GlaxoSmithKline (GSK) adds an early-stage drug to its respiratory pipeline offering a new approach to chronic obstructive pulmonary disease (COPD)
GlaxoSmithKline's respiratory medicines portfolio spans newly approved products to treat COPD as well as drug candidates in various stages of clinical development to treat this common lung disease. The pharmaceutical giant is now adding another drug to its pipeline, paying $85 million for the rights to an early stage drug that brings a new treatment to chronic obstructive pulmonary disease.
The drug comes from San Diego-based Empirico, a startup that discovers and develops small interfering RNA (siRNA) therapeutics. Drugs in this class use RNA interference to reduce gene expression of disease motor proteins. Empirico's drugs are derived from proprietary technologies, one for genetically validated target discovery and the other for the discovery and development of siRNA drugs. The target of Empirico's COPD drug candidate EMP-012 remains undisclosed.
GlaxoSmithKline (GSK) has a long history in respiratory medicines. Its top respiratory product is Trelegy, an inhaled combination therapy approved to treat asthma and chronic obstructive pulmonary disease. The drug generated revenue of 2.7 billion pounds (about $3 billion) last year. Nucala, an antibody designed to inhibit the pro-inflammatory signaling protein IL-5, was originally approved in 2015 to treat severe asthma. The monthly shot is also a blockbuster, with revenue set to reach £1.7 billion ($2.2 billion) across all approved indications by 2024.
COPD is Nucala's latest approved use. The FDA approved the indication in May, putting the Glaxo product in competition with Dupixent, the blockbuster antibody drug from Sanofi and Regeneron Pharmaceuticals that last year became the first biologic drug approved for chronic obstructive pulmonary disease. Like Dupixent's regulatory approval for COPD, the new FDA approval of Nucala specifically covers COPD patients characterized by high levels of eosinophils, a type of white blood cell. An exaggerated immune response by eosinophils leads to so-called type 2 inflammation. An estimated 40% of COPD patients have a disease driven by type 2 inflammation. Empirico's EMP-012 provides an opportunity to help others.
GSK did not disclose details about EMP-012's target, but said the drug addresses unique inflammatory pathways. The company added that the target is “supported by extensive genetic data and translational insights, providing confidence in its potential.” In addition to addressing a new target, Empirico's drug also has enhanced potency and a longer dosing interval, GSK said, without specifying that interval.
GlaxoSmithKline said Empirico's drug can be used as a monotherapy or in combination with assets in its COPD portfolio and pipeline. The pipeline includes depemokimab, an IL-5 drug. The long-acting antibody is designed to be administered every six months. The IL-33-targeting antibody GSK3862995 is in phase 1 testing.
In announcing the deal on Tuesday, Kaivan Khavandi, GlaxoSmithKline's senior vice president and global head of respiratory, immunology and inflammation, said the agreement reflected the pharmaceutical company's goal to advance new targets that address underlying drivers of disease.
“With its anticipated long-acting properties and ability to target different inflammatory pathways, EMP-012 complements our pipeline of multiple treatment modalities for the treatment of COPD and builds on inhaled and biologic therapies currently available in this area of unmet need,” he said.
Under the terms of the agreement, GlaxoSmithKline acquires full global development and commercial rights to EMP-012. Empirico will complete the drug's ongoing Phase 1 testing; GlaxoSmithKline is responsible for further clinical development, regulatory submissions and commercialization upon approval. In addition to the $85 million upfront payment, the deal also entitles Empirico to receive up to $660 million in development, regulatory and commercial milestone payments. If EMP-012 enters the market, Empirico will receive royalties from GSK on global net sales of the product.
Illustration: CIPhotos via Getty Images
