GSK’s respiratory drug lineup spans a newly approved product for chronic obstructive pulmonary disease as well as therapeutic candidates in various stages of clinical development for treating this prevalent lung disorder. The pharmaceutical giant is now adding one more to its pipeline, paying $85 million to secure rights to an early-stage drug that brings a novel approach to COPD.
The drug comes from San Diego-based Empirico, a startup that discovers and develops small-interfering RNA (siRNA) therapies. Drugs in this class of medicines leverage RNA interference to reduce a gene’s expression of a disease-driving protein. Empirico’s drugs come from proprietary technologies, one for genetically validated target discovery and the other for discovery and development of siRNA medicines. The target for Empirico’s COPD drug candidate, EMP-012, remains undisclosed.
GSK has a long history in respiratory drugs. Its top respiratory product is Trelegy Ellipta, an inhaled combination therapy with approvals in both asthma and COPD. This drug tallied £2.7 billion (about $3 billion) in revenue last year. Nucala, an antibody designed to inhibit the pro-inflammatory signaling protein IL-5, was initially approved in 2015 for severe asthma. The once-monthly injection is also a blockbuster seller, accounting for £1.7 billion (about $2.2 billion) in revenue in 2024 across all of its approved indications.
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COPD is the newest approved use for Nucala. FDA approval in May in this indication keeps the GSK product competitive with Dupixent, the blockbuster Sanofi and Regeneron Pharmaceuticals antibody medication that last year became the first biologic drug approved for COPD. Like Dupixent’s COPD regulatory nod, the new FDA approval of Nucala specifically covers patients whose COPD is characterized by high levels of eosinophils, a type of white blood cell. Excessive immune response from eosinophils leads to what’s called type 2 inflammation. An estimated 40% of COPD patients have disease driven by type 2 inflammation. Empirico’s EMP-012 offers the opportunity to help the rest of them.
Without disclosing details about EMP-012’s target, GSK said this drug addresses a distinct inflammatory pathway. The company added that the target is “backed by extensive genetic data and translational insight, providing confidence in its potential.” Beyond addressing a novel target, GSK said Empirico’s drug offers enhanced potency and a longer dosing interval, though that interval was not specified.
GSK said Empirico’s drug could be used as a monotherapy and in combinations with assets across its COPD portfolio and pipeline. That pipeline includes depemokimab, an IL-5 drug. This long-acting antibody is designed for dosing every six months. An IL-33-targeting antibody, GSK3862995, is in Phase 1 testing. In July, GSK licensed HRS-9821, an early-stage Hengrui Pharma COPD drug candidate designed to block two enzymes, PDE-3 and PDE-4. That mechanism could make the drug competitive with Verona Pharma’s Ohtuvayre, an inhalable PDE-3/4 inhibitor that was approved for COPD last year. Merck recently closed its acquisition of Verona for $10 billion, a price that reflects the market opportunity in COPD and other respiratory diseases.
In the Tuesday announcement of the deal, Kaivan Khavandi, GSK’s senior vice president & global head, respiratory, immunology & inflammation, said the agreement reflects the pharma company’s goal to advance novel targets addressing underlying drivers of disease.
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“With its expected long-acting characteristics and ability to target distinct inflammatory pathways, EMP-012 complements our pipeline of diverse modalities in COPD and builds on the current landscape of inhaled and biologic therapeutics in this area of substantial unmet need,” he said.
Under the terms of the agreement, GSK gets full global development and commercial rights to EMP-012. Empirico will complete the ongoing Phase 1 test of the drug; GSK is responsible for further clinical development, regulatory submissions, and if approved, commercialization. Beyond the $85 million upfront payment, the deal puts Empirico in line for up to $660 million in development, regulatory and commercial milestones payments. If EMP-012 reaches the market, Empirico will receive royalties on GSK’s global net global sales of the product.
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