Tag Archives: Catalyst

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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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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Beta Bionics Raises $50M, but No Lilly Investment

Beta Bionics announced it has secured $50M thus far in a Series B round. Interestingly, the press release states Novo has participated in the Series B, but there was no mention of Lilly. Recall, Both Novo and Lilly previously invested $5M each in the Series A financing. Zealand also committed $5M to the Series B fresh off its $205M cash injection from the sale of Soliqua/Lyxumia royalties. Below, FENIX provides thoughts on the Beta Bionics financing including Lilly’s apparent decision to refrain from further investment.

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“Smart CGM is a new category” – Medtronic ADA 2018 investor event summary

In conjunction with the ADA 2018 congress, Medtronic hosted an investor event (slide presentation) and the diabetes senior management team provided additional insights into their evolving business philosophy beyond the June 5 investor day. Below, FENIX provides a summary of the investor event, which had a large amount of news, as well as analysis behind Medtronic’s deliberate strategic choice to compete near-term in CGM features and solutions vs. hardware convenience.

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Senseonics Eversense CGM approved in the US; sPMA for insulin-dosing claim to follow

Senseonics has announced approval of Eversense, their implantable CGM, in the US and held an investor call. Of note, Senseonics did not mention anything regarding the updated components discussed during the adcom (sensor end cap and insertion tool); however, it was approved with the smaller gen 2 transmitter. Below, FENIX has conducted an analysis of the approval, safety labeling, and market implications.

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Victoza T2DM Pediatric Study Completed

The CT.gov record for Novo’s pediatric Victoza study (ELLIPSE) has recently been updated to “completed.” Assuming Novo files ELLIPSE by the end of Q2 ’18, approval is projected in H1 ’19 with an 8 to 10-month review. Below, FENIX provides implications and market context for the Victoza pediatric label update.

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Novo’s oral semaglutide beats Jardiance in PIONEER 2

Novo Nordisk has announced topline results from the Ph3 PIONEER 2 study comparing oral semaglutide to BI/Lilly’s Jardiance. Interestingly, this is the second oral semaglutide trial to have topline results (PIONEER 1 FENIX insight); and in each case, Novo has only disclosed on-treatment results. Below, FENIX provides insight into PIONEER 2 results and the impact on oral semaglutide commercialization.

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New Oramed Oral Insulin Ph2b Study Initiated

Oramed has initiated a Ph2b dose ranging study evaluating its oral insulin (ORMD-0801) in T2DM subjects (CT.gov record). According to the press release, the trial is a “prerequisite to Phase 3 confirmatory studies under FDA’s BLA.”

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