Category Archives: Topics

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in the context of the recent insulin conversion from a drug to a biologic as well as the November 2019 immunogenicity draft guidance.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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Cellectis Q4 ’19 Earnings Update

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.

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Kite Acquires Rights to Certain Teneobio Antibodies for Multiple Myeloma CAR-T Therapies (including BCMA)

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).

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CGM: Thoughts on Lifescan/Sanvita CGM Trial Impact from COVID-19

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.

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Biocon’s Malaysian Facility Passes Pre-Approval Glargine FDA Inspection

Biocon has issued a press release announcing they received the FDA “Establishment Inspection Report” for the bs-glargine pre-approval inspection of its Malaysian manufacturing facility. The closing of the inspection comes after several failed inspections over the past few years. Below, FENIX provides thoughts on Biocon passing its inspection, including the impact on the impending June 2020 bs-glargine FDA action date.

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Glucagon: Zealand Submits NDA for Dasiglucagon HypoPal Rescue Pen

Zealand Pharma announced it has submitted the dasiglucagon HypoPal Rescue Pen NDA for the treatment of severe hypoglycemia. Below, FENIX shares thoughts on the filing as well as the potential impact on the current glucagon rescue market including Lilly’s Baqsimi and Xeris’s Gvoke.

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DAPA-CKD Stopped Early for Overwhelming Efficacy

AstraZeneca announced that an independent data monitoring committee (DMC) has recommended stopping the DAPA-CKD study early due to overwhelming efficacy. According to CT.gov, the early trial closeout is ~8 months ahead of the full trial completion date (initially scheduled to complete in November 2020). Below, FENIX provides thoughts on DAPA-CKD in the context of Janssen’s CREDENCE, which was also stopped early, as well as potential read through to BI/Lilly and Lexicon.

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FENIX Analysis: Ozempic and Trulicity CV Indication Initial Promotion

Novo Nordisk and Lilly have updated their Ozempic and Trulicity HCP websites with new messaging for their respective CV protection indications. Below, FENIX provides an initial HCP website promotional analysis, which includes insight into how the differences in the respective indications could potentially blur HCP perceptions of the Ozempic and Trulicity brands.

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Senseonics Suspends US Commercial Sales to New Patients

In a recent 8K SEC filing, Senseonics disclosed that it will no longer ship Eversense implantable CGMs to new customers in the US; however, the company intends to maintain supply for existing customers. The news comes just days after Senseonics announced plans to explore strategic options for the company, including a potential sale. Below, FENIX provides additional thoughts on Senseonics’s current position.

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