WUXI, China, Oct. 2, 2023 /PRNewswire/ -- WuXi Biologics
("WuXi Bio") (2269.HK), a leading global Contract Research,
Development and Manufacturing Organization (CRDMO), congratulates
its strategic partner, Amicus Therapeutics ("Amicus") (Nasdaq:
FOLD), on receiving U.S. FDA's approval for Pombiliti™
(cipaglucosidase alfa-atga) + Opfolda™ (miglustat) 65mg capsules.
This two-component therapy is indicated for those adults living
with late-onset Pompe disease (LOPD) weighing ≥40 kg and who are
not improving on their current enzyme replacement therapy
(ERT).
Pombiliti™, a recombinant human GAA enzyme (rhGAA) naturally
expressed with high levels of bis-M6P (Mannose 6-Phosphate), was
started at WuXi Biologics in 2012 with just an initial concept and
now realizes commercialization enabled by WuXi Biologics'
proprietary integrated technology platform and unparalleled
manufacturing capacity. As the exclusive commercial drug substance
manufacturing partner and key commercial drug product supplier,
WuXi Biologics is now providing commercial manufacturing services
for Pombiliti™ at five facilities across its global manufacturing
network.
Bradley Campbell, President
and Chief Executive Officer of Amicus Therapeutics, commented,
"This approval marks a major milestone for the Pompe disease
community in the United States.
Bringing this new treatment option to market has required immense
dedication and strong partnership between the WuXi Biologics team
and Amicus, relying on our shared dedication to patients and our
ability to execute on our vision to bring high quality therapies to
the rare disease community. Over many years of hard work, our joint
efforts have brought this medicine from an idea, to a molecule, to
clinical manufacturing and commercial supply, delivering on our
commitment to people living with late-onset Pompe disease."
Dr. Chris Chen, CEO of WuXi
Biologics, commented, "We're honored to enable Amicus to
achieve this great milestone, which we've been looking forward to
for over 11 years. This close partnership not only showcases our
successful strategy, 'follow the molecule', but also inspires us to
accelerate the discovery, development and manufacturing of more
rare disease biologic therapeutics for global partners. I am
confident that the collaboration between our two companies, both of
which share a passion for patients, will achieve greater successes
in the journey of benefiting global patients with rare
diseases."
About Pompe Disease
Pompe disease is an inherited lysosomal disorder caused by
deficiency of the enzyme acid alpha-glucosidase (GAA). Reduced or
absent levels of GAA lead to accumulation of glycogen in cells,
which is believed to result in the clinical manifestations of Pompe
disease. Pompe disease ranges from a rapidly deteriorating
infantile form with significant impact to heart function, to a more
slowly progressive, late-onset form primarily affecting skeletal
muscle and progressive respiratory involvement. Late-onset Pompe
disease can be severe and debilitating with progressive muscle
weakness throughout the body that worsens over time, particularly
skeletal muscles and muscles that control breathing.
About Pombiliti + Opfolda
Pombiliti + Opfolda, is a two-component therapy that consists of
cipaglucosidase alfa-atga, a bis-M6P-enriched rhGAA that
facilitates high-affinity uptake through the M6P receptor while
retaining its capacity for processing into the most active form of
the enzyme, and the oral enzyme stabilizer, miglustat, that's
designed to reduce loss of enzyme activity in the blood.
About WuXi Biologics
WuXi Biologics (stock code: 2269.HK) is a leading global
Contract Research, Development and Manufacturing Organization
(CRDMO) offering end-to-end solutions that enable partners to
discover, develop and manufacture biologics – from concept to
commercialization – for the benefit of patients worldwide.
With over 12,000 skilled employees in China, the United
States, Ireland,
Germany and Singapore, WuXi Biologics leverages its
technologies and expertise to provide customers with efficient and
cost-effective biologics discovery, development and manufacturing
solutions. As of June 30, 2023, WuXi
Biologics is supporting 621 integrated client projects, including
22 in commercial manufacturing.
WuXi Biologics views Environmental, Social, and Governance (ESG)
responsibilities as an integral component of our ethos and business
strategy, and we aim to become an ESG leader in the biologics CRDMO
sector. Our facilities use next-generation biomanufacturing
technologies and clean-energy sources. We have also established an
ESG committee led by our CEO to steer the comprehensive ESG
strategy and its implementation, enhancing our commitment to
sustainability.
For more information about WuXi Biologics, please visit:
www.wuxibiologics.com.
Contacts
Media
PR@wuxibiologics.com
Business
info@wuxibiologics.com
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