Category Archives: Dual/triple agonist

BI Returns Amylin Analog WW Rights to Zealand

Late Friday, Zealand announced it regained the WW development rights for its Amylin analog program, which was previously licensed to Boehringer Ingelheim. Of note, BI will continue to develop BI456906 (QW GLP-1/GCG dual agonist in Ph2) that was also licensed from Zealand for the treatment of T2DM and obesity. Below, FENIX provides insights on the potential factors influencing BI’s decision to return the development rights of the Amylin analog program back to Zealand.

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AstraZeneca Q4 ’19 Earnings Update

AstraZeneca hosted its Q4 ’19 and FY ’19 earnings call and provided updates to its diabetes business. Of note, AZ disclosed it received Fast Track designation for the development of cotadutide (dual GLP-1/GCG agonist) for the treatment of NASH. Below, FENIX provides highlights and insights from the call.

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New Novo GLP-1/GIP Ph1 Trial?

A CT.gov record has been observed for a new Novo Nordisk Ph1 trial evaluating the co-administration of subcutaneous semaglutide and a novel, unidentified compound (NNC0480-0389). Below, FENIX provides an overview of the trial as well as insights as to why NNC0480-0389 is believed to be a GIP agonist.

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Novo Q4 ’19 London Earnings; Sanofi and BD Q4 ’19 Earnings Updates

Novo Nordisk hosted its post-Q4 ’19 earnings event in London. Furthermore, Sanofi and Becton Dickinson held their respective Q4 ’19 earnings calls. Below, FENIX provides highlights and insights from the earnings calls including Sanofi’s plans to divest its interest in efpeglenatide as well as thoughts on how Novo’s QW basal insulin icodec could have broader implications to the hybrid closed-loop market.

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Tirzepatide CVOT Record Available on CT.gov

A new CT.gov record for Lilly’s tirzepatide CVOT (SURPASS CVOT) has been observed. The trial details are consistent with Lilly’s discussion during its recent Q4 ’19 earnings call. Below, FENIX provides an overview and brief thoughts on the SURPASS CVOT study.

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Positive Topline Novo QW Insulin Results; Novo Q4 ’19 Earnings Update

Novo Nordisk hosted its Q4 and FY 2019 earnings call and provided updates to its diabetes business, including a Rybelsus launch update as well as Ph2 topline results for its QW insulin LAI287 (now called insulin “icodec”). Below, FENIX provides highlights and insights from the call.

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Lilly and Roche Q4 ’19 Earnings Updates

Lilly and Roche hosted their respective Q4 and FY 2019 earnings calls and provided updates to their respective diabetes businesses. Of note, Lilly disclosed additional information regarding the impending initiation of the tirzepatide T2DM CVOT, and Roche indicated it plans to pursue smartphone pump control. Below, FENIX provides highlights and insights from the calls including thoughts on how Lilly’s tirzepatide CVOT trial design compares to the 2008 FDA Guidance.

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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 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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Tirzepatide CVOT vs. Trulicity; Lilly 2020 Guidance Summary

Today, Lilly hosted its 2020 Guidance and Investment Community Meeting and discussed potential key milestones for 2020. Importantly, Lilly disclosed that its tirzepatide CVOT will be conducted H2H vs. Trulicity. Below, FENIX provides highlights and insights from the call including thoughts on why a tirzepatide CVOT vs. Trulicity makes sense.

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