Takeda bumps Entyvio peak sales, lays out dengue vaccine plans and celiac pipeline in latest earnings call

27 Oct 2022
endpts.com
Vaccine
Takeda projected optimism in Thursday’s first-half fiscal earnings call across its portfolio, announcing a boost in peak sales estimates for its already blockbuster IBD med Entyvio along with positive news on its dengue vaccine Qdenga and celiac disease pipeline. The positive outlook punctuated overall sales growth on first-half revenue of $13.6 billion, up 5.5%. CEO Christophe Weber attributed the growth to strong sales led by Entyvio (+17%), hereditary angioedema drug Takhzyro (+31%) and plasma product HyQvia (+17%). For Entyvio, anticipating a subcutaneous approval on the horizon, Takeda upped peak annual sales for the drug to $7.5-$9 billion, a jump up from previous projections of $5.5-$6.5 billion. It projected $5.4 billion in sales for the current fiscal full year 2022 sales (ending March 2023) and said it’s on track to file for the subcutaneous injectable version of the currently IV-only drug by end of fiscal year 2023 (ending March 2024). Takeda received a CRL for subcutaneous Entyvio in 2019; however, that was related to the design and labeling of the device and not product safety or efficacy data, the pharma reported last year. Takeda is working with the FDA on the new submission. When asked about the range, Ramona Sequeira, Takeda’s president of the global portfolio division, said the lower end of the new peak would reflect a rejection of the subcutaneous version — which Takeda does not expect — but would rather account more for competition in the space. Entyvio competitors in the crowded markets for ulcerative colitis and Crohn’s disease include J&J’s Janssen’s Stelara, Pfizer’s Xeljanz and AbbVie’s Humira, Rinvoq and Skyrizi, along with multiple sclerosis oral med Zeposia from Bristol Myers Squibb getting a recent UC nod. On the vaccine business, Takeda touted its Qdenga dengue vaccine prospects already approved in Indonesia, recently notching a positive CHMP recommendation and ready for FDA filing before the end of its fiscal 2022. With an 84% decrease in hospitalizations and 61% reduction in symptomatic cases — plus no important safety risks over the four-and-a-half-year study — Takeda said it’s confident in Qdenga’s prospects. While Sanofi’s Dengvaxia is already approved, Qdenga would be different in that it does not require a pre-vaccination blood test to determine if a person has already had the disease. Sequeira tackled a Qdenga pricing question, first pointing out the global problem of dengue disease which is endemic in 100 countries, and said Takeda will roll out tiered pricing that will segment markets based on “healthcare sophistication.” She demurred on specifics, pointing to a Dec. 15 investor meeting where more of Takeda’s Qdenga commercial plans will be discussed. Regarding pipeline development, Takeda R&D chief Andy Plump highlighted its celiac disease portfolio and progress. It recently inked a deal with Zedira and Dr. Falk Pharma on a Phase II drug known as TAK-227. Zedira and Dr. Falk are currently running a 12-week Phase IIb study with celiac patients who are already on a gluten-free diet, as a follow-up to the Phase IIa study challenge study, Plump said. After the Phase IIb is complete, Takeda will take over for the Phase III one-year study following newly released FDA guidelines for what would be needed for a celiac disease drug approval. There is currently no approved drug therapy for celiac disease, although more than a dozen candidates are in trials. This summer, 9 Meters discontinued its candidate larazotide, which was the only Phase III drug under study. Plump said, “We’ll need both histological and patient-reported outcomes, both of which we’ve seen benefits on in our Phase IIa study.” Other Takeda celiac programs include TAK-062, a short-acting oral for potential mealtime dosing, and TAK-101, a systemic immune-modifying nanoparticle candidate.
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