Category Archives: Topics

Sanofi Q3 ’18 Earnings Update

Sanofi hosted its Q3 ’18 earnings call (press release) and provided updates on its diabetes and CV business unit including perspective on the recent restructuring announcement (previous FENIX insight). Additionally, Sanofi discussed its 2019 managed care outlook for Lantus, Toujeo, Admelog, and Praluent (PCSK9i). Below are highlights from the call. Financial Highlights Q3 ’18 WW diabetes sales decreased by -9.2% YOY to €1.37B, primarily driven by declining US glargine sales. US diabetes sales for the same quarter also declined by -24.3% YOY to €571M reflecting changes in Medicare Part D (MPD) coverage and declining US glargine net prices. Of note,……

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UPDATED: Invokana 3P-MACE Indication Approved

Janssen announced FDA approved Invokana and its metformin FDCs for the reduction of 3P-MACE in patients with T2DM and established CVD. The approval comes slightly later than the 3-month PDUFA extension FDA requested on July 13, 2018. Below, FENIX provides thoughts on how the CANVAS/R approval will impact the SGLT2i market, including potential read-through to AZ’s DECLARE (full results to be presented at AHA on November 10), and potential inclusion on updated guidelines.

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New Lilly RNAi Drug Development Collaboration

Lilly announced a new collaboration with Dicerna for the development and commercialization of RNAi therapeutics treating cardio-metabolic disease, neurodegeneration, and pain. It remains unclear if or how this collaboration will impact Lilly’s diabetes business unit. Below, FENIX provides general thoughts on RNAi treatments as well as potential diabetes-related targets that Lilly/Dicerna could be pursuing.

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Biocon CY Q3 ’18 (FY Q2 ’19) Earnings Update

Biocon hosted its CY Q3 ’19 (FY Q2 ’19) earnings call and briefly discussed its insulin pipeline including bs-glargine, bs-aspart, and oral insulin tregopil. Below are highlights from the call.

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Oral Semaglutide + Basal Insulin (PIONEER 8) Positive Topline Results

Novo Nordisk announced positive topline results from PIONEER 8 which evaluated oral semaglutide vs. placebo on background basal insulin. FENIX has updated the PIONEER results summary table which now includes data from data from PIONEER 1, 2, 3, 4, 5, 7, 8, and 10. The last 2 studies in the PIONEER program, PIONEER 6 (CVOT), and PIONEER 9 (monotherapy in Japanese subjects) are projected to read out by YE ’18. Below, FENIX provides thoughts on why PIONEER 8 is anticipated to be a highly impactful study given recent changes to the ADA/EASD guidelines that recommend GLP-1RA before basal insulin.

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Merck Q3 ’18 Earnings Update; No BS-Glargine Discussion

Merck hosted its Q3 ’18 earnings call and only briefly discussed its diabetes business. Of note, this is the first time in recent memory that Merck has provided an accompanying slide presentation with its earnings release. Consistent with previous quarters, nearly all of the event was dedicated to Keytruda, and there was no discussion of Merck’s discontinuation of bs-glargine. Below are highlights from the call.

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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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