Daewoong Pharm, which handed over the domestic selling right of Gliatilin, a cognition-enhancing medicine developed by Italfarmaco, to rival Chong Kun Dang Pharmaceutical, will target overseas markets with another of its generic drug.

Daewoong Pharm developed Gliatamine, a generic of Gliatilin, and has been selling it in the domestic market through its subsidiary Daewoong Bio. But the company has developed another generic, Gliastar, and was licensed to sell it by the Ministry of Food and Drug Safety(MFDS) last Wednesday.

Daewoong Pharm

Daewoo can sell Gliastar in the domestic market, too, as the ministry’s approval was not limited to export purpose only, but the drugmaker will not release it in the local market. The company’s strategy is to sell Gliatamine to home consumers while targeting foreign markets with Gliastar, company officials said.

There are lots of gossips among industry watchers, however, as to why Daewoong has developed a second generic of Gliatilin while it already had one with some whispering “Daewoong is out for revenge.”

Daewoong had recorded annual sales of 60 billion won ($52 million) for 15 years from Gliatilin until the company terminated its sales right contract with Italfarmaco last year. After the contract cancellation, Daewoong waged legal battles with the government by filing administrative suits against the Ministry of Health and Welfare and the MFDS.

Daewoong had its product license nullified in March 2016 after the company handed over its sales rights to Chong Kun Dang, after which the MFDS changed its reference listed drug – a benchmark drug for conducting bioequivalence test – from Daewoong Gliatilin to Chong Kun Dang Gliatilin.

Daewoong Pharm filed the administrative suit claiming the administrative procedures were unfair and won over the MFDS. After its defeat, the ministry reselected Daewoong Gliatilin as the reference listed drug.

Instead, the ministry supplemented relevant regulations by revising part of the “criteria for bioequivalence test of medical products,” which included clearer determination of original company’s products among the selection criteria of the reference listed drugs and deleting canceled items from RLD.

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