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Anterogen, Entering Rare Disease Market with Korean Domestic Stem Cell Therapeutics

기사입력 : 2017-06-19 10:35|수정 : 2017-06-19 10:35
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바이오스펙테이터 Sungmin Kim 기자

In a process of six cases of domestic clinical trials using allogeneic adipose derived mesenchymal stem cells… “Proving excellent technology in rare diseases with regards to crohn fistula”

“Anterogen’s ultimate targeting market is a rare disease market in Japan, America, and Europe. Anterogen has strategized to achieve a top with excellently effective therapeutics in rare disease market in which having no reasonable treatment alternatives. It is not aiming at a large-scale market but a niche market where there is no competitor. The rare disease market is growing and increasing its sales in worldwide.”

This difference is what the representative of Anterogen, Lee Sung Koo, has: different target market from other companies. It is interesting to view Anterogen’s recent movement that reflects exactly what he meant. Anterogen had recently signed a contract with Ishin pharmaceuticals in Japan, with a total of 90 billion won down payment and milestone. Anterogen just received a total payment of 3.8 billion won solely as licensing fee regarding the technology, and has entered into the clinical stage in Japan. In addition, two other IND were approved from the U.S. Food and Drug Administration (FDA) with the same therapeutics.

This therapeutic product, which is accelerating into the global market, is the ‘ALLO-ASC-Sheet’ for rare skin diseases: a patch preparation using mesenchymal stem cells. Its beginning was in an effort to overcome the limitations of conventional stem cell therapy. Compared to the reputation of ‘stem cells’, stem cell therapy had continuously failed in clinical trials due to limited efficacy and its uniformed product manufacturing. So far, there are only seven cases of treatment that had been approved globally. And this can be interpreted in the same context. Stem cell therapies have been in the market for a while but were not getting spotlights because of its complicate procedures and expensive price from the reason of personalized medicine characteristics, almost impossible logistics.

Meanwhile, the ALLO-ASC-Sheet is very effective and is a “ready-made” which can be stored for a year in deep freezer. And its attraction is doubled by exporting of a finished product to overseas market with the stem cells were already manufactured and banked in Korea. Anterogen is joining hands with Emtek to advance its entrance to global market to provide the sheets in a large-scale and will establish factories that meet the cGMP standards and requirements.

Anterogen is a biotech company founded in 2000 and launched ‘Cupistem’, the only therapeutic that can be billed through insurance among four KFDA approved therapeutics. Since 2014, when it was designated as an insurance billable product, about 150 patients have been prescribed to date. It is noteworthy that Cupistem is the first product to demonstrate company’s technology, showing excellent therapeutic efficacy in Crohn fistula where no other treatments available.

▲Clinical efficacy of Cupistem

▲Clinical efficacy of Cupistem

Among the stem cells, Anterogen uses mesenchymal stem cells derived from fat tissue. Stem cells are generally well known for their ability to differentiate into damaged cells and tissue but Anterogen’s concept is to utilize paracrine effects of mesenchymal stem cells.

There are mesenchymal stem cells in the bone marrow, umbilical cord blood and adipose tissue of our body, which are capable of differentiating into cartilage, bone, muscle cells, and secrete immunomodulatory and regenerative substances. It has even more advantage that there is almost no immunogenicity following transplantation when used as a therapeutic agent. Representative Lee spoke, “We collaborated with Korea Biotechnology Research Institute to investigate stem cells and its genotyping in relation to its functional pathway” Anterogen has a number of patents related to it.

Currently undergoing six clinical trials using allogeneic mesenchymal stem cells… “Accelerating Global Expansion”

Anterogen is currently conducting six clinical trials in Korea, focusing on skin diseases. Lee said, “The skin disease is so short that it can be marketed as soon as it proves its effectiveness.” The ongoing clinical trials are based on allogeneic adipose derived mesenchymal stem cells. Based on the characteristics of the lesion, the clinical trial is using either the form of a sheet or an injection.

The most prominent project currently undergoing trials is ALLO-ASC-DFU, which targets patients with diabetic foot ulcers. Lee is expecting to release the product as soon as Phase 3 clinical trial is completed with "IND submission" to end Phase 2 clinical trials in Korea and proceed with phase 3 clinical trials.

Anterogen is also accelerating commercialization in Japan and the US, where the market for rare diseases is large, under clinical approval.

Anterogen has entered into licensing agreements for three indications with Japanese Pharmaceuticals Co., Ltd DEB, diabetic foot ulcers and burns. "There are relatively warm view of stem cells product in Japan," he said, referring to the reason that Anterogen's stem cell products first entered Japan and said “will get approval very soon as long as we demonstrate its effectiveness’’. Japan government is fully supportive of the development of stem cell treatment drugs and 100% insurance benefits will be paid for rare diseases products.

Sheets for DEB was licensed out to Ishin Pharmaceuticals in 2015 have recently received clinical approval from Japan's Ministry of Health and Welfare (PMDA). Ishin Pharmaceutical will prove the clinical efficacy with limited number of patients and apply for conditional marketing authorization. For sheet clinical trials, Anterogen supplies sheet products to Ishin Pharmaceuticals.

They also laid the foundation for entry into the United States. Anterogen sheet was approved by the FDA last year and for Clinical Phase 1 / 2a in DFU (diabetic foot ulcers patients, followed by Clinical Phase 1 in patients with DEB earlier this year.

On the vision that Anterogen is pursuing, Lee said, Anterogen would export new drugs developed with domestic technology to the world. It is our goal to become a global pharmaceutical company to sell. Anterogen is committed to making authentic products so that health care providers around the world trust us and recognize us by our company name like we all know famous pharmaceutical companies."

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