July 19, 2021
Sanofi K.K.
Asahi Kasei Pharma Corporation

Sanofi K.K. (Head office: Shinjuku-ku, Tokyo; President: Takahiko Iwaya; hereinafter “Sanofi”) and Asahi Kasei Pharma Corporation (Head office: Chiyoda-ku, Tokyo; President: Yoshikazu Aoki; hereinafter “Asahi Kasei Pharma”) announced that both companies have entered into a license agreement for marketing in Japan of Plaquenil® Tablets 200 mg (generic name: hydroxychloroquine sulfate; hereinafter “Plaquenil®”) for the treatment of cutaneous lupus erythematosus (CLE)¹⁾ and systemic lupus erythematosus (SLE)²⁾ in Japan.

In correlation with this agreement, the marketing business of Plaquenil® will be transferred from Sanofi to Asahi Kasei Pharma on October 1, 2021. Sanofi will remain as the marketing authorization holder of Plaquenil® in Japan and continue manufacturing the product.

Plaquenil® is a 4-aminoquinoline derivative that possesses anti-inflammatory, immunomodulatory, and antimalarial properties. It has a mechanism of action and chemical structure that are similar to chloroquine, a drug that had been commercially available in Japan as a treatment for malaria and other conditions but has a lower affinity for tissues than chloroquine. It has been reported that the incidence of retinal disorders, one of the major adverse drug reactions to chloroquine, among patients receiving hydroxychloroquine is relatively low.

Plaquenil® is now approved in more than 70 countries worldwide and is positioned as a standard therapy for patients with cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) in many countries.

The Ministry of Health, Labour and Welfare (MHLW) evaluated this drug at its Study Group on Unapproved and Off-label Drugs of High Medical Need and positioned it as a drug with an important medical need. Sanofi started the development of Plaquenil® in Japan according to a request from the MHLW in December 2010, obtained approval of the drug for the treatment of CLE and SLE in July 2015, and launched it in September 2015.

Sanofi and Asahi Kasei Pharma will work together to continue their contribution to the treatment of CLE and SLE.

• 1）Cutaneous lupus erythematosus (CLE): Erythematosus is a collagen disease, and lupus erythematosus ("lupus" means "wolf" in Latin) is named because it produces red blotches reminiscent of wolf bites. CLE is a type of erythematosus that principally produces skin symptoms, especially red blotches that frequently appear on the face, ears, and around the neck. Although no epidemiological studies have been conducted to estimate the prevalence of CLE in Japan, CLE is thought to be as prevalent as SLE.
• 2）Systemic lupus erythematosus (SLE): SLE is an autoimmune disease characterized by systemic inflammation caused by the deposition of immune complexes such as DNA-anti-DNA antibody immune complexes in tissues. The disease causes a diverse range of symptoms affecting various parts of the body, including fever, generalized fatigue, skin symptoms including red blotches (erythema), and arthritis. It predominantly develops in women in their 20s to 40s and usually pursues a cycle of remission and deterioration that eventually results in a chronic condition. It has been reported that the number of patients with SLE in Japan has increased over time, and it is estimated that currently more than 60,000 people in Japan are suffering from SLE, based on the sum total of patients holding an intractable disease medical treatment recipient certificate and patients holding an intractable disease registrant certificate according to the MHLW's Report on Public Health Administration and Services as of the end of FY2012.

About Sanofi

Sanofi is dedicated to supporting people through their health challenges. As a global biopharmaceutical company focused on human health, we protect people with our vaccines and ease their pain and suffering with our innovative treatments. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Please visit the website http://www.sanofi.co.jp for details about Sanofi K.K, the Japanese subsidiary of Sanofi.

About Asahi Kasei Pharma

In accordance with the Asahi Kasei Pharma Mission "To sincerely care for each individual life and solve their unmet medical needs with a wealth of ideas and solid science," Asahi Kasei Pharma operates pharmaceutical and diagnostic businesses in the Health Care Business Unit of the Asahi Kasei Group. For more information, please visit https://www.asahikasei-pharma.co.jp/en/.

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