Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 70

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 70
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 2022 in over 20 countries, reported positive read-outs having reached its co-primary end points. Sarclisa is also being investigated with several innovative agents in MM in an umbrella Phase 1/2 study. Jevtana Jevtana (cabazitaxel), a chemotherapy drug and cytotoxic agent, is a semi-synthetic second-generation taxane that prevents many cancer cells from dividing, which ultimately results in destroying many such cells. It is approved in combination with prednisone for the treatment of patients with metastatic castration resistant prostate cancer previously treated with a docetaxel- containing treatment regimen. Jevtana was granted marketing authorization by the FDA in June 2010, by the EC in March 2011, and in Japan in July 2014. The medicine is marketed in over 75 countries. In Europe, generic competition started for Jevtana from the end of March 2021. In the US, the Jevtana composition of matter patent expired in September 2021. Sanofi has filed patent infringement suits under the US Hatch-Waxman Act against generic manufacturers for cabazitaxel in the US District Court for the District of Delaware asserting three Orange Book listed US patents for Jevtana. Sanofi entered into settlement agreements with most of the defendants and went to trial against the remaining defendant, Sandoz, on one of the patents in January 2023; see Note D.22.b. to the consolidated financial statements, included at Item 18. of this annual report. The district court issued a final judgment in favor of Sanofi in connection with the Jevtana patent litigation against Sandoz in June 2023, and on August 2, 2023, Sandoz appealed to the Court of Appeals for the Federal Circuit. On October 5, 2023, Sanofi and Sandoz filed a joint stipulation voluntarily dismissing Sandoz’s Appeal, bringing this matter to conclusion. Fasturtec/Elitek Fasturtec/Elitek is used for the management of plasma uric levels in patients with leukemia, lymphoma, and solid tumor malignancies receiving anticancer therapies. Other medicines Lantus Lantus (insulin glargine 100 units/mL) is a long-acting analog of human insulin, indicated for once-daily administration for the treatment of diabetes mellitus in adults, adolescents and children aged two years and above. Lantus relies on more than 20 years of clinical evidence in diabetes