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Thursday, October 3, 2024

Novo CEO Reluctantly Agrees to Meet With PBMs on Ozempic, Wegovy Prices

 

In a Senate hearing last week on Novo Nordisk’s drug pricing, CEO Lars Fruergaard Jørgensen said he would be willing to sit down with the three largest pharmacy benefit managers who committed that they would expand coverage of Ozempic and Wegovy if Novo lowers its list prices for the blockbuster drugs.

Pressured by Sen. Bernie Sanders (I-Vt.), chair of the Senate health committee, Novo Nordisk CEO Lars Fruergaard Jørgensen in a Tuesday hearing agreed in principle to discussions with the three major pharmacy benefit managers, who committed to Sanders that a list price reduction would not negatively impact formulary placement for type 2 diabetes and obesity drugs Ozempic and Wegovy.

“I am delighted to announce today that I have received commitments in writing from all of the major PBMs that if Novo Nordisk substantially reduced the list price for Ozempic and Wegovy they would not limit coverage. In fact, all of them told me they would be able to expand coverage for these drugs if the list price was reduced,” Sanders said at the hearing.

Asked by Sanders whether Novo would be willing to sit down with PBMs to discuss their offer, Jørgensen said he would but would not commit upfront to lowering the list prices. Sanders offered to broker a deal between Novo and the three PBMs—Cigna’s Express Scripts, CVS’ Caremark and UnitedHealth’s Optum Rx—to which Jørgensen replied he would support “anything that can help get patients access.”

Novo has blamed the high list prices for its drugs on the PBMs as the company must pay rebates to these powerful prescription drug middlemen, who negotiate between pharma companies and health insurers to get onto their formularies.

In written testimony submitted to Tuesday’s hearing on Ozempic and Wegovy U.S. pricing, Jørgensen said “with PBMs asking that more money be paid to them in the form of rebates, discounts, and fees each year—unilateral manufacturer cuts to list prices do not consistently alleviate the cost burden on patients, and may in fact create harmful unintended consequences.”

BMO Capital Markets analyst Evan Seigerman in a note to investors was skeptical that the Sanders-brokered “good faith discussions” between Novo and the PBMs will have much impact, as “real action remains questionable” coming out of Tuesday’s Senate hearing.

“In our view, Novo highlighted several core problems with the U.S. healthcare system which will need to be addressed in order to provide any substantive benefit to patients,” Seigerman wrote. “These problems are multi-factorial and will likely require patients, providers, pharmaceutical companies, and PBMs to all come to the table to provide a productive solution.”

Following last Tuesday’s hearing, Sanders’ committee placed blame for the “outrageously high prices” of Ozempic and Wegovy squarely on Novo.

The Senate health committee released a majority staff report on Novo’s “untenable drug pricing strategy in America” based in part on “new information” provided by PBMs and health insurance plans.

“Contrary to claims from Novo Nordisk,” the report concluded that PBMs and health insurance plans “are not the reason for high prices for Ozempic and Wegovy” in the U.S.

The Pharmaceutical Care Management Association (PCMA)—a PBM lobbying group—in a Tuesday statement about the Senate hearing said that “despite PBMs pledging to continue facilitating coverage of these drugs, Big Pharma companies are still unwilling to commit to lowering the price of the drugs they create and instead, continue to try to redirect blame onto PBMs.”

However, the Federal Trade Commission in July released a scathing report about PBM business practices, including charging payers higher prices than what they pay to pharmacies—so called spread pricing—thereby “profit[ting] at the expense of patients by inflating drug costs and squeezing Main Street pharmacies.”

PBM reform remains a hot button issue in Congress with several bills being considered that would require PBMs to declare how much of a profit they’re making while negotiating drug prices.

https://www.biospace.com/business/novo-ceo-reluctantly-agrees-to-meet-with-pbms-on-ozempic-wegovy-prices

WuXi Mulls Sale of Some US, European Operations: FT

 

The Financial Times reported Thursday that WuXi AppTec is looking to sell its cell and gene therapy manufacturing unit, with facilities in Philadelphia, while WuXi Biologics wants to offload some of its production sites in Europe.

The two Chinese biotech companies, being targeted by the BIOSECURE Act as threats to U.S. national security, are considering selling off some of their businesses, according to the Financial Times.

