DUBLIN, June 15, 2021 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKKQ), a global
biopharmaceutical company, today announced that the U.S. Food and
Drug Administration (FDA) has approved StrataGraft®
(allogeneic cultured keratinocytes and dermal fibroblasts in murine
collagen – dsat) for the treatment of adults with thermal burns
containing intact dermal elements for which surgical intervention
is clinically indicated (deep partial-thickness burns). Please see
Important Safety Information for StrataGraft below.
Experience the interactive Multichannel News Release here:
https://www.multivu.com/players/English/8801751-mallinckrodt-stratagraft
This project was funded in part with $86
million from 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), under contract HHSO100201500027
for Stratatech Corporation, a Mallinckrodt company, to develop StrataGraft.
The FDA approval is supported by data from the pivotal Phase 3
STRATA2016 clinical trial of a single application of
StrataGraft in patients with acute thermal burns containing intact
dermal elements (deep partial-thickness burns) involving
3%-37% total body surface area, which was conducted at U.S.
burn centers. Results, which were recently published in
Burns, showed a significantly smaller area of
burn wounds treated with StrataGraft required autografting by 3
months compared to the area of burn wounds treated exclusively with
autograft (p<0.0001).
"While autografting is effective in providing closure of the
original wound in patients with deep partial-thickness burns, it
can lead to donor site complications, including pain, itching,
increased risk of infection and scarring," said Tracee Short, M.D., burn surgeon and burn unit
medical director at the Regional Burn Center at Baton Rouge
General. "The approval of StrataGraft represents an important
advancement in the treatment of patients with deep
partial-thickness burns. Burn surgeons will now have a new biologic
treatment to eliminate or reduce the need for autografting."
Each year, approximately 40,000 patients in the United States require hospitalization for
the treatment of severe burns.1 Autograft is the current standard
of care for deep partial-thickness burns – 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 involves the surgical harvesting of
healthy skin from an uninjured site on the patient and
transplanting the skin graft to the injury, creating a donor site
wound and leaving the patient with more wounded areas requiring
care.
"Today's FDA approval of StrataGraft marks a significant
milestone for the burn care community and underscores our
unwavering commitment and ability to bring paradigm-changing
treatment options to patients with severe and critical conditions,"
said Steven Romano, M.D.,
Executive Vice President and Chief Scientific Officer at
Mallinckrodt. "We are deeply
appreciative of the patients who participated in the StrataGraft
clinical trials, the physicians and study investigators involved in
the clinical development program, and our employees, who have
worked tirelessly over the last 20 years to help us bring
StrataGraft to burn surgeons and the patients they treat."
In the pivotal Phase 3 clinical trial, 96% (68 of 71) of
the StrataGraft-treated burn sites across all participants did not
require autografting. The difference in the percent area of
StrataGraft and control autograft treatment sites that required
autografting by 3 months was 98% (p<0.0001). The proportion
of patients achieving durable closure of the StrataGraft treatment
site at 3 months without autograft placement was 83% (95% CI: 74,
92). The proportion of patients achieving durable closure of the
autograft control treatment site at 3 months without additional
autograft placement was 86% (95% CI: 78, 94).
"Multiple health security threats can result in severe burn
wounds, and, to save lives in a public health emergency, healthcare
providers need products that are effective and easy to use," said
BARDA Director Gary Disbrow,
Ph.D. "Having new products available on the commercial market
to improve routine care for burn patients gives healthcare
providers a level of familiarity and comfort in using the products.
This improves our healthcare response during a national emergency
and reduces the long-term cost of national preparedness."
Clinical trials demonstrated that the safety profile of
StrataGraft with regard to wound-related events, including
erythema, swelling, local warmth and wound site infections, was
comparable to that of autografting in clinical studies. The most
common (>2%) adverse reactions were pruritus (itching),
blisters, hypertrophic scar and impaired healing. There were
no reports of rejection to StrataGraft in the clinical studies, and
no patients discontinued study participation due to adverse
reactions.
About StrataGraft
StrataGraft is a viable,
bioengineered, allogeneic, cellularized scaffold product derived
from keratinocytes grown on gelled collagen containing dermal
fibroblasts. StrataGraft is designed to deliver viable cells to
support the body's own ability to heal. StrataGraft contains
metabolically active cells that produce and secrete a variety of
growth factors and cytokines. Growth factors and cytokines are
known to be involved in wound repair and regeneration. The product
is designed with both dermal and epidermal layers composed of
well-characterized human cells. StrataGraft is intended to be
applied in appropriate aseptic conditions, such as the operating
room, and can be sutured, stapled or secured with a tissue
adhesive.
The FDA granted StrataGraft 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. At the time of approval, the FDA awarded
Stratatech Corporation, a Mallinckrodt
company, a Priority Review Voucher (PRV).
Mallinckrodt is currently conducting
a StrataGraft 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 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 in the treatment of
pediatric populations. The safety and effectiveness of
StrataGraft in pediatric patients (<18 years) have not been
established.
BARDA expressed interest in StrataGraft as a medical
countermeasure in response to large-scale burn incidents, and
provided funding and technical support for the continued
development of StrataGraft. 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.
IMPORTANT SAFETY INFORMATION
INDICATION
StrataGraft® is an allogeneic
cellularized scaffold product indicated for the treatment of adults
with thermal burns containing intact dermal elements for which
surgical intervention is clinically indicated (deep
partial-thickness burns).
IMPORTANT SAFETY
INFORMATION
Contraindications
- Do not use in patients with known allergies to murine collagen
or products containing ingredients of bovine or porcine
origin.
Warnings and Precautions
- StrataGraft contains glycerin. Avoid glycerin in patients with
known sensitivity (irritant reaction) to glycerin.
- Severe hypersensitivity reactions may occur. Monitor for both
early and late symptoms and signs of hypersensitivity reaction
following StrataGraft application, and treat according to standard
medical practice.
- StrataGraft contains cells from human donors and may transmit
infectious diseases or infectious agents, eg, viruses, bacteria, or
other pathogens, including the agent that causes transmissible
spongiform encephalopathy (TSE, also known as Creutzfeldt-Jakob
disease [CJD or variant CJD]).
StrataGraft is a xenotransplantation product because of an historic
exposure of the keratinocyte cells to well-characterized murine
cells. The cell banks have been tested and found to be free of
detectable adventitious agents, and mouse cells are not used in the
manufacture of StrataGraft; however, these measures do not entirely
eliminate the risk of transmitting infectious diseases and disease
agents.
Transmission of infectious diseases or agents by StrataGraft has
not been reported.
- Because StrataGraft is a xenotransplantation product,
StrataGraft recipients should not donate whole blood, blood
components, plasma, leukocytes, tissues, breast milk, ova, sperm,
or other body parts for use in humans.
Adverse Reactions
- The most common adverse reactions (incidence ≥2%) were itching
(pruritus), blisters, hypertrophic scar, and impaired healing.
Other adverse events reported are included in the full Prescribing
Information.
Pediatric Use
- The safety and effectiveness of StrataGraft in pediatric
patients (<18 years) have not been established.
Please see full Prescribing
Information.
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, including anticipated launch timing, its
potential impact on patients and anticipated benefits associated
with its use, and future clinical trial plans. 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
Ben
Rickles
Real Chemistry
404-502-6766
brickles@realchemistry.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
VP, Restructuring and Investor Relations
daniel.speciale@mnk.com
Government Affairs
Mark
Tyndall
Senior Vice President, US General Counsel & Government
Affairs
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.
©2021 Mallinckrodt.
US-2001740 06/21
________________________
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