Category Archives: Dual/triple agonist

Diabetes Takes a Backseat During Part II Drug Pricing Hearing

Today, the Senate Finance Committee held the second drug pricing hearing of 2019 (Drug Pricing in America: A Prescription for Change, Part II). Part I was held on January 29, 2019. While the Part I drug pricing hearing spent much time discussing insulin pricing, diabetes-specifically was hardly mentioned. When a specific drug was mentioned, it was most often AbbVie’s Humira. Below, FENIX provides diabetes-related highlights and insights from the hearing.

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Farxiga LCM and Litigation Update; AZ Q4 ’18 Earnings Summary

AstraZeneca hosted its Q4 ’18 earnings call and provided a brief update on its diabetes business including Farxiga LCM initiatives (T2DM CVOT, T1DM, HF, and CKD). Of note, as part of AZ’s business reorganization, MedImmune has been fully integrated including the dissolution of the MedImmune name. Below, FENIX provides highlights and insights from the earnings call including thoughts the generic dapa patent dispute, PDUFA projections for Farxiga T1DM and DERIVE CKD, and AZ’s dual agonist from MedImmune.

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Sanofi Discontinues 2 Dual-Agonist Programs; Q4 ’18 Earnings Update

Today, Sanofi hosted its Q4 ’19 earnings call, provided updates to its diabetes business, and disclosed that it discontinued SAR425899 (GLP-1/GCGR) and SAR438335 (GLP-1/GIP) for the treatment of obesity in T2DM and T2DM, respectively. Of note, Sanofi’s CEO will be testifying at the February 26, 2019 Senate Committee hearing on drug pricing. Below, FENIX provides highlights from the call as well as thoughts on Sanofi’s position in diabetes, obesity, and NASH.

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No REWIND PRV Mentioned; Lilly Q4 ’18 Earnings Update

Lilly hosted its Q4 ’18 earnings call and provided brief updates to its diabetes business including its REWIND outlook, Jardiance tailwinds, URLi regulatory filing, and CAROLINA topline results. Of note, Lilly discontinued development of the Ph2 DACRA-042 compound from KeyBioscience. Below, FENIX provides highlights and analysis from the call.

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JPM 2019 Day 2: LLY, SNY, LXRX, ABT, PODD, MYL

The second day of the 2019 J.P. Morgan Healthcare conference included diabetes-related presentations from Lilly, Sanofi, Lexicon, Mylan, Abbott, and Insulet. Separately, Lilly announced plans to further increase drug pricing transparency using Trulicity TV DTC. The commercials will include a portion directing patients to a Lilly website for more information on list price and average copays. Below, find a topline summary of key JPM takeaways by company followed by more in-depth coverage. In case you missed it, here is a link to FENIX’s Day 1 JPM 2019 insights. Lilly Lilly’s CEO provided a brief introduction to the company and referenced the……

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Lilly 2019 Guidance Summary

Today, Lilly hosted its 2019 Guidance and Investment Community Meeting and discussed potential key milestones for 2019. Importantly, Lilly announced late stage development plans in obesity and NASH and provided more information on the Ph3 dose titration for its QW injectable GIP/GLP-1 dual agonist tirzepatide. Connected care was also featured, and several comments were made on guidelines updates and new PBM coverage positively affecting Trulicity and Jardiance in 2019. Below, FENIX provides a summary and thoughts on diabetes-related highlights from the event.

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Thoughts on the Regulatory Environment in Diabetes

The regulatory environment in diabetes has greatly evolved in the last 10 years since the 2008 FDA CV risk guidance. As recently as ADA and now through EASD in 2018, FENIX considers the regulatory environment in the US and Europe to be highly favorable for sponsors developing diabetes drugs, devices, and technological solutions. Below, FENIX provides its perspective in a winners and losers analysis on how the highly favorable regulatory environment could be positively impactful to the key upcoming 2019 market events in diabetes from sponsors like Lexicon, Sanofi, AZ, Janssen, Novo Nordisk, Xeris, Lilly, BI, Dexcom, Senseonics, Abbott/Bigfoot, Tandem, Insulet, and Medtronic.

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REWIND Safety Issue? Lilly Q3 ’18 Earnings Update

Lilly hosted its Q3 ’18 earnings call and provided updates to its diabetes business including commentary on the recent REWIND topline results. Of note, Lilly’s first Ph3 study for its GIP/GLP dual agonist, now called tirzepatide, has been posted on CT.gov. Furthermore, Lilly said it has purchased a priority review voucher (PRV), but did not disclose how it will be used. Below, FENIX provides its new thoughts on REWIND safety, why Lilly’s PRV would be used for REWIND, and other key highlights from the earnings call.

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Positive Trulicity CVOT Creates Many Market Implications

Lilly announced positive topline results from the Trulicity CVOT, REWIND, demonstrating a reduction in 3P-MACE in a patient population which included ~70% primary prevention. Of note, Lilly did not provide any Hazard Ratios so the amount of CV protection remains unclear. Below, FENIX provides thoughts on the potential impact to guidelines and the GLP-1RA market if FDA grants a broader CV indication (reduction in 3P-MACE in T2DM patients with CV risk factors) than the Victoza, Jardiance, and Invokana labels.

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Novo Q3 ’18 London Earnings Event

Novo Nordisk hosted its post-Q3 ’18 earnings event in London. The session was primarily comprised of Q&A with topics including high dose Ozempic as well as an update on Novo’s priority review voucher. Below are highlights from the call.

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