STAINES-UPON-THAMES, United
Kingdom, June 9, 2020
/PRNewswire/ -- Mallinckrodt
plc (NYSE: MNK), a global biopharmaceutical company, today
announced that Stratatech, a Mallinckrodt company, has
completed its rolling submission of a Biologics License Application
(BLA) to the U.S. Food and Drug Administration (FDA) for
StrataGraft®, a regenerative skin tissue therapy in
development for the treatment of adult patients with deep
partial-thickness thermal burns. The company previously
announced initiation of the rolling submission in April.
StrataGraft skin tissue is an investigational product, and its
safety and effectiveness have not yet been established by the
FDA.
"Completion of the BLA submission is the culmination of many
years of hard work and brings us one step closer to our goal of
providing StrataGraft skin tissue as a new treatment option for
patients in the United States with
deep partial-thickness thermal burns, if approved," said
Steven Romano, M.D., executive
vice president and chief scientific officer at Mallinckrodt. "We would like to thank the many
researchers, clinical trial investigators and patients who helped
us reach this important milestone. We look forward to working
closely with the FDA during the regulatory review process."
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 accepted for presentation at the American
Burn Association 52nd Annual Meeting, with support from
the STRATA2011 clinical trial, previously published in
Burns.
The FDA granted StrataGraft skin tissue orphan drug status,
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.
Funding and technical support for the continued development of
StrataGraft skin tissue, including the pivotal Phase 3 clinical
study (STRATA2016) and the Biological Licensing Application process
for StrataGraft tissue in the United
States, is being provided by the Biomedical Advanced
Research and Development Authority (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.1 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
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.
Cautionary Statements Related to Forward-Looking
Statements
This release includes forward-looking statements
concerning StrataGraft regenerative skin tissue, including
expectations with regard to related regulatory filings, 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
Media Relations
Sheryl
Seapy
W2O for Mallinckrodt
213-262-9390
sseapy@w2ogroup.com
Investor Relations
Daniel J.
Speciale, CPA
Vice President, Investor Relations and IRO
314-654-3638
daniel.speciale@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-2000850
05/20.
1 https://www.gao.gov/assets/590/588738.pdf.
Accessed February 12, 2020.
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SOURCE Mallinckrodt plc