08 Feb 2018
Denali Therapeutics and Lonza Pharma & Biotech Announce Exclusive Partnership to Develop and Produce Biologic Medicines
  • Partnership aims to develop drugs for neurodegenerative diseases
  • Denali will draw on Lonza's expertise in developing and manufacturing complex biologic molecules

Basel (CH) and South San Francisco, CA (USA), 8 February 2018 – Lonza Pharma & Biotech and Denali Therapeutics (NASDAQ: DNLI) announced today an exclusive strategic partnership on Denali's biologic pipeline products for neurodegenerative diseases. The agreement covers all stages of the development and manufacturing,

A major hurdle for treating neurodegenerative diseases is the inability of most biologics to cross the tightly controlled blood-brain barrier (BBB). Denali is engineering its biologic product candidates to overcome this fundamental obstacle. Manufacturing these sophisticated therapies requires a tailor-made approach, together with expertise and agility in cell line, process and formulation development.

Through this partnership Denali will have access to Lonza's extensive expertise and technologies: from cell-line development using the GS Xceed® gene expression system to process development and manufacturing at facilities in Slough (UK) and Hayward, CA (USA). In addition, Lonza's in-house Drug Product Services in Basel (CH) will focus on ensuring that Denali's finished product candidates are designed with optimal formulation, stability and delivery system in mind.

Lonza Pharma & Biotech's COO, Marc Funk, commented, “We're taking up the challenge with Denali and helping them bring potential therapies to patients suffering from these debilitating diseases. This partnership will allow us to do what we do best for our customers – leverage our expertise across the development cycle and anticipate Denali's needs as they move from pre-clinical to clinical and beyond.”

Denali's CEO, Ryan Watts, Ph.D., commented, “We are thrilled to work with Lonza to develop our biologic candidates for patients suffering from neurodegenerative diseases. Lonza's expertise and experience in manufacturing biologics is hugely helpful to Denali in developing our pipeline.”

Neurodegenerative diseases represent one of the great unmet medical needs and scientific challenges of today. The prevalence of Alzheimer's disease, Parkinson's disease and other neurodegenerative diseases is increasing and represents a significant medical and financial burden on patients, families and society at large.

Denali aims to discover and develop therapies to defeat degeneration, including diseases such as Alzheimer's, Parkinson's and ALS. Denali selects its targets based on validated genetic drivers of neurodegeneration, develops molecules that effectively cross the BBB and uses biomarkers to select the right patient population and demonstrate target and pathway engagement in clinical trials.