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Thursday, February 16, 2023

ISS Joins Glass Lewis in Urging Amarin Shareholders Vote “AGAINST” Sarissa Proposals

 Independent Report Acknowledges That Sarissa’s Campaign to Remove Amarin’s Chairman and De Facto Seize Board Control Would be Detrimental to Shareholder Value

Board Urges Shareholders to Follow ISS and Glass Lewis's Recommendations and Vote “AGAINST” All of Sarissa’s Proposals on the WHITE Proxy Card

Amarin Corporation plc (NASDAQ: AMRN) (“Amarin” or the “Company”) today announced that the leading independent proxy advisory firm, Institutional Shareholder Services (“ISS”), has recommended that shareholders vote “AGAINST” all of Sarissa’s proposals on the WHITE proxy card at the upcoming General Meeting of Shareholders, scheduled for February 28, 2023.

In its February 16, 2023, report, ISS determined that Sarissa’s campaign is nothing more than a transparent attempt to de facto seize control of the Board by removing Amarin’s new Chairman, Per Wold-Olsen, and installing seven of its underqualified individuals. ISS joins Glass Lewis in highlighting that Sarissa has failed to make a compelling case for change and recommending shareholders vote “AGAINST” the removal of Per Wold-Olsen and “AGAINST” the election of every Sarissa nominee. ISS stated1:

  • “The board has appropriately refreshed itself and the company's positioning for commercial success appears to be improving. [Sarissa] has not presented convincing criticisms in either of these areas. As such, [Sarissa] has not made a compelling case for change.

  • “The company's strategic turn and operational execution since the appointment of Mikhail as CEO are particularly instructive. Quarterly revenue has stabilized, and the company has generated a small positive adjusted cash flow over the past two quarters... They nonetheless represent tangible steps forward that have clearly improved the company's position, and suggest that the company's current strategy is a credible path forward.

  • “The board's refreshment then, appears to have been proactive, thorough, and appropriate for the company's ongoing repositioning.”

  • “…contrary to the [Sarissa’s] assertion about unsustainable cash burn, has been successful in stabilizing its cash levels over the past three quarters.”

  • “… the underperformance since Mikhail took over is not necessarily a surprise, as the value of the company now primarily depends on the success of commercialization efforts in Europe, which remain in early stages.”

Ahead of scheduled arguments, U.S. Supreme Court nixes border policy case

 

The U.S. Supreme Court on Thursday removed from its argument calendar a Republican bid to keep in place a COVID-19 pandemic-related policy introduced under former President Donald Trump that has allowed American officials to quickly expel hundreds of thousands of migrants at the U.S.-Mexico border.

The Justice Department had said in a court filing that the case would become moot when the policy, known as Title 42, expires as a result of an announcement by President Joe Biden's administration that the COVID-19 public health emergency will end effective May 11. The justices were due to hear oral arguments in the case on March 1.

At issue in the case, which the court agreed to hear in December, was whether a group of Republican state attorneys general may intervene to defend the Title 42 expulsions after a U.S. judge ruled the public health order unlawful in a lawsuit by asylum-seeking migrant families represented by the American Civil Liberties Union.

The Justice Department, in a Feb. 7 filing, told the Supreme Court: "The anticipated end of the public health emergency on May 11, and the resulting expiration of the operative Title 42 order, would render this case moot."

The Supreme Court in December left in place the Title 42 policy, granting in a 5-4 vote the request by Republican state attorneys general to put on hold U.S. District Court Judge Emmet Sullivan's November decision invalidating the emergency public health order. Conservative Justice Neil Gorsuch joined the court's liberal members - Sonia Sotomayor, Elena Kagan and Ketanji Brown Jackson - dissenting from that decision.

Title 42 was first implemented in March 2020 under Trump, a Republican, when the COVID-19 pandemic began.

Biden, a Democrat, kept Title 42 in place after taking office in January 2021 despite fierce criticism from within his own party. Biden as a candidate had promised to reverse some of Trump's hardline immigration policies.

Biden's administration sought to lift the policy after U.S. health authorities said last year it was no longer needed to prevent the spread of COVID-19.

https://www.marketscreener.com/news/latest/Ahead-of-scheduled-arguments-U-S-Supreme-Court-nixes-border-policy-case--43011138/

CMS, insurers clash over whether Medicare Advantage is going to be cut in proposed rule

 Health insurers and the Biden administration are at loggerheads over whether Medicare Advantage (MA) plans will see a pay cut next year, the ramifications of which come amid increased regulatory scrutiny for the popular program.

