STAINES-UPON-THAMES, United
Kingdom, Aug. 10, 2020
/PRNewswire/ -- Mallinckrodt
plc (NYSE: MNK), a global biopharmaceutical company, today
announced that the U.S. Food and Drug Administration (FDA) has
accepted for review the Stratatech Biologics License Application
(BLA) for StrataGraft®, an investigational regenerative
skin tissue therapy in development for the treatment of adult
patients with deep partial-thickness thermal burns. The FDA granted
the application priority review and assigned a Prescription Drug
User Fee Act (PDUFA) target date of February 2, 2021.
Autograft, the current standard of care for deep
partial-thickness thermal burns, involves the surgical harvesting
of healthy skin from an uninjured site on the patient and
transplanting the skin graft to the injury, leaving the patient
with more wounded areas requiring care. Each year, approximately
40,000 patients in the U.S. require hospitalization for the
treatment of severe burns.1 The Biomedical Advanced
Research and Development Authority (BARDA), part of the Office of
the Assistant Secretary for Preparedness and Response at the U.S.
Department of Health and Human Services (HHS), expressed interest
in StrataGraft skin tissue as a medical countermeasure in
response to large-scale burn incidents, and provided funding and
technical support for the continued development of StrataGraft skin
tissue.
"Treatment advances are needed that can help minimize or
eliminate the need for autografting. The FDA's acceptance of the
BLA submission for StrataGraft skin tissue for review takes us one
step closer to providing adult burn patients in the United States with a potential new
treatment option for deep partial-thickness thermal burns," said
Steven Romano, M.D., Executive
Vice President and Chief Scientific Officer at Mallinckrodt. "We are focused on delivering
solutions to patients with severe and critical conditions, and look
forward to working with the FDA during the regulatory review
process for StrataGraft skin tissue."
The StrataGraft skin tissue BLA is based on data from the
pivotal Phase 3 STRATA2016 clinical trial, previously
published as an abstract in the Journal of Burn Care &
Research and presented via a prerecorded video at the virtual
American Burn Association 52nd Annual Meeting, with
support from the STRATA2011 clinical trial, previously
published in Burns. Top-line results from the Phase 3 trial
of StrataGraft skin tissue, which met both primary endpoints in
adults with deep partial-thickness thermal burns, including
autograft sparing and durable wound closure, were announced in
September 2019.
The completion of the BLA rolling submission was
announced on June 9, 2020. The
FDA granted StrataGraft skin tissue orphan drug designation,
and it was among the first products designated by the Agency as a
Regenerative Medicine Advanced Therapy (RMAT) under the provisions
of the 21st Century Cures Act.
About StrataGraft
StrataGraft regenerative skin tissue is an investigational
treatment being developed to reduce autograft in patients with
severe thermal burns. An engineered, bilayer tissue, StrataGraft
skin tissue is designed to mimic natural human skin with both inner
dermis-like and outer epidermis-like layers. StrataGraft skin
tissue can be sutured, stapled or secured with an adhesive.
StrataGraft skin tissue is cryopreserved in order to deliver viable
cells upon application.
Mallinckrodt is currently conducting
a StrataGraft skin tissue continued access clinical trial
(StrataCAT, NCT04123548) under an Expanded Access Program (EAP).
The trial sites involved in the pivotal Phase 3 trial (STRATA2016,
NCT03005106) have the opportunity to participate in this
multicenter, open-label study. The company is planning to evaluate
StrataGraft skin tissue for the treatment of adults with
full-thickness burns (also referred to as third-degree burns).
Additionally, Mallinckrodt plans to
conduct a study evaluating StrataGraft skin tissue in treatment of
pediatric populations.
StrataGraft skin tissue is an investigational product, and
its safety and effectiveness have not yet been established by the
FDA.
