Tag Archives: Diabetes

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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Nemaura to Use Wellness Category for US CGM Launch

Nemaura announced plans to launch its non-invasive sugarBEAT CGM in the US under the wellness category following feedback from the FDA (press release). Below, FENIX provides insight on this new foray for CGM in the US, especially in the context of how other marketed CGMs use a non-adjunctive claim to dose insulin for diabetes management.

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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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