Expansion of indications to desmoid tumors, etc.
Orphan drug designation target within this year
Medfacto(96,700 -3.69%)Announced on the 15th that the investment of 100 billion won for the clinical progress of Baekto Seotip’s rare and intractable disease was completed.
The issuance of 30 billion won convertible preferred stock and 70 billion won convertible bonds has been completed. With the secured funds, it plans to speed up the progress of clinical trials related to rare and intractable diseases.
Medfacto is preparing for the Orphan Drug Designation (ODD) for the combination therapy of Baektoseotip and Imatinib for the purpose of treating desmoid tumors. Orphan drugs can be marketed early with only the results of phase 2 clinical trials for a small number of patients.
Tazberic, which was approved as a treatment for epithelial sarcoma, a rare incurable disease last year, was approved for marketing by the US Food and Drug Administration (FDA) as a result of phase 2 clinical trials of about 60 patients.
Medfacto will be designated as an orphan drug for desmoid tumors in the first half of the year, and plans to promote multinational clinical trials in Korea and the United States as well as fast track (rapid screening) designation. In the second half of the year, the indications will be expanded to two rare and intractable diseases, including osteosarcoma.
To this end, it is also promoting the establishment of a local subsidiary in the United States. MedFacto plans to target the US orphan drug market through its local subsidiary and use it as a base for multinational clinical trials.
An official from MedFacto said, “The successful financing is expected to give momentum to the promotion of the rare incurable disease business.” I plan to try to do it.”
Reporter Minsoo Han [email protected]
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