- The first new biological product originated from a Korean biopharmaceutical company to enter
the $3.6bn European Hemophilia A market
- An achievement followed by the launches in US and Canada. Anticipated royalties and sales
milestone payments as per sales in major global markets
On January, 10, SK Chemicals (CEO, Mahnhoon Park) announced that AFSTYLA received a final marketing authorization from the European Medicines Agency (EMA). This makes AFSTYLA the first new biological product originated from a Korean company to enter the EU market.
AFSTYLA was originated from SK Chemicals and out-licensed to CSL, an Australian company in 2009. Since then, CSL has been conducting global development including manufacturing, clinical trials and registration.
AFSTYLA was approved by U.S. Food and Drug Administration (FDA) in May last year, making it the first new biological product originated from a Korean biopharmaceutical company to enter the US Hemophilia A market. It was also approved by Health Canada in December. AFSTYLA is currently under registration process in countries such as Australia.
AFSTYLA is a recombinant Human Coagulation Factor VIII specially designed as the first and only single-chain Factor VIII structure for the treatment of hemophilia A. As a single chain structure form of Factor VIII, AFSTYLA provides longer-lasting protection from bleeds with the option of twice weekly dosing and has greater molecular stability compared to other recombinant Factor VIII products composed of two heavy and light chains in separately associated structure.
Furthermore, AFSTYLA demonstrated an excellent safety profile with no inhibitor development in global clinical trials. Inhibitor development is the major complication of Factor VIII replacement therapy in hemophilia A patients..
CSL expects AFSTYLA to take its place in the global hemophilia A market as an innovative and effective therapy. Accordingly, SK Chemicals anticipates royalty and sales milestone payments from the global sales of CSL.
"We look forward to the positive impact AFSTYLA can have on haemophilia A patients in the European Union." said Dr. Andrew Cuthbertson, Chief Scientific Officer and R&D Director, CSL Limited.
"We are very pleased to witness another meaningful achievement of our long term investments in R&D", said Dr. Mahnhoon Park, CEO of SK Chemicals. "We will keep building our capabilities as a global leading company through continuous success in biopharmaceutical products such as vaccine and blood derivatives."
According to Datamonitor (www.datamonitor.com), the hemophilia A market size in EU 5 (Germany, France, UK, Spain and Italy) reached about 3.6 billion USD, and the whole global market size was 7.2 billion USD as of year 2015. The value of hemophilia A market would continue to grow and the global market is expected to reach 8.3 billion USD, about a 17 % increase, by year 2020.
[Photo]
AFSTYLA®, a Treatment for Hemophilia A, Receives an EU Marketing Authorization.
[Terminology]
1) Hemophilia A
This refers to a congenital hemorrhagic disorder caused by deficiency of blood coagulation factor VIII. Most patients are male. In the case of patients with type A hemophilia, hemorrhage usually develops or persists in muscles, joints or internal organs. According to the Centers for Disease Control and Prevention (CDC), one in about 6,000 men is born with hemophilia.
2) AFSTYLA
This represents an abbreviation of "Affinity Style Long Acting," which means the hemophilia treatment is stable because of its strong binding force in vivo and lasts for a long time.
3) Blood Coagulation Factor VIII
There are 13 factors involved in blood coagulation. The lack of the eighth factor leads to the occurrence of type A hemophilia.
[About CSL]
CSL Limited (www.csl.com.au)
CSL founded in 1916 is a leading global biotherapeutics company with a dynamic portfolio of life-saving innovations, including those that treat hemophilia and immune deficiencies, as well as vaccines to prevent influenza. It - including its two businesses CSL Behring and Seqirus - operates in over 30 countries with more than 16,000 employees.
the $3.6bn European Hemophilia A market
- An achievement followed by the launches in US and Canada. Anticipated royalties and sales
milestone payments as per sales in major global markets
On January, 10, SK Chemicals (CEO, Mahnhoon Park) announced that AFSTYLA received a final marketing authorization from the European Medicines Agency (EMA). This makes AFSTYLA the first new biological product originated from a Korean company to enter the EU market.
AFSTYLA was originated from SK Chemicals and out-licensed to CSL, an Australian company in 2009. Since then, CSL has been conducting global development including manufacturing, clinical trials and registration.
AFSTYLA was approved by U.S. Food and Drug Administration (FDA) in May last year, making it the first new biological product originated from a Korean biopharmaceutical company to enter the US Hemophilia A market. It was also approved by Health Canada in December. AFSTYLA is currently under registration process in countries such as Australia.
AFSTYLA is a recombinant Human Coagulation Factor VIII specially designed as the first and only single-chain Factor VIII structure for the treatment of hemophilia A. As a single chain structure form of Factor VIII, AFSTYLA provides longer-lasting protection from bleeds with the option of twice weekly dosing and has greater molecular stability compared to other recombinant Factor VIII products composed of two heavy and light chains in separately associated structure.
Furthermore, AFSTYLA demonstrated an excellent safety profile with no inhibitor development in global clinical trials. Inhibitor development is the major complication of Factor VIII replacement therapy in hemophilia A patients..
CSL expects AFSTYLA to take its place in the global hemophilia A market as an innovative and effective therapy. Accordingly, SK Chemicals anticipates royalty and sales milestone payments from the global sales of CSL.
"We look forward to the positive impact AFSTYLA can have on haemophilia A patients in the European Union." said Dr. Andrew Cuthbertson, Chief Scientific Officer and R&D Director, CSL Limited.
"We are very pleased to witness another meaningful achievement of our long term investments in R&D", said Dr. Mahnhoon Park, CEO of SK Chemicals. "We will keep building our capabilities as a global leading company through continuous success in biopharmaceutical products such as vaccine and blood derivatives."
According to Datamonitor (www.datamonitor.com), the hemophilia A market size in EU 5 (Germany, France, UK, Spain and Italy) reached about 3.6 billion USD, and the whole global market size was 7.2 billion USD as of year 2015. The value of hemophilia A market would continue to grow and the global market is expected to reach 8.3 billion USD, about a 17 % increase, by year 2020.
[Photo]
AFSTYLA®, a Treatment for Hemophilia A, Receives an EU Marketing Authorization.
[Terminology]
1) Hemophilia A
This refers to a congenital hemorrhagic disorder caused by deficiency of blood coagulation factor VIII. Most patients are male. In the case of patients with type A hemophilia, hemorrhage usually develops or persists in muscles, joints or internal organs. According to the Centers for Disease Control and Prevention (CDC), one in about 6,000 men is born with hemophilia.
2) AFSTYLA
This represents an abbreviation of "Affinity Style Long Acting," which means the hemophilia treatment is stable because of its strong binding force in vivo and lasts for a long time.
3) Blood Coagulation Factor VIII
There are 13 factors involved in blood coagulation. The lack of the eighth factor leads to the occurrence of type A hemophilia.
[About CSL]
CSL Limited (www.csl.com.au)
CSL founded in 1916 is a leading global biotherapeutics company with a dynamic portfolio of life-saving innovations, including those that treat hemophilia and immune deficiencies, as well as vaccines to prevent influenza. It - including its two businesses CSL Behring and Seqirus - operates in over 30 countries with more than 16,000 employees.
SK Chemicals Co. Ltd. published this content on 10 January 2017 and is solely responsible for the information contained herein.
Distributed by Public, unedited and unaltered, on 12 January 2017 17:00:07 UTC.
Original documenthttp://www.skchemicals.com/en/prcenter/new_view.asp
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