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Sunday, January 16, 2022

RNA is hot, mergers are not: Summing up a health summit

 JPMorgan Chase & Co.'s annual healthcare conference in San Francisco, which will wrap up on Thursday, has long been considered the industry's flagship event. Executives flock to outline priorities for the year ahead, or set plans in motion behind closed doors. It's a stage on which to announce deals or a setting for clinching them.

However, after the  caused a surge in coronavirus cases, the event, now in its 40th year, was forced to go virtual for the second January in a row. While that meant less mingling over cocktails and more squinting at laptops, there's still plenty to be divined from the health sector's favorite crystal ball.

Here are five takeaways:

Rna is having a moment

Those at the upper echelons of the drug industry constantly ask themselves: "How do you not miss the next big thing?" At this year's conference, executives set their sights on the messenger RNA technology behind Pfizer Inc. and Moderna Inc.'s Covid-19 vaccines.

Pfizer announced a trio of small deals on Monday to bolster its development of mRNA products. The technology is likely to have uses in infectious disease, rare diseases and cancer, Chief Executive Officer Albert Bourla said in an interview. Other large pharmaceutical companies also signaled interest in drug candidates based on the information-carrying part of cells. Amgen Inc. could potentially pay billions to Arrakis Therapeutics Inc. through a new RNA collaboration, while Eli Lilly & Co. and Johnson & Johnson have said they're monitoring the emerging field for assets.

Partnerships replace megamergers

For yet another year, megadeals were absent from the conference. Instead, drug giants including Pfizer, Amgen and Bayer AG turned to partnerships. Such pacts give big companies a way to dabble in exciting but unproven technology without making a huge bet. "Partnerships will give us exactly what we want without dedicating the amount of capital that would be needed if we wanted to acquire the companies," Bourla said, noting Pfizer's success with vaccine partner BioNTech SE. While research, development and commercialization collaborations give small drugmakers needed cash, they might not provide immediate gratification to investors who want to see buzzy names scooped up at a premium.

The pandemic remains the story

As the conference kicked off Monday, the U.S. reported more than 1.4 million new virus infections—the highest daily count recorded by any country in the world. Hospitalizations and deaths are also rising.

The jarring resurgence of Covid has left health-care companies scrambling to develop new tools. This week, Pfizer's Bourla described headway on a "hybrid" Covid vaccine that will target both omicron and the original virus, while Moderna said its clinched $18.5 billion in vaccine orders for this year. Later-to-market Novavax Inc. said it had shipped the first doses of its Covid-19 vaccine to Europe, where it was cleared last month.

On the treatment front, Regeneron Inc. said it would move an omicron-fighting antibody treatment into trials this quarter, and Gilead Sciences Inc. said U.S. regulators may soon approve a shorter course of its Covid drug remdesivir for use among patients outside the hospital. Novartis AG is looking to bring forth its own treatment, and partners Vir Biotechnology Inc. and GlaxoSmithKline Plc on Wednesday said the U.S. government agreed to buy another 600,000 doses of its Covid treatment sotrovimab.

For these drugmakers, business is not proceeding as usual. But investors continue to see opportunity in next-generation products to tackle omicron and future variants of concern.

The patent cliff persists

Merck & Co.'s cancer drug Keytruda, which brought in $14.4 billion in sales in 2020, is set to face cheaper competition starting in 2028. For Bristol Myers Squibb Co., multiple myeloma medication Revlimid and Abraxane, another profitable cancer drug, face new threats starting in 2022. Revlimid, which Bristol acquired when it bought drugmaker Celgene in 2019, became the company's top-selling drug the following year, bringing in $12 billion in sales.

Termed "LOEs" in industry parlance, short for loss of exclusivity, these developments were a focus of both companies' presentations this week. Executives spoke about their plans to replace lost revenue with new medications in areas like cancer in the years ahead, and through business development.

Merck "will continue to be science-led, unbounded by therapeutic area, but mindful of the need for a more balanced portfolio over time. All of this is with an eye to ensuring we can successfully navigate through the period of likely biosimilar competition to Keytruda late this decade," Chief Executive Rob Davis said in his opening remarks on Monday.

