Category Archives: Topics

New Medtronic/BCBS CGM Outcomes-Based Contract

Medtronic announced it has signed an outcomes-based contract (OBC) with BCBS of Minnesota for the standalone Guardian Connect CGM. According to the press release, the OBC is based on time-in-range metrics. In return, Guardian Connect will be distributed through the BCBS Minnesota pharmacy benefit. While the press release does not specify, it is believed that both insulin-dependent T1DM and T2DM patients are eligible. Below, FENIX provides thoughts on the Medtronic CGM OBC and how it could impact other CGM manufacturers, notably Dexcom and Abbott.

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CGM: WaveForm and A. Menarini Form Partnership for Ex-US Distribution

WaveForm Technologies (subsidiary of AgaMatrix) announced it has formed a partnership with A. Menarini to commercialize WaveForm’s CGM in EMEA and Latin America. The WaveForm CGM is not yet available; however, the company anticipates receiving CE Mark in 2019. Below, FENIX provides thoughts on the partnership.

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Sanofi Pursuing U200 Lispro; New Ph1 Study

Sanofi has initiated a new Ph1 trial evaluating a U200 concentration of its bs-lispro. Below, FENIX provides thoughts on why Sanofi is pursuing U200 Admelog including its likely use in the pre-filled patch pump that is being developed in partnership with Verily and Sensile Medical.

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Livongo for Diabetes Integration with Amazon Alexa

Livongo announced that its Livongo for Diabetes program now integrates with Amazon Alexa to provide glucose values and health tips via Alexa voice commands. According to the press release, the integration is HIPAA compliant. Below, FENIX provides brief thoughts on the initial Alexa integration.

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Sanofi To Layoff Diabetes Sales Reps; Details Remain Scarce

Sanofi is reportedly set to lay off an undisclosed number of diabetes US sales reps starting in June 2019. Below, FENIX provides thoughts on the new layoffs in the context of increasing US pricing pressures on Sanofi’s insulin franchise as well as the recent sotagliflozin CRL.

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New Cigna/ESI Insulin Savings Program Introduced Ahead of Congressional Hearing

Cigna and Express Scripts announced a new insulin “Patient Assurance Program” that will cap the out-of-pocket cost for a 30-day insulin supply to $25 for eligible patients on participating plans (Cigna purchased ESI in December 2018). Of note, the new savings program was announced ~1 week ahead of the third Senate Finance Committee hearing on drug pricing which is scheduled for April 9, 2019, at 10:15 AM ET. The third installment, titled “Drug Pricing in America: A Prescription for Change, Part III,” will focus specifically on the role of PBMs. Below, FENIX provides thoughts on the Cigna/ESI insulin savings program as an obvious strategy to redirect the focus away from themselves and back onto insulin manufacturers.

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Thoughts on Lilly Drug Pricing Transparency

With the ongoing national discussion on drug pricing and increasing scrutiny particularly focused on insulin, Lilly released its 2018 Annual Transparency Report which included detailed information on Humalog pricing. Recall, Lilly recently announced the creation of a Humalog authorized generic with a list price 50% lower than Humalog. Below, FENIX provides an overview and insights on Lilly’s drug pricing transparency including Lilly’s apparent strategy to direct legislative pressure onto PBMs.

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CREDENCE sNDA Filed; Priority Review Unclear

Janssen announced it has filed an sNDA for the Invokana renal outcomes study, CREDENCE. Full results from CREDENCE are scheduled to be presented on April 14 at the World Congress of Nephrology meeting. Recall, on July 16, 2018, Janssen announced that CREDENCE stopped early for positive efficacy findings. Of note, Janssen’s press release did not state whether the company requested a priority review by FDA. Below, FENIX provides thoughts on the CREDENCE filing and potential approval timelines based on whether or not FDA grants priority review.

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Glytec Partners with Dario For Outpatient Insulin Titration

DarioHealth announced a joint marketing agreement with Glytec to allow Dario’s connected BGM to integrate into Glytec’s Glucommander Outpatient insulin titration solution. Below, FENIX provides thoughts on why the partnership between Glytec and Dario makes sense for both companies.

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Cellnovo to Close Operations?

Cellnovo announced that it does not have sufficient capital to support a broader launch of its Gen 3 tubed patch pump which is negatively impacting the company’s overall operations. According to the press release, Cellnovo “[intends] to continue contacts initiated with strategic partners and investors in order to protect the value of the assets.” Given the financial situation, Cellnovo initiated collective proceedings in the UK and conciliation proceedings in France. Below, FENIX provides thoughts on Cellnovo’s market position and the potential closure of its operations.

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