Category Archives: Topics

Abbott Q1 ’20 Earnings Update; Provention Bio Initiates Rolling BLA for Teplizumab; Lilly Launches Additional Humalog AGs; Insulet’s COVID-19 Response

A series of diabetes-related news has been observed: Abbott hosted its Q1 ’20 earnings update, Provention Bio announced the initiation of a rolling BLA submission for teplizumab, Lilly announced the launch of lispro authorized generics (LAG) for Humalog Mix 75/25 and Humalog Junior, and Insulet initiated its COVID-19 response plan. Below, FENIX provides highlights and insights for the respective news items.

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J&J Q1 2020 Earnings Update

On Tuesday, April 14, J&J held their Q1 ‘20 earnings call (press release / slides). While the call focused predominantly on J&J’s response to the COVID-19 crisis, the company stated that filing of JNJ-4528 (BCMA CAR-T) continues to be projected for H2 2020. J&J also emphasized their determination to reduce the impact of the pandemic on their ongoing clinical trials. Below, FENIX provides highlights and analysis from the call, including how JNJ-4528’s upcoming filing may impact BMS’s ide-cel, the current BCMA CAR-T frontrunner.

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Afrezza Promotional Update; MannKind Receives $4.9M Forgivable Loan

MannKind recently updated the Afrezza patient website with new promotional messaging, which aligns with the recent corporate rebranding. Additionally, MannKind announced the company has received a forgivable loan under the Paycheck Protection Program of the CARES Act. Below, FENIX provides an analysis of the updated Afrezza messaging as well as brief thoughts on the impact of COVID-19 to MannKind and the Afrezza brand.

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Novo Offers Free Insulin in COVID-19 Response

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.

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J&J Q1 ’20 Earnings Update

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.

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Thoughts on i2O, the Harvard Oral Peptide Delivery Spinout

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.

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Livongo Partners with Prognos Health

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.

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Abbott’s Libre in Hospitalized Patients; Companion Medical Launches Fixed Dose and Meal Estimation

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.

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Lannett Bs-glargine Regulatory Update

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.

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Trulicity CV Protection DTC Initiated; Lilly Announces $35 Co-Pay for COVID-19 Help

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.

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