF trials and what it could mean for AZ.

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Voluntis Deprioritizes Diabetes in Favor of Oncology

Voluntis announced it is moving in a new strategic direction, which includes deprioritizing its Insulia diabetes solution in favor of its oncology business. Of note, the updated strategy comes a day after Voluntis entered into an agreement with BMS to create a mobile solution to support treatment and track symptoms for oncology patients. Below, FENIX provides thoughts on Voluntis’s reprioritization in the context of other digital health solutions from Onduo and Livongo.

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Thoughts on Tandem Basal IQ iAGC Designation

Tandem recently announced it received FDA clearance for its Basal IQ algorithm as an Interoperable Automated Glycemic Controller (iAGC). Basal IQ is the second algorithm to receive the iAGC designation behind Tandem’s Control IQ (approved in December 2019). Below, FENIX provides thoughts on the Basal IQ iAGC clearance in the context of FDA’s iAGC special controls as well as potential implications to other glycemic control algorithm developers.

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Nemaura Launches sugarBEAT CGM App on Google Play

Nemaura Medical announced it has launched an updated sugarBEAT app on Google Play (download here) ahead of the BEAT diabetes subscription-based service UK launch in April 2020. Recall, Nemaura recently disclosed plans to conduct a H2H trial comparing its non-invasive CGM to a “highly successful major incumbent CGM sensor.” Below, FENIX provides brief thoughts on the new app in the context of Nemaura’s overall non-invasive CGM ecosystem.

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Livongo Q4 ’19 Earnings Update

Livongo hosted its Q4 and FY 2019 earnings call and provided updates to its business. Unsurprisingly, the vast majority of the call focused on the user and revenue growth outlook for the Livongo platform. Below, FENIX provides highlights and insights from the call.

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Omnipod Horizon Pivotal Trial Delayed

Insulet announced it will be pausing Omnipod Horizon pivotal trial due to a recently-discovered “software anomaly.” The updated software is expected to be available by the end of April 2020; however, the Omnipod Horizon launch timeline has been pushed back to early 2021. Below, FENIX provides potential insights on the delay as well as implications to other insulin delivery algorithm developers.

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