Conferences have changed (maybe for good)

Without the buzz in the halls of the Westin St. Francis and around San Francisco's Union Square, the JPMorgan Healthcare Conference feels like any other investor meeting these days. The pandemic has proven that deals can be done from anywhere, at any time. Investors can tune into presentations from home. When Covid relents, will people still be willing to shell out for a costly annual pilgrimage?

Philip Gotwals, the global head of business development and licensing at the Novartis Institutes for BioMedical Research, thinks enthusiam for the conference—and others like it—has waned. "The genie's out of the bottle now and it's going to be very hard to put back," he said in an interview. "People are going to change their approach."

Perhaps the excitement of convening in person once again may energize the conference, whenever, and if ever, it returns.

https://medicalxpress.com/news/2022-01-rna-hot-mergers-summing-health.html

China cuts interest rates as economic growth slows

 China has unexpectedly cut a key interest rate for the first time in almost two years as official figures showed its economic growth had slowed.

Gross domestic product (GDP) grew by 4% for the last three months of 2021 from a year earlier, the National Bureau of Statistics said.

That was better than most economists had predicted but was a lot slower than the previous quarter.

In another sign of weakness retail sales growth for December fell to 1.7%.

For the year as a whole, official data showed that China's economy grew by 8.1%, which beat economists' forecasts and came in well above Beijing's annual target of "over 6%."

However, some economists highlighted that the growth data, which was the slowest in a year and a half, has yet to take into account the effect of the latest coronavirus outbreaks.

"The GDP figure didn't reflect the impact of domestic spread of the omicron variant since late December which will hit the service industry significantly, especially offline consumption and transportation, Yue Su from the Economist Intelligence Unit said.

To help boost the economy the People's Bank of China (PBOC) said it was lowering the interest rate on 700bn yuan (£80.6bn; $110bn) worth of one-year medium-term lending facility loans to 2.85%. It was the first such cut since April 2020.

Another PBOC lending measure, the seven-day reverse repurchase rate, was also cut, while the bank pumped another 200bn yuan of medium-term cash into the financial system.

The moves put China further apart from other major central banks around the world.

While in the UK, the Bank of England raised interest rate last month for the first time in more than three years, in response to calls to tackle surging price rises.

China's economic outlook has been clouded by growing concerns about the effects of Beijing's regulatory crackdown on businesses, the financial health of some of the country's biggest property firms and the spread of the Omicron variant of Covid-19.


https://www.bbc.com/news/business-60019830

Ivermectin Scripts for COVID Cost Insurers Nearly $130M Annually: Study

 Commercial and Medicare Advantage insurers are spending an estimated $129.7 million annually on ivermectin prescriptions for COVID-19, even though the antiparasitic drug has not been shown to be effective against the virus, according to a new JAMA study.

The researchers analyzed a sample of a prescription drug database covering the period from December 1, 2020, through March 31, 2021. Ivermectin prescriptions for COVID-19 surged in the United States at the end of 2020, according to the paper.

The investigators identified oral ivermectin prescriptions dispensed during the study period, excluding those for patients who lacked continuous enrollment or who had a diagnosis code for a parasitic infection during the week before the prescription. The researchers assumed the remaining prescriptions were for COVID-19.

Of the 5939 ivermectin prescriptions written in this sample, 348 (5.9%) were excluded. Of the remaining 5591 prescriptions, 4700 (84.1%) were for privately insured patients. The mean age of those patients was 51.8 years.

Mean out-of-pocket spending on the ivermectin prescriptions was $22.48 for privately insured patients and $13.78 for Medicare Advantage patients. Mean insurer reimbursement was $35.75 and $39.13, respectively. Aggregate total spending was $273,681 for privately insured patients and $47,143 for Medicare Advantage patients, of which insurer reimbursement represented 61.4% and 74%, respectively.

To assess the potential magnitude of US insurer spending on ivermectin prescriptions for COVID-19, the authors estimated private and Medicare plan spending on these prescriptions during the week of August 13, 2021, the most recent week for which dispensing data were available. They used their analysis of the earlier sample to inform those estimates.

The researchers assumed that all 88,000 ivermectin prescriptions dispensed in that week were for COVID-19, except for 3600, the average weekly dispensing total in the 12 months before the pandemic.

They also assumed that 52% (43,888) and 28% (23,632) of the remaining 84,400 prescriptions were paid by private and Medicare plans, reflecting the overall distribution of payer type for US prescriptions.

