Polyphor AG (SIX: POLN) and Shanghai Fosun Pharmaceutical (Group) Co. Ltd, through its Swiss affiliate Fosun Pharmaceutical AG announced today that they have entered into an exclusive licensing agreement for balixafortide in China.
Under the terms of the agreement, Polyphor and Fosun Pharma will develop and commercialize balixafortide for the Chinese market with an initial focus on metastatic breast cancer. China is projected to be the second largest market globally for breast cancer treatments. Additional cancer indications and combination therapies will be evaluated jointly by the companies. Polyphor retains all rights to balixafortide outside of China.
As part of the agreement, Polyphor will receive a USD 15 million upfront payment, is eligible for additional development milestone payments of up to USD 19 million, sales milestone payments of up to USD 148 million, and royalties on sales. The agreed upon royalty rates start in the low double digits and increase to the mid-teens based on net sales achieved in the territory.
Fosun Pharmaceutical AG is a wholly-owned subsidiary of Shanghai Fosun Pharmaceutical (Group) Co. Ltd ("Fosun Pharma", stock code: 600196.SH; 02196.HK), a leading healthcare company in China. It is listed on both the Shanghai Stock Exchange and the Hong Kong Stock Exchange.
"This agreement between Polyphor and Fosun Pharma represents an important next milestone for the development and commercialization of balixafortide, and is a strong validation from a leading innovative Chinese healthcare company," says Gokhan Batur, CEO of Polyphor. "Fosun Pharma's proven expertise to develop and commercialize oncology treatments in China, as well as their research and development capabilities to expand into additional cancer indications, make them the ideal partner for us."
"We are pleased to partner with Polyphor to bring balixafortide to China to benefit patients with metastatic breast cancer in China," says Wu Yifang, President and CEO of Fosun Pharma. "Polyphor is a leading company in the field of oncology and antimicrobial resistance, with a leading technology platform for macrocyclic peptides. The collaboration will enrich Fosun Pharma's pipeline in the field of oncology and provide more treatment options for the unmet clinical needs of the market."
Balixafortide is a potent and highly selective blocker of CXCR4 and is currently the only CXCR4 antagonist in Phase 3 development for a solid tumor. CXCR4 plays a key role in tumor growth, invasion, angiogenesis, metastasis and resistance to therapeutics. CXCR4 overexpression correlates with poor prognosis in many cancer subtypes. CXCR4 antagonism was shown to change tumor-stromal interactions, sensitize cancer cells to cytotoxic drugs, and reduce tumor growth and metastatic burden. The mechanism of action includes immune cell trafficking, tumor infiltration and activation of immune cells (tumor cell elimination), and reduction in immunosuppressive cells in the tumor microenvironment. Based on these multifaceted modes of action, it is suggested that CXCR4 antagonism could play a crucial role in a range of therapies including chemotherapy and immunotherapies. Balixafortide is currently being evaluated in the pivotal study FORTRESS (POL6326-009) which is an international, multicenter, randomized active-controlled, open-label Phase III trial which will investigate the efficacy, safety and tolerability of intravenous balixafortide given with eribulin versus eribulin alone in the treatment of HER2 negative, locally recurrent or metastatic breast cancer.