Galderma Granted Key Manufacturing License Updates for New Biologics Capabilities at Its Center of Excellence
June 19 2024 - 1:00AM
Business Wire
- The Swedish Medical Products Agency has issued a license update
authorizing the future manufacture and bioanalytical testing of
Galderma’s proprietary investigational ready-to-use liquid
botulinum toxin A, RelabotulinumtoxinA
- This further establishes Galderma’s Uppsala site as a
world-class center of excellence and enhances Galderma’s autonomy
in bringing new blockbuster platforms in dermatology to market
Galderma today announced that the Swedish Medical Products
Agency (Läkemedelsverket) issued key manufacturing license updates
that will allow the company to pursue its ambitious growth and
innovation roadmap.
The license updates, issued following the agency’s good
manufacturing practices (GMP) inspection of Galderma’s center of
excellence in Uppsala, Sweden, enable Galderma to manufacture and
perform bioanalytical testing on RelabotulinumtoxinA (QM1114). One
of Galderma’s key innovation pipeline assets in Injectable
Aesthetics, RelabotulinumtoxinA is a next-generation liquid
neuromodulator in Injectable Aesthetics developed using Galderma’s
proprietary PEARL™ technology. This technology preserves the
molecule’s integrity, resulting in a highly active, complex-free
botulinum toxin A.
“Our commitment to leading
innovation in dermatology is reflected in our high-performance
operations. These new license updates granted by the Swedish
authorities reflect Galderma’s skills and the capacities we are
building to support our rapid growth trajectory. As we work to
extend our category leadership globally, these new capabilities
will increase Galderma’s autonomy to manufacture and commercialize
the next generation of scientifically differentiated innovations in
dermatology.”
ADRIAN MURPHY
HEAD OF GLOBAL
OPERATIONS
GALDERMA
Galderma’s center of excellence in Uppsala is one of the
company’s four state-of-the-art manufacturing and R&D
facilities around the world. Galderma is currently expanding this
site in response to growing global demand for science-based premium
dermatology solutions. The new facility—scheduled for completion by
the end of 2025—will be strategically positioned to cater to the
higher demand for injectable aesthetics treatments worldwide and
the development of upcoming products. With a modular design that
allows for seamless further expansion in the future, this
forward-looking approach aligns with both Galderma’s growth
strategy and its environment, social and governance (ESG)
roadmap.
About RelabotulinumtoxinA (QM1114) Developed by Galderma,
RelabotulinumtoxinA is a highly active, innovative, complex-free
and ready-to-use liquid botulinum toxin A with a proprietary
strain. Manufactured using a unique state-of-the-art process, it is
designed as a liquid. This avoids the need to reconstitute from
powder and thus eliminates the variability, errors and risks
associated with reconstitution, which would be expected to improve
the consistency of results. RelabotulinumtoxinA is currently being
investigated globally, with a view to expanding its neuromodulator
portfolio – part of the broadest injectable aesthetics portfolio on
the market.
About Galderma Galderma (SIX: GALD) is the emerging
pure-play dermatology category leader, present in approximately 90
countries. We deliver an innovative, science-based portfolio of
premium flagship brands and services that span the full spectrum of
the fast-growing dermatology market through Injectable Aesthetics,
Dermatological Skincare and Therapeutic Dermatology. Since our
foundation in 1981, we have dedicated our focus and passion to the
human body’s largest organ—the skin—meeting individual consumer and
patient needs with superior outcomes in partnership with healthcare
professionals. Because we understand that the skin we are in shapes
our lives, we are advancing dermatology for every skin story. For
more information: www.galderma.com
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version on businesswire.com: https://www.businesswire.com/news/home/20240618347979/en/
Christian Marcoux, M.Sc. Chief Communications Officer
christian.marcoux@galderma.com +41 76 315 26 50
Sébastien Cros Corporate Communications Director
sebastien.cros@galderma.com +41 79 529 59 85
Emil Ivanov Head of Strategy, Investor Relations and ESG
emil.ivanov@galderma.com +41 21 642 78 12
Jessica Cohen Investor Relations and Strategy Director
jessica.cohen@galderma.com +41 21 642 76 43