In the week of August 13, 2021, private and Medicare plans paid an estimated $1,568,996 and $924,720, respectively, for ivermectin prescriptions for COVID-19, the study shows. Multiplying those amounts by 52 weeks yielded an estimated total annual payment of $129,673,240.

Restrict Coverage?

The authors noted that this wasteful spending exceeds the estimated annual Medicare spending on unnecessary imaging for low back pain. The amount of waste, they said, is even higher because their estimates don't include Medicaid spending.

And, by encouraging some people not to get vaccinated, they maintained, the unwarranted ivermectin prescriptions probably resulted in additional COVID-19 cases that would have increased insurance costs.

The researchers suggest that insurance companies restrict ivermectin coverage by requiring prior authorization of the drug. These restrictions could reduce wasteful spending, they noted, while impacting only a small number of patients who had conditions for which the drug is indicated.

https://www.medscape.com/viewarticle/966690

Surgeon General: ‘Next few weeks will be tough’ as Omicron spreads

 US Surgeon General Vivek Murthy warned Sunday that the “next few weeks will be tough” as COVID-19 infections driven by the Omicron variant continue to surge.

Murthy said that the country is still pushing around 800,000 new cases per day, though some regions, such as New York, have begun to see a plateau in infections.

“The challenge is that not the entire country is moving at the same pace. The Omicron wave started later in other parts of the country,” Murthy said on CNN’s “State of the Union,” adding, “the next few weeks will be tough.”

Omicron’s brutal winter wave is why it’s “so important that we are surging resources to hospitals that are struggling,” Murthy said.

“It’s why it’s so important that we all double down on precautions that we’re taking because one thing that we’re learning during this surge, is that our vaccines are still working very well to keep people out of the hospital and to save their lives,” he said. “That’s why we want everyone to get vaccinated to get boosted as soon as they can.”

US Surgeon General Vivek Murthy warned Sunday that the "next few weeks will be tough" as Omicron continues to surge.
US Surgeon General Vivek Murthy warned Sunday that the “next few weeks will be tough” as Omicron continues to surge.
Drew Angerer/Getty Images
According to the US Surgeon General, the US is still pushing around 800,000 new cases per day.
According to the US Surgeon General, the US is still pushing around 800,000 new cases per day.
Alex Wong/Getty Images
Travelers make their way through Miami International Airport on December 28, 2021  after thousands of flights were canceled.
Travelers make their way through Miami International Airport on December 28, 2021 after thousands of flights were canceled.
Joe Raedle/Getty Images

The nation’s top doctor also spoke Saturday about how it was “very disappointing” that the Supreme Court blocked the Biden administration‘s vaccine-or-test requirement for large private businesses.

“It was a setback for public health because what these requirements ultimately are helpful for is not just protecting the community at large but making our workplaces safer for workers as well as for customers,” Murthy told ABC’s “This Week.”

But he said the administration was “strongly encouraging companies to put these requirements in place voluntarily.”

“In fact, many have done so already. A third of the Fortune 100 companies have put these in place, and many more outside have,” he said.

Pressed on the number of cases in the country that are breakthrough infections, Murthy declined to provide figures but argued that the “most important job of vaccines is to save your life and keep you out of the hospital.”

  A patient takes a COVID test outside District Urgent Care on December 23, 2021.
A patient takes a COVID test outside District Urgent Care on December 23, 2021.
Alex Wong/Getty Images

“And by that measure, these vaccines and boosters are working and working well,” he said. “Now, you will hear as many people have already heard about people who have cases that are mild or asymptomatic, people who test positive despite being vaccinated or boosted. But keep in mind, what is often being prevented there is a more severe infection.”

https://nypost.com/2022/01/16/us-surgeon-general-warns-next-few-weeks-will-be-tough-as-omicron-spreads/

China Urges Local Govts to Minimize Impact From COVID-19 Curbs Over Lunar New Year

 China's state planner on Sunday urged local governments to minimise the impact from COVID-19 restrictions over the upcoming Lunar New Year holiday to help a rebound in consumption, as rising cases of the Omicron variant threaten economic growth.

"Local governments should avoid simplified, one-size-fits-all ... COVID-19 epidemic and control measures (over the holiday) and minimise the impact on the people's life," the National Development and Reform Commission said in a statement.

