Tag Archives: Januvia

Obesity Spotlight Series: Who is the Next Sanofi?

In the twelfth installment of FENIX’s Obesity Spotlight Series, FENIX asks a provocative question: In today’s obesity market, who will be the next Sanofi? Once a diabetes powerhouse, Sanofi missed both the SGLT2i and GLP-1RA waves, and with the modern-day obesity market projected to exceed $150B by 2035 (view article), the company now finds itself on the sidelines of arguably the biggest growth opportunity in the industry’s history. This Spotlight examines how Sanofi’s past strategic mishaps transformed a potential contender into an observer and which other major pharmas may now be drifting toward the same fate.

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Thoughts on The TrumpRx Launch: The Future Booking.com of Obesity Drugs?

The White House recently launched TrumpRx.gov (view website), an online platform that allows consumers to search for the lowest available cash-pay prices for their prescription medications (view image below). Importantly, the website itself is not the direct point of purchase for consumers; instead, it is a central hub that informs patients of the available out-of-pocket pricing options before redirecting them to purchase the drug by what appears to be two contrasting pathways (discussed below). Below, FENIX outlines how TrumpRx operates, its potential value creation, and why the platform may disproportionately benefit AOM manufacturers.

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Akero Wins with F4 MASH Endpoint; Semaglutide + Enobosarm Combination Data; January 2025 CHMP Agenda

Three cardiometabolic-related news items have been observed: Akero Therapeutics announced positive topline results from its Ph2b SYMMETRY trial (view press release), Veru announced Ph2b semaglutide + enobosarm topline data (view press release); and the CHMP agenda for this month’s meeting (Jan 27-30) has been released (view here). Below, FENIX provides highlights and insights for the respective news items.

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Medicare Price Negotiations; Lilly Targets HCPs Promoting Compounded GLP-1RAs; Arrowhead to Advance Obesity Pipeline; New AZ Ph2 Oral GLP-1RA Obesity Trial; Rivus Ph2 HFpEF Topline Results; Zealand and Fractyl Q2 ’24 Earnings Updates

A series of cardiometabolic-related news items have been observed from CMS, Lilly, Zealand, AstraZeneca, Fractyl Health, and Rivus Pharmaceuticals. Below, FENIX provides highlights and insights for the respective news items.

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Lilly Completes Acquisition of Sigilon and Versanis; Galectin and Nemaura Q2 ‘23 Earnings; August CHMP Agenda

Five cardiometabolic-related news items have been observed: Lilly announced it completed the Sigilon Therapeutics (view press release) and Versanis Bio (view press release) acquisitions; Galectin Therapeutics (view press release) and Nemaura Medical (view press release) reported their respective Q2 ’23 earnings; and the CHMP agenda (view here) for this month’s meeting (August 14-17) has been released. Below, FENIX provides highlights and insights into the respective news items.

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Forxiga Pediatric Indication and Generic Sitagliptin Receive Positive CHMP Opinions

Two cardiometabolic-related news items have been observed: AstraZeneca’s Forxiga received a positive CHMP opinion to include treatment of children aged 10 years and older with T2DM; and generic sitagliptin received a positive CHMP opinion. Below, FENIX provides highlights and insights for the respective news items.

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Lexicon, Merck, and Intercept Q2 ’21 Earnings Update

Three cardiometabolic-related news items have been observed: Lexicon, Merck, and Intercept hosted their Q2 ’21 earnings calls and provided updates to their respective CV/Met businesses. Below, FENIX provides highlights and insights for the calls.

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Thoughts on Pediatric Exclusivity for Saxenda and Januvia

Two diabetes-related news items have been observed: late last week, FDA approved Saxenda for the treatment of obesity in adolescents (view press release); and FDA issued a press release stating the Januvia franchise has not been proven to improve glycemic control in pediatric patients (ages 10-17) with T2DM (view updated Januvia label). Below, FENIX provides thoughts on how the label updates are anticipated to impact the respective brands.

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Lilly, Novartis, Pfizer, and Merck Q3 ’20 Earnings Updates

Lilly, Novartis, Pfizer, and Merck each hosted their respective Q3 ’20 earnings calls and provided updates across a variety of topics. Importantly, it was disclosed that FDA has requested an advisory committee meeting to discuss Novartis’s Entresto PARAGON-HF submission. Below, FENIX provides highlights and insights from the respective earnings calls.

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Merck Q2 ’20 Earnings Update

Merck hosted its Q2 ’20 earnings call (press release; slides) but did not provide any update to its diabetes business beyond the financial performance of its Januvia and Steglatro franchises. Unsurprisingly, much of the call was focused on the company’s COVID-19 vaccine development and oncology portfolio. Below, FENIX provides diabetes-related financial highlights and insights from the call.

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