On October 18, 2013 Ablynx reported that it has granted an exclusive,royalty-bearing license to Eddingpharm, a leading Chinese specialtypharmaceutical 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 MacaoSpecial Administrative Regions, and Taiwan, for all indications, includingosteoporosis and bone metastases (Press release, Eddingpharm, OCT 18, 2013, View Source [SID:1234513851]).
Under the terms of the agreement, Eddingpharm will be responsiblefor the clinical development, registration and commercialisation in GreaterChina of anti-RANKL Nanobody therapeutics. Ablynx will have access to the datagenerated by Eddingpharm to support potential licensing discussions in othergeographic regions.
Ablynx will receive a EUR2 million upfront payment fromEddingpharm and is entitled to receive commercial milestone payments plustiered, double-digit royalties of up to 20%, based on annual net sales ofALX-0141 generated by Eddingpharm in Greater China.
ALX-0141 is a bivalent bi-specific therapeutic molecule composedof two Nanobodies targeting the Receptor Activator of Nuclear factor Kappa-BLigand (RANKL). This bivalent anti-RANKL construct is linked to a Nanobody thatbinds to human serum albumin, extending the drug’s in vivo half-life, and whichmay in turn lead to preferential targeting of diseased tissue. A Phase I studyin healthy post-menopausal women showed that a single administration ofALX-0141 has a strong and very long lasting inhibitory effect on boneresorption biomarkers and was well tolerated with no serious adverse events ordose-limiting toxicity being observed.
Dr Edwin Moses, Chairman and CEO of Ablynx added:
"Eddingpharm is well-positioned to further develop andcommercialise ALX-0141 in Greater China, which represents a rapidly growingarea for bone related disorders. Our Nanobody has strong potential in thismarket, with very good efficacy, as measured by biomarkers, and a clean safetyprofile, and we look forward to collaborating with Eddingpharm and supportingthem to move the programme further in development and beyond."
Mr Ni Xin, Founder, Chairman and CEO of Eddingpharm commented:
"We are very pleased that Ablynx has entrusted Eddingpharmto develop and commercialise its anti-RANKL Nanobody in Greater China. Togetherwith Ablynx, we are committed to bringing this innovative medicine to millionsof patients in the region. This partnership represents a key milestone towardsour goal of establishing Eddingpharm as the partner of choice in China forbiotechnology companies around the world."
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