Stellar and Araclon Biotech Sign Exclusive KLH Supply Agreement
Stellar Biotechnologies, Inc. and Araclon Biotech SL have announced that the companies have executed a definitive exclusive supply agreement to meet Araclon's Phase (II and III) clinical trial requirements for Keyhole Limpet Hemocyanin (KLH) used in Araclon's active immunotherapies against Alzheimer's disease.
Stellar is a leader in sustainable manufacture of KLH, an immune-stimulating protein widely used as a carrier molecule in immunotherapy development. KLH manufacturing is limited by the fact that this important molecule can only be produced from a scarce marine source and Stellar believes it is the only company that has the technology to manage the controlled production of this resource.
Araclon, headquartered in Spain and majority-owned by global healthcare company Grifols, is developing beta amyloid-targeting active immunotherapies for neurodegenerative diseases with a primary focus on Alzheimer's disease. Araclon's patented, innovative technology against Alzheimer's involves immunization against amyloid-beta (Aβ) together with KLH as a carrier protein.
The purpose of the agreement is to ensure a stable supply to Araclon of Stellar KLH™ for the ongoing clinical development of Araclon's Alzheimer's drugs, including the development of manufacturing processes, production capacity and regulatory support.
Under the agreement, Araclon will manage and fund all product development and regulatory submissions for its products. Stellar will supply GMP-grade Stellar KLH™ protein and will provide technical and regulatory support to Araclon.
The agreement requires Stellar to deliver the first batch of Stellar KLH™ to Araclon by December 31, 2014. Araclon and Stellar have entered into a mutually exclusive contract for the supply of KLH for Araclon's beta amyloid peptide in the Alzheimer's space throughout the term of the agreement for use in Araclon's upcoming clinical trials with an active immunotherapy against Alzheimer's disease at agreed prices.
Stellar and Araclon have agreed upon 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 additional one-year periods.
"This new collaboration with Araclon Biotech is an excellent demonstration of Stellar's core business model which is to partner with the companies and organizations developing the many KLH-based immunotherapies now in clinical development," said Frank Oakes, President and CEO of Stellar Biotechnologies, Inc. "Stellar has the technology to deliver a reliable source of KLH today that can also be scaled up sustainably to address the industry's future KLH demand as promising immunotherapy products reach commercial markets."
"An agreement with Stellar Biotechnologies is very important to Araclon. A stable supply of GMP grade KLH is needed to advance in our Alzheimer's immunotherapy program through Phase II and III clinical trials," commented a source at Araclon.