Pharmaceuticals
Korea-based biotechnology company Medipost announced on December 16 that it signed a license agreement with Indian pharmaceutical company Alkem Laboratories Ltd for its stem cell-based cartilage repair drug Cartistem. This is the first time for local stem cell drugs to penetrate the Indian market.
The Korean firm transferred exclusive sales rights and distribution rights in India to the other party, and will get license fees, milestone payments, and royalties. Alkem will be in charge of carrying out clinical trials of the drug and getting a clinical trial approval by the Drug Controller General of India (DCGI).
Medipost is planning to launch Cartistem in 3 or 4 years, and 40 billion won (US$38 million) in sales is expected, 10 years after the introduction.
Prior to its entry in the Indian market, the Korean company signed license agreements for the drug with Hong Kong and Macao in November 2012, and also with Australia and New Zealand in February 2013. Currently, the firm is reported to be discussing the same agreement with other countries. In addition, clinical trials are being conducted in the US under the USFDA’s approval in order to make inroads into the US market.
Pharmicell, another stem cell therapy developer, said that its task for the USFDA’s clinical trial project involving its stem cell therapy for cirrhosis was selected as a support project for global consulting by the Korea Health Industry Development Institute. The task is related to the transfer of manufacturing technology to a local contract manufacturing organization (CMO) and the production of prototypes for clinical trials in the US.
An official at Pharmicell remarked, “We finalized a deal with CTRM, one of the CMOs in the US, to make our stem cell therapy for use in clinical trials, and started to transfer the related technology.” The company anticipates that those clinical trials will proceed smoothly because of promising data for clinical trials of cirrhosis conducted in Korea, and the publication of the research article in an international journal.
The two Korean biotech companies were chosen as favored firms in the field of stem cell-based treatments by the HSBC Global Research in a recent research report titled Disruptive Technologies.