Tag Archives: Diabetes

Sanofi Q2 ’18 Earnings Update; Pfizer Discontinues Ph1 T1DM Compound

Sanofi and Pfizer hosted their respective Q2 ’18 earnings calls. Sanofi only briefly discussed its diabetes business including continued headwinds for its glargine franchise. Of note, Sanofi has recently updated the name of its efpeglenatide CVOT to “AMPLITUDE-O.” Pfizer did not discuss its Steglatro (ertugliflozin) franchise; however, in the pipeline update, it was noted that PF-06342674 (IL-7 receptor precursor modulator) for the treatment of T1DM has been discontinued. Below are highlights from the respective calls.

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New Ozempic Concentrations; Potential Autoinjector in Ph1 Study

A new Ph1 trial comparing different concentrations of semaglutide between FlexTouch, NovoPen4, and a novel injection device (DV3372) has appeared on CT.gov. In the 68-participant study, the current formulation of Ozempic (1.34mg/mL concentration delivered via FlexTouch, a.k.a. PDS290) will be compared to three more concentrated formulations of semaglutide (0.5mg/mL, 1.0mg/mL, and 2.0mg/mL). Below, FENIX analyzes the trial design, including insights regarding a potential Ozempic autoinjector and a reusable injection device, as well as the value of higher concentrations in reducing the amount of pens needed.

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Lexicon Q2 ’18 Earnings Update

Lexicon hosted its Q2 ’18 earnings call and provided updates on sotagliflozin. Discussion centered on the potential FDA adcom for sotagliflozin in T1DM, DKA consensus guidelines being developed by ATTD, and the benefit of sotagliflozin in reducing hypoglycemia.

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Tandem Q2 ’18 Earnings Update

Tandem hosted its Q2 ’18 earnings call and provided updates to its insulin pump business including its closed-loop R&D programs. Tandem has scheduled an institutional investor day for September 25, 2018 where it will provide further updates on its pipeline and international business.

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Biocon/Mylan Glargine CRL; Biocon and Merck Q2 ’18 Earnings

Biocon hosted its CY Q2 ’19 (FY Q1 ’19) earnings call and provided an update on its biosimilar glargine development program including the CRL that was issued in early June 2018. Additionally, Merck hosted its Q2 ’18 earnings call and briefly touched on its diabetes business unit. Below, FENIX provides an overview of the calls and insight on Biocon’s glargine CRL.

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New Abbott Libre 14-Day Wear, 1-Hour Warm-up and Improved MARD Approved

FDA has approved an extended, 14-day wear time (previously 10-day) for Abbott Freestyle Libre in addition to reducing sensor warm-up time to 1 hour (previously 12 hours). In response to this expanded approval, Dexcom’s stock price dropped ~6% today. Abbott has not issued a press release yet, and the Libre US website is not yet updated. Below, FENIX provides insight into the Libre label update as it relates to the CGM market.

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AZ Q2 ’18 Earnings Update

AZ hosted their Q2 ’18 earnings call and briefly discussed their diabetes portfolio, with particular focus on Farxiga and the upcoming DECLARE CVOT results.

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Roche Q2 ’18 Earnings Update

Roche hosted its Q2 ’18 earnings call and briefly discussed its diabetes devices portfolio including Solo micropump, which recently received CE Mark. Importantly, Roche senior management disclosed their intentions to bring the Solo micropump to the US. Below are highlights from the call including insights from Roche’s recent collaboration and investment in Care Innovations.

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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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