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.
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.
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.
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.
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.
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.
The first tirzepatide Ph3 obesity study (SURMOUNT-1) has been observed on CT.gov. Below, FENIX provides an overview of the trial, thoughts on the tirzepatide obesity program in the context of Novo Nordisk’s ongoing Ph3 semaglutide obesity program (STEP), and a projection of how far behind Lilly could be.
Lilly announced plans to invest $400M in its Lilly Technology Center campus in Indianapolis. The capital investment is said to include enhancements to existing manufacturing facilities that make Lilly insulin, expanding capacity for other marketed diabetes products, and initial capital investments for future medicines. Below, FENIX provides brief thoughts on Lilly’s investments including insights into which products are likely benefiting.
Novo hosted its 2019 Capital Markets Day and provided updates on the strategic direction of the company through 2025 including commercial activities and R&D strategy. Of note, Novo provided clarity on Rybelsus positioning vs. Ozempic and competitor products as well as details on novel drug delivery technologies, including two oral peptide delivery methods being developed at MIT and the semaglutide+AM833 injection device. Below, FENIX provides details and insights from the call.
Novo Nordisk and Dicerna announced a partnership for the discovery and development of RNAi therapeutics targeting liver-related cardio-metabolic diseases including T2DM, NASH, obesity, other chronic liver diseases, and rare diseases. Following the announcement, Dicerna hosted a call with investors to discuss the implications to its business. Below, FENIX provides thoughts on the Novo/Dicerna partnership, particularly in the context of Dicerna’s other existing partnerships including Lilly and Boehringer Ingelheim (separately from the BI/Lilly CV/Met alliance).