Korean pharmacists Friday accused the government of turning a blind eye to the sales of Gliatilin, saying the medicine was approved in 2002 despite questionable clinical findings and marketed as a drug that prevents dementia.
The Korean Pharmaceutical for Democratic Society (KPDS) called for the government to reexamine its financing of Gliatilin, saying the drug is not approved in any other countries but Italy, the developer’s country of origin, and Korea.
“The drug has not been approved in any other developed countries in Europe and North America except Italy,” the KPDS said in a press release. “In fact, it is sold as a functional health food in the U.S.”
Gliatilin (ingredient: choline alfoscerate) is a cognitive-enhancing medicine developed by Italian pharmaceutical Italfarmaco. It has become a blockbuster drug in the country since its approval in 2002 as a prescription medication, having recorded accumulated sales of around 1.13 trillion won ($1 billion).
Health and government authorities have failed to take any corrective measures, even though the Ministry of Health and Welfare pointed out the “uncertainty of clinical benefit” in 2011, the society said. The negligence has led to the drug to be recognized as a “dementia preventive medicine,” thereby misleading citizens and putting a dent in national health funds, it stated.
“Evidence to prove the efficacy of Gliatilin has been weak. The ministry pointed out the uncertainty of clinical trials in 2011, but the government has taken no action while the drug filed medical costs of over $1 billion,” the society said.
At the same time, the fight over selling rights of the blockbuster drug in Korea has been fierce. Conflicts over sales rights led to a legal showdown between two Korean pharmaceuticals, Daewoong and Chong Kun Dang, when Italfarmaco switched distributors in 2016.
Gliatilin had been sold by Daewoong until 2015, but the Italian developer handed off the sales rights to Chong Kun Dang early this year. Daewoong had recorded annual sales of 60 billion won ($52 million) for 15 years from the drug sales until the fallout.
Daewoong then released a generic of Gliatilin, called Gliatamin, stirring a brawl with the developer earlier this year. Italfarmaco soon filed a trademark suit against the Korean pharma giant for having similar packaging and class of goods. The Patent Court ruled in favor of the Italian company and accepted the trademark invalidation claim. Daewoong said it would immediately appeal to the Supreme Court.
Striking back, Daewoong released a second generic of Gliatilin, Gliastar, and gained the health authority’s approval to sell the drug in the local market. The drugmaker, however, said it would try its hand at selling the drug abroad. The drug recorded around $45 million in sales worldwide in 2016, according to consulting firm Evaluate Group.
Considering the increasing number of dementia patients and increasing medical fees associated with the drug, the pharmacy society called for the government to take action and redirect the use money for the drug to helping dementia patients.
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