WuXi AppTec has put its Advanced Therapies manufacturing unit (ATU) for cell and gene therapies—with four facilities in Philadelphia—up for sale, FT reported, citing sources familiar with the matter. WuXi Biologics, meanwhile, has brought on advisers to help gauge buyers’ interest in some of its production sites in Europe.

“We are assessing options for continuing ATU’s operations in line with our priorities: our employees and the patients who need essential, time-critical and life-saving treatments,” a WuXi AppTec spokesperson wrote in an emailed statement to BioSpace.

The U.S. House of Representatives last month overwhelmingly passed the BIOSECURE Act in a 306–81 vote in favor of the proposed legislation, which seeks to prevent American biopharma companies from working with certain Chinese firms. WuXi AppTec and WuXi Biologics are among the China-based companies named in the bill, alongside Beijing Genomics Institute, MGI and Complete Genomics.

The BIOSECURE Act is now awaiting action from the Senate, where bipartisan support is also likely to be strong.

First introduced in January 2024, the BIOSECURE Act positions the biopharma industry as a core national security asset of the U.S. and is designed to prevent “foreign adversary biotech companies” from access to taxpayer dollars. Aside from trying to prevent key technologies from falling into the hands of the Chinese Communist Party (CCP), the proposed legislation also seeks to protect Americans’ genomic data and other sensitive biological information.

In May 2024, several House representatives filed an amended version of the BIOSECURE Act, which included a grandfather clause that would allow existing U.S. contracts with Chinese biotechs until Jan. 1, 2032.

If passed into law, the BIOSECURE Act is expected to have far-reaching implications for the biopharma industry, which currently is heavily dependent on third-party service providers based in China.

Companies including Merck, Kyverna Therapeutics and Iovance Biotherapeutics have warned investors that the BIOSECURE Act could have crippling effects on their production capacities for both licensed therapies and vaccines, as well as their respective investigational treatments.

A recent GlobalData report found the legislation could affect more than 120 U.S. drugs partnered with companies named in the BIOSECURE Act, of which about half are in clinical trials and a third are in early-stage preclinical studies and discovery.

Jaxon Tan, founder of Momentum AI Communications, and Ivy Yang, a columnist for the Financial Times Chinese, echoed these concerns in an opinion piece for BioSpace last month, writing that the BIOSECURE Act will affect both the supply of drugs in the U.S. and the industry’s ability to smoothly conduct clinical trials.

https://www.biospace.com/business/wuxi-mulls-sale-of-some-us-european-operations-ft

Iran's High-Value Oil Assets In IDF Crosshairs As Israel Vows "Painful" Response

 For months, oil traders shrugged off any threat of a supply shock in the Middle East, betting on softening demand from China and the West, along with hopes of increased production from OPEC+. Bearish sentiment dominated the global market in late summer and early fall. But this week, the oil market faced a rude awakening after Iran launched several waves of ballistic and hypersonic missiles against Israel, sending bears scrambling and prices jumping above $75/bbl. 

The broadening war in the Middle East comes as Israel has vowed a "painful" response to Iran's attack early in the week. Brent prices rose 4.5% in the last three days, with further gains likely ahead as Prime Minister Benjamin Netanyahu could use stealth fighter jets to neutralize the Islamic Republic's oil infrastructure export capabilities. 

On Tuesday, Helima Croft, head of the global commodity strategy at RBC Capital Markets, joined CNBC's "The Exchange," informing hosts and audience, "There has been a lot of complacency about this war," adding, "We do need to think about a scenario where Iranian oil supplies are at risk.

Citigroup analyst Francesco Martoccia told clients that any  IDF strike on Iran's export capacity could reduce 1.5 million barrels of crude per day from the global market overnight. He said a minor attack on energy infrastructure, such as downstream assets, could remove 300,000 to 450,000 barrels of daily output. 

For energy research desks, it is unclear how the IDF will respond to Iran. Scenarios include hitting energy infrastructure to high-value military assets and nuclear sites. 

Bloomberg provided readers on Thursday morning with a detailed map showing Iran's major energy installations, including oil and gas fields, pipelines, refineries and storage terminals: 

Source: Bloomberg 

We tend to agree with Ross Schaapp, head of research at GeoQuant, who told CNBC's "Squawk Box" on Wednesday that Israel might try to cripple Iran's ability to export oil. As the saying goes, 'follow the money'... and if Israel wants to neutralize Iran, in terms of paralyzing financial networks, start with crude export abilities. 

