-Post-hoc analyses showcase Mallinckrodt's commitment to patients with HRS
involving rapid reduction in kidney
function,1an acute and life-threatening
condition2-
DUBLIN, June 23,
2022 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKPF), a global
biopharmaceutical company, today announced two scientific posters
to be presented on the disease progression and treatment paradigms
for patients with hepatorenal syndrome (HRS) involving rapid
reduction in kidney function1 at the European
Association for the Study of the Liver (EASL) 2022 International
Liver Congress, taking place June 22
– 26 in London, UK. The full list
of Mallinckrodt's presentations is
below. For more information, please visit the EASL website
here.
Terlipressin is an investigational agent being evaluated for the
treatment of HRS involving rapid reduction in kidney
function1 in the U.S., and its safety and
effectiveness have not yet been established by the FDA.
Khurram Jamil, Vice President,
Hepatology, Clinical Development & Critical Care, said, "It
is our hope that this research may help inform clinicians on the
early identification and management of adult patients with HRS with
rapid reduction in kidney function.1 We look
forward to sharing new data from a retrospective analysis that
uncovers the influence of baseline serum creatinine (SCr) levels on
clinical outcomes for patients with HRS involving rapid reduction
in kidney function,1 and resharing the findings of
our subgroup analysis examining HRS gender differences and response
to treatment – recently presented at the 2022 American Transplant
Congress."
These studies are sponsored by Mallinckrodt Pharmaceuticals and
include:
Abstract 2952 Title: Early Treatment with Terlipressin in
Patients with Hepatorenal Syndrome Yields Improved Clinical
Outcomes in 3 Phase III North American Studies
- Presenter: Michael Curry,
MD
- Presentation Date: June 24,
2022; 9AM – 6PM BST
- Poster #: FRI537
Abstract 564 (Encore) Title: Gender Affects the Association
Between Serum Creatinine Levels and Clinical Response to
Terlipressin in Patients with Hepatorenal Syndrome Type of Acute
Kidney Injury
- Presenter: Khurram Jamil, MD
- Presentation Date: June 24,
2022; 9AM – 6PM BST
- Poster #: FRI490
Terlipressin is one of the most studied pharmacological agents
in HRS with more than 70 published manuscripts and presented
abstracts on clinical data to date.3 It has been
approved outside the U.S. for more than 30 years and is available
on five continents for its two indications in the countries where
it is approved.4,5,6
ABOUT HEPATORENAL SYNDROME
(HRS)
Hepatorenal syndrome (HRS) involving rapid reduction in kidney
function1 is an acute and life-threatening syndrome
involving acute kidney failure in people with advanced liver
disease.2 HRS is classified into two distinct types – a
rapidly progressive type that leads to acute renal failure and a
more chronic type that progresses over weeks to months.2
HRS is estimated to affect between 30,000 and 40,000 Americans
annually.7,8 If left untreated, the rapid reduction in
kidney function associated with HRS1 has a median
survival time of approximately two weeks and greater than 80
percent mortality within three months.9
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, ophthalmology, and oncology; immunotherapy and
neonatal respiratory critical care therapies; analgesics; cultured
skin substitutes 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 with regard to
terlipressin, including related to interactions with regulators,
steps being taken related to its manufacturing, and its potential
impact on patients. 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.
CONTACT
Media Inquiries
Heather
Guzzi
Senior Vice President, Green Room Communications
973-524-4112
hguzzi@greenroompr.com
Investor Relations
Daniel J.
Speciale
Global Corporate Controller & Chief Investor Relations
Officer
314-654-3638
daniel.speciale@mnk.com
Derek Belz
Vice President, Investor Relations
314-654-3950
derek.belz@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.
© 2022 Mallinckrodt. US-2200583 06/22
References
1 Data on File – Ref-05737. Mallinckrodt
Pharmaceuticals.
2 National Organization for Rare Disorders. Hepatorenal
Syndrome. Available at:
https://rarediseases.org/rare-diseases/hepatorenal-syndrome/.
Accessed June 16, 2022.
3 Data on File – Ref-05488. Mallinckrodt
Pharmaceuticals.
4 Data on File – Ref-05482. Mallinckrodt
Pharmaceuticals.
5 FDA Cardiovascular and Renal Drugs Advisory Committee.
Mallinckrodt Pharmaceuticals Terlipressin Advisory Committee
Briefing Document NDA #022231. July
2020.
6 European Association for the Study of the Liver
(EASL). Clinical practice guidelines for the management of patients
with decompensated cirrhosis. J Hepatol.
2018;69(2):406-460.
7 C Pant, B S Jani, M Desai, A Deshpande, Prashant Pandya, Ryan
Taylor, R Gilroy, M Olyaee. Hepatorenal syndrome in
hospitalized patients with chronic liver disease: results from the
Nationwide Inpatient Sample 2002–2012. J of Investig Med.
2016; 64:33–38.
8 United States Census Bureau: Quick Facts. Available
at: https://www.census.gov/quickfacts/fact/table/US/PST045218.
Accessed June 16, 2022.
9 Flamm, S.L., Brown, K., Wadei, H.M., et al. The
Current Management of Hepatorenal Syndrome–Acute Kidney Injury in
the United States and the
Potential of Terlipressin. Liver Transpl, 2021; 27:
1191-1202. https://doi.org/10.1002/lt.26072.
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