Tag Archives: Diabetes

Zealand/Beta Bionics Initiate iLet In-home Closed-Loop Trial

Zealand and Beta Bionics announced the first patients have been dosed in Beta Bionics’s iLet in-home closed-loop trial. Recall, during Zealand’s Q1 ’19 earnings call, senior management disclosed that the Ph3 pivotal dual-hormone iLet study is projected to initiate in 2020. Below, FENIX provides an overview of the trial as well as thoughts on the potential market outlook for a dual-hormone closed-loop system and impact on Zealand’s dasiglucagon business.

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Lilly’s Lispro Authorized Generic Now Available in US Pharmacies

Lilly announced that its insulin lispro authorized generic (LAG) is now available. In March 2019, Lilly disclosed its intention to launch the AG at a 50% lower WAC price compared to Humalog; $137.35 per vial (assumed to be a 10mL vial) and $265.20 for a package of five KwikPens. According to the press release, Lilly said it is working with payers to gain broad coverage of the LAG; however, at least one large national payer, ESI, recently said it will not cover the LAG. Below, FENIX provides thoughts and context to Lilly’s LAG lispro launch.

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CREDENCE Priority Review for Invokana; PDUFA Projected in Late September 2019

Janssen announced that FDA granted Priority Review for the Invokana CREDENCE renal outcomes sNDA which shortens the review time to 6 months. Recall, on March 28, 2019, Janssen announced the sNDA filing which suggests the PDUFA is on or around September 28, 2019. Below, FENIX provides an updated approval timeline as well as thoughts on how a renal protection indication may help to turn around the declining Invokana franchise.

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FENIX Analysis: Insulin Promotional Materials Post-AACE 2019

In the third installment of our post-AACE 2019 promotional material coverage, FENIX has conducted an analysis of insulin promotional materials covering all of the major brands including Tresiba, Lantus/Toujeo, Basaglar, Humalog, Admelog, Afrezza as well as the basal+GLP-1 fixed-ratio combinations (Xultophy and Soliqua).

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Glooko Appoints Mark Clements as CMO

Glooko announced it has appointed Mark Clements as the company’s new CMO. Recall, Clements is a pediatric endocrinologist from Kansas City, MO who has sat on the Glooko board since 2015. He also served as the Pediatric Chair of T1D Exchange. Below, FENIX provides insight into how Clements fits into Glooko’s business needs.

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Lifescan Enters CGM Market with New Partnership; Ty Lee Returns to Lifescan

Lifescan announced it has entered into an exclusive partnership with Sanvita Medical for the distribution of Sanvita’s CGM. According to the press release, the companies are planning to launch the CGM in North America and select EU countries starting as early as mid-2020. Additionally, Lifescan recently appointed former J&J VP, Ty Lee, as the new Head of Marketing. Below, FENIX provides insight on Lifescan being the last of the Big 4 BGM manufacturers to move into the CGM market and thoughts on Ty Lee re-joining the Lifescan organization.

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FDA Warns Against DIY Closed-Loop Systems

FDA issued a safety communication regarding the use of unauthorized devices as part of closed-loop systems. Additionally, FDA said it has identified companies who are “illegally marketing components, such as unauthorized continuous glucose monitors that some patients may integrate into unauthorized automated insulin dosing systems.” According to the FDA communication, the warning is based on a report that a patient received too much insulin resulting in the need for medical intervention. Below, FENIX provides insight on the FDA communication including the potential impact on current closed-loop systems in development as well as thoughts on potential systems that are being marketed illegally.

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New Tirzepatide vs. Semaglutide Ph1 T2DM Clamp Study; Ph3 SURPASS-1 Monotherapy Trial Initiated

Lilly recently initiated two new tirzepatide T2DM studies. The first is a Ph1 clamp study comparing tirzepatide to Novo’s QW injectable semaglutide, and the second is the Ph3 SURPASS-1 monotheraphy trial vs. pbo. Interestingly, the Ph1 trial is evaluating the effect of tirzepatide on α and β cell function. Below, FENIX provides thoughts on both studies including Lilly’s potential rationale for the H2H clamp trial as well as insight as to why SURPASS-1 is longer than Novo’s Ph3 semaglutide monotherapy trial.

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FENIX Analysis: SGLT2i Promotional Materials Post-AACE 2019

In the second installment of our post-AACE 2019 promotional material coverage, FENIX has conducted an analysis of SGLT2i promotional materials covering Jardiance, Farxiga, Invokana, and Steglatro as well as their respective FDCs with DPP-IVi and metformin. Of note, AZ recently updated the Farxiga patient website with a new “Hit Back-Now!” tagline which is further discussed below.

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Zealand Q1 ’19 Earnings Update

Zealand hosted its Q1 ’19 earnings call and provided updates to its diabetes business including dasiglucagon (hypoglycemia rescue, congenital hyperinsulinism, and bi-hormonal closed-loop) and its GLP-1/GCG dual agonist with Boehringer Ingelheim. Recall, Zealand recently disclosed that its dasiglucagon hypoglycemia rescue filing has been delayed to early 2020. Below, FENIX provides highlights and insights from the call.

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