GeoQuant's Schaapp noted that any IDF attack on Iranian energy infrastructure would send Brent prices higher "dramatically." 
This week, Brent's implied volatility gauge climbed to its highest level in nearly a year. In options markets, a surge in Brent call options shows traders forecasting $100/bbl. 

Bloomberg noted on Wednesday, "The equivalent of almost 27 million barrels of Brent December $100 calls traded by 11:20 am in New York while more than 7 million barrels worth of US crude December calls changed hands." 

Meanwhile, Bloomberg Intelligence analyst Henik Fung told Terminal users, "Traders unwinding short bets could push crude prices higher on a wider war-risk premium," adding, "WTI could retest $80 in the short term."

Scott Shelton, an energy specialist at TP ICAP Group Plc., noted, "The odds are against a material loss in production, but when it comes to geopolitics, it's always a hard call." 

Not anymore... 

The world awaits Israel's response. One top energy research desk emphasized to us on Wednesday that it's almost guaranteed Israel will make a retaliatory strike against Iran. The big question is, what will IDF stealth jets strike? 

https://www.zerohedge.com/commodities/irans-high-value-oil-assets-idf-crosshairs-israel-vows-painful-response

'Google CEO Eyes Atom Power For AI Data Centers As Big Tech Seeks Nukes To Ht Net Zero '

 Following the news of the Three Mile Island restart plans to power Microsoft's AI data centers and the revival of Holtec's Palisades nuclear plant in Michigan, Google CEO Sundar Pichai revealed in an interview with Nikkei Asia in Tokyo on Thursday that the tech giant is exploring the use of nuclear energy as a potential 'green' source to power its data centers. 

"For the first time in our history, we have this one piece of underlying technology which cuts across everything we do today," Pichai said of generative AI. He said, "I think the opportunity to do well here is something we are leaning into."

Three years ago, Google released plans to achieve net-zero emissions by 2030. However, the proliferation of AI data centers has led to a surge in the big tech's power consumption, which, in return, its greenhouse gas emissions in 2023 jumped 48% more than in 2019 on a carbon-dioxide equivalent basis. 

Behind the scenes, Google is likely scrambling to secure green energy and curb emissions as 2030 quickly approaches.

"It was a very ambitious target," Pichai said of the net-zero emissions targets, "and we will still be working very ambitiously towards it. Obviously, the trajectory of AI investments has added to the scale of the task needed." 

He continued, "We are now looking at additional investments, such as solar, and evaluating technologies like small modular nuclear reactors, etc."

Nikkei noted that Pichai wasn't clear on where Google might start sourcing nuclear power. A bulk of that power could come from reviving older nuclear power plants. This is exactly what Microsoft did when it signed a power agreement contract with dormant Three Mile Island on the Susquehanna River near Harrisburg, Pennsylvania. 

Recall that just last week, we wrote that Sam Altman-backed Nuclear SMR company Oklo announced it had finalized an agreement with the Department of Energy to advance the next phase of the SMR at the Idaho National Lab. And days ago, the Biden administration closed a $1.52 billion loan with Holtec's Palisades nuclear plant in Michigan to revive it. 

Sachem Cove Partners Chief Investment Officer Michael Alkin told Bloomberg shortly after the Microsoft-Three Mile Island deal, "It's a wake-up call to those that have not been paying attention," adding that demand already outstrips the supply of uranium and the restart of Three Mile Island "takes that to a bit of a different level."

Also, the funding markets are becoming more receptive to nuclear deals as governments and big tech understand the only way to hit ambitious net zero goals is not with solar and wind but with nuclear power. In late December 2020, we outlined to readers that this would happen in a note titled "Buy Uranium: Is This The Beginning Of The Next ESG Craze?"

Furthermore, here's Goldman's latest note on uranium prices, which are only expected to "stairstep" higher over time. 

https://www.zerohedge.com/commodities/google-ceo-considers-sourcing-nuclear-power-big-tech-jumps-atomic-power-train-hit-net

After Spending $640 Million On Migrants And Billions Abroad, FEMA Suddenly 'Broke'

 The Biden-Harris administration's 'America Last' policies have left the country vulnerable. Between draining the strategic petroleum reserve, sending hundreds of billions in cash and equipment to Ukraine (such as electrical transformers that are now needed for Hurricane Helene), and FEMA spending $640 million to help migrants, the agency tasked with emergency preparedness is now 'broke,' and doesn't have enough money to get through hurricane season which typically lasts through November.

