• Partnership aims to develop drugs for neurodegenerative diseases

• Denali will draw on Lonza’s expertise in developing and manufacturing complex biologic molecules 

BASEL, Switzerland and SOUTH SAN FRANCISCO, Calif., Feb. 08, 2018 (GLOBE NEWSWIRE) — 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.

About Denali
Denali is a biopharmaceutical company discovering and developing a broad portfolio of therapeutic candidates for neurodegenerative diseases. Denali pursues new treatments by rigorously assessing genetically validated targets, engineering delivery across the blood-brain barrier and guiding development with biomarker monitoring to demonstrate target engagement and select patients. Denali is based in South San Francisco. For additional information, please visit www.denalitherapeutics.com.

Contact Details
For Lonza Pharma & Biotech
Sanna Fowler, Associate Director, Public Relations
Lonza Pharma & Biotech
Tel: +41 61 316 8929
Email: sanna.fowler@lonza.com

For Lonza Corporate Communications
Constance Ward, Head External Communications
Lonza Group Ltd
Tel: +41 61 316 8840 
Email: constance.ward@lonza.com

For Denali Therapeutics
Morgan Warners
Tel: +1 (202) 295-0124
Email: mwarners@gpg.com

Additional Information and Disclaimer
Lonza Group Ltd (Lonza) has its headquarters in Basel, Switzerland, and is listed on the SIX Swiss Exchange. It has a secondary listing on the Singapore Exchange Securities Trading Limited (“SGX-ST”). Lonza is not subject to the SGX-ST’s continuing listing requirements but remains subject to Rules 217 and 751 of the SGX-ST Listing Manual.

Certain matters discussed in this news release may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements express or implied in this news release include, but are not limited to, the potential benefits of the partnership, plans to develop and manufacture Denali’s product candidates, plans to bring potential therapies to patients and other information relating to the partnership between Lonza and Denali.

These statements are based on current expectations and estimates of Lonza and Denali, although they can give no assurance that these expectations and estimates will be achieved.

Investors are cautioned that actual results are subject to risks and uncertainties and may differ materially from those indicated by the forward-looking statements included in this news release as a result of these risks and uncertainties, including but not limited to: the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of the agreement; Denali’s early stage of clinical drug development; Denali’s ability to conduct or complete clinical trials on expected timelines; the uncertainty that any of Denali’s product candidates will receive regulatory approval necessary to be commercialized; Denali’s ability to continue to create a pipeline of product candidates or develop commercially successful products; and other risks, including those described in Denali’s Prospectus filed with the SEC on 8 December 2017 and Denali’s other periodic reports filed with the SEC. Furthermore, except as otherwise required by law, Lonza and Denali disclaim any intention or obligation to update the statements contained in this news release.