Category Archives: Basal Insulin

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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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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AZ’s Head of CVRM Joins Novo

Novo Nordisk announced Ludovic Helfgott (pictured below), current global head of AZ’s CV, renal, and metabolism (CVRM), is joining Novo as the Executive VP of Biopharm. According to the press release, Helfgott will join Novo effective April 3, 2019 at which point Jesper Brandgaard, current head of Novo Biopharm and well-known former CFO, will retire. Below, FENIX provides thoughts on Helfgott’s appointment and potential future impact to Novo as well as an analysis of how the Biopharm position could help Helfgott’s career.

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Tidepool to Support Loop; New Study on Insulin Variability in US Pharmacies

JDRF, ADA, and the Helmsley charitable trust awarded a grant for a study evaluating the variability of insulin potency in US pharmacies. Additionally, Tidepool recently announced a program to support the DIY Loop automated insulin-delivery project through an FDA-regulated manner. Below, FENIX provides a brief overview and thoughts on each new project, including Tidepool’s potential motivation.

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Merck Cancels Bs-glargine Agreement with Samsung

Merck has reportedly asked Samsung Bioepis to cancel their development and commercialization deal for biosimilar glargine. The report comes from a filing with the Korean stock exchange. While it remains unknown, this news may signal Merck’s intention to abandon the global commercialization of its bs-glargine. According to the filing, Merck has offered to pay $155M to Samsung to end the contract. Below, FENIX provides thoughts on potential reasons to cancel the deal as well as read-through to the other basal insulin manufacturers.

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New ADA/EASD Guidelines Recommend GLP-1RA Over Insulin and Make Other New H2H Drug Recommendations

ADA and EASD have updated their T2DM consensus guidelines (journal publication) with notable changes to the framework of the treatment algorithm (pictured below). Now, the algorithm takes a patient-centric approach and suggests a stepwise methodology based on the highest priority for the patient (ASCVD, CKD, hypoglycemia minimization, weight loss, and cost). Importantly, the guidelines recommend the use of GLP-1RA over insulin as the first injectable therapy as well as other in-class H2H drug recommendations. Below, FENIX provides a winners-and-losers analysis, highlights of the guideline updates, and how the identified knowledge gaps may be addressed.

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HARMONY Superior; REWIND and PIONEER-6 Expectations High

Full results from the albiglutide CVOT, HARMONY Outcomes, have been published in the Lancet and were presented at EASD 2018. As somewhat of a surprise, results demonstrated a 22% RRR in the 3P-MACE primary endpoint (p=0.0006). In a press release, GSK announced the results and disclosed they are “exploring opportunities to divest this medicine to a company with the right expertise and resources to realise its full potential for patients.” Recall, FENIX recently presented a scenario highlighting a strong possibility that HARMONY could show superiority including GSK likely divesting albiglutide for its re-commercialization. Below, FENIX provides perspective on the potential market implications in a winners & losers analysis, as well as who albiglutide suitors are unlikely to be.

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