Stock Markets

Mallinckrodt Presents Data on TERLIVAZ ® (terlipressin) for Injection in Patients with Hepatorenal Syndrome (HRS) at Kidney Week 2024

Published

3 months ago

October 27, 2024

“ Pooled analysis from Phase 3 clinical trials highlights liver transplant rates in adult patients with HRS with rapid reduction in kidney function treated with TERLIVAZ¹ “

DUBLIN, Oct. 26, 2024 /PRNewswire/ — Mallinckrodt plc, a global specialty pharmaceutical company, today announced a poster presentation on TERLIVAZ^® (terlipressin) for injection in patients with hepatorenal syndrome (HRS) with rapid reduction in kidney function¹ at Kidney Week 2024, the annual meeting of the American Society of Nephrology (ASN) taking place in San Diego from October 23-27, 2024.

TERLIVAZ is the first and only FDA-approved product indicated to improve kidney function in adults with HRS with rapid reduction in kidney function,¹ an acute and life-threatening condition requiring hospitalization.² HRS involving rapid reduction in kidney function¹ is estimated to affect more than 42,000 Americans annually, approximately 0.01% of the U.S. population,³ making it a very rare condition; and rates of hospitalizations are increasing.⁴

Please see Limitation of Use and Important Safety Information, including Boxed Warning, below.

The poster presentation highlights a pooled analysis of data from the CONFIRM and REVERSE Phase 3 placebo-controlled trials of TERLIVAZ.⁵ The analysis examined the rates of hepatorenal syndrome-acute kidney injury (HRS-AKI) reversal, renal replacement therapy (RRT), and liver transplant (LT) among a subpopulation of patients listed for LT at baseline who met FDA label guidelines for treatment with TERLIVAZ (SCr 5 In this patient subpopulation, treatment with TERLIVAZ increased the rate of HRS-AKI reversal and reduced the need for RRT at all time points assessed.⁵ The increase in HRS-AKI reversal with TERLIVAZ did not negatively impact the LT rate in patients listed for LT at baseline.⁵

The rate of HRS-AKI reversal was 43% in the TERLIVAZ group (n=53) and 20% in the placebo group (n=35).⁵
The rate of RRT in the TERLIVAZ and placebo groups was 28% and 46% by Day 30; 32% and 54% by Day 60; and 36% and 54% by Day 90, respectively.⁵
The LT rate was similar in the TERLIVAZ and placebo groups at all time points assessed: 53% and 51% by Day 30; 66% and 57% by Day 60; and 66% and 63% by Day 90, respectively.⁵

The limitations of this study include, but are not limited to, small sample sizes, variables in methodology, and possible errors and omissions within the data sets.⁵

“This analysis of data from our Phase 3 trials furthers our understanding of the appropriate patient subpopulations and the potential impact of treatment on liver transplantation rates,” said Peter Richardson, MRCP (UK), Executive Vice President & Chief Scientific Officer. “For these critically ill patients with HRS-AKI, a liver transplant is the definitive treatment, and we know there are significant challenges associated with RRT; which makes continued research important.”

This study was sponsored by Mallinckrodt (OTC:) Pharmaceuticals. Presentation details can be found below:

Poster #PO0102-2: Hepatorenal syndrome-acute kidney injury reversal and liver transplant rates in patients treated with terlipressin⁵

Presenter: Justin Belcher
Session Type: Poster Presentation
Session AKI: Clinical, Outcomes, and Trials – Management
Session Date and Time: Saturday, October 26, 2024; 10:00 a.m. “ 12:00 p.m. PT

INDICATION AND LIMITATION OF USE

TERLIVAZ is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.

Patients with a serum creatinine >5 mg/dL are unlikely to experience benefit.

IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS OR FATAL RESPIRATORY FAILURE

TERLIVAZ may cause serious or fatal respiratory failure. Patients with volume overload or with acute-on-chronic liver failure (ACLF) Grade 3 are at increased risk. Assess oxygenation saturation (e.g., SpO₂) before initiating TERLIVAZ.

Do not initiate TERLIVAZ in patients experiencing hypoxia (e.g., SpO₂ 2 decreases below 90%.

Contraindications

TERLIVAZ is contraindicated:

In patients experiencing hypoxia or worsening respiratory symptoms.
In patients with ongoing coronary, peripheral, or mesenteric ischemia.

Warnings and Precautions

Serious or Fatal Respiratory Failure: Obtain baseline oxygen saturation and do not initiate TERLIVAZ in hypoxic patients. Monitor patients for changes in respiratory status using continuous pulse oximetry and regular clinical assessments. Discontinue TERLIVAZ in patients experiencing hypoxia or increased respiratory symptoms.

Manage intravascular volume overload by reducing or discontinuing the administration of albumin and/or other fluids and through judicious use of diuretics. Temporarily interrupt, reduce, or discontinue TERLIVAZ treatment until patient volume status improves. Avoid use in patients with ACLF Grade 3 because they are at significant risk for respiratory failure.

