GSK will buy Canadian-based biopharmaceutical company Bellus Health, investing $2 billion. The acquisition will give the U.K.-based pharmaceuticals company access to a cough medicine for the treatment of chronic cough (RCC for short). The drug is currently in Phase III clinical development with anticipated approval and launch in 2026. It is estimated that 28 million patients suffer from chronic cough, including ten million worldwide and six million in the United States and the European Union, with RCC for more than one year.
RCC is defined as a persistent cough for more than eight weeks that does not respond to treatment for an underlying condition or is otherwise unexplained. There are no approved medicines for RCC in both the U.S. and the EU. P2X3 is a validated biological target involved in hypersensitization of the cough reflex. The cough drug is based on the highly selective P2X3 antagonist. Current clinical data show that selective inhibition of P2X3 receptors reduces cough frequency in patients with RCC. This is with a relatively low incidence of taste disturbance that occurs with other drugs that generally target the P2X2/3 receptor. These taste disturbances often cause patients to discontinue treatment. Of note, low rates of less than 6.5 percent taste-related adverse events were reported at all doses in the Phase IIb study.
Luke Miels, Chief Commercial Officer of GSK said: “Patients suffering from severe forms of refractory chronic cough can experience over 900 coughs daily, resulting in quality-of-life issues." He emphasized that the novel, highly selective P2X3 antagonist has the potential to become a highly effective treatment with significant sales potential. The proposed acquisition complements the specialty drug portfolio and builds on the company's proprietary expertise in respiratory therapies.
The acquisition of Bellus expands the expertise of GSK in respiratory medicines and is further supported by GSK's leading research and development, manufacturing and commercialization capabilities. Following the expected approval and launch of the cough medicine in 2026, the acquisition is expected to generate significant sales from 2027. In December 2021, Bellus announced positive data from the Phase IIb "Soothe" study indicating that the primary endpoint was met for the 50 milligram and 200 milligram twice-daily doses. Based on these data, Bellus initiated the Phase III development program "Calm".
