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news.Stellar Biotechnologies and Araclon Biotech have signed a supply agreement to meet Araclon's Phase II and III clinical trial requirements for Keyhole Limpet Hemocyanin (KLH) used in its active immunotherapies against Alzheimer's disease (AD).
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Stellar is a manufacturer of KLH, an immune-stimulating protein widely used as a carrier molecule in the development of immunotherapies.
Spain-based Araclon is majority-owned by global healthcare firm Grifols and it develops beta amyloid-targeting active immunotherapies for neurodegenerative diseases with a primary focus on AD.
The Spanish firm’s technology against Alzheimer’s involves immunization against amyloid-beta (Aß) together with KLH as a carrier protein.
The partnership is aimed at ensuring a stable supply to Araclon of Stellar KLH for the ongoing clinical development of Araclon’s Alzheimer’s drugs, as well as the development of manufacturing processes, production capacity and regulatory support.
As part of the deal, Araclon will be responsible for managing and funding all product development and regulatory submissions for its products, while Stellar will supply GMP-grade Stellar KLH protein as well as offer technical and regulatory support to Araclon.
The deal will see Stellar deliver the first batch of Stellar KLH to Araclon before the end of December 2014.
The two firms have agreed on first negotiation rights for the exclusive supply of Stellar KLH in connection with the potential future commercialization by Araclon of its beta amyloid-targeting immunotherapy products.
The agreement has an initial five-year term, which may be renewed by Araclon, if necessary, for an additional one-year.