Tag Archives: Merck

Apple Watch 8 Reportedly Set to Include BGM; Lifescan Launches OneTouch Solutions; Xeris and Merck Collaboration; Dario Partners with New Employer Group; Tidepool Period Project Receives Financial Support

A series of cardiometabolic-related news items have been observed: New reports suggest the Apple Watch Series 8 may include a blood glucose reader (view article); Lifescan announced the launch of OneTouch Solutions; Xeris announced a collaboration agreement with Merck to leverage Xeris’s injection suspension technology “for the purpose of engineering ultra-high concentration, ready-to-use [mAb] formulations”; Dario announced a new agreement with a US national employer; and Tidepool announced it has received financial support from Amazon Web Services (AWS) for Tidepool Period Project. 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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ViaCyte Initiates Ph2 Encapsulated Cell Therapy Trial in T1DM; Lannett, Merck, Roche, and BD Q4 and FY ’20 Earnings Updates; Merck CEO to Retire

A series of diabetes-related news items have been observed: ViaCyte announced the initiation of a Ph2 study of encapsulated cell therapy for the treatment of T1DM; and Lannett, Merck, Roche, and BD hosted their respective CY Q4 ’20 earnings calls. Importantly, Merck announced the retirement of CEO, Kenneth Frazier. Below, FENIX provides highlights and insights for the respective news items, including the observation that Januvia franchise US sales were -16% for FY 2020.

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Verquvo (Vericiguat) Approved by FDA; Label Analysis, Entresto and CYTK Implications

Merck and Bayer received FDA approval of vericiguat, branded as “Verquvo,” for symptomatic chronic HF (Merck press release here and Bayer press release here). Recall, vericiguat received Priority Review from FDA in July 2020 despite the modest 10% RRR in the VICTORIA CVOT primary endpoint (view NEJM publication). For context, Verquvo is the first treatment for chronic HF approved specifically for patients following a hHF or need for outpatient intravenous diuretics. Below, FENIX details its Verquvo label analysis, including the potential for counter-detail by SGLT2i manufacturers, as well as thoughts on the cumulative regulatory tailwinds for Cytokinetics’s omecamtiv.

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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 In-licenses Hanmi’s Dual Agonist for NASH; Generic Empagliflozin Tentative Approval

Two diabetes-related news items have been observed: Merck announced it has entered into an exclusive licensing agreement with Hanmi for the development and commercialization of efinopegdutide, a QW GLP-1/glucagon dual agonist for the treatment of NASH (formerly HM12425A and JNJ-64565111) and Lupin received tentative FDA approval for its generic empagliflozin (view article). Below, FENIX provides thoughts on why Merck has Janssen and Novo to thank for the favorable deal terms.

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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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Ertugliflozin Fails to Demonstrate CV Benefit; Merck and Pfizer Q1 ’20 Earnings Updates

Merck and Pfizer hosted their respective Q1 ’20 earnings calls and provided updates to their diabetes businesses. Importantly, Merck disclosed that the VERTIS CV outcomes trial failed to meet superiority for CV protection. Full results from VERTIS CV are scheduled to be presented during the virtual ADA conference on June 16 at 11:15 AM ET. Below, FENIX provides highlights and insights from the respective earnings calls including thoughts on the surprising VERTIS CV results.

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