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Friday, March 8, 2024

Weight Loss Drugs Threatened by US Effort to Contain China

 Lawmakers are working to reduce the impact the proposal would have on the US drug supply 

Popular weight loss and diabetes drugs are getting caught up in a bid by US lawmakers to reduce the country’s reliance on Chinese biotech companies.

Much of the active base ingredient used in Eli Lilly & Co.’s Zepbound and Mounjaro medicines is produced by WuXi AppTec Co., one of the main companies in the crosshairs of the Biosecure Act currently under discussion in the US Congress, according to people familiar with the company’s operations.

https://www.bloomberg.com/news/articles/2024-03-06/weight-loss-drugs-threatened-by-us-effort-to-contain-china

AbbVie dropping MacroGenics-partnered ADC in light of early data

 AbbVie has cut short its call on the ADAM family. The ADAM9-targeted antibody-drug conjugate (ADC) IMGC936 fell short of safety and efficacy expectations in solid tumors, prompting AbbVie and its equal partner MacroGenics to walk away from the candidate.

MacroGenics worked with ImmunoGen, now part of AbbVie following a $10.1 billion deal, to advance the ADC to a phase 1 readout. ADAM9 is overexpressed in non-small cell lung, pancreatic, gastric, breast, ovarian and colorectal cancers, suggesting it could enable the safe delivery of cytotoxic payloads to tumor cells. 

However, phase 1 data failed to make the case for further development of IMGC936. MacroGenics broke the news after the market closed Thursday, telling investors that neither it nor AbbVie plan to advance the molecule because it “did not achieve pre-established clinical safety and efficacy benchmarks.”

The statement lacks further information, but MacroGenics CEO Scott Koenig, M.D., Ph.D., discussed challenges facing the program on an earnings call in November, when he told investors that “identifying the appropriate dose” has always been one of the issues for IMGC936. At that time, ImmunoGen was still finishing up the lung cancer cohort, pushing back the readout from 2023 to 2024. 

While the readout failed to support further development of IMGC936, MacroGenics continues to believe in the potential of ADAM9. The biotech has a second shot at the target, MGC028, that uses Synaffix’s linker-payload in preclinical testing. 

MacroGenics plans to present preclinical data on MGC028 in April. Koenig teased the presentation on an earnings call Thursday, explaining that MGC028 had “specific dose-dependent in vivo antitumor activity” in ADAM9-positive models, including in gastric, lung, pancreatic, colorectal, and head and neck cancers.

For AbbVie, the retreat from IMGC936 eliminates a long-shot chance to realize additional value from the ImmunoGen takeover while leaving the core case for the deal intact. The takeover gave AbbVie control of the approved, FRα-directed ADC Elahere, which could generate blockbuster sales if it moves into earlier lines of therapy, and expertise in a modality that could support the Big Pharma’s solid tumor strategy.

https://www.fiercebiotech.com/biotech/abbvie-ends-stay-adam-family-dropping-macrogenics-partnered-adc-light-early-data

UCB ups the ante with CDMO Samsung Biologics, signing $288M deal

 UCB of Belgium and CDMO Samsung Biologics of South Korea have expanded their seven-year partnership with a new drug substance manufacturing deal worth 382 billion Korean won ($288 million).

Among the drugs Samsung will manufacture for UCB is an anti-Tau candidate to treat progressive supranuclear palsy (PSP), which is in early-stage testing.

Over the last 11 months, UCB has gained FDA approvals for three biologics—Bimzelx for plaque psoriasis, and Zilbrysq and Rystiggo, both for myasthenia gravis.

The new deal, which is the third between the companies, builds on a $42 million contract they signed in 2017 and runs through the end of 2030.

Samsung Biologics boasts that it has the largest capacity at a single site than any drug manufacturer in the world. When the fifth plant at the complex is completed in 2025, Samsung will have 784,000 liters of capacity.

Last year the company signed two biosimilar manufacturing deals with Pfizer for close to $1.8 billion and another with Novartis for $391 million. With the CDMO industry struggling in 2023, Samsung continued its growth, with revenue coming in at $2.8 billion. While it was an increase of 19% from 2022, it didn’t measure up to the 71% revenue increase from 2022 when the company was busy cranking out COVID products.

