Regeneron's (REGN) Dupixent Meets Pivotal COPD Study Goal, Up 7%
Regeneron REGN along with partner Sanofi SNY announced positive data from the pivotal phase III BOREAS study on their blockbuster drug, Dupixent (dupilumab), for treating chronic obstructive pulmonary disease (COPD) in adults aged 40 through 80 years.
The study achieved both its primary and secondary endpoints. Data from the BOREAS study showed that participants who were administered Dupixent achieved a 30% reduction in moderate or severe acute COPD exacerbations — the primary endpoint — over a 52-week treatment period against placebo. Treatment with the drug also led to improved lung function, quality of life and reduction in disease symptoms.
Shares of Regeneron were up 6.8% on Mar 23 in response to the positive data announcement. Sanofi’s stock also rose 6.0% post the announcement.
Currently, people suffering from COPD indication have limited treatment options. No novel treatments have been approved targeting this indication in over a decade, even though the disease is the third leading cause of death worldwide. Management estimates that around 300,000 people are living with uncontrolled COPD with type II inflammation in the United States.
Following the latest data announcement, Regeneron/Sanofi’s Dupixent is now the first and only biologic to demonstrate clinically meaningful and statistically significant reductions in exacerbations over placebo in COPD patients. Many large-cap pharma giants like AstraZeneca AZN and GSK GSK have failed to achieve statistical significance in their clinical studies targeting COPD indications. Smoking is also a key risk factor for COPD.
A CNBC article also pointed out that based on this encouraging data, analysts at JP Morgan expect Regeneron to generate an additional $1.5 billion to $2 billion from Dupixent product sales, provided the drug is eventually approved for the COPD indication.
Shares of Regeneron have risen 11.2% in the year so far against the industry’s 6.4% decline.
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Dupixent is being jointly marketed by Regeneron and Sanofi under a global collaboration agreement. Sanofi records global net product sales of Dupixent, while Regeneron records its share of profits/losses in connection with the drug’s global sales. The drug is currently approved in the United States and Europe for five type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis and prurigo nodularis.
Dupixent has become the key driver of the top line for both Regeneron and Sanofi. Dupixent generated global product sales of $8.7 billion in 2022, which were recorded by Sanofi, representing 40% year-over-year growth. With outside U.S. revenues accelerating and multiple approvals for new indications and expansion in younger patient populations expected, its sales are likely to be higher.
Dupixent is now annualizing at close to €9.0 billion in sales after around five years on the market. Sanofi expects Dupixent to achieve more than €13 billion in peak sales and €10 billion in 2023.
Sanofi and Regeneron are also studying dupilumab in late-stage studies in a broad range of diseases driven by type II inflammation, like bullous pemphigoid and chronic spontaneous urticaria.
In 2018, AstraZeneca announced that two phase III studies – GALATHEA and TERRANOVA – evaluating its IL-5 inhibitor Fasenra (benralizumab) failed to meet the primary endpoint of a statistically-significant reduction of exacerbations in COPD patients. AstraZeneca’s Fasenra is currently approved by the FDA in severe eosinophilic asthma indications since 2017. Currently, AstraZeneca is evaluating another pipeline candidate, mitiperstat, in a mid-stage study in COPD indication, which was initiated in first-quarter 2023.
Like AstraZeneca, a similar setback was also faced by GSK in COPD studies. In 2018, the FDA issued a complete response letter (CRL) to GSK’s regulatory filing seeking label expansion for its successful IL-5 inhibitor Nucala (mepolizumab) in COPD. The FDA issued the CRL as it required more clinical data on the drug before granting approval in the COPD indication. The drug is still being evaluated in a late-stage study in COPD by GSK.
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