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Biz News Korea(Eng)
CrystalGenomics granted orphan drug status for CG’806
- Collected
- 2017.12.28
- Distributed
- 2017.12.29
- Source
- Go Direct
It said its application for orphan status for CG026806 (CG’806), an oral medicine to treat certain cases of acute myeloid leukemia, has passed the FDA and become eligible for passes in multiple clinical tests usual before marketing clearance.
The U.S. orphan drug act provides exceptional benefits to treatments of rare diseases to speed up their development. Under the act, CG’806 would secure exclusive marketing rights for the next seven years as well as research subsidies and tax incentives during the clinical trial period.
“The orphan designation could shorten the drug development process by about two years,” said an official at CrystalGenomics.
CrystalGenomics maintains rights over CG’806 in Korea and China, which is patented in China until Dec. 26, 2033. It sold the rights in other countries to Canada-based Aptose Biosciences Inc. in June 2016. Aptose plans to submit to the FDA an investigational new drug application for CG’806 and start a phase 1 clinical trial by the first half of 2018.
Shares of CrystalGenomics finished Wednesday up 16.5 percent at 24,000 won ($22.35).
By Shin Chan-ok and Kim Hyo-jin
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