Abraxis BioScience, Inc. has announced that the Korean FDA (KFDA) has granted marketing approval for ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) for the treatment of breast cancer after failure of standard chemotherapy for metastatic disease.
The Phase III clinical trial results on which this approval was based demonstrated that ABRAXANE doubled the response rate and significantly prolonged progression-free survival and overall survival versus Taxol® in the approved indication. ABRAXANE is now approved for marketing in 34 countries.
As previously announced, Abraxis granted an exclusive license to Green Cross Corporation for the commercialization of ABRAXANE in Korea. Green Cross made an upfront payment and will pay a royalty on net sales of ABRAXANE in Korea as well as milestone payments.
In a separate agreement, Green Cross has granted an exclusive license to Abraxis for the future commercialization of the following biosimilars in the U.S. and Canada: erythropoetin, pegylated G-CSF (granulocyte-colony stimulating factor), Interferon-Alpha, recombinant Factor VIII, and etanercept. Interferon Alpha has been launched in Korea by Green Cross.
Green Cross filed for regulatory approval with the KFDA for recombinant Factor VIII in the second quarter of 2008 and Green Cross has completed Phase III studies for erythropoetin. Pegylated GCSF and etanercept are in early stages of development. Once approval has been received, Abraxis will pay Green Cross a milestone on each product in addition to royalties on net sales.
Green Cross currently expects to launch ABRAXANE in Korea in the first quarter of 2009 following pricing approval. Green Cross plans to establish a dedicated sales force for ABRAXANE and implement various marketing campaigns to support a successful launch. Abraxis has two additional global partnerships for the commercialization of ABRAXANE with Taiho Pharmaceuticals in Japan and Biocon Limited in India.
“The approval for ABRAXANE in Korea provides an effective new treatment option to physicians and patients in Korea in the fight against metastatic breast cancer. We look forward to expanding the global market presence of ABRAXANE,” said Patrick Soon-Shiong, M.D., chairman and chief executive officer of Abraxis BioScience.
“This approval represents an exciting new direction for Green Cross’s oncology business and we are very pleased to bring this unique and efficacious drug to cancer patients in Korea,” said B.G. Rhee, Ph.D., executive vice president of Green Cross.
In Korea, there are approximately 20,000 cases of metastatic breast cancer. The Korean oncology market for 2007 is estimated at US$533 million of which the chemotherapy market and its taxanes component are estimated at US$400 million and US$77 million, respectively, per IMS.
In addition to the approval in Korea, ABRAXANE is approved for marketing in the U.S. and is currently co-promoted in collaboration with AstraZeneca Pharmaceuticals LP. ABRAXANE is the fastest growing taxane in the U.S.