Dipharma SA und Alvogen geben die Markteinführung von Diterin® 100 mg Tabletten in Südkorea bekannt
First drug now registered and commercially available in the Republic of South Korea for the treatment of Hyperphenylalaninemia (HPA) due to Phenylketonuria (PKU).
Chiasso, Switzerland and Seoul, South Korea, February 3rd, 2017 – Dipharma S.A. and Alvogen today announced that the pharmaceutical product Diterin® (Sapropterin Dihydrochloride 100mg tablets), indicated for the treatment of hyperphenylalaninemia (HPA) due to phenylketonuria (PKU), is now commercially available in the Republic of South Korea.
Diterin® is the only drug approved in South Korea by the Korean Ministry of Food and Drug Safety for the treatment of HPA due to PKU, a rare genetic disease leading to an abnormally high concentration of phenylalanine (Phe) in the blood, which can cause brain damage to people affected by it.
“We are happy to provide Diterin® to the South Korean market, as this treatment can make a difference in the management of Phe levels for many patients suffering from lifelong PKU, contributing to prevent the appearance of potential transient to non-reversible mental impairment” said Peter Vazharov, Alvogen S&M VP, Asia Pacific together with Marc-Olivier Geinoz, CEO of Dipharma S.A., who added: “As part of Dipharma’s mission, we will continue to expand our portfolio of high-quality products – including Diterin® – to offer improved solutions to each and every patient suffering from inborn errors of metabolism all around the world”.
Dipharma S.A. also confirms that patents and patents applications were filed protecting Diterin® and its active pharmaceutical ingredient – Sapropterin Dihydrochloride – in many countries of the world, including South Korea. This commercial launch is resulting from an exclusive collaboration agreement between Dipharma S.A. and Alvogen, under which Alvogen owns the exclusive rights to commercialize Diterin® 100mg tablets in the Korean market. Dipharma S.A. is currently working to make Diterin® available in all the countries worldwide.