SK Chem gets U.S. nod for hemophilia drugSK Chemical obtained a license to sell a new drug for hemophilia from the United States, the company said Friday.
This is the first time a Korean drug maker has received approval to sell a biomedical product, which is different from biosimilar products of already established drugs, by the U.S. Food and Drug Administration.
In 2009, SK Chemical licensed sales of the same drug to an Australian pharmaceutical company, CSL Limited. The company said the drug is currently waiting sales permission from authorities in Europe and Australia.
Korean drug companies have been chalking up milestones recently. Hanmi Pharmaceutical stunned the business world last November when it reached a licensing agreement with Janssen Pharmaceuticals worth $915 million to develop a drug treating diabetes and obesity.
SK Chemical’s new drug NBP601, which treats Type-A hemophilia, requires fewer injections than other treatments and has no side-effects, according to the company.
Type-A hemophilia accounts for 80 percent of all hemophilia cases, who have trouble stopping bleeding.
According to clinical trials, users of NBP601 only need to inject the medicine twice a week compared to three or four times for existing treatments.
The most serious side-effect produced by other type A hemophilia treatments is the creation of a neutralizing antibody that interferes with treatment. That side effect has not been reported with SK Chemical’s NBP601.
“NBP601 has an enhanced stability of molecular structure and the effect of the medicine is longer,” said Dr. Lisa Boggio of Rush University Medical Center in Chicago, U.S., who participated in the drug’s clinical trials. “It is the FDA’s first approval for a single-chain [molecular structure] product.”
The U.S. market for type-A hemophilia medicine is 3.6 trillion won ($3 billion) based on 2014 data accumulated by Datamonitor, a global market research intelligence. It is the biggest part of the world’s 8.4 trillion won market for such medicine. By 2023, the U.S. market is expected to grow roughly 33 percent to 4.9 trillion won, Datamonitor said.
BY KIM JEE-HEE [firstname.lastname@example.org]