According to AP,

The agency is being stretched as it works with states to assess damage from Hurricane Helene and delivers meals, water, generators and other critical supplies. The storm struck Florida last week, then plowed through several states in the Southeast, flooding towns and killing more than 160 people.

Mayorkas was not specific about how much additional money the agency may need, but his remarks on Air Force One underscored concerns voiced by President Joe Biden and some lawmakers earlier this week that Congress may need to pass a supplemental spending bill this fall to help states with recovery efforts.

"We are meeting the immediate needs with the money that we have. We are expecting another hurricane hitting," said Mayorkas, adding "FEMA does not have the funds to make it through the season."

And while the administration sends billions more to UkraineVP Kamala Harris has offered a laughable $750 in FEMA relief for hurricane victims.

Basically:

As journalist Breanna Morello notes, "Days before Hurricane Helene, the media was helping Democrats push for more FEMA funding," but "FEMA funds are being abused and given to illegal aliens."

"Communities were wiped off the map," said North Carolina governor, Roy Cooper, at a Tuesday press conference.

As American Greatness notes further;

Mayorkas made his comments as Joe Biden and Kamala Harris traveled to the Southeast for photo ops amid the devastation left in the storm’s wake.

Harris visited Augusta, Georgia, one of the cities hit hardest by Hurricane, two days after Trump, along with Christian evangelist Franklin Graham’s relief organization Samaritan’s Purse, surveyed the damage in Valdosta, Georgia, and passed out truckloads of supplies. During her stop, Harris announced that FEMA would provide whopping $750 in relief funds for people who have immediate needs.

As of April, more than $174 billion in American tax dollars have been appropriated to assist Ukraine. A total of $640.9 million has been spent to feed, clothe and house noncitizens.

Congress recently provided $20 billion in funding to FEMA’s disaster relief fund as part of a short-term government spending bill to fund the government through Dec. 20, according to the AP. The bill reportedly “gave FEMA flexibility to draw on the money more quickly as needed.”

Mayorkas claimed Wednesday that FEMA has been able to meet the immediate needs of Americans in communities devastated by the hurricane, however according to multiple reports, the federal government has offered little to no help.

According to independent journalist Breanna Morello, the Biden-Harris regime and North Carolina Governor Roy Cooper (D) are refusing to deploy search and rescue teams to help Americans trapped after Hurricane Helene.

These teams have been in the area since Sunday, but have not been granted authorization to rescue anyone.

“They’re waiting to get authorization through Title 10,” Morello reported on X Wednesday.

Title 10 of the United States Code covers roles, missions, and organization of the United States Armed Forces, and establishes the legal basis for the Department of Defense.

“For some reason that’s not coming down,” she said.

If you want to dig deeper into this egregious misuse of American taxpayer funds, click into the thread below:

Meanwhile, the propaganda wing of the Democrat party is doing it's thing...

https://www.zerohedge.com/political/america-last-after-spending-640-million-migrants-and-billions-abroad-fema-suddenly-broke

Clover Health: No action by SEC

 Clover Health Investments (NASDAQ: CLOV) disclosed"


By letter dated September 26, 2024 (the “Notice”), the Staff of the Securities and Exchange Commission's (the "SEC") Division of Enforcement notified Clover Health Investments, Corp. (the “Company”) that the SEC had concluded its investigation of the Company commenced in February 2021 (the "Investigation"), and based on the information that the SEC had as of the date of the Notice, the Staff did not intend to recommend an enforcement action by the SEC against the Company relating to the Investigation. The Notice was provided under the guidelines set forth in the final paragraph of Securities Act Release No. 5310.

The Investigation was previously disclosed by the Company in its periodic reports under the Securities Exchange Act of 1934, as amended. Additional information regarding the Investigation can be found in the Company’s prior filings, including the Company’s Form 10-Q for the quarterly period ended June 30, 2024, filed with the SEC on August 8, 2024

https://www.streetinsider.com/Corporate+News/Clover+Health+Investments+%28CLOV%29+says+SEC+concluded+its+investigation/23781200.html

Theriva Positive Review in Phase 1b/2a Trial for Allogeneic Hematopoietic Cell Transplant

 

DSMC has reviewed the safety and pharmacokinetic data from Cohort 2 and recommended that the study proceed to enroll patients into Cohort 3