Marketing right for SGLT2 inhibitor Apleway to be transferred from Sanofi to Kowa

Tokyo & Nagoya: Chugai Pharmaceutical Co., Ltd., Kowa Company, Ltd.(Kowa), and Sanofi K.K. (Sanofi) announced changes to marketing arrangements of tofogliflozin hydrate (hereinafter, tofogliflozin), an SGLT2 inhibitor created by Chugai in Japan.

Under the license agreements in 2012, tofogliflozin has been marketed by Kowa under the brand name "DEBERZA Tablets 20 mg" (hereinafter, "DEBERZA"), and by Sanofi under the brand name as "Apleway Tablets 20 mg" (hereinafter, "Apleway"), following regulatory approvals in 2014.

Chugai and Sanofi agreed to terminate their license agreement. Kowa and Sanofi agreed that the marketing right for Apleway will be transferred from Sanofi to Kowa as of April 1, 2020, and the marketing authorization for the product will be also transferred by around June 2020. With these changes to marketing arrangements, tofogliflozin will be marketed solely by Kowa.

Chugai, Kowa, and Sanofi will continue working on to ensure a stable supply of the product, provide appropriate information, and promote proper use so that the changes to marketing arrangements will not cause any inconvenience to patients, healthcare professionals and other stakeholders. They will also cooperate to achieve the transfer of marketing right and succession of the marketing authorization to carry out their responsibilities.

The changes will not affect Chugai's consolidated earnings forecast for the business term ending in December 2020.

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Tofogliflozin hydrate, a selective inhibitor of sodium-glucose cotransporter 2 (SGLT2) created by Chugai, lowers blood glucose by inhibiting glucose reabsorption in the renal tubule and inducing excretion of excess blood glucose into the urine.

Marketing authorization for the product was granted by MHLW on March 24, 2014, for the indication of type 2 diabetes mellitus. The drug is marketed by Kowa and Sanofi, with brand names as "DEBERZA Tablets 20 mg" and "Apleway Tablets 20 mg," respectively. Overseas, Kowa owns the exclusive rights to develop and market "DEBERZA," as well as to conduct research, develop, and market its combination drug in the US and EU.

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