STAINES-UPON-THAMES, United
Kingdom, April 6, 2020
/PRNewswire/ -- Mallinckrodt
plc (NYSE: MNK), a leading global specialty pharmaceutical
company, today announced that Stratatech,
a Mallinckrodt company, has initiated the rolling
submission of a Biologics License Application (BLA) to the U.S.
Food and Drug Administration (FDA) seeking approval to market
StrataGraft®, a regenerative skin tissue therapy, for
the treatment of adult patients with deep partial-thickness thermal
burns. StrataGraft skin tissue is an investigational product, and
its safety and effectiveness have not yet been established by the
FDA.
"This is a significant step forward. Approval of StrataGraft
regenerative skin tissue therapy could be a potential new
treatment option for patients with deep partial-thickness
thermal burns," said Steven
Romano, M.D., executive vice president and chief scientific
officer at Mallinckrodt. "We look
forward to working closely with the FDA during its review of the
application for StrataGraft skin tissue once the submission is
complete."
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.
A rolling submission allows the company to submit portions of
the regulatory application to the FDA as they are
completed.1 Mallinckrodt expects to complete the submission of
the BLA in the coming months.
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.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 extremely 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 future research plans and 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-2000493 04/20.
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1U.S. Food
and Drug Administration. "Guidance for Industry Expedited Programs
for Serious Conditions - Drugs and Biologics." Available
at https://www.fda.gov/files/drugs/published/Expedited-Programs-for-Serious-Conditions-Drugs-and-Biologics.pdf.
Accessed February 6, 2020.
2 https://www.gao.gov/assets/590/588738.pdf. Accessed
February 12, 2020.
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SOURCE Mallinckrodt plc