Chinese specialty pharmaceutical firm Eddingpharm has received an exclusive, royalty-bearing license from Ablynx to develop and commercialize its anti-RANKL Nanobody, ALX-0141, in China, the Hong Kong and Macao Special Administrative Regions, and Taiwan, for all indications, including osteoporosis and bone metastases.
As per the deal, Eddingpharm will be responsible for the clinical development, registration and commercialization of anti-RANKL Nanobody therapeutics in China, while Ablynx will have access to the data generated by Eddingpharm to support possible licensing discussions in other regions.
An upfront payment of EUR2m will be paid by Eddingpharm to Ablynx, which is also eligible to receive commercial milestone payments plus tiered, double-digit royalties of about 20%, based on annual net sales of ALX-0141 generated by Eddingpharm in China.
ALX-0141 is a bivalent bi-specific therapeutic molecule composed of two nanobodies targeting the Receptor Activator of Nuclear factor Kappa-B Ligand (RANKL) and is linked to a nanobody that binds to human serum albumin, extending the drug's in vivo half-life that may lead to preferential targeting of diseased tissue.
The company said, the Phase I trial carried out in healthy post-menopausal women demonstrated that a single administration of ALX-0141 has a strong and very long lasting inhibitory effect on bone resorption biomarkers and was well tolerated with no serious adverse events or dose-limiting toxicity being observed.
Ablynx chairman and CEO Edwin Moses said, "Eddingpharm is well-positioned to further develop and commercialise ALX-0141 in Greater China, which represents a rapidly growing area for bone related disorders."
Eddingpharm founder, chairman and CEO Ni Xin said," Together with Ablynx, we are committed to bringing this innovative medicine to millions of patients in the region."