Category Archives: Topics

Lannett To Forego Bs-Glargine U100 Interchangeability; Lannett Q2 ’20 Earnings Update

Yesterday, Lannett (press release) hosted its CY Q2 ’20 (FY Q4 ’20) earnings call and provided updates to its biosimilar glargine U100 development and regulatory plans. Importantly, Lannett disclosed that its bs-glargine U100 strategy is to forego interchangeability and compete as an “affordable alternative.” Below, FENIX provides highlights and insights from the call, including thoughts on Lannett’s strategy as the 5th-to-market bs-glargine U100 in the US.

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Medtronic CY Q2 ’20 (FY Q1 ’21) Earnings Update

Medtronic hosted its CY Q2 ’20 (FY Q1 ’21) earnings call (press release; slides) and briefly discussed its diabetes business. Of note, Medtronic rescheduled its Investor Day event for October 14, 2020. Below, FENIX provides highlights and insights from the call.

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Kymriah Sales Unaffected By COVID-19, but Ph3 Adult ALL Trial Withdrawn; Novartis Q2 2020 Earnings Update

On Tuesday, July 21, Novartis held their Q2 2020 earnings call (press release / financial report / presentation). Of note, Kymriah sales were resilient despite COVID-19, growing +103% WW QoQ and +27% WW versus Q1 2020. Interestingly, the Ph3 OBERON trial investigating Kymriah in adult ALL has been omitted from Novartis’s pipeline. Below, Celltelligence provides thoughts on Novartis’s cell therapy program, particularly surrounding the withdrawal of the Ph3 OBERON study and the ongoing risks posed by competitors, Gilead and Autolus, on Kymriah’s continued sales growth.

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Bayer Commits ~$100M in One Drop Series C

One Drop and Bayer announced an updated agreement for the joint development of digital health products in CV, oncology, and women’s health. As part of the agreement, Bayer has led One Drop’s $34.7M Series C funding round and has committed to an additional $64M in development fees and potential commercial milestone payments. Below, FENIX provides thoughts on how One Drop got this far with Bayer, if One Drop took a down round, and some potential irony with Bayer’s focus on diabetes.

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One Drop Launches New Membership Program; AZ Partners with RenalytixAI for Chronic Disease Precision Medicine

Two diabetes-related news items have been observed: yesterday, One Drop announced it has launched a new “Digital Membership” platform and AstraZeneca has entered into a partnership with RenalytixAI for “precision medicine strategies” in CV, renal, and metabolic diseases. Below, FENIX provides highlights and insights from the respective news items, including thoughts on why One Drop’s Digital Membership may be an admission that its current diabetes solution and commercial infrastructure is lacking.

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Sensyne to Launch New Diabetes Remote Monitoring Software

Sensyne Health announced it has developed a new diabetes remote management system called “DBm-Health,” which focuses on people at risk of diabetes, pre-diabetes, T1DM, and T2DM. Sensyne plans to launch DBm-Health in the UK over the coming months with a US launch scheduled “toward the end of the current financial year” (March 31, 2021). Of note, Sensyne already offers other remote monitoring solutions for gestational diabetes, hypertension, heart failure, COPD, and COVID-19 (view Sensyne website). According to Sensyne, the new DBm-Health solution was created in response to increasing HCP demand for remote monitoring systems. Below, FENIX provides thoughts on the Sensyne DBm-Health solution, including insight into how some perceived deficiencies of the platform may preclude its use with patients and HCPs.

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FDA Warns Xeris for Misleading Gvoke DTC

FDA’s Office of Prescription Drug Promotion (OPDP) has issued a letter to Xeris regarding misleading advertising for its Gvoke glucagon product (view OPDP letter here; view Xeris Gvoke DTC here). Below, FENIX provides an overview of OPDP’s asserted false or misleading claims as well as implications to the ongoing Gvoke launch.

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Invokana Boxed Warning Removed

The Invokana franchise US labels have been updated (view Invokana label here), and the Boxed Warning for lower limb amputations has been removed. However, it should be noted that warnings for lower limb amputations are still listed under “warnings and precautions.” Below, FENIX provides an overview of the Invokana franchise label updates as well as thoughts on the impact of the Boxed Warning removal.

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Novo Signs New CKD Development Deal with Evotec

Evotec and Novo Nordisk announced a new strategic collaboration focusing on the discovery and development of treatments targeting CKD. Recall, in August 2018, Novo and Evotec entered into an initial partnership targeting diabetes, obesity, NASH, and DKD (previous FENIX insight). Below, FENIX provides brief thoughts on the new collaboration in the context of Novo’s ziltivekimab acquisition, also for the treatment of CKD (previous FENIX insight).

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AZ to Withdraw Qtrilmet Marketing Authorization; CHMP Agenda August 17-20

The CHMP agenda for this month’s meeting (August 17-20) has been released, and it includes one notable item: Qtrilmet marketing authorization withdrawal. Of note, the August 2020 CHMP meeting agenda was just posted today despite the fact that the meeting started on August 17. Additionally, the August CHMP meeting does not include oral explanations, only written procedures. Below, FENIX provides diabetes-related highlights and insights from the August 2020 CHMP agenda.

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