Tag Archives: Diabetes

Roche and Senseonics Expand Partnership

Roche announced it has expanded its partnership with Senseonics to integrate data from the Eversense CGM into Roche’s digital diabetes management solutions (mySugr app and Accu-Chek Smart Pix). According to the press release, the data integration will be available by early 2019. Interestingly, the press release does not discuss what geographies are covered in the partnership expansion. While the Roche/Senseonics commercial partnership is currently limited to Ex-US geographies (Europe, Middle East, and Africa), the expansion of their collaboration could suggest that a US partnership/acquisition is on the horizon. Below, FENIX provides thoughts on how Eversense data integration fits into both companies’ strategies.

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HARMONY @ EASD: Why You, AZ, and LLY, Should Care

With the upcoming Tanzeum CVOT (HARMONY Outcomes) presentation at EASD 2018 (Tues Oct 2 at 1200pm CET) and in the context of the DECLARE topline results and EXSCEL EU label update for Bydureon (previous FENIX insight), FENIX has conducted an analysis that describes the rationale where by HARMONY Outcomes could act as a potential catalyst for AZ to conduct their next large T2DM CVOT, either as GLP-1RA+SGLT2i or GLP-1/GCG dual-agonist on SGLT2i background therapy. In conjunction, FENIX has conducted a pieces-of-the-puzzle analysis that balances the likelihood HARMONY reads out positive for superiority at EASD.

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Tandem to Pioneer iPump Regulatory Pathway; Shares Close to $50

Tandem hosted its 2018 Institutional Investor & Analyst Day as well as announcing an increase to its 2018 sales guidance. Of note, Tandem disclosed plans to create a new pump category called iPump (via the de novo regulatory pathway), interoperable insulin delivery algorithms, and plans to accelerate development of its t:sport pump. Below, FENIX provides highlights from the investor event with insight into the potential market impact of Tandem’s pipeline, including how iPump could work for Medtronic.

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Bydureon EU label to Include All-Cause Mortality Data from EXSCEL

AstraZeneca announced Bydureon received a positive CHMP opinion to include EXSCEL CVOT data in the EU label. Importantly, the CHMP opinion also recommends inclusion of the pre-specified all-cause mortality secondary outcome data, which demonstrated a 14% RRR. Below, FENIX provides thoughts on the CHMP opinion and insight into potential read-through to a US Bydureon label update.

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DECLARE Hits on HF Endpoint but Not 3P-MACE; Bad News for CANVAS Review?

AstraZeneca announced that results from the Farxiga CVOT, DECLARE, demonstrated superiority for the “CV death or hospitalization for heart failure (hHF)” composite endpoint, but did not meet statistical significance for 3-point MACE. Full results from the study will be presented at the American Heart Association conference on November 10 at 345pm CST by TIMI’s Stephen Wiviott. Below, FENIX provides thoughts on the topline results as well as insight into potential negative read-through to the CANVAS/R review for Invokana.

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Oral Semaglutide Superior to Trulicity in Japanese Subjects (PIONEER 10)

Novo Nordisk announced positive topline results from the PIONEER 10 study evaluating oral semaglutide vs. Trulicity in Japanese T2DM patients. Below is an updated PIONEER data summary table including available data from PIONEER 1, 2, 3, 4, 5, and now 10. FENIX also provides thoughts on PIONEER 10 including Novo’s potential opportunity to leverage PIONEER 10 data to model a “SUSTAIN 7-like” trial (oral sema vs. Trulicity 1.5mg) for western markets. Furthermore, PIONEER 10 will likely help Novo’s GLP-1RA market position in Japan where Victoza now trails Trulicity (discussed below).

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Dance Biopharm Raises $24.5M for Inhaled Insulin Development

Dance Biopharm announced it has raised $24.5M in private equity financing to help support the development of its inhalable insulin, Dance 501. According to the press release, Dance Biopharm plans to initiate Ph3 studies in 2019. Below, FENIX provides thoughts on Dance 501 including potential read through from Afrezza.

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Dasiglucagon Ph3 Meets Primary and Secondary Endpoints

Zealand Pharma announced positive topline results and held a subsequent investor call to discuss data from its Ph3 pivotal dasiglucagon hypoglycemia rescue trial. Below, FENIX provides an overview of the results and potential impact on the glucagon rescue market.

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Novo Cuts 400 Jobs in Denmark/China and Confirms Shift in R&D Strategy

Novo Nordisk announced plans to restructure its R&D organization which includes cutting 400 R&D jobs in Denmark and China. Novo is also establishing a new BD unit in Cambridge, MA to help facilitate additional R&D collaborations. This news comes as no surprise and is consistent with FENIX’s previous insight regarding Novo’s shift in R&D strategy as evidenced by 7 external R&D collaborations/acquisitions thus far in 2018. Below, FENIX provides thoughts on Novo’s new R&D strategy.

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Oramed Oral GLP-1RA Receives IND Approval

Oramed announced FDA cleared its IND application for ORMD-0901, an oral GLP-1RA believed to be using exenatide. According to the press release, Oramed is planning to initiate a Ph1 PK study in Q3 ’18 with intentions to move into Ph2 in 2019. The Ph1 study has not yet been posted on CT.gov, but the press release said the Ph1 study will be a 4-way crossover vs. Byetta in 15 healthy subjects. Below, FENIX provides thoughts on ORMD-0901 in the context of Novo’s oral semaglutide.

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