Pharmaceutical giant GSK (NYSE: GSK) (LSE: GSK) (formerly GlaskoSmithKline) announced the acquisition of Canadian late-stage biopharmaceutical company, BELLUS Health (TSX: BLU) (NASDAQ: BLU) adding camlipixant, a drug working with refractory chronic cough (RCC) presently in Phase III trials to its list of potential producers.
The specifics include paying USD$14.75 per share of common stock in cash with a total of approximately USD$2 billion.
Approximately 28 million patients suffer from chronic cough, with 10 million patients globally and 6 million in the United States (US) and European Union (EU) suffering from RCC for over a year. RCC is defined as a persistent cough that lasts for more than eight weeks and does not respond to treatment for an underlying condition or is otherwise unexplained.
This condition significantly impacts quality of life, with patients experiencing depression (53 per cent), urinary incontinence (approximately 50 per cent), pain, rib fractures, social withdrawal, and loss of sleep. Unfortunately, there are no approved medicines for RCC in the US and EU.
P2X3 is a validated biological target that plays a role in cough reflex hypersensitization, and camlipixant is a highly selective P2X3 antagonist. Current clinical data suggest that camlipixant can reduce cough frequency for patients suffering from RCC by selectively inhibiting P2X3 receptors.
Unlike other medicines that broadly target the P2X2/3 receptor and lead to taste disturbance adverse events, camlipixant has a relatively low incidence of the taste disorder, dysgeusia. This is important because taste disturbances often lead to patients discontinuing treatment. In the phase IIb trial, low rates of taste-related adverse events were reported at all doses.
“Patients suffering from severe forms of refractory chronic cough can experience over 900 coughs daily, resulting in quality-of-life issues,” said Luke Miels, chief commercial officer for GSK.
“Camlipixant, a novel, highly selective P2X3 antagonist, has the potential to be a best-in-class treatment with significant sales potential.
#News for #investors and #media: Today we announced the proposed acquisition of @BELLUSHealth, a clinical stage biopharmaceutical company that further strengthens our specialty medicines and respiratory pipeline.
— GSK (@GSK) April 18, 2023
GSK expects positive phase III data due in 2024
GSK has expressed that the proposed acquisition of BELLUS is a great fit for their portfolio of specialty medicines, and aligns well with their expertise in respiratory therapies. GSK is confident that their leading R&D, manufacturing, and commercialization capabilities will support and enhance BELLUS’s research and development efforts.
Once camlipixant receives regulatory approval and launches in 2026, the acquisition is expected to have a positive impact on adjusted EPS from 2027 onwards. This acquisition also has the potential to generate significant sales throughout 2031 and beyond.
In December 2021, BELLUS announced positive data from the SOOTHE phase IIb trial, which met the primary endpoint for the 50 milligrams and 200 milligrams twice-daily doses. Based on these findings, BELLUS initiated the CALM phase III development programme, consisting of the CALM-1 and CALM-2 trials. The data from these trials is anticipated to be available in H2 2024 and 2025, respectively. Additionally, BELLUS is also evaluating a once-daily formulation for camlipixant, which is currently in phase I.
The acquisition of BELLUS by GSK will be carried out through a plan of arrangement, which involves acquiring all outstanding shares of BELLUS in exchange for USD$14.75 per share in cash. This transaction is subject to customary conditions, such as court approval, approval by at least 66.67 per cent of the votes cast at a meeting of BELLUS’ shareholders, approval by a majority of the votes cast by non-interested shareholders, and regulatory agency approval. The deal is expected to close in Q3 of 2023 or earlier.
The per-share price represents a premium of about 103 per cent to BELLUS’ closing stock price on April 17, 2023, and approximately 101 per cent to BELLUS’ volume-weighted average price (VWAP) over the past 30 trading days. The board of directors of BELLUS has unanimously recommended that shareholders approve the acquisition.
GSK will consider the acquisition as a business combination and predicts it will be accretive to adjusted EPS in 2027, which is the anticipated first year of sales for camlipixant.