Ablynx, a biopharmaceutical company engaged in the discovery and development of Nanobodies, has granted an exclusive, royalty-bearing license to Eddingpharm, a leading Chinese specialty pharmaceutical company, to develop and commercialise its anti-RANKL Nanobody, ALX-0141, in the mainland of the People's Republic of China, the Hong Kong and Macao Special Administrative Regions, and Taiwan, for all indications, including osteoporosis and bone metastases.
Under the terms of the agreement, Eddingpharm will be responsible for the clinical development, registration and commercialisation in Greater China of anti-RANKL Nanobody therapeutics. Ablynx will have access to the data generated by Eddingpharm to support potential licensing discussions in other geographic regions.
Ablynx will receive a €2 million upfront payment from Eddingpharm and is entitled to receive commercial milestone payments plus tiered, double-digit royalties of up to 20 per cent, based on annual net sales of ALX-0141 generated by Eddingpharm in Greater 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). This bivalent anti-RANKL construct is linked to a Nanobody that binds to human serum albumin, extending the drug's in vivo half-life, and which may in turn lead to preferential targeting of diseased tissue. A phase I study in healthy post-menopausal women showed 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.
Dr Edwin Moses, chairman and CEO of Ablynx 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. Our Nanobody has strong potential in this market, with very good efficacy, as measured by biomarkers, and a clean safety profile, and we look forward to collaborating with Eddingpharm and supporting them to move the programme further in development and beyond."
Ni Xin, founder, chairman and CEO of Eddingpharm commented, "We are very pleased that Ablynx has entrusted Eddingpharm to develop and commercialise its anti-RANKL Nanobody in Greater China. Together with Ablynx, we are committed to bringing this innovative medicine to millions of patients in the region. This partnership represents a key milestone towards our goal of establishing Eddingpharm as the partner of choice in China for biotechnology companies around the world."
The global market for drugs to treat osteoporosis is expected to reach $11.4 billion in 2015, increasing at a compound annual growth rate (CAGR) of 9.2 per cent over the period 2010 to 2015, according to a recent report published by Transparency Market. The study also expects the market in China for osteoporosis treatments to grow at a CAGR of 13.5 per cent from 2010 to 2015 to reach $2.5bn in 2015. Increased prevalence of osteoporosis among the Chinese female population is the principal growth driver of this drug sector. The other key growth drivers for the Chinese osteoporosis market include the increasing elderly aged population, rising living standards of the Chinese people and increasing awareness and bone health education. According to Global Data, the global market for bone metastasis is expected to grow to $6.4 billion in 2017 with China counting for approximately 22 per cent of the global market.