Denali Therapeutics and Lonza Pharma & Biotech Announce Exclusive Partnership to Develop and Produce Biologic Medicines
February 08 2018 - 8:00AM
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 Lonza
Lonza is one of the world’s leading and
most-trusted suppliers to the pharmaceutical, biotech and specialty
ingredients markets. As an integrated solutions provider, Lonza is
boosting its value creation along and beyond the healthcare
continuum with a strong focus on patient healthcare, consumer
preventive healthcare and consumer's healthy environment.
Lonza harnesses science and technology to create
products that support safer and healthier living and that enhance
the overall quality of life. With the recent Capsugel acquisition,
Lonza now offers products and services from the custom development
and manufacturing of active pharmaceutical ingredients to
innovative dosage forms for the pharma and consumer health and
nutrition industries.
Benefiting from its regulatory expertise, Lonza
is able to transfer its know-how from pharma to hygiene and
fast-moving consumer goods all the way to coatings and composites
and the preservation and protection of agricultural goods and other
natural resources.
Founded in 1897 in the Swiss Alps, Lonza today
is a well-respected global company with more than 100 sites and
offices and approximately 14,500 full-time employees worldwide. The
company generated sales of CHF 5.1 billion in 2017 with a CORE
EBITDA of CHF 1.3 billion. Further information can be found at
www.lonza.com.
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 & BiotechSanna
Fowler, Associate Director, Public RelationsLonza Pharma
& BiotechTel +41 61 316 8929sanna.fowler@lonza.com
For Lonza Corporate CommunicationsConstance
Ward, Head External CommunicationsLonza Group LtdTel +41
61 316 8840 constance.ward@lonza.com
For Denali TherapeuticsMorgan
WarnersTel +1 (202) 295-0124mwarners@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.
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