Novo Nordisk announced plans to give away 90-day supplies of insulin for people who have lost their health insurance due to the COVID-19 pandemic. Below, FENIX provides thoughts on Novo’s response as well as insight into how Novo could be using the program for lead generation and to neutralize biosimilar insulin competition.
Johnson & Johnson hosted their Q1 ’20 earnings call and briefly touched on the Invokana franchise. Unsurprisingly, much of the call was focused on the impact of COVID-19, which led J&J to lower its 2020 guidance. Below, FENIX provides diabetes-related highlights and insight from the call.
A new Harvard spinout called i2O Therapeutics has raised $4M in seed funding from Sanofi Ventures and JDRF T1D Fund. Of note, the company was created with the intention of commercializing a novel oral peptide delivery technology initially directed toward diabetes. Below, FENIX provides insight into why i2O may be using oral insulin development as a stepping stone to other molecules and thoughts on how Sanofi may be leveraging its diabetes expertise without committing to R&D.
Livongo announced a partnership with Prognos Health to integrate Prognos’s clinical lab insights with the Livongo applied health signals platform. Prognos is a clinical data repository that uses AI to form data-driven insights for pharma, HCPs, and payers. Below, FENIX provides insights on the partnership and thoughts on how Prognos could improve outcomes in the wake of the COVID-19-driven movement toward telemedicine.
Two diabetes-related news items have been observed: Abbott issued a press release announcing the FreeStyle Libre 14 day CGM is now being utilized in the US for diabetes patients hospitalized during the COVID-19 outbreak and Companion Medical announced they have launched fixed dose and meal estimation options for the InPen app. Below, FENIX provides thoughts on how Abbott’s COVID-19 response may act as lead generation for Libre, Dexcom’s potential response to Abbott, and insights on Companion Medical’s updated InPen app.
Lannett announced it has a Biosimilar Biological Product Development Type II meeting scheduled with FDA on June 9 to discuss the next steps in the clinical advancement of its biosimilar glargine. Lannett is developing the bs-glargine in partnership with YiChang HEC ChangJiang Pharmaceutical Co. (HEC Pharm). Below, FENIX provides insights on the Lannett development program in the context of the recent insulin conversion from a drug to a biologic as well as the November 2019 immunogenicity draft guidance.
Two diabetes-related items have recently been observed from Lilly: the launch of the Trulicity CV protection patient DTC and a press release announcing Lilly’s Insulin Value Program and $35 co-pay as a COVID-19 response measure. Below, FENIX provides thoughts on the CV protection indication promotion for Trulicity, how it compares to Novo Nordisk’s recent Ozempic CV protection indication DTC, and brief thoughts on the Lilly insulin program.
On Thursday, March 5, Cellectis held their Q4 ‘19 earnings call, providing updates on their CAR-T clinical development program as well as their expanding manufacturing capabilities. In addition, the company provided further color around their recently-updated deal with Servier. Below, FENIX provides highlights and insights from the call, including their significance in the context of an increasingly-competitive CAR-T landscape.
On Thursday April 2, Kite (a Gilead company) announced that it had entered into a license and collaboration agreement with Teneobio, granting Kite exclusive rights to specific antibodies targeting BCMA in multiple myeloma. Kite’s decision to re-enter the BCMA space follows Gilead’s discontinuation of its own BCMA CAR-T, KITE-585, in late 2018. Below, FENIX provides key takeaways and analysis from this new agreement, particularly in the context of Teneobio collaborations with other key players in the BCMA space: AbbVie and Poseida Therapeutics (who also has the backing of Novartis).
With the ongoing COVID-19 pandemic, a number of clinical trials have been impacted across the industry. Lifescan/Sanvita Medical’s CGM pilot study, in particular, is ongoing but it remains unclear if or how COVID-19 will impact the overall development of the novel CGM. Recall, in May 2019, Lifescan announced it entered into an exclusive agreement with Sanvita Medical to distribute the Sanvita CGM. Below, FENIX provides thoughts on the impact of COVID-19 on Lifescan/Sanvita’s CGM trial, the possibility of FDA favoritism for Libre 2 from Abbott’s COVID-19 testing wins, as well as the potential impact on Dexcom’s CGM business.