Category Archives: Topics

LLY Dual Agonist Advances to Ph3; Q2 ’18 Earnings Update

Lilly hosted its Q2 ’18 earnings call and provided updates on its marketed and pipeline products. Lilly announced three major pipeline updates including advancement of their QW GIP/GLP-1 agonist to Ph3 after meeting a “high bar” in Ph2 trials, filing of nasal glucagon, and discontinuation of their Ph1 GPR142 agonist. Of further interest, President of Lilly Diabetes, Enrique Conterno, indicated the median follow-up for REWIND would be ~5 years (providing an additional ~1 year for Kaplan-Meier curve separation compared to the 3.8-year median follow-up for LEADER).

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Glucagon: Thoughts on Mylan Generic and Novel Launch Timings

The glucagon market for severe hypoglycemia rescue will be evolving in the near future with the anticipated filings of new ready-to-use products from Lilly and Xeris. However, the upcoming Mylan rescue product announced a few months ago will play a significant role in the rescue market ahead of the novel product launches. Below, FENIX provides a rich analysis on the potential timing of the upcoming glucagon rescue entrants from Lilly and Xeris, including also what Mylan’s product may or may not be.

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Roche Patch Pump CE Marked

Roche has received CE Mark for the Accu-Chek Solo micropump. Recall, during Roche’s Q4 ’17 earnings call, the company added the Solo micropump to its European launch timeline. The device had been noticeably absent in recent years. In the coming weeks, Roche will initiate a limited pilot launch starting in Austria, Poland, Switzerland, and the UK. Below, FENIX provides insight into the Solo micropump including its potential use in a closed-loop system.

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CARMELINA CVOT Neutral; No Mention of Superiority

Boehringer Ingelheim and Lilly have announced topline results from CARMELINA, the Tradjenta CVOT, which demonstrated no increased CV risk. BI/Lilly did not discuss whether or not CARMELINA met superiority, but it is assumed the trial was neutral given results from the other DPP-IVi CVOTs. Below, FENIX provides insight into the results including implications from the pre-specified superiority testing plan.

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Novartis Discontinues LIK066 in obesity; Novartis and Abbott Q2 ’18 Earnings Updates

Novartis and Abbott both held their respective earnings calls today and provided updates to their respective commercial and pipeline products. Of note, Novartis disclosed it has discontinued development of LIK066 (dual SGLT1/2 inhibitor) for the treatment of obesity. Abbott believes it will be able to reach 1 million global Libre users by YE ’18. Below are highlights from the respective Q2 ’18 earnings calls.

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Thoughts on CREDENCE

CREDENCE was recently stopped early, bringing a multitude of thoughts and potential implications to the diabetes market. Below, FENIX provides deep, rich analysis on the potential results of CREDENCE, the possibility for CREDENCE to be in a combined FDA review with CANVAS/R, market and label implications, read-through to DECLARE, and how ARB history seems to be repeating itself with SGLT2i.

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J&J Q2 ’18 Earnings Update

J&J hosted its Q2 ’18 earnings call and provided brief updates on its diabetes business. Importantly, senior management did not make any comments regarding the early stopping of the CREDENCE study or the delay in the CANVAS/R CV indication. Below are highlights from the Q2 2018 J&J earnings call.

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Thoughts on CeQur/Calibra Acquisition and T2DM Patch Pump Market

CeQur announced it has acquired global rights to commercialize the OneTouch Via patch pump. CeQur’s interest in OneTouch Via is curious since CeQur has developed its own patch pump (PaQ). According to the press release, CeQur plans to launch the OneTouch Via (branded under a new, undisclosed name) in mid-2019. Below, FENIX provides thoughts on whether CeQur will commercialize both devices as well as insight into the T2DM pump market.

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Invokana Renal Outcomes Study (CREDENCE) Stopped Early

Janssen announced its Invokana renal outcomes study, CREDENCE, has stopped early for overwhelming efficacy. The trial was stopped early based on the recommendation of the Independent Data Monitoring Committee (IDMC) after a planned interim analysis. The news comes ~3 days after FDA delayed approval of Invokana’s CV safety indication.

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Thoughts on Beta Bionics and Implications to Stable Glucagon, Senseonics, and Fiasp

Beta Bionics has initiated (press release) their home-use clinical trial (CT.gov record)of an insulin-only iLet AP system. Additionally, Ed Damiano, Beta Bionic’s CEO, presented at the Friends For Life conference and provided an update on the iLet commercial device. Below, FENIX provides analysis of the iLet study as well as implications to the glucagon market.

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