With new approvals in hand and a plan to pile on several indications for Bimzelx, UCB expects its revenue to grow from 5.25 billion euros ($5.7 billion) in 2023 to a range of 5.5 and 5.7 billion euros ($6.0 to $6.2 billion) this year.

https://www.fiercepharma.com/manufacturing/ucb-ups-ante-cdmo-samsung-biologics-signing-353m-deal

Lantern in H.C Wainwright 1st Annual AI Based Drug Discovery & Development Meet

 

  • Lantern Pharma will present virtually on Thursday, March 7th at 2 pm Eastern.
  • Lantern’s CEO & President, Mr. Panna Sharma will be interviewed in the form of a fireside chat by HCW’s Healthcare & Life Sciences Analyst and Director of Equity Research
  • Institutional investors, companies, and industry professionals are encouraged to register at this link or contact their representative at HCW.

In fiery SOTU, Biden proclaims “We finally beat big pharma”

Just days after the US presidential race officially narrowed to a contest between President Joe Biden and former president Donald Trump, it’s no surprise that Biden’s State of the Union speech seemed primarily concerned with scoring political and electoral points.

For the pharma industry, it should be equally unsurprising that a few of those points were scored at the industry’s expense. Even so, the President bragging, “We finally beat big pharma,” as he did relatively early on in last night’s speech, certainly left no doubt about how he views his relationship with drugmakers.

In a speech that ran more than an hour, President Biden’s brief but fiery remarks about pharma came in at the 21-minute mark.

“Americans pay more for prescription drugs than anywhere else in the world. It’s wrong and I’m ending it,” Biden said. “With a law I proposed and signed – and not one of you Republican buddies voted for – we finally beat big pharma.”

The President described the $35-per-month insulin price cap and $2,000-per-month prescription drug cost cap that the IRA secured for seniors on Medicare and called to extend both to all Americans, including those with private insurance.

“This year, Medicare is negotiating lower prices for some of the costliest drugs on the market that treat everything from heart disease to arthritis,” he said. “Now, it’s time to go further and give Medicare the power to negotiate lower prices for 500 drugs over the next decade. They’re making a lot of money, guys. And they’ll still be extremely profitable.”

He emphasised the effect of the negotiations on not only individual Americans, but on the federal deficit.

“That’s not just saving seniors money, it’s saving taxpayers money,” he said of the Medicare negotiations. “We cut the federal deficit by $160 billion because Medicare will no longer have to pay those exorbitant prices to Big Pharma.”

Interestingly, Biden reiterated twice that pharma would “still be extremely profitable”, but neither comment appeared in the prepared version of his speech, suggesting that perhaps Biden felt the need to soften his attack on the industry in the moment. Throughout the night, the President ad-libbed extensively.

A familiar talking point

The discussion of prescription drug prices wasn’t unexpected tonight. Biden came out strong on the issue in last year’s speech and at that point he wasn’t about to enter a general election. The White House also released a fact sheet yesterday highlighting the administration’s record and even proposing some further reforms.

In it, the administration proposed increasing the number of Medicare drugs up for negotiation, calling on Congress to expand the $2,000 out of pocket prescription drug cap to include private insurance, and working with manufacturers to expand access to cell and gene therapies. It also mentions calls to Congress to limit Medicare cost-sharing to $2 for high-value generic drugs and to expand the rebates required by the IRA when pharma raises prices faster than inflation.

The Bidens also invited a patient affected by the IRA’s drug pricing policies to the State of the Union. According to advocacy group Patients for Affordable Drugs Now, Dr Jill Biden was joined in her box by Steven Hadfield, who takes Januvia, one of the first 10 drugs selected for Medicare negotiation under the IRA, for his diabetes.

“The Inflation Reduction Act has been a lifeline, reducing my insulin costs from $400 to $35 per month,” Hadfield said in a statement provided by P4ADNow. “Medicare’s ability to negotiate lower drug prices offers hope for millions of patients like me. Less expensive drugs would finally allow me to rest more often or hopefully help me transition from working full-time to working part-time. I am honoured to be a guest of First Lady Jill Biden during the State of the Union as President Biden advocates for lower drug prices. He understands that drugs don’t work if people can’t afford them.”

