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English
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oda_MaterialEventDisclosureGeneralAbstract|
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Evet (Yes)
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Hayır (No)
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05.08.2021, 16.08.2021, 10.12.2021, 31.03.2022
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Hayır (No)
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In our statement dated August 5, 2021, we mentioned in summary that our subsidiary, EİP Eczacıbaşı İlaç Pazarlama A.Ş. (EİP), has signed a licensing and supply agreement with the United States (USA) based Sesen Bio Inc. for the marketing and sales rights of the drug with the brand name "Vicineum" in Turkey and the Turkish Republic of Northern Cyprus, that according to such agreement, a upfront payment of USD 1.5 million would be made, that the process of registration of the mentioned drug with the Food and Drug Administration (FDA) was ongoing; In our statement dated August 16, 2021, we mentioned that on August 13, 2021, the FDA responded to the application of the drug product Vicineum with a deficiency letter, that a Type A meeting with the FDA was expected in the last quarter of 2021; in our statement dated December 10, 2021, we mentioned that according to the Type A meeting between the FDA and Sesen Bio Inc., Sesen Bio Inc. should conduct an additional clinical trial in order to file an approval application again with the FDA; and in our statement dated March 31, 2022, we mentioned that the Phase III study protocol and the majority of the statistical analysis plans were agreed upon at the Type C meeting held with the FDA on March 28, 2022, and that for any articles that remained open, further discussions with FDA were planned in the subsequent months.
As a result of these developments and in order to align the licensing and supply agreement signed with Sesen Bio on August 5, 2021 with the changing conditions, the amendment protocol dated May 9, 2022 was executed in which the upfront payment of USD 1.5 million was linked to obtaining FDA approval for the drug product "Vicineum", and provisions were included in the agreement regarding the right of termination of the agreement by EİP in case of failure to obtain FDA approval.
The necessary public announcements will be made on the steps becoming certain in the FDA approval procedures.
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.
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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.