Shares in AstraZeneca PLC, the U.K.'s largest drugmaker, which is developing a COVID-19 vaccine with Oxford University, were boosted by phase 3 data showing that Tezepelumab is effective in severe and uncontrolled asthma, offering hope for patients that have lacked effective treatment options to date.
Cambridge, U.K.- based AstraZeneca reported that tezepelumab met its primary endpoint by reducing exacerbations when added to standard of care asthma treatment over 52 weeks in the phase 3 Navigator trial. No meaningful side effects were observed in the trial, in which the standard of care was medium- or high-dose inhaled corticosteroids and at least one further medicine to control the condition, with or without oral corticosteroids.
AstraZeneca shares closed the session 2.7% higher at 8,530.00 pence. The FTSE 100 index closed up 1.7% at 6,296.8 as markets rallied following Pfizer Inc. and BioNTech SE's positive COVID-19 vaccine results. Like Pfizer, AstraZeneca is developing a vaccine against the coronavirus.
Tezeplumab also demonstrated efficacy in smaller patient groups consisting of those with low levels of a type of white blood cell called eosinophils, which accounts for about 30% of patients, for whom there is no drug available today. Medicines to treat severe, uncontrolled asthma include GlaxoSmithKline PLC's Nucala, Sanofi and Regeneron Pharmaceuticals Inc.'s Dupixent and AstraZeneca's own Fasenra. But these are only approved for patients with high levels of eosinophils.
"Our surveyed consultants believe tezepelumab has the potential to become the standard of care in asthma as a first-use biologic, and the efficacy and safety results from Navigator provide a strong pathway to reach that goal," said SG Cowen analyst Steve Scala. "With demonstrated efficacy in low eosinophil cell count subgroups, tezepelumab could achieve broad-label approval for an area with high unmet medical need."
Peter Welford at Jefferies is forecasting "a perhaps conservative" $1.5 billion worldwide peak sales at 50% probability for 80p/share net present value (1%) as profits are shared with partner Amgen Inc. Barclays have penciled in peak sales forecast of $2.0 billion, of which a total of $1.02 billion will go to AstraZeneca and the rest to its partner. Both companies share costs and profits equally, with AstraZeneca taking the lead in development and Amgen in manufacturing.
Severe asthma affects about 34 million people worldwide and onset can often happen in adulthood. Tezepelumab, which was granted breakthrough status in 2018 in the U.S., is a potentially first-in-class medicine that blocks the action of thymic stromal lymphopoietin, or TSLP, which plays a key role in inflammation in asthma. Full data from Navigator trial, the first phase 3 trial to show benefit in severe asthma by targeting TSLP, will be unveiled at a medical meeting in 2021.
"We think tezepelumab could compete with Dupixent sales but the market is large, underserved, and tezeplumab worked in a population where Dupixent saw less activity," said Alethia Young at Cantor Fitzgerald.
Sanofi's Dupixent was used in only 9% of the biologics class as of December 2019, which shows how underpenetrated the market still is, Young said in a research note. "We think the drugs will find their own niche given tezepelumab saw statistically significant reductions for low eosinophil groups whereas Dupixent did not have benefit in this subgroup." Furthermore, tezepelumab is only focused on severe patients, whereas Dupixent is focused on moderate-to-severe patients.
"Tezepelumab works differently from any other asthma biologic medicine and targets multiple inflammatory pathways that contribute to asthma symptoms and exacerbations," said AstraZeneca's head of Biopharmaceuticals R&D, Mene Pangalos. "These are exciting data that bring us one step closer to delivering a medicine to severe asthma patients, including those with low eosinophil counts."