Pharma industry groups, meanwhile, have continued to maintain that the prescription drug price negotiations in the IRA are not negotiations at all, but price setting. PhRMA put out a statement responding to the President’s address.

“The IRA is stifling lifesaving research — like the very research needed to get the president’s Cancer Moonshot off the ground — and creating access barriers for patients,” the group wrote. “There is bipartisan support for fixing some of the flaws of the IRA, yet, the administration is rushing to make this bad law worse. Letting government bureaucrats arbitrarily set the price of medicines allows politics to dictate which cures are worth investing in and who should get access to them. It puts the government between patients and their doctors.”

A few nods to cancer research

Outside of the four and a half minutes spent on the IRA, the President made two other allusions to the pharma industry in a more complimentary light. Early on in the speech, he dropped a reference to the promise of mRNA technology beyond COVID.

“The pandemic no longer controls our lives,” Biden said. “The vaccines that saved us from COVID are now being used to beat cancer, turning setback into comeback. That’s what America does.”

And the President alluded briefly to his Cancer Moonshot towards the end of his speech as well, saying, “We can do big things like end cancer as we know it. And we will.”

https://pharmaphorum.com/news/fiery-sotu-biden-proclaims-we-finally-beat-big-pharma

'COVID-19 May Lead To Persistent Cognitive Impairment, Brain Fog, And Lower IQ Scores'

 by Megan Redshaw via The Epoch Times (emphasis ours),

A new study found that COVID-19 infection can cause cognitive deficits that persist for over a year and lower IQ scores in severe cases. Those with persistent symptoms that resolved had small cognitive deficits similar to those with a shorter illness duration.

In a large-scale observational study published on Feb. 29 in the New England Journal of Medicine (NEJM), researchers invited 800,000 people with varying levels of COVID-19 exposure and duration to take an online cognitive assessment and follow-up survey. Cognitive difficulties have been implicated in numerous syndromes following COVID-19, including long COVID, suggesting infection may have lasting effects on the mental processes of the brain.

The study’s authors hypothesized there would be measurable cognitive deficits after COVID-19 that would scale with the severity and duration of the illness. They also speculated that objective impairments in executive and memory function, especially poor memory and brain fog, would be observable in those with persistent symptoms.

Using an assessment tool for cognitive function, researchers estimated global cognitive scores among participants with a history of previous SARS-CoV-2 infection who had symptoms for at least 12 weeks—whether resolved or not—and among a control group of uninfected participants. While cognitive and memory deficits were small for people with mild infection who recovered from COVID-19 quickly, impairments were more pronounced in those with severe disease.

Greater Impairment With More Severe Disease

Of 112,964 participants who completed the survey, those who recovered from COVID-19 with symptoms that resolved in less than four weeks or by 12 weeks post-infection had similar small deficits in global cognition compared with those who had never had COVID-19.

Participants who had mild COVID-19 with resolved symptoms experienced a 3-point drop in IQ compared to uninfected participants. Those with unresolved persistent symptoms had a 6-point loss in IQ, and those with COVID-19 admitted to the intensive care unit experienced a 9-point loss in IQ. Reinfection with SARS-CoV-2 caused an additional loss in IQ of nearly 2 points compared to those who were not reinfected. An IQ, or intelligence quotient, is a number used to represent the relative intelligence of an individual.

According to the study, memory, reasoning, and executive function tasks were the strongest indicators of impaired cognitive function, and these scores correlated with brain fog symptoms reported by participants. More significant deficits were seen in those with unresolved persistent symptoms and those infected with earlier variants of the SARS-CoV-2 virus compared with those who never had COVID-19. Additionally, study participants who were hospitalized had greater deficits in cognitive function compared to those who were not hospitalized. 

“By using an innovative cognitive test which has also been completed by people who did not have COVID-19, this important and well-conducted study provides the first accurate quantification of the scale of cognitive deficits in people who had COVID-19,” Maxime Taquet, a fellow in psychiatry at the National Institute for Health and Care Research at the University of Oxford, said in a statement

Mr. Taquet said researchers found a small but obvious association between COVID-19 and cognition that was more pronounced at extremes.

