Date: 2014-09-01
Type of information: Licensing agreement
Compound: ozoralizumab (ATN-103)
Company: Ablynx (Belgium) Eddingpharm (China)
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Type agreement:
Action mechanism: Ozoralizumab is a next-generation TNFa blocker with clinical proof-of-concept in rheumatoid arthritis. The molecule consists of two Nanobodies targeting TNFalpha, 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.
Disease: rheumatoid arthritis and other indications
Details: * On September 1, 2014, Ablynx 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-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. Under the terms of the agreement, Eddingpharm will be responsible for the clinical development, registration and commercialisation in Greater China of anti-TNFα Nanobody therapeutics. Ablynx will have access to the clinical data generated by Eddingpharm to support potential licensing discussions in other geographic regions. Clinical Phase IIa proof-of-concept was achieved in May 2011 in patients with active rheumatoid arthritis, 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. Ablynx and Eddingpharm have already signed a license agreement in 2013 for anti-RANKL Nanobody, ALX-0141, for the treatment of bone related disorders.
Financial terms: 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.
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