The pharmaceutical industry is following with interest whether Cellgram AMI (licensed name: HeartiCellgram-AMI), approved six years ago as Korea’s first stem cell therapy, will be able to pass the forthcoming reexamination process.

The Ministry of Food and Drug Safety approved Cellgram made by Pharmicell파미셀 on July 1, 2011, for the stem cell therapy of acute myocardial infarction, on condition that it should pass reexamination after treating more than 600 patients over the following six years. The ministry was applying Post Marketing Surveillance (PMS) to the treatment to confirm its safety and efficacy. Pharmicell should submit the data for reexamination by June 30.

Source: Pharmicell’s website

The company, however, has failed to meet the condition of 600 patients in six years, requesting the ministry to readjust the minimal number of patients to 60. The ministry held a Central Pharmaceutical Affairs Council meeting in March and decided not to accept Pharmicell’s request, leading some industry watchers to speculate about the possible cancellation of its approval.

The cost of uncovered Cellgram-AMI for one shot is 18 million won ($15,000) and is in the process for insurance coverage. The therapy has generated 8.7 billion won in sale since its first release.

“Because most stem cell therapies are uncovered, and their production costs are higher than those of ordinary new drugs, it’s understandable their prices remain high,” a council member said. “Related systems have been improving, but the PMS scheme still seems to be a little alienated from such a reality.”

“In the reexamination process, some will say the market for stem cell therapies have yet to be reinvigorated sufficiently with others acknowledging it is the nation’s first stem cell treatment,” the member said. “Because this is the world’s first stem cell therapy, the approval cancellation will have a harmful effect on national reputation. We will have to make a prudent decision.”

The council member said the committee might accept Pharmicell’s request to downward readjustment of the case criterion. He cited the example of a product made by another company, which could pull down the number of minimal cases as it marked another “first” in the nation. As far as the safety is concerned, the participants maintained a strict foundation for judgment, however, he added.

"The members took into account the considerable influence the cancellation could have exerted on the related industry’s structure,” he said. “The officials readjusted the case criteria because they knew it was not because of problems in efficacy or function that the company had failed to meet the minimal cases. As the ministry’s decision directly leads to public health, a decision should come only after strict, in-depth assessment procedure.”

If Cellgram-AI passes the reexamination, its approval will remain valid or carry some warnings in use. If the drug fails to meet requirements or other problems occur, officials can nullify its approval after taking an administrative step.

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