“The risk of having more severe cognitive problems was almost twice as high in those who had COVID-19 compared to those who did not, and three times as high in those who were hospitalized with COVID-19,” he noted.

In an editorial published Feb. 29 in the NEJM, Drs. Ziyad Al-Aly and Clifford Rosen said the study’s results are concerning and have broad implications that require further evaluation to determine the functional impact of a 3-point loss in IQ and why one group of participants was more severely affected than another. 

Whether these cognitive deficits persist or resolve along with predictors and trajectory of recovery should be investigated. Will Covid-19-associated cognitive deficits confer a predisposition to a higher risk of Alzheimer’s disease or other forms of dementia later in life? The effects on educational attainment, work performance, accidental injury, and other activities that require intact cognitive abilities should also be evaluated,” they wrote. 

Study Implications for People With Long COVID

The study’s participants were part of a larger community sample of nearly 3 million people in the Real-time Assessment of Community Transmission (REACT) study assessing SARS-CoV-2 transmission in England. Although the researchers did not say whether participants in the study had long COVID, people with long COVID frequently report persistent cognitive impairment.

There is no accepted universal definition for the condition, but the Centers for Disease Control and Prevention (CDC) broadly defines long COVID as “signs, symptoms, and conditions that continue to develop after acute COVID-19 infection” that can last for “weeks, months, or years.” The term “long COVID” also includes post-acute sequelae of SARS-CoV-2 infection, long-haul COVID, and post-acute COVID-19.

Nearly 7 percent of U.S. adults surveyed by the CDC in 2022 said they’ve experienced long COVID. Although U.S. regulatory agencies claim vaccinating against COVID-19 can reduce the risk of developing long COVID and the current paper suggests vaccination with two or more doses may provide a slight cognitive advantage, a recent paper published in the Journal of Clinical Medicine did not find a significant link between the presence of comorbidities or infection severity and the emergence of long COVID symptoms.

The NEJM study has several limitations, including reliance on subjective reporting to identify individuals with ongoing symptoms and self-selection bias. People with long COVID may have enrolled in the study, but those with more severe impairments may not have been able to participate in the survey. Additionally, certain groups were overrepresented in the study compared with the base population. Baseline cognitive data before SARS-CoV-2 infection was also unavailable, so researchers could not assess cognitive change or infer causality.

https://www.zerohedge.com/medical/vcovid-19-may-lead-persistent-cognitive-impairment-brain-fog-and-lower-iq-scores

UnitedHealth hack could take months for full recovery

 UnitedHealth Group, the largest U.S. health insurer, is likely to need several months to make a full recovery from a cyberattack that has been one of the most disruptive hacks against America's healthcare infrastructure, security experts said.

Since its Change Healthcare unit was breached on Feb. 21 by a hacking group called ALPHV, also known as "BlackCat", UnitedHealth has said it is working to restore impacted channels, and that some of its systems are returning to normal. While it has not provided a timeline for full recovery, cybersecurity analysts say that is likely quite far off.

“The amount of disruption suggests they don’t have alternate systems at the ready,” said Chester Wisniewski, a director at the cybersecurity firm Sophos. “It’s been 13, 14 days, and that is already longer than I’d expect for backup systems to be spun up.”

Change processes about 50% of medical claims in the U.S. for around 900,000 physicians, 33,000 pharmacies, 5,500 hospitals and 600 laboratories. About 1 in 3 U.S. patient records are touched by its health technology offerings, making it an attractive target for hackers looking to gain access to a large swathe of healthcare data.

Customers directly impacted may see a fix sooner, “but the back end, it takes a couple months, or upwards of a year,” said Wisniewski, who has tracked such breaches for over 20 years.

A UnitedHealth spokesman said the company was focused on investigating the hack and restoring operations at Change Healthcare.

U.S. officials have stepped in to help curb the chaos stemming from the breach that has hit smaller medical care providers particularly hard, with many struggling to process payments.

Similar breaches last year against gambling firm MGM Resorts International and consumer products company Clorox impacted them for months, costing MGM at least $100 million in damages and Clorox a drop of more than $350 million in quarterly net sales.