Ablynx announced that it has expanded its relationship with Eddingpharm royalty-bearing license to develop and commercialise Ablynx’s anti-TNFα Nanobody®, ozoralizumab (ATN-103), in the mainland of the People’s Republic of China, the Hong Kong and Macao Special Administrative Regions, and Taiwan, for all indications, including rheumatoid arthritis (RA).
Ablynx will have access to the clinical data generated by Eddingpharm to support potential licensing discussions in other geographic regions.
Ablynx will receive an upfront payment of €2 million, payable in two tranches, and is entitled to receive development and commercial milestone payments plus tiered, double-digit royalties of up to 20%, based on annual net sales of ozoralizumab generated by Eddingpharm in Greater China.
Ozoralizumab is a next-generation TNFα blocker with clinical proof-of-concept in RA. The molecule consists of two Nanobodies targeting TNFα, which are linked to a Nanobody that binds to human serum albumin, extending the drug’s half-life in vivo and improving its distribution to inflamed joints. Clinical Phase IIa proof-of-concept was achieved in May 2011 in patients with active rheumatoid arthritis (RA), indicating that the highest dose of ozoralizumab (80 mg every 4 weeks) resulted in a statistically significant improvement of ACR20 responses compared with placebo at week 16. An open-label extension study over 48 weeks was well tolerated, adverse event rates were within expectations, serious infections remained rare, and no clinically meaningful immunogenicity could be observed. Clinical development of ozoralizumab was funded by Pfizer prior to Ablynx regaining the worldwide rights to develop and commercialise anti-TNFα Nanobodies in November 2011.