Drug developers caught in low success rate

By Choi Sung-jin

Hanmi Pharmaceutical, Korea’s front-runner in developing drugs, is facing a double whammy _ medical and financial, and technical and moral problems.

Hanmi’s newly developed lung cancer treatment, “Olita Tab,” has killed two patients enrolled in its clinical tests because of adverse drug reactions, and the company has allegedly delayed posting a public notice at the stock market in what investors suspect is an attempt to prevent a plunge in its share prices.

Aside from the controversy over its belated reporting ― which will be probed by financial regulators ― the lethal side-effects part should be discussed in a calmer atmosphere, industry experts said Monday.

Hanmi’s biggest dilemma is whether to continue its clinical trial on the other 127 patients regardless of the two deaths and withdrawal from the license deal by Boehringer Ingelheim. At a hurriedly arranged news conference Sunday, however, CEO Lee Gwan-sun made clear the company would push ahead with the ongoing test until next August as originally planned, although it would suspend trials on new patients.

Company officials said 90 percent of 731 patients treated with this drug, with the component name of Olmutinib (HM 61713), had shown their symptoms controlled, with half of the patients experiencing more than 30 percent reduction in the size of their cancer.

Accordingly, Hanmi’s researchers are set to push ahead with clinical trials on patients who showed no adverse reactions.

“Moreover, the 127 patients are those who had no other alternatives and volunteered to become test subjects as a last resort, so the interruption of medication could throw them into more dangerous states,” a researcher said.

The German company’s withdrawal from the license deal and clinical test might also be less influenced by the ill effects than the marketing of a similar lung cancer drug by one of its competitors, the experts said, pointing out that the adverse drug reactions shown in Olmutinib had also been reported in other anticancer drugs and antibiotics.

“We have already reported atypical responses to the licensing authorities of many countries, but none of them recommended that we stop developing the drug,” said Sohn Ji-woong, a Hanmi vice president responsible for research and development. “In consultation with outside experts, we will decide after carefully assessing the potential risks on patients who have benefitted from its effects.”

Some other experts have called for Hanmi to stop the clinical test now that serious ill effects had killed two people. Moreover, another new drug, which applies a similar theory to Olmutinib’s, won U.S. Food and Drug Association approval last November, meaning there is already an alternative.

The latest fiasco is shaking Hanmi’s success story.

Hanmi invested 35 billion won ($31.5 million) into developing Olmutinib since the late 2000s and signed an export contract with the German pharmaceutical giant in July last year. The midsize Korean drug maker emerged as the star in the nation’s pharmaceutical sector last year by exporting five other new drugs worth about 8 trillion won combined.

Some people had been concerned about the share price rise and other adverse effects stemming from excessive expectations, which were buried under the largest drug exports in Korea’s history.

In the world of developing drugs, however, export technology did not immediately lead to commercial success, the experts said, noting Boehringer Ingelheim’s withdrawal might have alerted Hanmi to such reality.

Nor are royalties paid as a lump sum but by piecemeal in accordance with each successful phase of the test. “I am afraid the recent suspension of development will lead to distrust in the overall development of new drugs,” an expert said.

The main reason an export contract is not synonymous with commercial success is the great uncertainty that keeps the successful development rate at 10 percent or lower. Many drugs that hit the media limelight in the early stages of research or animal tests prove to be less effective and less safe than expected.

“It’s common for the development of drugs to be suspended after signing export contracts in the global pharmaceutical markets,” said Professor Kim Sung-hoon of Seoul National University College of Medicine. “The ongoing episode should serve as an occasion to better understand the characteristics of developing drugs.”