Shots:
Tozorakimab reinforced its potential as a first-in-class COPD biologic with a third positive Phase III trial (MIRANDA), complementing OBERON and TITANIA and strengthening AstraZeneca’s regulatory package while validating IL-33 as a critical therapeutic pathway in COPD.
The MIRANDA trial demonstrated efficacy across one of the broadest COPD populations studied for a biologic, including former and current smokers, patients across…
Shots:
GSK has entered into a worldwide exclusive license agreement with Empirico to develop & commercialize EMP-012
As per the deal,Empirico will lead P-I development of EMP-012, following which GSK will take over global development, regulatory filings, & commercialization, with Empirico receiving $85M upfront, ~$660M in development, regulatory & commercial milestones, & tiered royalties on…
Shots:
Fosun Pharma has granted Expedition global rights to develop, manufacture, & commercialize XH-S004, excl. Mainland China, Hong Kong SAR, & Macau SAR, where Fosun will retain its rights
As per the deal, Fosun will receive $120M incl. upfront & development milestone payments, with ~$525M in sales milestones
XH-S004 (DPP-1 inhibitor, PO) is being investigated…
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GSK will obtain an exclusive global license to HRS-9821, an add-on maintenance therapy for COPD, along with exclusive option rights to develop & commercialize ~11 more programs in oncology, respiratory, immunology, & inflammation globally (excl. mainland China, Hong Kong, Macau, & Taiwan for both)
Each of the ~11 additional programs will have its own…
Shots:
Merck has entered into a definitive agreement to acquire Verona Pharma incl. its asset Ohtuvayre (ensifentrine), expanding its cardio-pulmonary pipeline & portfolio
As per the deal, Merck will acquire Verona Pharma for $107 per American Depository Share (ADS), each representing 8 ordinary Verona shares, for an aggregate of ~$10B; closing expected in Q4'25
Ohtuvayre…
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P-III (AERIFY-1 & AERIFY-2) trials assessed itepekimab (SC, Q2W or Q4W) vs PBO as an add-on therapy in pts (40-85yrs.) with mod. to sev. COPD, who haven’t smoked for ≥6mos.; data to be discussed with regulatory bodies
AERIFY-1 (n=1127) met its 1EP of reduced exacerbations, with Q2W (n=375) showing a 27% reduction at Wk.…
Shots:
Viz.ai has entered into a multi-year collaboration with Sanofi & Regeneron to deploy and evaluate its AI-powered chronic obstructive pulmonary disease (COPD) workflow solution
Sanofi, Regeneron, and Viz.ai collaborated on an AI-powered solution to improve care for high-risk COPD pts, focusing on how the Viz COPD module can enhance EHR workflows, access to care,…
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The UK’s MHRA has approved Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF) with HFO-1234ze(E), a next-generation, near-zero global warming potential (GWP) propellant for treating COPD in adults; regulatory review is ongoing in EU, China & other regions
Approval was based on a next-generation propellant clinical development program assessing Trixeo + HFO-1234ze(E) vs Trixeo + HFA-134a,…
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Recently AstraZeneca and Amgen presented the results in late-breaking session from the COURSE trial, a proof-of-concept study evaluating tezepelumab in COPD
The PoC study was carried out in people with moderately to very severe COPD with a broad range of eosinophil levels
Today, at PharmaShots we have Robert Fogel from AstraZeneca, Janet Franklin from…
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The CHMP’s positive opinion of Dupixent as an add-on maintenance therapy for uncontrolled COPD patients with type 2 inflammation was based on P-II (BOREAS & NOTUS) studies assessing its safety & efficacy for the same
Studies met the 1EP depicting a 34% reduction in annualized moderate or severe acute COPD exacerbations, sustained lung function…

