● SK chemicals’ Hemophilia product ` NBP601 `, gets the U.S. FDA Marketing Approval
- Entered USD 3 billion hemophilia A market in U.S.... AFSTYLA marketing applications being reviewed in EU, Switzerland & Australia.
- First successful case of global commercialization through licensing-out the technology at the preclinical stage: New milestone of domestic biopharmaceuticals R&D is achieved.
- Significant improvement on efficacy and convenience with the world’s first and only single-chain recombinant Factor VIII for the treatment of hemophilia A
On 28th, SK chemicals (CEO, Mahn Hoon Park) announced that U.S. Food and Drug Administration (FDA) has approved NBP601 (Product Name: AFSTYLA) for the treatment of hemophilia A. NBP601 is a recombinant anti-hemophilia factor VIII, which was out-licensed the global right to CSL Limited (CSL) by SK chemicals in 2009. NBP601 is the first FDA marketing authorization for domestically researched biopharmaceuticals to be approved in U.S. Regulatory agencies in EU, Switzerland, Australia, etc. are also currently reviewing CSL’s marketing authorization application for NBP601.
After SK chemicals’ the first out-licensing among domestic biopharmaceuticals, NBP601 demonstrated innovative treatment option for US hemophilia A patients. Mahn Hoon Park, CEO of SK chemicals, said, “The approval acknowledges our promise to develop innovative therapies. The excellent efficacy and patient convenience will be the driving force behind the global commercialization.”
NBP601 is the first and only single-chain factor VIII for hemophilia A that is specifically designed for long-lasting therapeutic effect. The structure of factor VIII is based on two linked protein chains-a heavy one and a light one. NBP601 uses a strong covalent bond that creates a single-chain factor VII, to improve the stability of factor VIII and provide longer-lasting factor VIII activity
According to the global clinical result (AFFINITY Clinical Program), NBP601 was presented the long-lasting protection from bleeds with twice weekly dosing. NBP601 improved medication compliance for patients who have to be given 3-4 times periodically for routine prophylaxis to prevent bleeding episodes. Also, no patient in the clinical studies developed an inhibitor reaction, one of the major complications of factor VIII replacement therapy in hemophilia A patients.
Datamonitor (www.datamonitor.com), a global research company, forecasts that the hemophilia A therapeutics reached a U.S. market size of USD 3.0 billion in 2014. The value of the U.S. hemophilia market will rise by USD 4.1 billion with 33% growth during 2014 to 2023.
SK chemicals look forward to the positive impact sales of NBP601 on patients with hemophilia A in U.S
[GLOSSARY]
☞ Hemophilia A
Primarily affecting males, hemophilia A is a congenital bleeding disorder characterized by deficient or defective factor VIII. People with hemophilia A may experience prolonged or spontaneous bleeding, especially into the muscles, joints or internal organs. According to the United States Centers for Disease Control and Prevention (CDC), the condition affects approximately 1 in 6,000 male births.
☞ Afstyla
Abbreviation for “Affinity Style Long Acting”. Means anti-hemophilic drug, safe and providing longer-lasting efficacy with its high covalent bond within the body.
☞ AFFINITY
AFFINITY clinical development program
☞Inhibitor reaction
Pathological formation of neutralizing antibodies that removes or reduces the effect of a drug
[About the company]
About CSL
CSL is a leading global biotherapeutics company with a dynamic portfolio of life-saving innovations, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL — including our two businesses CSL Behring and Seqirus — operates in over 30 countries with more than 16,000 employees. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For more information, please visit www.csl.com.au.