Insurer groups and some politicians charge that the latest 2024 payment rule will wind up being a 2.27% cut to MA plans after considering risk adjustment changes and other factors. The Centers for Medicare & Medicaid Services (CMS) has pushed back, arguing that isn’t true.

The debate comes amid increasing scrutiny of MA and after CMS has proposed an overhaul to plan audits to curb overpayments.

“We think it is important not to cherry-pick the numbers,” said CMS Administrator Chiquita Brooks-LaSure during a call with reporters last week. “When we look at all the elements, we do see a net positive so an increase of little over 1%.”

At issue is the proposed advance notice released earlier this month that details the payments to MA and Part D plans for the 2024 coverage year. The proposed rule lays out the payment policies and changes to MA capitation rates for the upcoming year as well as outlining key changes to risk adjustment. 

When the rule was announced Feb. 1, CMS expected a 1.03% increase for plans. The agency came to this number after factoring in a decline in payments when taking in risk adjustment changes. 

Since the rule was released, the insurance industry has pushed back that it will actually result in a 2.27% cut to plans if finalized. 

The advocacy group Better Medicare Alliance (BMA) said that the rule “would raise costs and cut benefits for 30 million American seniors who rely on Medicare Advantage, a vital part of Medicare,” said BMA President and CEO Mary Beth Donahue in a statement.

The insurance lobbying group AHIP told Fierce Healthcare that a series of policy changes would result in the 2.27% cut to average MA payments, not 1.03% as CMS predicted.

AHIP pointed to other factors including a 1.24% decline in quality bonus payments under MA and Part D star ratings for 2024. The agency has sunset certain flexibilities that let plans score higher on their star ratings to help with financial pressures caused by the COVID-19 pandemic. 

Another area of change is that county benchmarks which are used to set the payment rates for MA plans are expected to increase by 2.09% in 2024. This is less than half the growth rate for this year at 4.88% and “well below the projected growth in per enrollee Medicare costs (5 percent),” AHIP told Fierce Healthcare. 

AHIP also doubted CMS’ estimates that the risk scores and risk adjustment payments would offset any reduction. 

“CMS has provided no information on how they estimate this coding trend,” the group said. “Consequently, there is no way to validate the accuracy of the CMS coding trend estimate.”

Brooks-LaSure said during the call that when taking in all the elements, “we do see a net increase.”

She added that MA plans have seen better updates in recent years compared to other parts of the Medicare program. 

CMS finalized a 4.75% bump to MA plan payments for 2023 and 5.59% for 2022. 

The advance notice clash comes after CMS last month released a new final rule that overhauls how the agency conducts risk adjustment data validation (RADV) that compares claims data from a sample of plans to patients' medical records to ensure they match up. The goal of the new rule is to clamp down on overpayments to MA plans, which advocates like the Medicare Payment Advisory Commission found increased in recent years.

Industry groups have pushed back on the RADV rule and its removal of a fee-for-service adjuster that brings the error rate for MA plans in line with traditional Medicare. Plans have argued that without the adjuster they will be held to an impossible standard with no errors whatsoever in claims.

Some plans such as Humana have weighed legal action to challenge the rule. 

But the fight over the CMS rule could play out in the political arena instead of the courtroom. On the day the rule came out, BMA released a letter from 61 bipartisan senators calling for CMS to ensure any payment rule and policy change “enable MA to continue providing the affordable, high-quality care our constituents rely on every day.”

Several Republicans in Congress have also latched onto the industry’s arguments about a pay cut after President Joe Biden said that the GOP wants to cut Medicare and Social Security during the State of the Union. 

“It’s President Biden who is proposing to cut Medicare Advantage, a program used by almost 4 in 10 Arkansas seniors,” tweeted Sen. Tom Cotton, R-Arkansas. “This would be a mistake.”

https://www.fiercehealthcare.com/payers/cms-insurers-clash-over-whether-medicare-advantage-going-be-cut-proposed-rule

Fetterman in hospital for clinical depression

 

U.S. Senator John Fetterman checked himself into Walter Reed medical center on Wednesday to receive treatment for severe clinical depression, his office said.

The 53-year-old Pennsylvania Democrat, who suffered a stroke last year, was evaluated by the attending physician for Congress on Monday, who recommended inpatient care, his chief of staff, Adam Jentleson, said in a statement on Thursday.

"While John has experienced depression off and on throughout his life, it only became severe in recent weeks," Jentleson said. "After examining John, the doctors at Walter Reed told us that John is getting the care he needs, and will soon be back to himself."

