This year was a year where the word “safety” was particularly highlighted in the healthcare industry. The N-Nitrosodimethylamine (NDMA), a potentially carcinogenic substance, which caused a ruckus after being detected in valsartan-based antihypertensive treatment last year, was further extended to ranitidine and nizatidine. Earlier this month, the medical community was startled when the carcinogenic substance was found in some metformin products, which is the most widely used diabetes treatment in Korea. Also, the importance of drug safety was further highlighted through Allergan's breast implant safety issue and Kolon Life Science's Invossa incident. Along with safety issues, Korea Biomedical Review looked back on major issues that have affected the medical industry this year. - Ed
Many of the local biopharmaceutical companies that attracted high expectations from their investors ultimately let their shareholders down after announcing unsatisfactory phase 3 clinical trials this year. Whenever such negative news broke out, related stock prices fluctuated wildly.
Sillajen was the first to kick off a series of unsuccessful phase 3 clinical trials this year. The company stopped its global phase 3 clinical trial for Pexa-Vec in treating liver cancer on Aug. 2, after the independent Data Monitoring Committee (DMC) advised the company to suspend the clinical trials after assessing the futility of phase 3 clinical trial.
The company administered Pexa-Vec and Nexavar (sorafenib), a targeted therapy, on liver cancer patients and compared the results with patients receiving Nexavar alone. As a result, the group treated with the combined therapy failed to improve overall survival compared to the control group.
From the date the company announced its failure in the global phase 3 clinical trial, Sillajen saw its shares hit the lower limit for three consecutive days. The company’s market cap also fell to 1 trillion won ($860.5 million), one-third of the company’s market cap the day before the announcement.
As of now, the share price of the company, which hasn't had much positive news since the event, is hovering around 13,000 to 15,000 won. Considering that the company was regularly ranked as the second or third company in terms of market cap in the Kosdaq market after exceeding 100,000 won per share last year, the company is going through a painful period.
On Sep. 23, Helixmith announced bad news regarding its phase 3 clinical trial.
The company said it failed to make conclusions due to data contamination for its gene therapy Engensis, also known as VM202-DPN, in treating diabetic peripheral neuropathy (DPN).
In the aftermath, Helixmith shares also plunged to its lower limit for two consecutive days.
Helixmith later explained that it had confirmed the safety and efficacy of Engensis in a separate clinical analysis from a 12-month long-term follow-up observations of 101 patients in the phase 3-1 trials. However, the company’s explanation did not lead to the recovery of its share price.
Helixmith shares, which had reached nearly 200,000 won just before the company announced the results of its phase 3-1 trials, now stand around 80,000 won. The company is focusing on finding the cause of the data error and plans to announce the results next month.
HLB shares, showing different aspects from its announcement of phase 3 trials’ top-line results, fluctuated most wildly in the stock market.
In June, HLB announced that it would have difficulty in applying for a U.S. Food and Drug Administration approval for its anticancer drug rivoceranib as it did not meet the statistical significance of the primary indicators.
The announcement led to HLB shares, which was about 70,000 won before the report, to be cut in half after hitting its lower limit for two consecutive days
HLB shares, which had struggled for three months, recently bounced back after the company reversed its stance and decided to go ahead with an application for new drug approval in the U.S. armed with the full data from its phase 3 clinical trial.
HLB, which released the full data on Sept. 29, said that while the company did not reach significant results in the overall survival as the primary indicator, the company managed to show significantly higher efficacy in the progression-free survival period (PFS).
The company added that it plans to use this data in applying for the new drug approval in the U.S
With the announcement, HLB shares started to soar and hit a 52-week high of 213,900 won. The high prices have allowed the company to end the year with a share price 10-times higher than its lowest share price this year.
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