Ineligibility for Liver Transplant: TERLIVAZ-related adverse reactions (respiratory failure, ischemia) may make a patient ineligible for liver transplantation, if listed. For patients with high prioritization for liver transplantation (e.g., MELD ‰¥35), the benefits of TERLIVAZ may not outweigh its risks.

Ischemic Events: TERLIVAZ may cause cardiac, cerebrovascular, peripheral, or mesenteric ischemia. Avoid use of TERLIVAZ in patients with a history of severe cardiovascular conditions or cerebrovascular or ischemic disease. Discontinue TERLIVAZ in patients who experience signs or symptoms suggestive of ischemic adverse reactions.

Embryo-Fetal Toxicity: TERLIVAZ may cause fetal harm when administered to a pregnant woman. If TERLIVAZ is used during pregnancy, the patient should be informed of the potential risk to the fetus.

Adverse Reactions

The most common adverse reactions ( ‰¥10%) include abdominal pain, nausea, respiratory failure, diarrhea, and dyspnea.

Please click here to see full Prescribing Information, including Boxed Warning.

ABOUT HEPATORENAL SYNDROME (HRS)
Hepatorenal syndrome (HRS) involving rapid reduction in kidney function¹ is an acute and life-threatening condition that occurs in people with advanced liver disease.² HRS is classified into two distinct types “ a rapidly progressive type that leads to acute renal failure where patients are typically hospitalized for their care and a more chronic type that progresses over weeks to months.² HRS involving rapid reduction in kidney function¹ is estimated to affect more than 42,000 Americans annually, approximately 0.01% of the U.S. population,³ making it a very rare condition; and rates of HRS hospitalizations are increasing.⁴ If left untreated, HRS with rapid reduction in kidney function¹ has a median survival time of less than two weeks and greater than 80 percent mortality within three months.⁶

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, hepatology, nephrology, pulmonology, ophthalmology, and oncology; 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.

CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release contains forward-looking statements, including with regard to TERLIVAZ^®, its potential to improve health and treatment outcomes, 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: the effects of Mallinckrodt’s recent emergence from bankruptcy; satisfaction of, and compliance with, 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 or adverse side effects or adverse reactions associated with TERLIVAZ; and other risks identified and described in more detail in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Mallinckrodt’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, 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
Green Room Communications
908-577-4531
mediainquiries@grcomms.com

Investor Relations
Derek Belz
Vice President, Investor Relations
314-654-3950
derek.belz@mnk.com

Mallinckrodt, the “M” brand mark, TERLIVAZ, and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners.

References

¹ TERLIVAZ^® (terlipressin) for Injection. Prescribing Information. Mallinckrodt Hospital Products Inc. 2023.
² National Organization for Rare Disorders. Hepatorenal Syndrome. Available at: https://rarediseases.org/rare-diseases/hepatorenal-syndrome/. Accessed October 2024.
³ United States Census Bureau: Quick Facts. Available at: https://www.census.gov/quickfacts/fact/table/US/PST045218. Accessed October 2024.
⁴ Singh J., Dahiya D.S., Kichloo A., et al. Hepatorenal Syndrome: A Nationwide Trend Analysis from 2008 to 2018. Annals of Med. 2021;53:1. 2018-2024 doi.org/10/1080/07853890.
⁵ Belcher J.M., Regner K.R., Mujtaba M.A., et al. Hepatorenal syndrome-acute kidney injury reversal and liver transplant rates in patients treated with terlipressin. Abstract to be presented at the American Society of Nephrology (ASN) 2024 Annual meeting. October 2024.
⁶ 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.

Stock Markets

Trump to withdraw from Paris climate agreement, White House says

Published

2 hours ago

January 21, 2025

By Valerie Volcovici and Jasper Ward

WASHINGTON (Reuters) -President Donald Trump will once again withdraw the United States from the Paris climate deal, the White House said on Monday, removing the world’s biggest historic emitter from global efforts to fight climate change for the second time in a decade.

The decision would place the United States alongside Iran, Libya and Yemen as the only countries in the world outside the 2015 pact, in which governments agreed to limit global warming to 1.5 degrees Celsius above pre-industrial levels to avoid the worst impacts of climate change.

The announcement, in a document from the White House, reflects Trump’s skepticism about global warming, which he has called a hoax, and fits in with his broader agenda to unfetter U.S. oil and gas drillers from regulation so they can maximize output.

The United States is already the world’s top producer of oil and thanks to a years-long drilling boom in Texas, New Mexico and elsewhere fueled by fracking technology and strong global prices since Russia’s invasion of Ukraine.

Trump also withdrew the U.S. from the Paris deal during his first term in office, though the process took years and was immediately reversed by the Biden presidency in 2021. The withdrawal this time around is likely to take less time – as little as a year – because Trump will not be bound by the deal’s initial three-year commitment.

