Pharmicell ushers in 'stem cell renaissance'

A Pharmicell employee looks into a microscope at the firm’s research center in Seongnam, Gyeonggi Province. The world’s first maker of mass cell therapy “Hearticellgram-AMI” will transfer its core technologies to Saudi Arabia by 2017 for $80 million. The firm also seeks to enter major markets including the United States and China. / Courtesy of Pharmicell

‘Stroke, heart failure, liver failure, spinal cord injury will be conquered’

By Park Si-soo

Pharmicell CEO Kim Hyun-soo

The “miracle” started in September 2011.

A middle-aged Korean man surnamed Kwon saw his near dead heart tissue, caused by a myocardial infarction, revived dramatically through treatment using the world’s first mass produced stem cell therapy.

Since then several other stem cell-based therapies for commercial use have been invented, giving “freedom” to scores of people suffering from such ailments as knee cartilage defects, Crohn’s disease and grafted tissue rejection.

In May, American scientists successfully recovered stem cells from cloned human embryos, a much-anticipated achievement that could lead to a new breakthrough for such hard-to-cure illnesses as Parkinson’s disease and diabetes.

In the latest breakthrough, a team of Japanese scientists created a functional human liver in a lab using stem cells derived from skin and blood early this month, prompting speculation that people will be able to replace their livers with new ones like a battery in an automobile.

Perhaps all of these cases have left strong enough impression with people to believe that it’s a matter of time before all human diseases will be curable.

Yet Kim Hyun-soo, CEO of Pharmicell, the first developer of an authorized stem cell therapy that treated Kwon, is skeptical of the magic bullet scenario, saying there is still a “long way to go.” Instead, he said the state-of-the-art therapy will make it possible to “conquer” strokes, heart or liver failure, and spinal cord injury in the current generation.

“It’s still premature to say the four diseases will be completely conquered within the timeframe. But one thing I can say for sure is that stem cell therapy will become one of the most widely used treatments,” Kim said. “In addition, you will find it more powerful and convenient to use in five or ten years time. Furthermore its cost will go down continuously.”

The Seoul-based company garnered international attention in July 2011 by getting a license to sell “Hearticellgram-AMI,” a stem cell therapy for acute myocardial infarction, from the Korea Food and Drug Administration (KFDA). The pioneering therapy takes somatic stem cells extracted from the patient’s own body that are then cultured and directly injected into his or her damaged heart. Currently there are only five stem cell therapies authorized for commercial use in the world.

The firm has seen a steep rise in sales since the KFDA endorsement. It posted 11.1 billion won ($9.85 million) last year, up from 9.6 billion won in 2011. In the first quarter of this year alone, the company raked in 10.2 billion won, the highest quarterly sales in the company’s history. Despite the hike, the firm posted a net operating loss of 1.5 billion won during the same period, as a result of aggressive investment.

“We have a bright future,” Kim said. “We had a money-losing operation until last year. With the current sales trend, however, we will be able to swing into the black for the first time by the end of the year.”

Globalization

Pharmicell is set to make a sizable investment in Saudi Arabia to build a stem cell research center and manufacturing facility at King Fahad Medical City, the “Medical System Twinning Project.”

Under the project, jointly initiated by the Korean and Saudi Arabian governments, the company will also transfer core technologies and know-how to the Middle East country until 2017 in exchange for $80 million.

Other institutes involved are Seoul National University Hospital (a heart science center), Gachon University Gil Medical Center (a brain imaging science center), Samsung Medical Center (a neuroscience research center) and the Korea Cancer Center Hospital (a radiation therapy center).

“Everything is all set,” the CEO said. “This project will help bolster Pharmicell’s profile in Middle Eastern nations and, hopefully, around the world.”

He said Pharmicell’s winning the lucrative contract with Saudi Arabia — in competitive bidding with some 20 other stem cell therapy developers — reflects the country’s recognition of the firm’s technologies and experiences.

“Some say our way of making the therapy (using somatic stem cells extracted from the patient’s own body) is easier than that using stem cells from a third person’s body. That’s true. But it’s still not something anybody can emulate easily,” he said.

Kim underscored that the firm’s core competitiveness lies with its mass production ability and tight control of product quality.

“Stem cell therapy is totally different from conventional treatments. It’s easy to mass produce conventional drugs and keep their quality unchanged in storage because they are made of protein, heavy metals or chemical substances. But our products are made of living stem cells whose quality is always changeable,” Kim said. “Pharmicell is the world’s first company proven to have the ability to carry out the two (mass production and quality control) at the same time. Perhaps that’s why Saudi Arabia selected us as a partner in the project.”

The firm is stepping up efforts to enter the United States, the world’s largest market in the industry. To that end, it’s now in talks with U.S. Food and Drug Administration to start testing its therapy’s safety and efficacy. The therapy is now available in Hong Kong.

“We see huge potential in Hong Kong since a growing number of rich people in mainland China visit the territory for medical treatment.”

The global markets for stem cell products are forecast to reach $6.6 billion by 2016, up from $4.3 billion in 2012, according to BCC Research, a publisher of technology market research reports. The American market is expected to reach nearly $2.3 billion by 2016, while the European market will grow to $ 1.5 billion during the same period, it said.

Who is Kim Hyun-soo?

Born in 1964, Kim graduated from Yonsei University’s medical school in Wonju, Gangwon Province. Prior to joining Pharmicell as CEO in 2002, he worked as a medical school professor at Ajou University from 1997 to 2002.

Kim has experienced various advisory positions for state bodies, including the Ministry of Health and Welfare, the Korean Food and Drug Administration, and the now-defunct Ministry of Science. He currently holds a professorship at Yonsei medical school.