
It was reported that SMA drug was licensed in Turkey on behalf of Gen İlaç ve Sağlık Ürünleri Sanayi ve Ticaret A.Ş.
The statement made to the Public Disclosure Platform (KAP) is as follows: "Until now, our company has been used in the treatment of Spinal Muscular Atrophy (SMA) disease, which has been supplied to patients on the basis of prescription for personal treatment from abroad, approved by the Ministry of Health and paid by the Social Security Institution (SGK). The license application made by our company for the drug named 'SPINRAZA 12 mg/5 ml Intrathecal Injection Solution' with the active ingredient 'Nusinersen sodium', which is the only treatment method met, has been positive. The Turkish Medicines and Medical Devices Agency informed us in its letter dated 29.11.2022 (which we received on 30.11.2022) that the pharmaceutical license was issued on behalf of our company with the date 25.11.2022 and number 2022/677. With the finalization of the licensing process, the sales and marketing rights of this drug, which has been provided by an alternative reimbursement agreement between SGK and our company, have been exclusively given to our company in Turkey. The drug in question is currently the only licensed drug in our country that can be used for the treatment of SMA disease. It is expected that the contribution of the drug to the total sales of our company in 2023 will be between 1.100.000.000 TL and 1.250.000.000 TL in current exchange rates.