Fetterman had a stroke last year while campaigning for one of the key political swing state's two U.S. Senate seats.

https://www.marketscreener.com/news/latest/U-S-Senator-Fetterman-in-hospital-for-clinical-depression-statement--43011153/

Judge to weigh key evidence ahead of first Zantac cancer trial

 

GSK Plc is expected to urge a California judge on Thursday to limit what expert testimony jurors can hear in the first trial over claims that the company's heartburn drug Zantac caused cancer.

The trial, scheduled to begin Feb. 27 before Alameda County Superior Court Judge Evelio Grillo, will offer the first test of how Zantac cancer claims may fare in state courts.

A federal judge in December threw out all of the Zantac cases in federal court, some 50,000, after finding the opinions of the experts put forth by plaintiffs to establish their cancer was caused by the drug were not backed by sound science.

Tens of thousands of cases still remain in state courts, many consolidated before Grillo in California.

The plaintiff in the upcoming trial, James Goetz, says he developed bladder cancer from taking Zantac sold by British drugmaker GSK. Thursday's hearing will decide what his expert witnesses can say to support that claim.

Goetz's lawyers are also expected to seek to limit the expert testimony that GSK can use. Grillo will consider whether both sides' proposed testimony has scientific support, using a legal standard created by California's Supreme Court.

Representatives for GSK and for plaintiffs' lawyers did not immediately comment on the upcoming hearing.

Zantac, first approved in 1983, became the world's best selling medicine in 1988 and one of the first drugs to top $1 billion in annual sales.

Originally marketed by a forerunner of GSK, it was later sold successively to Pfizer Inc, Boehringer Ingelheim and finally Sanofi SA. All four drugmakers are facing Zantac lawsuits and have denied that the pill causes cancer.

In 2019, some manufacturers and pharmacies halted sales of the drug over concerns that its active ingredient, ranitidine, degraded over time to form a chemical called NDMA. While NDMA is found in low levels in food and water, it is known to cause cancer in larger amounts.

The U.S. Food and Drug Administration in 2020 pulled all remaining brand name Zantac and generic versions off the market, citing research showing the amount of NDMA in the products increases the longer the drug is stored and could potentially become unsafe.

Lawsuits began piling up soon after the recalls began from people who said they developed cancer after taking Zantac. Plaintiffs said the companies knew, or should have known, that ranitidine posed a cancer risk and that they failed to warn consumers.

Cases have been filed linking Zantac to at least 10 types of cancer. The federal litigation was limited to bladder, stomach, esophageal, liver and pancreatic cancers, but cases over other cancers remain in state courts.

https://www.marketscreener.com/news/latest/Judge-to-weigh-key-evidence-ahead-of-first-Zantac-cancer-trial--43011143/

Tesla recalls 362,000 U.S. vehicles over Full Self-Driving software

 

Tesla Inc is recalling 362,000 U.S. vehicles because its Full Self-Driving software may cause a crash, the National Highway Traffic Safety Administration said Thursday.

The agency said the Tesla software allows a vehicle to "exceed speed limits or travel through intersections in an unlawful or unpredictable manner increases the risk of a crash." Tesla will release an over-the-air (OTA) software update, free of charge. Tesla said is not aware of any injuries or deaths that may be related to the recall issue.

https://www.marketscreener.com/quote/stock/TESLA-INC-6344549/news/Tesla-recalls-362-000-U-S-vehicles-over-Full-Self-Driving-software-43010554/

Bellicum releases early oncology trial results after patient death

 

  • The most common grade 3+ adverse events were myelosuppression, characteristic of the lymphodepletion chemotherapies used in CAR-T studies. 
  • Two patients experienced Grade 3 cytokine release syndrome (CRS). One patient experienced Grade 4 immune effector cell neurotoxicity syndrome (ICANS) with concurrent hemophagocytic lymphohistiocytosis (HLH). 
  • ICANS improved to grade 1 with the standard of care and withholding subsequent doses of rimiducid, the patient died on study day 20 due to sepsis. 
  • Bellicum Pharmaceuticals Inc  announced the presentation of early Phase 1 results for BPX-601 at the American Society of Clinical Oncology Genitourinary Cancers Symposium. 
  • These interim results demonstrated the preliminary efficacy of BPX-601 PSCA-directed GoCAR-T cells in combination with rimiducid in heavily pre-treated patients. These initial data from 2 cohorts consisted of 8 patients.
  • Four of eight (50%) patients achieved a PSA50 response, three of whom achieved a PSA90 response.
  • Of the six patients with soft tissue disease, two achieved partial responses.