Category Archives: Other

AZ Partners with Silence Therapeutics for siRNA Targeting; AZ Leverages BrightInsight for Digital Platform

AstraZeneca has entered into two new collaborations: Silence Therapeutics and BrightInsight. The partnership with Silence Therapeutics covers the discovery and development of novel siRNA targeting of CV, renal, metabolic, and respiratory diseases. Separately, the collaboration with BrightInsight is intended to support AZ’s digital health solutions for the “chronic disease management space”. Below, FENIX provides highlights and insights related to the respective partnerships, including Silence’s accompanying investor call.

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BI Returns Amylin Analog WW Rights to Zealand

Late Friday, Zealand announced it regained the WW development rights for its Amylin analog program, which was previously licensed to Boehringer Ingelheim. Of note, BI will continue to develop BI456906 (QW GLP-1/GCG dual agonist in Ph2) that was also licensed from Zealand for the treatment of T2DM and obesity. Below, FENIX provides insights on the potential factors influencing BI’s decision to return the development rights of the Amylin analog program back to Zealand.

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Glooko Enables Free Remote Care Solution; Hovorka’s AP App Launched in UK; Valeritas Receives Court Approval on Zealand Sale

A series of diabetes-related news has been observed, including Glooko’s new remote patient care solution, the UK launch of Roman Hovorka’s artificial pancreas app ‘CamAPS FX’ for T1DM, and the court approval of the Valeritas sale to Zealand. Below, FENIX provides highlights and insights from the respective news items.

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Medtronic To Move Away From Its Non-Intensive Diabetes Strategy

According to a March 18 Medtronic research note from Morgan Stanley entitled “Diabetes Group Restructured”, Medtronic is restructuring its diabetes group to focus its core efforts on insulin-dependent T1DM+T2DM patients while moving away from their non-intensive strategy. Below, FENIX provides thoughts on the new direction for Medtronic’s business.

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DarioHealth Q4 ’19 Earnings Update

DarioHealth hosted its Q4 ’19 earnings call (press release) and provided brief updates to its commercial developments and strategic collaborations. Of note, management indicated that they currently have ~46k active users, including the users from the membership program and those with device usage. Below, FENIX provides additional highlights and insights from the call.

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Mylan/Aurobindo Invalidates Two Tradjenta Patents; PRV-031 (Teplizumab) Ph3 PROTECT Trial Paused

According to new court documents (view here) released yesterday, two Boehringer patents on Tradjenta were ruled invalid by the U.S. Court of Appeals for the Federal Circuit upon reviewing the appeal by Mylan and Aurobindo. Additionally, Provention Bio announced a temporary pause in the patient randomization of the Ph3 PROTECT trial for PRV-031 (teplizumab) in patients with newly diagnosed T1DM amid the COVID-19 crisis (press release). Of note, the company is on track to complete its rolling BLA submission for teplizumab treatment of at-risk patients for T1DM in Q4 ’20. Below are the key highlights and insights from these new items.

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Lilly to Join New Part D Senior Savings Model for Affordable Insulins; Welldoc Partners With Dexcom

Yesterday, FENIX observed a series of diabetes-related news including an announcement that Welldoc partnered with Dexcom to integrate G6 into the BlueStar platform (press release) as well as Lilly plans to participate in the new Part D Senior Savings Model for affordable insulins (press release). Below, FENIX provides brief thoughts on these announcements.

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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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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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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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