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Sanofi amends Regeneron pact, details study results for rare disease therapy

Following Sanofi's plans to exit diabetes and cardiovascular research, the Paris-based drugmaker and Regeneron Pharmaceuticals Inc. are changing their collaboration on two medicines into a royalty-based model.

Sanofi will receive sole global rights to rheumatoid arthritis therapy Kevzara and sole rights to the cholesterol drug Praluent outside the U.S., while Regeneron will hold exclusive U.S. rights for Praluent.

The companies will separately commercialize the drugs in their respective regions.

The proposed agreement does not affect the existing partnership on eczema therapy Dupixent. It is expected to be finalized in the first quarter of 2020.

Sanofi's new CEO on Dec. 9 announced his plan to simplify its corporate structure as it withdraws from diabetes and cardiovascular research.

Sutimlimab study results

In a statement on Dec. 10, Sanofi released detailed results of a late-stage study, dubbed Cardinal, in which sutimlimab reduced the symptoms of a rare blood disease.

The drugmaker's treatment met the trial's primary goal as a higher proportion of adult patients with primary cold agglutinin disease, or CAD, responded to the drug. CAD is a rare, chronic and serious blood disease that results in the constant and premature destruction of red blood cells by the body's immune system. People with the disease have chronic anemia, debilitating fatigue, acute hemolytic crisis and a poor quality of life.

On average, patients who received the experimental medicine in the trial saw a 2.6 gram/deciliter increase in their hemoglobin, a protein that carries oxygen in the blood. About 71% of patients no longer needed a blood transfusion after the fifth week of the trial.

Average levels of total bilirubin, a compound in the body that was used to gauge the destruction of oxygen-carrying red blood cells, increased rapidly and reached normal levels by week 3.

The hemoglobin and total bilirubin sustained their post-treatment levels over the trial's duration.

Lastly, patients rated their quality of life on the Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire 7.2 points higher by the end of week 1. The average increase in FACIT-Fatigue score for 26 weeks was 10.9 points.

About 91.7% of patients in the trial experienced an adverse effect during treatment. While 29.2% of patients experienced a serious adverse effect and 8.3% experienced an infection during treatment, the effects did not result from sutimlimab's use, according to the investigator handling the trial.

Sanofi intends to submit the results, which were presented at the American Society of Hematology annual meeting, to the U.S. Food and Drug Administration soon. The experimental therapy for CAD, which has no approved treatment, previously received a breakthrough therapy designation from the FDA, as well as an orphan drug tag from the FDA, European Medicines Agency and Japan's Pharmaceutical and Medical Devices Agency, although regulators have not reviewed its effectiveness or safety.