[SK Chemicals`s Afstyla ]
SK Chemicals Co. said on Tuesday its hemophilia A drug Afstyla has been approved by the European Medicines Agency (EMA), marking the first case of Korea’s novel biologic drug to be marketed across Europe.
Hemophilia A is a blood-coagulation disorder in which the blood fails to clot normally because of a deficiency or abnormality of the clotting factor protein VIII. The main difficulty for people with the disease is internal bleeding into the muscles, joints and soft tissues even without external injury. Hemophilia A affects mostly men, and approximately 1 in every 6,000 males is born with the disorder.
According to Datamonitor, the hemophilia A treatment market in Germany, Britain, France, Spain and Italy was valued at 4.2 trillion won ($3.5 billion) as of 2015, with 8.2 trillion won globally. The world’s hemophilia A market is expected to continue growth, hitting 9.5 trillion won by 2020.
“Afstyla is the world’s first recombinant factor VIII single chain therapy that provides long-lasting protection from bleeding with twice weekly administration,” said SK Chemicals. “There was no single report of neutralizing antibody responses, a major adverse event that inhibits the drug’s efficacy, in global clinical trials," it added.
SK Chemicals signed a license deal for Afstyla with Australian pharmaceutical company CSL in 2009. Under the deal, CSL is responsible for global clinical trials and regulatory approval. The drug was also approved by the U.S. Food and Drug Administration in May last year, and is now available in the U.S. market.
Industry sources believe that SK Chemicals is eligible to receive milestones and royalty payments of 5 to 10 percent of Afstyla sales from its Australian partner. If the drug accounts for 10 percent in the EU market, SK Chemicals would rake in at least 20 billion won a year.
“Our continuous R&D and investment have been paid off,” said SK Chemicals chief executive officer Park Man-hoon. “We will be committed to enhance our competitiveness in the global market by focusing on biopharmaceuticals including vaccines and blood products,” he added.
Shares of SK Chemicals closed Wednesday at 65,500 won, down 0.46 percent or 300 won from the previous session.
By Kim Hye-soon
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