Alteogen said that the U.S. Food and Drug Administration has granted an orphan drug designation (ODD) to ALT-P1, a drug to treat the deficiency of growth hormone for children.
FDA's ODD is a system that helps smoothe the development and approval of therapeutic drugs for rare or life-threatening diseases. ODD drugs receive tax benefits, exemption of license application fees, and seven-year monopoly after obtaining authorization.
ALT-P1 has completed adult clinical phase 2a in Korea and is preparing for clinical phase 2 and phase 3 trials globally.
The growth hormone deficiency treatment is a biobetter using the company's NexP platform technology and its source technology patented in 10 countries, including the U.S. The company signed a licensing agreement with Cristalia, a Brazilian firm, for technology transfer and global clinical development of the drug in July.
Under the accord, Cristalia will invest about 50 billion won ($42.4 million) into conducting phase 2 and 3 clinical trials in Brazil after producing the treatment's candidate.
"As the growth hormone deficiency drug was registered as an ODD, we will be able to accelerate our entry into the U.S.," a company official said. "We will also step up efforts to expand our presence in the global market through worldwide clinical trials."
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