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SNY stock moving higher in pre-market trading (blue shaded area) on December 10, 2019.

Sanofi and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced their intent to simplify their antibody collaboration for Kevzara® (sarilumab) and Praluent® (alirocumab) by restructuring into a royalty-based agreement. Under the proposed restructuring, Sanofi is expected to gain sole global rights to Kevzara and sole ex-U.S. rights to Praluent. Regeneron is expected to gain sole U.S. rights to Praluent. Under the proposed terms of the agreement, each party will be solely responsible for funding development and commercialization expenses in their respective territories. These changes are expected to increase efficiency and streamline operations for the products. The existing collaboration relating to Dupixent® (dupilumab) will remain unchanged following the restructuring. Completion of the proposed agreement is expected to be finalized in the first quarter of 2020.

A pivotal Phase 3 open-label, single-arm trial evaluating the safety and efficacy of sutimlimab in people with primary cold agglutinin disease (CAD) met its primary and secondary endpoints. These results were presented today at the Late-Breaking Abstracts Session of the 61st Annual Meeting of the American Society of Hematology in Orlando, FL.

  • Sutimlimab, a novel investigational C1s inhibitor, has the potential to be the first approved treatment for cold agglutinin disease, a serious, chronic, rare blood disorder
  • Results met the primary and secondary endpoints and demonstrated rapid inhibition of hemolysis and clinically significant improvements in anemia and fatigue within one week of treatment
  • U.S. FDA submission planned in the near future

Sutimlimab is the first investigational treatment designed to selectively target and inhibit C1s in the classical complement pathway, a part of the immune system that is responsible for activating the mechanism of hemolysis in CAD. It has the potential to be the first approved therapy for this rare autoimmune hemolytic anemia. Sanofi intends to submit a Biologics License Application for sutimlimab, for which it has received Breakthrough Therapy designation, to the US Food and Drug Administration in the near future.

“Cold agglutinin disease can be a debilitating condition, with many patients suffering from crippling fatigue and generally experiencing a poor quality of life,” says principal investigator and presenting author Alexander Röth, M.D., Department of Hematology, University Hospital, University of Duisburg-Essen, Germany. “These positive data from the Phase 3 CARDINAL study provide clinically significant evidence that sutimlimab, by inhibiting hemolysis and improving anemia, has the potential to be an important new treatment for CAD and make a meaningful impact on patients’ lives.”

The primary efficacy outcome was a responder rate based on a composite of an increase in hemoglobin ≥2 g/dL from baseline or reaching a hemoglobin level ≥12 g/dL at the 26-week treatment assessment timepoint and the absence of transfusions from Weeks 5 to 26, further, patients were not allowed to receive other CAD-related treatments. The secondary efficacy measures assessed improvement in key indicators of the disease process: hemoglobin, bilirubin (a measure of red blood cell destruction in CAD), Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score (a quality of life measure of fatigue), lactate dehydrogenase (LDH), and transfusion usage.

CARDINAL Phase 3 study data (final Part A) presented at the Late-Breaker Session at ASH

Twenty-four patients enrolled and received at least one dose of sutimlimab (mean age of 71.3 years). 62.5% of patients (n=15) had received ≥1 prior targeted therapy within the last 5 years. Two patients withdrew from the study early for reasons unrelated to study drug. All 22 patients who completed Part A of the study elected to continue sutimlimab in Part B, an ongoing safety and durability of response extension study.

Efficacy and Safety Data:

  • The pre-specified primary endpoint was met. 54% (n=13) of patients met the composite endpoint criteria, with 62.5% (n=15) of patients achieving a hemoglobin ≥ 12 g/dL or an increase of at least 2 g/dL and 71% (n=17) of patients remaining transfusion-free after week 5.
  • The study showed an overall mean increase in hemoglobin of 2.6 g/dL at treatment assessment timepoint; 83% (n=20) of the 24 patients enrolled achieved a clinically significant mean hemoglobin improvement of ≥1 g/dL.
  • Hemoglobin improved rapidly, with a mean increase from baseline of ≥1 g/dL by week 1 and ≥2 g/dL by week 3. Mean hemoglobin levels were maintained at >11 g/dL (from a mean baseline 8.6 g/dL) after week 3, demonstrating a sustained effect throughout the remainder of the treatment period.
  • Mean total bilirubin, a key marker of hemolysis in CAD, achieved near normalization after the first week of treatment (24.6 µmol/L; upper limit of reference range 20.5 µmol/L), with normalized bilirubin levels (< upper limited of reference range) maintained from week 3 through the remainder of the study.
  • Mean FACIT-Fatigue score demonstrated a clinically meaningful improvement in fatigue by week 1 of treatment with an increase of 7.2 points. The overall mean FACIT-Fatigue score increase from baseline at the 26-week treatment assessment timepoint was 10.9 points.
  • 22 patients (91.7%) experienced at least 1 treatment-emergent adverse event.
  • 7 patients (29.2%) experienced at least 1 treatment-emergent serious adverse event (TESAE) of which none were assessed by the investigator as related to sutimlimab.
  • 2 patients (8.3%) experienced at least 1 TESAE of infection, of which none were assessed by the investigator as related to sutimlimab. No patient discontinued sutimlimab due to infection and there were no meningococcal infections identified.

“CAD is a disease in which the immune system attacks red blood cells and causes a cascade of symptoms for patients. In our study, sutimlimab achieved clinically meaningful results by impacting the central mechanism of CAD, bringing about marked improvements in patients’ hemolysis, anemia and fatigue,” said John Reed, M.D., Ph.D. Global Head of Research and Development at Sanofi. “We are eager to share these results with regulatory authorities beginning with the U.S. FDA in the near future in an effort to provide patients with a first-in-class targeted therapy that we believe has the potential to change the treatment paradigm for CAD.”

Results from this trial will be submitted to regulatory authorities, starting with the U.S. Food and Drug Administration (FDA) in the near future. Sutimlimab has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) and Orphan Drug status by the FDA, European Medicines Agency and the Pharmaceuticals and Medical Devices Agency in Japan. The efficacy and safety of sutimlimab has not been reviewed by any regulatory authority.

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