Category Archives: Topics

Is Glooko Eying an IPO? New Partnership with Pack Health for Patient Coaching

Pack Health announced it has formed a partnership with Glooko to allow for the integration of Glooko’s patient data into Pack Health’s coaching platform. Of note, the press release states that the two companies have already completed a live beta test of the integrated systems. Below, FENIX provides thoughts on the partnership including insight as to how Glooko may be looking leverage Pack Health to follow in Livongo’s footsteps for a potential Glooko IPO.

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Medtronic Files CGM for Non-Adjunctive Claim

Medtronic announced it has filed a PMA with FDA seeking a non-adjunctive (insulin dosing) claim for the Guardian Sensor 3 as part of the 670G platform. The timing is consistent with Medtronic’s CGM roadmap from its 2019 ADA investor presentation. Below, FENIX provides thoughts on the filing including the curious observation that Medtronic chose to file as part of the SAP system and not the standalone Guardian Connect CGM.

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REWIND CHMP Decision This Week; CHMP Agenda Highlights

The CHMP agenda for this week’s meeting has been released, and it includes eight notable items of which Lilly’s REWIND is likely the most significant. Below, FENIX provides diabetes-related highlights and insights from the CHMP agenda.

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Abbott Q2 ’19 Earnings Update

Abbott hosted its Q2 ’19 earnings call and provided updates to its FreeStyle Libre commercial performance and LCM initiatives. Curiously, Abbott did not provide an update on the number of global Libre users which it had been consistently disclosing over recent quarters. Below, FENIX provides highlights and insights from the call.

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J&J Q2 ’19 Earnings Update

Johnson & Johnson hosted their Q2 ’19 earnings call and briefly discussed the Invokana franchise. Of note, management did not comment on the recent decision to return JNJ-64565111 rights back to Hanmi. Below, FENIX provides highlights and diabetes-related insights from the call.

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MannKind Partners with GoodRx

MannKind announced it formed a partnership with GoodRx to “help raise awareness on ways patients can save money on their mealtime insulin.” Recall, GoodRx is a platform designed for patients without insurance or high-deductible plans to help them compare drug prices and identify savings opportunities (e.g. copay cards). Of note, the MannKind press release appears to suggest that the sole purpose of the partnership is to promote the Afrezza copay card. Below, FENIX provides brief thoughts on the MannKind partnership with GoodRx.

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Dapa T1DM CRL Received by AZ

Today, AZ announced it received a CRL from FDA for the Farxiga T1DM label expansion. The news comes on the heels of the July 12 NICE recommendation for Forxiga T1DM reimbursement in the UK. Below, FENIX provides thoughts on what the AZ CRL could mean for the SGLTi class in T1DM, including read-through to BI/Lilly and Lexicon/Sanofi.

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New Legislation to Impact Generic Insulin Approvals

Senators Dick Durbin, Kevin Cramer, and Tina Smith introduced a new bipartisan bill called the Affordable Insulin Approvals Now Act, with the intention to accelerate approvals of generic insulin products. According to the sponsors, the new bill is intended to address the unintended consequence of the 2018 Biologics Price Competition and Innovation Act which created a deadline (March 23, 2020) whereby all pending applications for generic insulin would be automatically rejected. Under the new bill, FDA would be required to continue the reviews of any pending applications. Below, FENIX provides thoughts on the Affordable Insulin Approvals Now Act in the context of the insulins that may be impacted by the March 23, 2020 cutoff date (e.g. Biocon/Mylan bs-glargine, Biocon/Mylan bs-aspart, Sanofi bs-aspart, and Sandoz bs-glargine which was in-licensed from Gan & Lee).

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Novo Semaglutide Pen Story Continues to Evolve

Novo initiated a Ph1 trial evaluating its new semaglutide injection pen (DV3396) as well as “two different forms of semaglutide” in patients who are overweight or obese. Recall, Novo recently initiated a separate Ph2 trial comparing injection site pain with DV3396 and FlexTouch pens. Below, FENIX provides updated insights regarding the DV3396 injection device based on new information from this Ph1 study.

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New Ozempic Pen Ph2 Trial

A CT.gov record has been observed comparing FlexTouch (PDS290) to the DV3396 pen which appears to be a modified version of the previously studied DV3372 pen (previous FENIX insight). Below, FENIX provides additional insight into Novo’s next-gen semaglutide pen platform.

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