2005-11-30-Korean Firm Finds Easier Way to Make Generic Flu DrugUnderstanding Avian Influenza
2005-11-30-Korean Firm Finds Easier Way to Make Generic Flu Drug
A domestic pharmaceutical company has developed a new substance that will make it easier to produce a generic form of the only available influenza drug Tamiflu, easing concerns that stocks could run out if bird flu mutates to spread from human to human. Chong Kun Dang said Wednesday the development would allow it to start producing generic Tamiflu as soon as it is given the green light.
The company says it has found a way of replacing the difficult-to-obtain shikimic acid with a byproduct from the production of diabetes drugs. Shikimic acid is a basic natural vegetable substance that is synthesized to make oseltamivir phosphate, the key component of Tamiflu. Korean drug makers would otherwise have to import it.
But Chong Kun Dang said a stable supply of the anti-flu drug would be possible because with the innovation it can easily be made with ingredients available here. The firm says its method also overcomes dangers from the existing synthesizing process.
It has submitted the method and the trial product to the Korea Food and Drug Administration (KFDA) and plans to seek patents for the method at home and abroad.
If a pandemic of human-to-human transmissible bird flu were to hit the country, the KFDA would either temporarily suspend Roche's exclusive rights to Tamiflu or allow domestic drug companies to produce the drug in partnership with the Swiss pharmaceutical giant. Sixteen local pharmaceutical firms have expressed willingness to manufacture the drug, but only Ilyang Pharm, Chong Kun Dang and Estech Pharma have submitted products and related documents to the KFDA, while Hanmi Pharmaceutical recently succeeded in producing a trial batch of generic Tamiflu.