Date: 2013-10-18
Type of information: Licensing agreement
Compound: ALX-0141
Company: Ablynx (Belgium) Eddingpharm (China)
Therapeutic area: Bone diseases - Cancer - Oncology
Type agreement: licensing
Action mechanism: 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.
Disease: all indications, including osteoporosis and bone metastases
Details: * On October 18, 2013, Ablynx has announced that it 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.
Financial terms: 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%, based on annual net sales of ALX-0141 generated by Eddingpharm in Greater China.
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