It said low-risk places in China meet the reasonable demand for short trips from urban and rural residents, and step up the supply of everyday products over the holiday period.

China has reported local cases of the highly transmissible Omicron variant in at least five provinces and municipalities, including a first infection in capital Beijing on Saturday, just weeks ahead of the Olympic Winter Games in February.

Local governments are on high alert to potential COVID-19 cases from outside, with many urging residents to stay put for the third straight year during what is usually the busiest travel period of the year.

China's economy likely grew at its slowest pace in 1-1/2 years in the fourth quarter, weighed down by weaker demand due to a property downturn, curbs on debt and strict COVID-19 measures.

The NDRC on Sunday also said it supports the healthy development of the property market and the legitimate demand from home buyers, while asking local governments to step up oversight of unfair competition and other monopolistic behaviours over the holiday period.

"The measures are aimed to further release the potential of consumer spending and push for a stable start to the economic growth in the first quarter," the NDRC said.

https://www.usnews.com/news/world/articles/2022-01-15/china-urges-local-govts-to-minimize-impact-from-covid-19-curbs-over-lunar-new-year

Shortage of COVID-19 Testing Kits 'Not Unique' to Australia: PM

 Australian Prime Minister Scott Morrison on Monday said the shortages of at-home antigen tests were "not unique" to the country as authorities deal with a runaway Omicron outbreak that has driven up hospitalisation rates and strain testing systems.

Australia is facing a shortage of at-home rapid antigen test kits after asymptomatic close contacts were told to bypass government-funded testing hubs, where high volumes delayed results by several days, and take their own tests.

"The rapid antigen tests are in short supply all around the world. This is not something that is unique to Australia going through it," Morrison told radio station 2GB on Monday. "It's part of dealing with Omicron. Omicron has disrupted everything."

The country's competition regulator on Monday flagged "significant concerns" about reports of price gouging of testing kits amid reports of stockpiling and called inflated prices "clearly outrageous."

After successfully containing the virus earlier in the pandemic, Australia has reported nearly 1.3 million cases over the last two weeks, overwhelming hospitals and testing clinics.

Daily infections on Monday dipped in New South Wales and Victoria, Australia's most populous states, amid expectations the Omicron wave had neared its peak in the country. But net new hospitalisations remain elevated, with more people admitted than at any other time in the pandemic.

A total of 52,970 cases were reported between New South Wales, Victoria and Tasmania, by late morning with other states due to report later. National daily numbers had touched a record 150,000 last Thursday but have been steadily falling since then.

The outbreak has also threatened to slow down Australia's economic recovery with the growing toll of workers out sick or ordered to isolate leading to staff shortages and disrupting business supply chains.

"There is little doubt the rapid spread of Omicron is changing people's behaviour and impacting confidence," Federal Treasurer Josh Frydenberg wrote in an opinion column in The Australian newspaper, but he hoped the outbreak will peak soon.

So far, Australia has reported around 1.6 million infections and 2,691 deaths since the pandemic began.

https://www.usnews.com/news/world/articles/2022-01-16/shortage-of-covid-19-testing-kits-not-unique-to-australia-pm-says

Australia Regulator: 'Significant Concerns' of Price Hike in COVID Antigen Tests

 Australia's competition regulator on Monday said it had "significant concerns" about reports of price gouging of COVID-19 rapid antigen tests and sought information from suppliers, retailers and pharmacy chains about rising costs.

Australia is facing a shortage of at-home rapid antigen test kits after authorities urged asymptomatic close contacts to bypass government-funded testing hubs, where high volumes delayed results, and take their own tests.

"In the middle of a significant outbreak of COVID-19 in a pandemic, the excessive pricing of rapid antigen tests required to diagnose the illness and protect other members of the public, is of significant concern," the Australian Competition and Consumer Commission (ACCC) Chair Rod Sims said.

Sims said there were reports of kits costing even up to A$500 ($361) at online retailers and A$70 per test at stores when they were available for around A$10 at pharmacies weeks ago.

"This is clearly outrageous," Sims said in a statement.

After successfully containing the virus earlier in the pandemic, Australia has reported nearly 1.3 million cases over the last two weeks, overwhelming hospitals and testing clinics amid reports of stockpiling of at-home testing kits.