Tag Archives: Diabetes

JNJ 2019 Pharmaceutical Business Review

JNJ hosted its 2019 Pharmaceutical Business Review and provided updates on the company’s global pharmaceutical strategy including its diabetes and cardiovascular business. Of note, discussion on Invokana was limited with prepared remarks primarily highlighting the recent CREDENCE results. Below, FENIX provides diabetes-related highlights and insights from the presentation.

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Lilly oral dual agonist comments @ BAML

Lilly’s president of diabetes, Enrique Conterno, participated in a fireside chat at the 2019 BAML Conference (webcast link here). For what is believed to be the first time, Conterno commented that Lilly is looking to develop an oral GIP/GLP-1 based on its current understanding from tirzepatide (injectable GIP/GLP-1) and having a non-peptidic oral GLP-1RA (OWL833) licensed from Chugai (Ph1 ready; previous FENIX insight).  Below, FENIX provides thoughts on Lilly’s oral GLP-1 development strategy.

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Zealand’s Dasiglucagon Filing Delayed; Positive Ph3 Dasiglucagon Topline Results

Zealand announced positive topline results for its confirmatory Ph3 hypoglycemia rescue study evaluating dasiglucagon administered via the HypoPal autoinjector. Of note, Zealand also said its FDA filing timeline has been pushed back to early 2020 (previously YE ’19) based on recruitment difficulties with its Ph3 pediatric study. Below, FENIX provides an overview of the Ph3 HypoPal topline results in the context of Zealand’s pursuit of a commercial partner as well as thoughts on the potential impact of the regulatory filing delay.

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FDA Issues Final Guidance on Biosimilar Interchangeability

Late last week, FDA issued the final guidance on biosimilar interchangeability titled, “Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry.” Below, FENIX provides thoughts on the FDA interchangeability guidance in the context of the insulin market.

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FENIX Analysis: GLP-1RA Promotional Materials Post-AACE 2019

In advance of ADA 2019 beginning June 7, FENIX has conducted a comprehensive analysis of new and recent promotional materials obtained at the AACE 2019 conference. In the first installment, FENIX analyzes GLP-1RA promotional materials, to be followed by a separate analysis on SGLT2i, insulin (+GLP-1RA/insulin FRC), and diabetes devices. The GLP-1RA FENIX analysis covers Ozempic, Trulicity, Bydureon, and Victoza.

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Senseonics, BD, and Xeris Q1 ’19 Earnings Updates

Senseonics and Beckton Dickinson hosted their respective CY Q1 ’19 earnings calls and provided updates to their diabetes businesses. Additionally, Xeris Pharmaceuticals released its Q1 ’19 earnings but did not have an associated call. Of note, BD disclosed that the launch of its T2DM patch pump (called “Swatch”) will be delayed after it received feedback from FDA. Below, FENIX provides highlights and insights from the calls.

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MannKind and Mylan Q1 ’19 Earnings Updates

MannKind and Mylan both hosted their respective Q1 ’19 earnings calls. Of note, Mylan did not discuss its biosimilar insulin programs (including bs-glargine) or bs-glucagon. Below, FENIX provides highlights and insights from the MannKind earnings call.

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LY3305677 Lilly’s Oxyntomodulin? New Ph1 Trial Observed

A new Ph1 study of an early Lilly compound has been observed on CT.gov. LY3305677 is believed to be Lilly’s Ph1 injectable oxyntomodulin analog. Recall, in 2016, Lilly opted out of developing the Transition Therapeutics oxyntomodulin analog (TT401; now being developed by OPKO as OPK88003). Below, FENIX provides the rationale for why LY3305677 is likely Lilly’s oxyntomodulin and thoughts on its development in light of tirzepatide (GLP/GIP dual agonist) already moving to Ph3 in both T2DM and obesity.

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Novo Q1 ’19 London Earnings Update

Novo Nordisk hosted its post-Q1 ’19 earnings event in London. The session included a brief presentation from management followed by Q&A. Below, FENIX provides highlights and insights from the call.

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