Sanofi Reports Positive Phase III Data for Dupixent in Chronic Spontaneous Urticaria, Reinforcing €10B Sales Ambition

Compiled and Translated by | Tom Li

Recently, Sanofi announced Phase 3 trial data for Dupixent in moderate-to-severe chronic spontaneous urticaria. The trial results demonstrated that, compared with patients treated with antihistamines alone, Dupixent significantly improved itching and hives.

Clinically, physicians typically treat this condition with antihistamines or Roche’s Xolair, but the disease remains inadequately controlled in many patients. During a conference call with analysts on Thursday, Bill Sibold, Executive Vice President of Sanofi Genzyme, stated that among the 300,000 patients eligible for biologic therapy, approximately 15% are currently taking Roche’s Xolair. However, roughly half of these patients still have uncontrolled disease. Sanofi believes that Dupixent therapy could ultimately cover approximately 30% of the patient population refractory to antihistamines.

Sibold stated that Dupixent possesses the "right characteristics" for success in the chronic spontaneous urticaria field, given its favorable safety profile and the ability for patients to self-administer the therapy and manage their condition at home. Sanofi plans to submit the regulatory filing for Dupixent for the treatment of chronic spontaneous urticaria next year. Developed on Regeneron’s VelocImmune platform, Dupixent is the first and currently only fully human antibody targeting IL-4Rα. The drug inhibits IL-4 and IL-13 signaling and is currently co-commercialized by Sanofi and Regeneron. Previously, Dupixent has reported positive pivotal data across five indications.

Dupixent received FDA approval in late March 2017 and is currently approved for the treatment of multiple conditions driven by type 2 inflammation, including moderate-to-severe atopic dermatitis (in patients aged ≥6 years), moderate-to-severe asthma (in patients aged ≥12 years), and chronic rhinosinusitis with nasal polyps (CRSwNP, in adult patients). In March this year, the FDA accepted a supplemental Biologics License Application (sBLA) for Dupixent to treat pediatric patients aged 6 to 11 years with uncontrolled moderate-to-severe asthma. In December last year, the European Commission expanded the EU marketing authorization for Dupixent (dupilumab) to include the treatment of children aged 6 to 11 years with severe atopic dermatitis.

For atopic dermatitis and two other inflammatory indications, Dupixent generated revenue of €1.24 billion in the second quarter of 2021, up 57% on a constant currency basis. Sibold stated during a Thursday conference call that Dupixent's current annual sales stand at €5 billion.

In addition to its blockbuster drug Dupixent, vaccines represent another key pillar of the company's strategy, with the vaccine business generating €1 billion in revenue this quarter, a 16% increase. Together with GlaxoSmithKline, the company plans to launch a COVID-19 vaccine by the end of this year. Sanofi has also been committed to strengthening its oncology business, which generated €226 million in revenue in the second quarter, reflecting a 25% increase.

According to the company's latest financial report for the second quarter of 2021, Sanofi reported Q2 net sales of €8.744 billion, up 6.5% year-on-year. Net income stood at €1.21 billion, down 84% year-on-year. Earnings per share (EPS) were €0.97, compared with €6.07 in the same period last year. Sanofi’s free cash flow for the second quarter was €1.428 billion, a 29% year-on-year decrease. Net cash generated from operating activities in the first half of the year amounted to €4.754 billion, up 21% year-on-year. Meanwhile, Sanofi continues to actively implement cost-cutting measures, achieving annualized savings of €2.1 billion to date.

Sanofi will utilize its surplus cash to invest in its business to help drive its growth momentum. Previously, in February this year, Sanofi set a €10 billion annual sales target for Dupixent, with CEO Hudson stating that the drug's development is "still in its early stages."

Source: Sanofi's Dupixent, amid €10B sales push, posts positive data in chronic spontaneous urticaria