The world’s first medication using stem cells collected from other people got the green light for commercial sales from South Korea’s drug agency on January 19. [see our post on Cartistem: Stem Cell Treatments in South Korea.]
Cartisem is used to treat degenerative arthritis and knee cartilage defects by regenerating knee cartilage using stem cells developed from umbilical cord blood taken from newborn babies, the Korea Food and Drug Administration said. It is developed by Seoul-based Medipost Co., Ltd., a biotechnology company listed in the Kosdaq.
“Stem cell treatments are the third-generation bio medicines,” Dr. Yoon-sun Yang, Medipost’s CEO and President, told The Korea Herald in a recent interview.
The new drug’s market launch show’s Korea’s growing ability to compete in the field of biotechnology, she said. “Unlike the existing market for chemical products dominated by American and European giants, Korea is competing with them in a nip-and-tuck race for stem cell therapies,” she opined.
The drug is currently undergoing simultaneous clinical trials (phase I and II) among patients in the United States. Both trials, which will take one and a half year to complete, have been approved by the U.S. Food and Drug Authority—making Medipost the first non-U.S. company allowed by the agency to conduct first- and second-phase trials for stem cell medication.
The trials will assess the safety and efficacy of Cartisem in U.S. patients with degenerative arthritis and traumatic knee cartilage defects. After the two trials, a third one (phase III) will be undertaken in South Korea.
“The clinical trials to be conducted give a representative example that will again show that South Korea is an international power in stem cell research—ranking second after the U.S.,” Medipost said in a release.
The upstart company also predicted that, “Once the clinical trials end, the world’s medical circles will pay attention to (South) Korea.”
Medipost has been working on developing Cartistem for nearly 10 years and in 2010, signed a licensing deal with Dong-A Pharmaceutical, a South Korean drug maker, to sell the stem-cell based product in that country.
The agreement granted Dong-A Pharmaceutical the exclusive domestic sales rights, while co-developing and conducting clinical trials for additional indications with Medipost. The biotech company received an up-front fee, milestone payments and running royalties.
This January, Dr. Yang announced the successful completion of the phase III clinical trials in Korea, indicating that Cartistem is safe and effective.
“Satisfactory results were obtained and that it is non-toxic and … manufacturing facilities … are consistent with standards set by the KFDA,” Dr. Yang said.
Medipost said it is expecting Cartisem to capture a large proportion of the arthritis drug market, worth hundreds of billions of won, since Cartistem is Korea’s first stem cell-based therapeutic agent and generic medicines are not available.
“There are so many arthritis patients around the world, and there will be even more as the aging process accelerates,” Yang said in a press release posted on the company website.
“Current remedies like cell therapy and joint replacement surgery have limitations on the size of lesions or the type of joint and don’t work with degenerative diseases. But Cartistem has no concern with any of those issues.”
The arthritis market alone has great potential for growth, Dr. Yang said. Currently, five million to 7.5 million Koreans are suffering from degenerative arthritis, making up 10 percent to 15 percent of the local population.
Yang noted that arthritis with diabetes requires high medical fees for long periods and aside for the artificial joint market for the elderly, there are few better alternatives to Cartistem. The arthritis market for patients with arthritis at the age of 30-60 is worth hundreds of billions of won alone, she said.
More than 54,000 Koreans underwent knee joint surgery in 2009, National Health Insurance Corporation data shows, and the average operation cost 7.23 million won.
Dr. Yang values the Korean market’s potential for Cartistem at up to 250 billion won (US$229.4 million), which she said “grows exponentially” in the global market.