First Approval from Europe
A Korean new bio medicine is pushing into the European market for the first time. SK Chemicals Co., the chemical and pharmaceutical arm of South Korea's conglomerate SK Group, announced on January 10 that it has won final approval from the European Medicines Agency (EMA) to sell its hemophilia drug Afstyla. It is the first Korean biomedical product, not a biosilimar, to be approved for use on the European market. SK Chemicals developed Afstyla to the preclinical phase with its own technology and licensed the drug to Australia's biotechnology firm CSL Ltd. in 2009. After that, CSL has developed a production process and executed global clinical trials and applications for sales approval.
Afstyla received an approval from the U.S. Food and Drug Administration (FDA) in May 2016, which was the first sales in the United States among Korean technologies-based new bio medicines, and also won an approval from the Canadian health authorities in December. The drug is now waiting for an approval in Switzerland and Australia.
A coagulation factor VIII Afstyla is world’s first and only single-chain product for hemophilia A, developed by SK chemicals. Compared with the existing medicine for hemophilia A in which two proteins have been combined, Afstyla uses a covalent bond that forms one structural entity, a single polypeptide-chain, to improve the stability with two times weekly dosing.
During the global trials, there was no single report on neutralizing antibodies from the patients treated by Afstyla, which represents stability of the medicine. The neutralizing antibody reaction which inhibits efficiency of a drug by forming an antibody is considered as the most serious side effect of medicine for hemophilia A. CSL is expecting that Afstyla will be able to keep its leading position in the global hemophilia A market as an innovative effective therapy
In accordance with this, SK chemicals is expecting royalty from global sales by CSL. The specific amount has not been released but the securities industry sources believe that about 5 percent of sales will be paid for royalties. In short, when the drug sees its global sales reach 300 billion to 400 billion won (US$249.9 million to 333.19 million) this year, SK Chemicals will be paid royalties worth 15 billion to 20 billion won (US$12.49 million to 16.66 million).
According to global research company Data Monitor, the market scale of hemophilia A treatment in five major EU countries – Germany, Britain, France, Spain and Italy – reached 4.2 trillion won (US$ 3.5 billion) in 2015 and the global market scale recorded 8.2 trillion won (US$ 7.2 billion). Its market is continuously growing and the global market in 2020 is expected to reach to 9.5 trillion won (US$ 8.3 billion).