STAINES-UPON-THAMES, United
Kingdom, July 18, 2017
/PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global
specialty pharmaceutical company, today announced that
StrataGraft® regenerative skin tissue is among the
first products to be designated as a Regenerative Medicine Advanced
Therapy (RMAT) by the U.S. Food and Drug Administration (FDA) under
the provisions of the 21st Century Cures Act. The
company's investigational, tissue-based therapy is currently under
evaluation in a Phase 3 trial to assess its efficacy and safety in
the promotion of autologous skin regeneration of complex skin
defects due to thermal burns that contain intact dermal elements
(also known as deep partial thickness burns).
Passed in 2016, the 21st Century Cures Act allows the FDA to
grant accelerated review approval to products that meet certain
criteria. A product may receive an RMAT designation if the
drug is1:
- defined as a cell therapy, therapeutic tissue engineering
product, human cell and tissue product, or any combination product
using such therapies or products;
- intended to treat, modify, reverse, or cure a serious or
life-threatening disease or condition; and
- preliminary clinical evidence indicates the drug has the
potential to address unmet medical needs for such disease or
condition.
"We are very pleased the FDA has determined StrataGraft meets
the criteria for RMAT designation, as this offers the possibility
of priority review and/or accelerated approval," said
Steven Romano, M.D., Chief
Scientific Officer and Executive Vice President, Mallinckrodt. "This provides the potential to
bring a much-needed therapeutic option to patients even sooner than
originally planned."
The RMAT designation allows for earlier and increased
interactions with the FDA, including discussions of whether
priority review and/or accelerated approval would be appropriate
based on surrogate or intermediate endpoints that would be
reasonably likely to predict long-term clinical benefit; or
reliance upon data obtained from a meaningful number of sites. Once
approved, when appropriate, the FDA can require various
post-approval commitments.2
"RMAT designation of StrataGraft skin tissue speaks to the
strength of the clinical data generated during the prior clinical
study," said Lynn-Allen Hoffman,
Senior Vice President, Regenerative Medicine, Mallinckrodt. "Mallinckrodt is committed to developing advanced
regenerative medicine therapies such as StrataGraft for patients
with serious conditions."
Find more information about the ongoing StrataGraft Phase 3
clinical trial here on the ClinicalTrials.gov website. Prior
clinical study details can be seen here. This project has been
funded in part with federal funds from the Office of the Assistant
Secretary for Preparedness and Response, Biomedical Advanced
Research and Development Authority (BARDA), under Contracts No.
HHSO100201300017C and HHSO100201500027C. BARDA is supporting the
development of StrataGraft tissue as a potential medical
countermeasure for large-scale burn incidents.
About Serious Thermal Burns Containing Intact Dermal
Elements
Deep partial-thickness burns are complex skin
injuries where the entire epidermis and more than two thirds of the
dermis is destroyed. The treatment for severe complex skin wounds
with substantial loss of the dermis such as deep partial-thickness
burns is the surgical harvesting of a sheet of healthy skin from an
uninjured site on the patient and transplantation of this
autologous skin graft to the injury once the wound is ready to
receive an autograft. While this process can be effective in
providing closure of the original wound, it has significant
limitations related to the donor site wounds created during
surgical removal of autologous skin tissue for grafting. These
donor site wounds are extremely painful, prone to infection and
scarring, and can themselves convert to full-thickness wounds that
must then be managed to promote healing. In addition, the amount of
healthy skin available for harvesting is frequently limited in
large burns, necessitating sequential re-harvesting of available
donor sites. As a result, there is an urgent need for alternatives
to donor site harvesting for treatment of severe burns and other
complex skin defects.
About StrataGraft Regenerative Skin Tissue
StrataGraft
regenerative skin tissue is a viable, full-thickness product being
developed for severe burns and other complex skin defects that is
not yet approved by the U.S. Food and Drug Administration. It was
designed to mimic natural human skin, with both dermal and fully
differentiated epidermal layers. Unlike first generation products,
StrataGraft skin tissue can be sutured, stapled or secured with an
adhesive and remains intact in the wound bed, providing critical
barrier functionality during the wound healing process. StrataGraft
skin tissue is produced using NIKS® cells grown in
accordance with Good Manufacturing Practice. Because the continuous
NIKS skin cell line has been thoroughly characterized, StrataGraft
tissue is virus-free, non-tumorigenic, and offers batch-to-batch
genetic consistency.
ABOUT MALLINCKRODT
Mallinckrodt is a global business that develops,
manufactures, markets and distributes specialty pharmaceutical
products and therapies. Areas of focus include autoimmune and rare
diseases in specialty areas like neurology, rheumatology,
nephrology, pulmonology and ophthalmology; immunotherapy and
neonatal respiratory critical care therapies; and analgesics and
hemostasis products. The company's core strengths include the
acquisition and management of highly regulated raw materials and
specialized chemistry, formulation and manufacturing capabilities.
The company's Specialty Brands segment includes branded medicines
and its Specialty Generics segment includes specialty generic
drugs, active pharmaceutical ingredients and external
manufacturing. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Mallinckrodt uses its website as a
channel of distribution of important company information, such as
press releases, investor presentations and other financial
information. It also uses its website to expedite public access to
time-critical information regarding the company in advance of or in
lieu of distributing a press release or a filing with the U.S.
Securities and Exchange Commission (SEC) disclosing the same
information. Therefore, investors should look to the Investor
Relations page of the website for important and time-critical
information. Visitors to the website can also register to receive
automatic e-mail and other notifications alerting them when new
information is made available on the Investor Relations page of the
website.
CONTACTS
Investor
Relations
Coleman N. Lannum, CFA
Senior Vice President, Investor Strategy and IRO
314-654-6649
cole.lannum@mallinckrodt.com
Daniel J. Speciale, CPA
Director, Investor Relations
314-654-3638
daniel.speciale@mallinckrodt.com
Media
Rhonda Sciarra
Senior Communications Manager
908-238-6765
rhonda.sciarra@mallinckrodt.com
Meredith Fischer
Chief Public Affairs Officer
314-654-3318
meredith.fischer@mallinckrodt.com
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1
https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm537670.htm
Accessed July 8, 2017.
2
https://blogs.fda.gov/fdavoice/index.php/2017/03/this-is-not-a-test-rmat-designation-goes-live/
Accessed July 8, 2017.
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SOURCE Mallinckrodt Pharmaceuticals