• Evonik to supply commercial quantities of simufilam, a drug candidate for the treatment of Alzheimer’s disease
• The late clinical phase quantities will be produced at Evonik’s Tippecanoe site in Indiana, USA
• Evonik is recognized as one of the largest contract manufacturing organizations (CMO)

Essen, Germany. Evonik has entered into a supply agreement with Cassava Sciences, a clinical-stage biotechnology company focused on neuroscience. Evonik will supply Cassava Sciences with large-scale, clinical-grade quantities of simufilam, a drug candidate for the treatment of Alzheimer’s disease.

“We are delighted to be collaborating with Cassava and contributing to fight Alzheimer’s together. We are committed to supporting Cassava in their goals to maintain the quality of life for millions of patients around the world and to further advance potential treatment options”, said Thomas Riermeier, head of Evonik’s Health Care business line.

As one of the world’s top CMOs for active pharmaceutical ingredients and intermediates, Evonik’s Health Care business is part of the life science division Nutrition & Care and represents a key growth lever for Evonik. The agreement with Cassava Sciences is the latest milestone in a long heritage of contributions to the development and production of active pharmaceutical ingredients (APIs).

“I am pleased with our success to date in being an effective collaborator with Evonik, a company with a long, successful and reliable track record of supporting pharmaceutical supply chains,” said Remi Barbier, President and CEO of Cassava Sciences.

Cassava’s simufilam is produced at Evonik’s Tippecanoe site in the state of Indiana, USA.

“Evonik has a highly flexible and agile approach, which enables us to implement tailor-made solutions for biotechnology and pharmaceutical clients. Our global network includes highly specialized facilities in Europe and the US with the capabilities required for all stages of drug production, from small quantities for feasibility testing and clinical trials, to large-scale, clinical-grade final products,” said Andreas Meudt, head of Evonik Health Care’s Exclusive Synthesis business.

Evonik serves as a fully integrated contract development and manufacturing organization (CDMO) with capabilities to manufacture customized APIs, select and supply functional excipients, develop parenteral or oral formulations, and manufacture finished drug products. In addition to this integrated portfolio of services, many customers are also attracted by Evonik’s reliability and commitment to sustainability.

To address the specific needs of large or complex projects, Evonik has established a broad portfolio of advanced technologies which can be combined to support multi-step API synthesis. These technologies include continuous processes, fermentation, PEGs and mPEGs, catalysts, biocatalysts, cryogenic chemistry and polymer APIs.

Alzheimer’s disease

Worldwide, around 50 million people have dementia, and Alzheimer's disease may contribute to 60–70% of cases. Dementia is one of the major causes of disability and dependency among older people.

Simufilam

Cassava’s simufilam (formerly known as PTI-125) is an investigational drug that represents an entirely new approach to treat Alzheimer’s disease. Simufilam is a proprietary, small molecule (oral) drug that restores the normal shape and function of altered filamin A (FLNA), a scaffolding protein, in the brain. Cassava is conducting clinical studies to test the candidate for the treatment of Alzheimer's disease with promising results.