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Arecor adds Lilly
CAMBRIDGE, U.K.—Based on their corporate mantra that "subtle changes in formulation can lead to substantial improvements in stability," Arecor Ltd. and Eli Lilly & Co. will work together to assess Arecor's advanced protein formulation technologies for possible use with Lilly's growing pipeline of biological-based drugs.
Under this agreement, Arecor will develop stable aqueous or higher concentration formulations of emerging protein and peptide drug candidates developed by Lilly. In addition, Arecor will work with Lilly to offer improved formulations of Lilly's existing therapeutic proteins in several therapeutic areas.
According to Tom Saylor, Arecor's CEO, "Lilly's strong support of innovation and emerging technologies offers Arecor the potential to apply our broad-ranging expertise in biomolecule stabilization to a leader in pharmaceutical application of the next generation of biologics."
Saylor quickly adds that Lilly is but one of several big pharma partners, including Genzyme and GlaxoSmithKline PLC, to work with the 2007 start-up that was spun out of Unilever Research, which remains its largest shareholder.
"The next generation of protein and peptide therapeutics present significant formulation challenges," Saylor notes. "We look at the problem of stability from a physical chemistry standpoint and adjust the charge environment of the protein. We ask, 'what is the degradation pathway?' It may be aggregation, hydrolysis and deamidation. By fine-tuning the environment, we enhance stability. Proteins and vaccines are often fragile entities, and stability can represent significant constraints in the development of new products and extending the use of existing products."
Arecor has developed Arestat, a patented set of tools for stabilization that address the main pathways of degradation. The nature of the Arestat formulations is non-obvious, and in some cases even counterintuitive, Saylor says. Arestat formulations are based on unique combinations of excipients and conditions that allow efficient control of equilibrium-based interactions affecting stability of biologics. As a simple reformulation, Arestat can be readily incorporated into standard manufacturing practice, without covalent modification of the biologic and using excipients approved for the route of delivery. Arecor's stabilization tools may enable new products and presentations, which would otherwise not be possible without additional processing or changes to standard manufacturing practices, Saylor adds.
Arecor considers itself a pioneer in the stabilization of biologic molecules, a key challenge in the development of many therapeutic proteins, vaccines and diagnostics. The company was established to provide formulation solutions to pharmaceutical and biotech companies developing proteins, vaccines and diagnostics based upon new insights into interactions between proteins and their immediate environment. Arecor currently has active feasibility programs and licenses with many of the top pharmaceutical and biotech companies on a wide range of proteins and vaccines, and to date has developed two approved medical devices and successfully reformulated more than 40 peptides, proteins and vaccines. The company's technology has been applied to fusion and pegylated proteins; concentrated and single-chain antibodies; live attenuated viruses and virus-like particles; conjugated vaccines; and point-of-care diagnostic kits.
One of the benefits of providing higher concentrations, in antibodies for example, is that therapies may be administered by subcutaneous injection rather than by infusion. In the case of rituximab, an anti-CD20 antibody used in the treatment of certain lymphomas, leukemias and rheumatoid arthritis, Arecor's chemists were able to reformulate the product at 100 mg/ml using the principles of one of the emerging Arestat platforms, greatly reducing aggregation. Background formulation parameters, such as osmolality, pH or surfactant, were unchanged.