[Reporter’s View] Amid hopes for K-drugs, beware

beware of the bubbles

It is not only the patients that are now interested in the research and development of new drugs.

 

The interest in high-value-added industry and aspirations for the development of the domestic industry has never been hotter.

 

Industry development is good.

 

New drugs?

 

Even better.

 

However, the rise of the stock market bubble that stirs investment interest in the sector is potentially detrimental to the advancement and success of the industry and new drug discovery.

 

New drug development would not have risen as a trend if it was easy.

 

Due to rising interest in Korea's biopharmaceutical industry grows, information about the pharmaceutical industries’ clinical trial failures, discontinuation, or efficacy issues are being constantly covered online.

 

When successful, reports on these clinical trials make it into the headline news.

 

The current trend is understandable.

 

Biosimilars from companies like Samsung and Celltrion are increasingly gaining recognition in the US and Europe, and the Korean government is coming up with a favorable drug pricing policy for domestically produced new drugs, based on the government's premise of devising a measure to foster the biopharmaceutical industry.

 

Let’s get one thing clear.

 

Suceeding in new drug development is far from easy.

 

According to an analysis conducted by the Biotechnology Innovation Organization (BIO) in the US, which examined data from 9,985 clinical trials either completed or underway by the U.S.

 

Food and Drug Administration (FDA) from 2006 to 2015, the success rates were 63.2% for Phase 1, 30.7% for Phase 2, and 58.1% for Phase 3 clinical trials.

 

When these rates are calculated to determine the probability of a new drug reaching the commercialization stage, the number renders to a mere 9.6%.

 

Development discontinuation and clinical trial failures in the pharmaceutical industry are common; it would rather be odder if they didn't occur.

 

However, the issue lies in transparency.

 

It's a fact that numerous pharmaceutical companies have jumped on the new drug development bandwagon, trying to take advantage of the rising tide.

 

Clinical data on candidate substances and presentations made at international conferences are being often distributed indiscriminately without adequate drug information.

 

Its phrases, "shows superior effectiveness compared to drug X," "the first treatment for X cancer," or "significantly improves survival duration," seem to be primarily aimed at influencing investor psychology, Such headlines do seem attractive, but the articles frequently lack basis.

 

Detailed information, such as the number of patients involved in clinical trials, the duration of the research, and quantitative data from comparing different cohorts on the drug's effectiveness and safety, are not provided.

 

Moreover, drug descriptions are frequently oversimplified to terms like ‘good drug’ stated by a company personnel.

 

Keep in mind that drug discovery is science and has patients as the end-customers.

 

Any success in new drug development by Korean companies are encouraging news.

 

Therefore, other companies should embrace the transparency and open up information for a fair evaluation.

 

They must stop worrying about IR (Investor Relations).

 

Just as they addressed the rebate issue, it is now the time for the companies to dispel any doubts about stock price manipulations.