Ablynx [Euronext Brussels: ABLX] today announced that it has expanded its relationship with Eddingpharm, one of the leading Chinese specialty pharmaceutical companies, by granting Eddingpharm an exclusive, royalty-bearing license to develop and commercialise Ablynx's anti-TNFa 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).
Under the terms of the agreement, Eddingpharm will be responsible for the clinical development, registration and commercialisation in Greater China of anti-TNFa Nanobody therapeutics. 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 TNFa blocker with clinical proof-of-concept in RA. The molecule consists of two Nanobodies targeting TNFa, 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-TNFa Nanobodies in November 2011.
Dr Edwin Moses, CEO of Ablynx, commented:
"We are pleased to have expanded our relationship with Eddingpharm beyond the license agreement that we signed in 2013 for our anti-RANKL Nanobody, ALX-0141, for the treatment of bone related disorders. China is a huge and developing market, and we believe that Eddingpharm is well-positioned to further develop and commercialise ozoralizumab in Greater China based on their deep knowledge of the local market, clinical development expertise and our Nanobody's potential in the treatment of inflammatory diseases, including RA."
Mr Ni Xin, Founder, Chairman and CEO of Eddingpharm, added:
"We are delighted that Ablynx has entrusted Eddingpharm to develop and commercialise a second Nanobody in Greater China. This partnership represents another strategic achievement for our Company in our goal to become a fully-integrated pharmaceutical company and demonstrates that Eddingpharm is the partner of choice in China for biotechnology companies around the world. Together with Ablynx, we are committed to bringing this second innovative Nanobody-based medicine to millions of patients in the region."
The rheumatoid arthritis market in China
China is expected to rank #2 in drug sales in 2016, one place behind the US, according to a study performed by Deutsche Bank, with the growth driven by improving living standards, an increased aging population and rising health consciousness.