This time could also be more damaging to global climate efforts, said Paul Watkinson, a former climate negotiator and senior policy advisor for France.

The U.S. is currently the world’s second-biggest greenhouse gas emitter behind China and its departure undermines global ambition to slash those emissions.

“It will be harder this time because we are in the thick of implementation, up against real choices,” Watkinson said.

The world is now on pace for global warming of more than 3 C by the end of the century, according to a recent United Nations report, a level scientists warn would trigger cascading impacts like sea level rise, heat waves, and devastating storms.

Nations have already been struggling to make steep cuts to emissions required to lower the projected temperature increase, as wars, political tensions and tight government budgets push climate change down the list of priorities.

Trump’s approach cuts a stark contrast to that of former President Joe Biden, who wanted the United States to lead global climate efforts and sought to encourage a transition away from oil and gas using a combination of subsidies and regulations.

Trump has said he intends to unwind those subsidies and regulations to shore up the nation’s budget and grow the economy, but has insisted he can do that while also ensuring clean air and water in the United States.

Li Shuo, an expert in climate diplomacy at the Asia Society Policy Institute, said the U.S. withdrawal risks undermining America’s ability to compete with China in key clean energy markets like solar power and electric vehicles.

“China stands to win, and the U.S. risks lagging further behind,” he said.

Stock Markets

CUBI FINAL DEADLINE: ROSEN, A LEADING NATIONAL FIRM, Encourages Customers Bancorp, Inc. Investors to Secure Counsel Before Important January 31 Deadline in Securities Class Action First Filed by the F

Published

2 hours ago

January 21, 2025

New York, New York–(Newsfile Corp. – January 20, 2025) – WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Customers Bancorp, Inc. (NYSE: NYSE:) between March 1, 2024 and August 8, 2024, both dates inclusive (the “Class Period”), of the January 31, 2025 lead plaintiff deadline in the securities class action first filed by the Firm.

SO WHAT: If you purchased Customers Bancorp securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

WHAT TO DO NEXT: To join the Customers Bancorp class action, go to https://rosenlegal.com/submit-form/?case_id=28067 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email case@rosenlegal.com for information on the class action. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than January 31, 2025. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.

WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources, or any meaningful peer recognition. Many of these firms do not actually litigate securities class actions, but are merely middlemen that refer clients or partner with law firms that actually litigate the cases. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm achieved the largest ever securities class action settlement against a Chinese Company at the time. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action (WA:) Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs’ Bar. Many of the firm’s attorneys have been recognized by Lawdragon and Super Lawyers.

DETAILS OF THE CASE: According to the lawsuit, defendants throughout the Class Period made materially false and/or misleading statements and/or failed to disclose that: (1) Customers Bancorp had inadequate anti-money laundering practices; (2) as a result, it was not in compliance with its legal obligations, which subjected it to heightened regulatory risk; and (3) as a result, defendants’ statements about Customers Bancorp’s business, operations, and prospects were materially false and misleading and/or lacked a reasonable basis at all times. When the true details entered the market, the lawsuit claims that investors suffered damages.

To join the Customers Bancorp class action, go to https://rosenlegal.com/submit-form/?case_id=28067 call Phillip Kim, Esq. toll-free at 866-767-3653 or email case@rosenlegal.com for information on the class action.

No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.

Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm or on Twitter: https://twitter.com/rosen_firm or on Facebook (NASDAQ:): https://www.facebook.com/rosenlawfirm.

Attorney Advertising. Prior results do not guarantee a similar outcome.

——————————-

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/237660

Stock Markets

Donald Trump sworn in as 47th US president

Published

2 hours ago

January 21, 2025

Investing.com — Donald Trump has been inaugurated as the 47th president of the United States. The swearing-in ceremony was conducted by Chief Justice John Roberts. Alongside him, JD Vance took the oath of vice presidency, administered by Justice Brett Kavanaugh.

In his inauguration speech, President Trump promised the beginning of a golden era for America. He is set to initiate a series of executive actions, as per incoming White House officials.

These potentially include the commencement of a process to terminate birthright citizenship and the declaration of a national emergency on the US-Mexico border. It is also anticipated that Trump will grant pardons to some individuals involved in the January 6 riots on his first day in office.

“We will tariff and tax foreign countries to enrich our citizens,” Trump said during his address. “For this purpose, we are establishing the External Revenue Service to collect all tariffs, duties and revenues.”

The inauguration event was attended by a host of political leaders, former presidents, and influential billionaires. Among the notable guests were Elon Musk and Jeff Bezos. Country music artist Carrie Underwood was also present, performing the song “America the Beautiful.”

Before the transition of power, former President Joe Biden granted pardons to several individuals. These included Gen. Mark Milley, Dr. Anthony Fauci, and members of Congress who were part of the committee investigating the events of January 6.

Preemptive pardons were also issued for Biden’s siblings, James and Frank, his sister Valerie, and their respective spouses.