Category Archives: Topics

JPM 2020 Day 4: Lexicon and Hanmi; Generic Jardiance Tentative Approval

On the final day of JPM 2020, there was a single diabetes-related presentation from Lexicon, which highlighted the upcoming CDER decision on sotagliflozin in T1DM as well as the expansion of the SOLOIST-WHF trial to include non-T2DM patients. Furthermore, Hanmi’s presentation at JPM was not webcast, but the company issued a press release with highlights of its obesity and NASH pipeline. Separately, FDA recently granted tentative approval to Alembic LTD for a generic version of BI/Lilly’s Jardiance. Below, FENIX provides highlights and insights from the respective news items including additional insight and context from the ongoing litigation between BI and Alembic.

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JPM 2020 Day 3: No Diabetes Webcasts; Tandem Launches Control IQ; ADA Endorses Drug Affordability Bills

On the third day of JPM 2020, there were no webcasts for any diabetes-related presentations. Separately, Tandem announced the launch of its t:slim X2 with Control IQ. Tomorrow (the final day of JPM 2020), FENIX will cover the Lexicon presentation (the only diabetes session). Below, FENIX provides brief thoughts on the Control IQ launch.

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JPM 2020 Day 2: LLY, NVO, LVGO, SNY, PODD, ABT, and BD

On the second day of JPM 2020, FENIX has provided coverage of presentations by major diabetes manufacturers including Lilly, Novo Nordisk, Livongo, Sanofi, Insulet, Abbott, and BD. Additionally, Lilly issued a separate press release announcing the addition of Humalog Mix75/25 KwikPen and the Humalog Junior KwikPen to its insulin savings program. Further, Biocorp issued a press release noting a strengthening of the relationship with Sanofi for the Mallya connected pen solution. Below, FENIX provides a topline summary of key takeaways by company followed by more in-depth coverage.

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JPM 2020 Day 1: DXCM, LVGO, Novo, Bigfoot Biomedical, Companion Medical, MDT

On the first day of JPM 2020, FENIX has provided coverage of presentations by major diabetes manufacturers including Dexcom, Medtronic, Teva, J&J, and Merck. Additionally, four separate diabetes-related news items have been observed including new collaborations between Dexcom/Livongo and Novo Nordisk/Fauna Bio as well as funding rounds from Companion Medical and Bigfoot Biomedical. Below, find a topline summary of key takeaways by company followed by more in-depth coverage.

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Livongo Partners with Higi; Dario Hires New President and Head of NA

Two diabetes-related connected care news items have been observed. First, Livongo announced it has partnered with Higi to make Livongo for Diabetes and Livongo for Hypertension available at Higi’s “Smart Health Stations.” Additionally, Dario Health appointed Rick Anderson as the company’s new President and General Manager of North America. Below, FENIX provides thoughts and insights into the respective news items.

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Farxiga DAPA-HF receives priority review; Fiasp pediatric approval in US; MannKind launching in Brazil

A series of diabetes-related news items were observed today from AstraZeneca, Novo Nordisk, and MannKind. AZ announced FDA filing acceptance and granting of priority review for the Farxiga DAPA-HF sNDA. According to AZ, the PDUFA date is in Q2 2020. Additionally, Novo announced US approval of Fiasp for pediatric populations. Further, MannKind announced that it has received approval of the proposed price of Afrezza in Brazil, and intends to commence marketing and distribution the week of January 13, 2020. Below, FENIX provides context and insights regarding these news items.

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Enrique Conterno’s Retirement Doesn’t Last Long

Fibrogen announced it has appointed Enrique Conterno as its new CEO. Recall, during Lilly’s Q3 ’19 earnings call, the company announced that Conterno would retire at the end of 2019 to be succeeded by Mike Mason. Below, FENIX provides brief thoughts on Conterno’s new role as the head of Fibrogen.

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Thoughts on ADA 2020 Standards of Care

ADA recently updated its Standards of Medical Care in Diabetes for 2020, which includes key additions across multiple drug classes. Of note, the standards now include a recommendation for initiating SGLT2i or GLP-1RA therapy in patients with ASCVD, HF, or CKD (SGLT2i only) who are already at their A1C goal. Interestingly, while the guidelines were updated to include discussion of the CANVAS/R, CREDENCE, DECLARE, REWIND, and CARMELINA trials, CAROLINA and DAPA-HF trials were not addressed. Below, FENIX provides thoughts and market implications for selected guideline updates.

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Novo Launches Insulin Savings Program

With the start of the new year, Novo Nordisk announced the launch of its insulin savings program called “My$99Insulin” as well as authorized generics (AG) of NovoLog and NovoLog Mix products. With the My$99Insulin program, patients are able to purchase “up to three vials or two packs of FlexPen/FlexTouch/Penfill pens of any combination of insulins from Novo Nordisk Inc. for $99.” Recall, Novo first disclosed plans to offer its insulin affordability program in September 2019. Below, FENIX provides additional thoughts on the My$99Insulin program.

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