The continued development of StrataGraft skin tissue, including
the pivotal Phase 3 clinical study (STRATA2016) and the BLA process
for StrataGraft skin tissue in the United
States, is being supported through a partnership with BARDA,
under the Assistant Secretary for Preparedness and Response, within
the U.S. Department of Health and Human Services, under Project
BioShield Contract No. HHSO100201500027C. These efforts are part of
BARDA's strategy to build emergency preparedness in response to
mass casualty events involving trauma and thermal burns by
developing novel medical countermeasures for adult and at-risk
populations. In the case of a mass casualty thermal burn event, the
Government Accountability Office estimates that more than 10,000
patients might require thermal burn care.2 The
limited number of specialized burn centers and related medical
infrastructure in the United
States creates a public health need for therapies that could
be deployed quickly for use in these and other care sites.
About Deep Partial-Thickness Thermal Burns
Deep partial-thickness thermal burns are complex skin injuries in
which the damage extends through the entire epidermis (outermost
layer of skin) and into the lower part of the dermis (innermost
layer of skin).
Autograft is considered to be a standard of care by many for
deep partial-thickness thermal burns. It involves the surgical
harvesting of healthy skin tissue from an uninjured site on the
patient and transplanting the skin graft to the injury. 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 the skin tissue for
grafting. Donor site wounds are painful and can create risks of
additional scarring and infection. In addition, the amount of
healthy skin available for harvesting is frequently limited in
those patients with large burns, necessitating sequential
re-harvesting of available donor sites. As a result, there is a
need for alternatives to donor site harvesting for the treatment of
severe burns.
About Mallinckrodt
Mallinckrodt is a global business
consisting of multiple wholly owned subsidiaries that develop,
manufacture, market and distribute specialty pharmaceutical
products and therapies. The company's Specialty Brands reportable
segment's 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; analgesics and
gastrointestinal products. Its Specialty Generics reportable
segment includes specialty generic drugs and active pharmaceutical
ingredients. 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
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website.
Cautionary Statements Related to Forward-Looking
Statements
This release includes forward-looking statements concerning
StrataGraft regenerative skin tissue, including the anticipated
regulatory review process, its potential impact on patients, and
anticipated benefits associated with its use. The statements are
based on assumptions about many important factors, including the
following, which could cause actual results to differ materially
from those in the forward-looking statements: satisfaction of
regulatory and other requirements; actions of regulatory bodies and
other governmental authorities; changes in laws and regulations;
issues with product quality, manufacturing or supply, or patient
safety issues; and other risks identified and described in more
detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form
10-K and other filings with the SEC, all of which are available on
its website. The forward-looking statements made herein speak only
as of the date hereof and Mallinckrodt
does not assume any obligation to update or revise any
forward-looking statement, whether as a result of new information,
future events and developments or otherwise, except as required by
law.
CONTACTS
For Trade Media Inquiries
Sheryl Seapy
W2O
213-262-9390
sseapy@w2ogroup.com
For Financial/Dailies Media Inquiries
Ron Bartlett
H+K Strategies
Senior Vice President
813 545 2399
ron.bartlett@hkstrategies.com
Investor Relations
Daniel J. Speciale
Vice President, Investor Relations and IRO
314-654-3638
daniel.speciale@mnk.com
Government Affairs
Mark Tyndall
Senior Vice President, Government Affairs & Chief Counsel,
Litigation
202-459-4141
mark.tyndall@mnk.com
Mallinckrodt, the "M" brand mark and
the Mallinckrodt Pharmaceuticals logo are trademarks of a
Mallinckrodt company. Other brands are
trademarks of a Mallinckrodt company or
their respective owners.
©2020 Mallinckrodt. US-2001226
07/20.
________________________
1 American Burn Association. Burn Incidence Fact Sheet.
http://ameriburn.org/who-we-are/media/burn-incidence-fact-sheet/.
Accessed May 15, 2020.
2 United States Government Accountability Office.
National Preparedness: Countermeasures for Thermal Burns.
https://www.gao.gov/assets/590/588738.pdf. Accessed February 12, 2020.
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SOURCE Mallinckrodt plc