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Hayır (No)
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-Unofficial Translation- Registration application for the drug with active substance "Nusinersen Sodium", named "SPINRAZA 12 mg/5 ml Intratekal Enjeksiyonluk Çözelti", which is the only treatment method approved by the Republic of Türkiye Ministry of Health and reimbursed by Social Security Institution (SGK) for the treatment of SMA (Spinal Musculer Atrophy) disease and which, until today, has been brought to Türkiye by our company within the scope of the Named Patient Program and offered to the use of patients has been concluded affirmatively. In its letter dated 29.11.2022 (which we received on 30.11.2022) Turkish Medicines and Medical Devices Agency notified us that the Marketing Authorization of this drug has been issued with the date 25.11.2022 and number 2022/677 in our company's name. With the conclusion of the registration process, the sales and marketing rights of the drug, which has been supplied by the alternative reimbursement agreements signed by SGK and our company until today, have been exclusively given to our company in Türkiye. Said drug is, presently, the only registered drug which can be used for the treatment of SMA disease. It is expected that the contribution of this drug to 2023 total sales of our company would be, with current exchange rates, between TL 1.100.000.000,00 (one billion one hundred million Turkish Lira) and TL 1.250.000.000,00 (one billion two hundred fifty million Turkish Lira). |
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.