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Our subsidiary EİP Eczacıbaşı İlaç Pazarlama A.Ş. ("EİP") will today (August 5th, 2021) execute a license and supply agreement with Sesen Bio Inc., a company based in the United States of America (USA), for the marketing and sales rights of the medicine bearing the "Vicineum" trademark, in Turkey and Northern Cyprus. Pursuant to the agreement, an upfront payment of US Dollars 1,500,000.- and a royalty fee at the rate of 30% over net sales will be paid to Sesen Bio Inc., which develops targeted fusion protein therapeutics for the treatment of cancer patients. Vicineum, is a medicine that contains oportuzumab monotax active product ingredient. It is a locally-administered targeted fusion protein that is composed of an anti-EPCAM, antibody fragment tethered to a truncated form of Pseudomonas Exotoxin A, for the treatment of BCG-unresponsive non-muscle invasive bladder cancer. The marketing authorization process of this medicine for the treatment of BCG-unresponsive of non-muscle invasive bladder cancer patients is still ongoing at the Food and Drug Administration (FDA) and it is targeted to launch the medicine by the last quarter of the year 2021. It is foreseen that the marketing authorization will be obtained in Europe within the first quarter of the year 2022. Upon launch of Vicineum in the USA market, the application documents required for the marketing authorization in Turkey will be prepared and application will be made to the Turkish Medicines and Medical Devices Agency (TITCK). It is foreseen that the application for the marketing authorization will be made within the year 2022 and planned to be launched in the status of a registered medicine (with marketing authorization) within the year 2025, upon obtaining payment approval from the Social Security Institution for the insured patients.
This statement has been translated into English for informational purposes. In case of a discrepancy between the Turkish and the English versions of this disclosure statement, the Turkish version shall prevail. |
We proclaim that our above disclosure is in conformity with the principles set down in “Material Events Communiqué” of Capital Markets Board, and it fully reflects all information coming to our knowledge on the subject matter thereof, and it is in conformity with our books, records and documents, and all reasonable efforts have been shown by our Company in order to obtain all information fully and accurately about the subject matter thereof, and we’re personally liable for the disclosures.