Category Archives: Uncategorized

New Sanofi Efpeglenatide + Glargine Study (AMPLITUDE-L)

A CT.gov record has been observed for a new study (AMPLITUDE-L) evaluating Sanofi’s QW GLP-1RA, efpeglenatide, on background insulin glargine. While not specified in the CT.gov record, it is assumed the trial would use Lantus given the “L” in the trial name. Below, FENIX conducted a comparative analysis of the Ph3 efpeglenatide studies in the context of the GLP-1RA class.

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Novo Partners with Flex for Connected Care Data Management

Novo Nordisk is partnering with Flex to help scale Novo’s diabetes connected care solutions. Interestingly, the press release also disclosed that Flex has already been working with Novo “to help design and manufacture elements of Novo Nordisk’s new connected insulin pens.” According to the press release, Novo has chosen to utilize Flex’s off-the-shelf solution called BrightInsight, which will allow Novo to integrate its apps, connected devices, and algorithms. Below, FENIX provides insight into why Novo’s connected care strategy made a partnership with Flex a necessity despite Novo already having a partnership with Glooko.

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Novo to Launch Connected Pens and New Connected Care Partnerships with Dexcom, Roche, and Glooko

With the start of the 2018 EASD conference, Novo Nordisk announced upcoming plans to launch two connected reusable pens (NovoPen 6 and NovoPen Echo) in addition to digital health partnerships with Dexcom, Roche, and Glooko. According to the press release, Novo plans to initiate the launch of its connected pens in Q1 2019. Importantly, Novo also disclosed intentions to launch connected disposable pens “later in 2019.” Below, FENIX provides thoughts on Novo’s connected pens and new partnerships.

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Xeris Glucagon Filing Accepted by FDA; June 10, 2019 PDUFA

Xeris Pharmaceuticals announced FDA has accepted the NDA filing for its stable glucagon with a PDUFA date on Monday, June 10, 2019, the Monday of ADA. This confirms FENIX’s previous belief that Xeris’s stable glucagon would have a 10-month review period. Below, FENIX provides thoughts on Xeris’s later-than-anticipated regulatory submission and impending market dynamics in the glucagon rescue market.

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Dexcom G6 Medicare Availability in Early 2019; New Data Partnership with Validic

Dexcom announced the G6 CGM will be available to Medicare patients starting early 2019. Additionally, Dexcom has entered into an agreement with Validic to integrate Dexcom CGM data into Validic’s data connectivity platform, called Validic Inform, which streams data from in-home connected devices into HCP systems. Below, FENIX provides thoughts on G6 Medicare availability as well as reasons why the Validic partnership makes sense for Dexcom.

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Dexcom G6 Medicare Availability in Early 2019; New Data Partnership with Validic

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New Ozempic “Real-World Pragmatic Study” with Anthem

Novo Nordisk and Anthem’s outcomes research subsidiary, HealthCore, announced they are working together on a “real-world pragmatic study” (called SEPRA as in SEmaglutide PRAgmatic) evaluating Ozempic vs. standard of care (defined as commercially available oral or injectable antidiabetic medication other than semaglutide). The study initiated in July 2018 and is currently recruiting patients. Below, FENIX provides insight into potential motivating factors for Novo conducting the study (e.g. pilot for an outcomes-based contract).

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Abbott and Roche Q3 ’18 Earnings Updates

Abbott and Roche held their Q3 ’18 earnings calls and provided updates on their diabetes businesses. Of note, Abbott disclosed it has reached >1M global Libre users, which is ahead of their YE ’18 goal. No updates were provided on US launch timings for Abbott Libre 2 or Roche Solomicro pump. Below are highlights from the respective events.

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MannKind Receives Warning for Afrezza Facebook Promo

FDA’s Office of Prescription Drug Promotion (OPDP) issued a letter to MannKind claiming misleading/false advertising for Afrezza Facebook posts. According to the letter, on February 9 and March 19, 2018, MannKind posted advertisements on Facebook that made “false or misleading claims and/or representations about the risks associated with Afrezza by suggesting that there are no safety concerns associated with the use of the drug.” The Facebook posts have since been deleted. Below, FENIX provides thoughts on the warning letter including any potential impact to the Afrezza brand.

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J&J Q3 ’18 Earnings Update

J&J hosted its Q3 ’18 earnings call but only briefly discussed the Invokana franchise. Senior management did not comment on the CANVAS/R review which is anticipated this month. Recall, in July 2018, J&J announced FDA extended the CANVAS/R sNDA review by 3 months. Below, FENIX provides thoughts on the CANVAS review as well as potential read-through from Lilly’s Ph2b dual agonist results to J&J’s dual agonist, JNJ-64565111.

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