Arecor adds Lilly

CAMBRIDGE, U.K.—Based on their corporate mantra that "subtlechanges in formulation can lead to substantial improvements in stability,"Arecor Ltd. and Eli Lilly & Co. will work together to assess Arecor'sadvanced protein formulation technologies for possible use with Lilly's growingpipeline of biological-based drugs.

Under this agreement, Arecor will develop stable aqueous orhigher concentration formulations of emerging protein and peptide drugcandidates developed by Lilly. In addition, Arecor will work with Lilly tooffer improved formulations of Lilly's existing therapeutic proteins in severaltherapeutic areas.

According to Tom Saylor, Arecor's CEO, "Lilly's strongsupport of innovation and emerging technologies offers Arecor the potential toapply our broad-ranging expertise in biomolecule stabilization to a leader inpharmaceutical application of the next generation of biologics."

Saylor quickly adds that Lilly is but one of several bigpharma partners, including Genzyme and GlaxoSmithKline PLC, to work with the2007 start-up that was spun out of Unilever Research, which remains its largestshareholder.

"The next generation of protein and peptide therapeuticspresent significant formulation challenges," Saylor notes. "We look at theproblem of stability from a physical chemistry standpoint and adjust the chargeenvironment of the protein. We ask, 'what is the degradation pathway?' It maybe aggregation, hydrolysis and deamidation. By fine-tuning the environment, weenhance stability. Proteins and vaccines are often fragile entities, andstability can represent significant constraints in the development of newproducts and extending the use of existing products."

Arecor has developed Arestat, a patented set of tools forstabilization that address the main pathways of degradation. The nature of theArestat formulations is non-obvious, and in some cases even counterintuitive,Saylor says. Arestat formulations are based on unique combinations ofexcipients and conditions that allow efficient control of equilibrium-basedinteractions 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 forthe route of delivery. Arecor's stabilization tools may enable new products andpresentations, which would otherwise not be possible without additionalprocessing or changes to standard manufacturing practices, Saylor adds.

Arecor considers itself a pioneer in the stabilization ofbiologic molecules, a key challenge in the development of many therapeuticproteins, vaccines and diagnostics. The company was established to provideformulation solutions to pharmaceutical and biotech companies developingproteins, vaccines and diagnostics based upon new insights into interactionsbetween proteins and their immediate environment. Arecor currently has activefeasibility programs and licenses with many of the top pharmaceutical andbiotech companies on a wide range of proteins and vaccines, and to date hasdeveloped two approved medical devices and successfully reformulated more than40 peptides, proteins and vaccines. The company's technology has been appliedto fusion and pegylated proteins; concentrated and single-chain antibodies;live attenuated viruses and virus-like particles; conjugated vaccines; andpoint-of-care diagnostic kits.

One of the benefits of providing higher concentrations, inantibodies for example, is that therapies may be administered by subcutaneousinjection rather than by infusion. In the case of rituximab, an anti-CD20 antibodyused in the treatment of certain lymphomas, leukemias and rheumatoid arthritis, Arecor's chemistswere able to reformulate the product at 100 mg/ml using the principles of oneof the emerging Arestat platforms, greatly reducing aggregation. Backgroundformulation parameters, such as osmolality, pH or surfactant, were unchanged.