Category Archives: Topics

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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DarioHealth Partners with Vitality Group

DarioHealth announced a partnership with Vitality Group to integrate Dario digital therapeutics for chronic conditions into Vitality’s wellness solution platform. According to Dario, the partnership is intended to accelerate penetration into the self-insured employer US market. Below, FENIX provides insight into the Dario/Vitality partnership as well as potential implications to Livongo and Onduo.

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Senseonics Exploring Strategic Alternatives

Senseonics announced today that the company is exploring strategic alternatives, including a potential sale. Below, FENIX provides a summary of the press release and a favors/disfavors analysis regarding a possible acquisition as the company searches for new financing sources.

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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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CHMP Agenda March 23-26; Lilly Halts Trial Enrollments Over COVID-19 Concerns

The CHMP agenda for this month’s meeting (March 23-26) has been released, and it includes two notable items (high-dose Trulicity Day 120 questions and Biocon/Mylan bs-aspart clock stop extension). Of note, as of the publication of this blast, the March CHMP agenda does not include the “Annex” section, so it is possible that other diabetes-related items are also being reviewed. Separately, Lilly announced it was halting new trial initiation and pausing trial enrollment for most of its clinical studies amid COVID-19 concerns. Below, FENIX provides diabetes-related highlights and insights from the March 2020 CHMP agenda and Lilly announcement.

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CRL for Empa 2.5mg in T1DM

BI/Lilly announced late Friday that the FDA has issued a CRL for the T1DM sNDA of empagliflozin 2.5 mg (press release). Of note, the CRL indicates that “the FDA is unable to approve the application in its current form.” Below, FENIX provides thoughts on the empa T1DM CRL in the context of other SGLTi T1DM initiatives.

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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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Thoughts on Lexicon Closing Its Sota CVOTs

Yesterday, Lexicon announced the early close out of its sotagliflozin CVOTs, SCORED and SOLOIST, mainly due to operational challenges with COVID-19 and the low likelihood of finding a commercialization partner (press release). Below, FENIX provides highlights and insights surrounding this update, including the potential generalization to BI/Lilly’s EMPEROR HF studies, and larger thoughts on Lexicon’s pivot away from sotagliflozin.

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Xeris Home Delivery via Amazon; Oramed End-of-Ph2 FDA Feedback

Two diabetes news items were observed today. First, Xeris made Gvoke PFS available for home delivery via Amazon Pharmacy and grounded its field force (press release). Of note, Gvoke PFS is now available for home delivery to commercially insured patients through PillPack by Amazon Pharmacy and Xeris has grounded its field force. Additionally, Oramed announced positive feedback from its oral insulin ORMD-0801 End-of-Phase2 (EoP2) CMC meeting with the FDA (press release). Below, FENIX provides highlights and thoughts surrounding these updates, including how the home delivery option could present an opportunity for Xeris and Zealand amid the COVID-19 pandemic.

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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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