Dive Brief:

• GSK will pay privately held Empirico $85 million for the rights to an experimental therapy that may treat a range of patients with chronic obstructive pulmonary disease, or COPD.
• Empirico is currently testing the drug, known as EMP-012, in a Phase 1 clinical trial. Once that research is complete, GSK will take over development and handle regulatory filings and marketing if the medicine wins approval, the two companies said Tuesday.
• As part of the deal, Empirico may receive payments of as much as $660 million more from GSK if the drug reaches certain development, regulatory and commercial milestones. Empirico will also be eligible for tiered royalties on worldwide sales.

Dive Insight:

GSK is already a major player in the respiratory market with well-known drugs including Advair and Trelegy Ellipta that are used to treat both asthma and COPD. In recent years, it’s been making a concerted effort to build up its COPD pipeline, striking a major alliance with Hengrui Pharma in July that came with a COPD medication.

The British drugmaker also fought through an initial rejection of a bid to expand the use of its Nucala medicine to include COPD patients in 2018. After conducting another major study in COPD, GSK finally won approval of the expanded label for Nucala earlier this year.

COPD is a fast-growing market with not enough successful treatments, GSK and Empirico say. They cited research suggesting that as many as 600 million people will suffer from the disease by 2050, with the condition becoming the leading cause of all hospital admissions.

Empirico’s drug is especially attractive because it has the potential to treat “a broad spectrum” of COPD patients, the companies say. Nucala and Regeneron and Sanofi’s Dupixent – the first biologic approved to treat COPD – focus on a subset of patients.

EMP-012 is an oligonucleotide designed to modulate gene expression. The drug targets an inflammatory pathway implicated in COPD that isn’t related to any specific risk factor, such as smoking, co-morbid disease or the “type 2 inflammation” Dupixent specifically disrupts. The companies said the medicine has potential as both a COPD monotherapy and as part of a combination with other GSK therapies.