À̹ÌÁö È®´ë Elevar Therapeutics is aiming to complete new drug application (NDA) filing of its precision cancer drug rivoceranib for two indications within one year, the company¡¯s new chief executive Saeho Chong told Maeil Business Newspaper on Wednesday.
Chong was tapped by Elevar¡¯s parent HLB of Korea a month ago to speed up regulatory approval in the U.S. based on his career in a private company and the Food and Drug Administration (FDA).
Elevar Therapeutics, a U.S.-based pharmaceutical company wholly owned by HLB, holds global marketing rights to rivoceranib and is overseeing all clinical trials of the drug.
Rivoceranib is a novel drug candidate with a mechanism of action to inhibit neovascularization and cancer cell proliferation. It is approved and distributed as an oral treatment called apatinib in China, and its cumulative sales hit more than 1 trillion won ($817 million) in the past seven years.
HLB endured steep stock price losses over the last two years due to uncertainty over its false disclosure controversy,
But all charges were recently dropped after the company was found innocent and the company is going all out to the NDA pathway to get the greenlight for rivoceranib from the FDA, said Chong,.
Chong, who obtained a doctorate in pharmacy from the State University of New York, built a rare career by working at both a drug-developing company and regulatory level of the FDA. Prior to joining Elevar, he worked at Alnylam for four and a half years as an executive responsible for NDA and drug development. During his tenure there, he achieved excellent performance with FDA clearances of four new drugs. While working at the regulator, Chong was responsible for NDA review of anticancer drugs.
À̹ÌÁö È®´ë Saeho Chong
¡°Companies should play a leading role in the course of regulatory discussions because the FDA provides an overall direction through pre-meetings and reviews with many developers that want to submit their NDA,¡± Chong said.
Regarding the efficacy of rivoceranib, Chong said that rivoceranib has already been proven effective and safe through clinical data and research papers in China, where the drug is now available. ¡°Due to its low toxicity compared to other cancer drugs in the same class, I think we¡¯re in a better position in the combination therapy setting.¡±
Touching on the drug¡¯s overall survival (OS) rate, which stirred a controversy due to its lower-than-expected number, he said it will not be a big concern for NDA strategy because OS is not the only indicator to evaluate the drug¡¯s profile. ¡°We will develop our NDA strategy advantageous to us by fully reflecting other indicators such as progression-free survival (PFS)."
HLB is evaluating the efficacy of riboceranib in the treatment of five cancer types. Of these, three are getting closer to potential NDA within one year.
A Phase 3 gastric cancer trial was already completed and is in the middle of complementary data work being conducted at the request of the FDA. A Phase 2 clinical trial for the first-line treatment of adenoid cystic cancer and a phase 3 global clinical trial for the first-line treatment of liver cancer are expected to be closed by the end of this year.
By Han Jae-beom and Minu Kim
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