Category Archives: Bolus Insulin

New Novo Insulin Savings Program

Novo Nordisk announced plans to initiate a new US insulin savings program starting on January 2, 2020. Under the new plan, Novo will offer a $99 Cash Card Program for a select volume of any of its insulin analog products as well as the launch of NovoLog and NovoLog Mix Authorized Generics (AG). Below, FENIX provides thoughts on the New Novo insulin program in the context of similar programs by Lilly and Sanofi.

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Lilly Wins in Arbitration with Adocia

Lilly announced that an arbitration panel ruled in favor of Lilly with regard to a claim filed by Adocia over the former partnership between the two companies. The panel decided that Lilly is not liable to pay damages. Adocia issued its own statement and held a subsequent call with investors in which it disagreed with the findings of the panel. Below, FENIX provides additional commentary from Adocia and insights into the future potential of the Adocia’s BioChaperone franchise.

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Novo: Updated FENIX Viewpoint; Novo Q2 ’19 London Earnings Update

Novo Nordisk hosted its post-Q2 ’19 earnings event in London. Consistent with previous quarters, the session included a brief presentation from Novo management followed by Q&A. Below, FENIX provides highlights from the call including a scenario of reasonable likelihood around FENIX’s previous assertion questioning whether Novo is able to pursue accelerated approval for its anti-IL 21 + liraglutide T1DM beta cell preservation therapy. Additionally, FENIX includes an example of recent precedence set by FDA whereby FDA used an adcom to inform a regulatory decision about granting accelerated approval.

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Novo: REDUCE-IT Adcom Readthrough to Oral Sema? MYL Generic Victoza Filed; Q2 ’19 Earnings Update

Novo Nordisk hosted its Q2 ’19 earnings call and provided updates to its diabetes business including the recent initiation of the first-in-human study of its novel basal insulin FSI965 as well as Ph2 completion of its anti-IL 21+liraglutide Ph2 trial in new-onset T1DM. Additionally, Novo disclosed that Mylan notified Novo of an ANDA Paragraph IV filing for generic Victoza. Below, FENIX provides highlights and insights from the call including potential readthrough from the recently scheduled Amarin REDUCE-IT adcom (and likely PDUFA delay) to the ongoing oral semaglutide FDA review.

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Empa T1DM Filed with FDA; Oral GLP-1RA Advanced to Ph1; Lilly Q2 ’19 Earnings Update

Lilly hosted its Q2 ’19 earnings call and provided updates across its diabetes business. Of note, Lilly’s pipeline now lists empa T1DM as being filed (FDA refused to accept the initial sNDA). Following the 36-week results from Lilly’s AWARD-11 study, Lilly said it plans to file high-dose Trulicity with regulatory authorities “by late 2019.” Furthermore, Lilly’s oral GLP-1RA, called “GLP-1 NPA” (GLP-1 non-peptide agonist), has advanced to Ph1. Below, FENIX provides diabetes-related highlights and insights from the call, including the assumption that the REWIND CHMP agenda listing for July was only for adoption of supplementary information.

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Sanofi Q2 ’19 Earnings Update

Sanofi hosted its Q2 ’19 earnings call and provided updates to its diabetes business unit including the recent Ph1 initiation for its GLP/GIP/GCG triple agonist (SAR441255). Unsurprisingly, Sanofi did not discuss its recent decision to terminate the Lexicon partnership for sotagliflozin. Below, FENIX provides diabetes-related highlights and insights from the call.

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Biocon CY Q2 ’19 (FY Q1 ’20) Earnings Update

Biocon hosted its CY Q2 ’19 (FY Q1 ’20) earnings call and briefly discussed its biosimilar insulin programs including bs-glargine and bs-aspart. Of note, Biocon recently initiated three Ph1 PK/PD studies for its rHI portfolio. Below, FENIX provides highlights and insights from the call.

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REWIND CHMP Decision This Week; CHMP Agenda Highlights

The CHMP agenda for this week’s meeting has been released, and it includes eight notable items of which Lilly’s REWIND is likely the most significant. Below, FENIX provides diabetes-related highlights and insights from the CHMP agenda.

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