HLB, a Kosdaq-listed firm, said it would introduce new anticancer pipelines other than rivoceranib, the investigational drug that the company is working on.
The company also commented on the controversy over whether its U.S. subsidiary would seek FDA approval for rivoceranib as a third-line or fourth-line treatment for gastric cancer.
On the company’s website on Wednesday night, HLB released a statement regarding a Korean newspaper's interview of Alex Kim, CEO of Elevar Therapeutics, the U.S. subsidiary of HLB that develops rivoceranib. The interview article came out during the J.P. Morgan Healthcare Conference in San Francisco.
After Kim said Elevar would seek U.S. approval for rivoceranib as fourth-line therapy for gastric cancer in the interview, the stock price of HLB plunged about 10 percent during after-hours trading on Wednesday.
Initially, HLB said it would seek the FDA nod for rivoceranib as third-line and fourth-line treatment.
After the interview, however, some investors raised concerns that applying for drug approval as a fourth-line treatment would only reduce the size of the target market and eventually make rivoceranib less profitable.
In response, HLB Chairman Jin Yang-gon said in a statement, “There have been some misunderstandings about Alex Kim’s interview article.” “We are seeking new drug application (NDA), but nothing has been confirmed regarding whether it will be third-line or fourth-line treatment.”
As rivoceranib targets terminal cancer patients, there is no significant difference between third-line and fourth-line treatments, Jin explained.
Jin said the company would determine the final direction, considering the speed of approval and marketability and gathering expert opinions. Also, HLB will speed up clinical trials on pipelines for large-scale treatment markets, including liver cancer, colon cancer, and gastric cancer, he added.
According to Kim, Elevar is considering introducing two anticancer drugs – one that has already been authorized and the other in clinical trials.
Elevar’s plan was part of HLB’s “greater goal,” and the company was in working-level discussions, Jin said.
The company strategically chose the third- and fourth-line treatment market for gastric cancer to obtain approval for the new drug as quickly as possible, Jin noted. However, some tried to undermine the value of rivoceranib, saying it was targeting a small market, although its efficacy was verified in China, and it showed good results in global phase-3 trials.
Introducing new pipelines will show the company’s will to overcome such controversy, he added.
After the European Society Medical Oncology’s meet, Elevar was able to build good reputations and have opportunities for negotiations, according to Jin.
“If the negotiations go successful, Elevar will own and sell more anticancer drugs. Then, it will boost the value of rivoceranib and HLB significantly.”
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