AstraZeneca PLC’s (LON:AZN) lupus treatment reported “significant” positive data in late-stage clinical trials, in the second attempt after last year’s underwhelming results in a race with rival Johnson & Johnson (NYSE:JNJ) to get similar candidates to market.
The FTSE 100-listed company said 47.8% of patients using anifrolumab in phase III achieved “a statistically significant and clinically meaningful reduction” of symptoms compared to 31.5% of those who used placebo, with both groups receiving treatment for a year.
The drug, which is a clone of human antibodies that block some proteins involved in the inflammatory process, would be the first new medicine approved for systemic lupus erythematosus in the last 60 years.
Benlysta has been approved for subcutaneous dosing to allow patients to conveniently self-inject at home, while AstraZeneca is still studying subcutaneous anifrolumab in phase II trials.
US rival J&J is in phase III trials of its lupus candidate, Stelara, which has shown a 60% response rate with the same benchmark as Benlysta, although the latter only reached 43% and 58% in two separate trials. Stelara can also be injected.
Potential market size
According to broker Shore Capital, the market opportunity for AstraZeneca could be between US$4bn and US$5bn, based on 130,000 patients with moderate-to-severe lupus in the US, while Benlysta reported 2018 sales of £473mln with 35% growth.
“The most recent company-compiled consensus from AstraZeneca had risk-adjusted (c50%) peak sales of $524m for anifrolumab,” analysts said in a note.
“We are comfortable with the consensus estimate given the potential market opportunity highlighted above and the difficulty with lupus drug discovery which leaves Benlysta as the only newly approved therapy in 60 years.”
Shares were little changed at 7,262p on Tuesday morning.