Category Archives: Bolus Insulin

Lilly to Invest $400M in Diabetes Manufacturing

Lilly announced plans to invest $400M in its Lilly Technology Center campus in Indianapolis. The capital investment is said to include enhancements to existing manufacturing facilities that make Lilly insulin, expanding capacity for other marketed diabetes products, and initial capital investments for future medicines. Below, FENIX provides brief thoughts on Lilly’s investments including insights into which products are likely benefiting.

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Novo 2019 Capital Markets Day Highlights and Analysis

Novo hosted its 2019 Capital Markets Day and provided updates on the strategic direction of the company through 2025 including commercial activities and R&D strategy. Of note, Novo provided clarity on Rybelsus positioning vs. Ozempic and competitor products as well as details on novel drug delivery technologies, including two oral peptide delivery methods being developed at MIT and the semaglutide+AM833 injection device. Below, FENIX provides details and insights from the call.

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Sanofi Ends Sensile Medical Partnership; Onduo Parnters with Hidrate; Other Diabetes-Related News

A series of diabetes-related news has been observed today including Sanofi canceling its deal with Sensile Medical, a new Onduo partnership with Hidrate, an update to Oramed’s oral insulin program, and pre-clinical islet replacement data from Kadimastem. Below, FENIX provides highlights and insights for each respective news item.

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New Ph1 LY900027 RAI Compound Could Be For Closed Loop

A Ph1 trial for a new Lilly compound (LY900027) has been observed on CT.gov. Below, FENIX provides thoughts on what the potential MOA could be particularly given the similarity in compound ID with Lilly’s ultra-rapid-acting insulin lispro (URLi), LY900014.

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AZ’s Qtrilmet Triple-combo Receives EC Approval; New Data from Fractyl, Dario, and Valeritas

Today, a series of diabetes-related news has been observed including the EC approval of AZ’s Qtrilmet (dapa+saxa+met triple FDC)as well as new data from Fractyl, Dario, and Valeritas related to the concurrent Diabetes Technology Meeting occurring in Bethesda. Below, FENIX provides highlights and insights on the respective news items.

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Oramed Oral Insulin (ORMD-0801) Ph2b T2DM Results Unclear

Oramed announced topline results from the first cohort of the Ph2b study evaluating its prandial oral insulin (ORMD-0801) in T2DM patients. Of note, the study is evaluating QD, BID, and TID dosing, but only the QD and BID arms demonstrated a statistically significant result on A1C. Oramed projects data from the second cohort of this Ph2b study will be available in Q1 ’20. Below, FENIX provides thoughts on the potential commercial opportunity for oral insulin as well as unanswered questions into why the TID treatment arm did not reach statistical significance.

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MannKind Q3 ’19 Earnings Update

MannKind hosted its Q3 ’19 earnings call and provided updates to its diabetes business. Of note, MannKind disclosed a new, three-pronged strategy to drive Afrezza adoption. Below, FENIX provides highlights and insights from the call.

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Mylan and BD Q3 ’19 Earnings Updates

Mylan and Becton Dickinson hosted their respective Q3 ’19 earnings calls. Of note, Mylan provided a brief update on its insulin development program (in partnership with Biocon). Below, FENIX provides diabetes-related highlights and insights from the calls.

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Novo has a PCSK9i; Novo Q3 ’19 Earnings Update

Novo Nordisk hosted its Q3 ’19 earnings call (press release) and provided updates to its diabetes business, including details on the Ozempic and Rybelsus launches, discontinuation of an oral GLP-1RA (OG2023SC) due to promising new formulations of oral semaglutide, and other pipeline activities. Of note, Novo disclosed that it is developing a PCSK9i compound for potential co-formulation with its other pipeline products. Below, FENIX provides highlights and insights from the call.

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Sanofi Discontinues Tri-Agonist; Sanofi Q3 ’19 Earnings Update

Sanofi hosted its Q3 ’19 earnings call and provided updates to its diabetes business unit. Importantly, Sanofi disclosed it has discontinued the development of its Ph1 GLP/GIP/GCG triple agonist (SAR441255). Of note, Q3 ’19 was the first earnings call with its new CEO, Paul Hudson. Sanofi will also be hosting a Capital Markets Day on December 10 to discuss the company strategy under new senior leadership. Below, FENIX provides highlights and insights from the call including thoughts on the future of Sanofi in the diabetes market.

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