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Regeneron Pharmaceuticals’ Dupixent, Kevzara, and Zaltrap

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Apr. 2 2018, Updated 7:32 a.m. ET

Dupixent’s revenue trends

In 4Q17, Regeneron Pharmaceuticals’ (REGN) Dupixent generated revenues of $139.0 million compared to $88.9 million in 3Q17. In fiscal 2017, Dupixent reported net revenues of $256.0 million.

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Recent developments

In March 2018, the FDA accepted Regeneron Pharmaceuticals’ and Sanofi’s (SNY) supplemental Biologics License Application (or sBLA) of Dupixent as additional maintenance therapy in some adult and adolescents with moderate-to-severe asthma. Regeneron Pharmaceuticals and Sanofi’s sBLA was supported by clinical data from three pivotal clinical trials of the LIBERTY ASTHMA clinical development program. The study included 2,888 adolescent and adult patients.

The FDA has provided a Prescription Drug User Fee Act (or PDUFA) action date of October 20, 2018. The approval of Dupixent for label expansion is expected to boost the revenue growth of the drug.

In January 2018, Japan’s Ministry of Health, Labor, and Welfare (or MHLW) approved the marketing and manufacturing authorization for Regeneron’s Dupixent for the treatment of adult individuals with atopic dermatitis that could not be controlled with existing therapies.

According to the collaboration agreement between Regeneron Pharmaceuticals and Sanofi, Sanofi plans to commercialize Dupixent in Japan. In March and September 2017, Dupixent received approval for the treatment of adult individuals with atopic dermatitis by the FDA and the European Commission, respectively.

Kevzara and Zaltrap: Revenue trends

In 4Q17, Kevzara generated revenues of $9.0 million compared to $3.0 million in 3Q17. In fiscal 2017, Kevzara reported net revenues of $12.0 million. Kevzara is used in the treatment of rheumatoid arthritis. In the rheumatoid arthritis drugs market, Kevzara’s peers include Bristol-Myers Squibb’s (BMY) Orencia, AbbVie’s (ABBV) Humira, and Amgen’s (AMGN) Enbrel.

In 4Q17, Zaltrap generated revenues of $25.0 million, compared to $16.0 million in 4Q16 for ~56.0% YoY growth. In fiscal 2017, Zaltrap reported net revenues of $84.0 million, compared to $72.0 million in 2016 for ~17.0% YoY growth.

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