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Tuesday, September 10, 2024

'Big Pharma lacks motive to prep for new pandemics'

 Covid-19 underlined the critical importance of vaccines. The pandemic caused 16 million global deaths, and the current scare surrounding Mpox emphasises how citizens remain fearful of fresh outbreaks. That suggests Big Pharma groups should be ploughing resources into a vaccine arsenal to tackle the next big virus. Yet right now they’re not, and it’s far from clear that they will.

The World Health Organization says the world should prepare for a virus that could be 20 times deadlier than Covid-19. Scientists call this hypothetical virus Disease X, and reckon the next outbreak could come from an unknown pathogen rather than an established virus like flu. This forecast is all the more troubling given pandemics are already becoming more frequent.

Five out of the past 12 pandemics occurred in the 20th century, according to the National Library of Medicine. Another two occurred in the 21st. Increased travel and more urban living are often cited as the causes for more regular outbreaks: given the frequency of travel, scientists estimate a deadly pathogen can spread around the world in a matter of hours.

This elevated risk poses a significant threat to the world economy. The International Monetary Fund estimated the global cost of the last pandemic was close to $13 trillion, reducing global GDP by 3% in 2020 alone. Health systems around the world are still battling to clear record waiting times for essential services. With the threat of another crippling health emergency on the cards, it stands to reason that Big Pharma companies would be investing in vaccines to deal with such an emergency.

Drugmaker bosses don’t have to be nice guys to think this a good idea. If a company produces a winning vaccine for a deadly virus, it stands to make a fortune. Pfizer’s PFE.N market value increased by 80% to $337 billion between 2019 and 2022 thanks to its MRNA jab for Covid-19. Its operating profit more than doubled to $40 billion in the same period. Meanwhile, Moderna’s MRNA.O share price increased 11-fold on the same technology and it went from a more than $500 million operating loss to nearly $9.5 billion of profit in 2022.

Despite all this, drugmakers are not future-proofing against pandemics. Pfizer and AstraZeneca AZN.L, the $257 billion drug giant which also produced a Covid-19 vaccine during the pandemic, are spending their cash on boosting their oncology franchises rather than churning out inoculations. Pfizer spent $43 billion on Seagen in an effort to double its cancer drug pipeline late last year. It has made no similar investment in battling future Covids. Meanwhile, AstraZeneca splurged $39 billion on Alexion in the height of the pandemic in 2021 in order to build up its rare disease portfolio, which positions it to win big if it comes up with a breakthrough for diseases that affect a small number of people. With little investment, there’s little hope that AstraZeneca’s vaccine and immune therapy business will grow beyond the 2% of sales it accounted for last year.

At first blush, this reticence is peculiar. Investors add a 50% premium when valuing vaccine businesses versus other pharma units, one investor told Reuters Breakingviews. Historically, that means GSK’s GSK.L relevant business would have been valued at around 15 times its expected EBITDA while its remaining pharma unit would only fetch about 9.5 times. Similarly, investors valued Sanofi’s SASY.PA pharma unit on 10.5 times while its vaccine business – which generates sales of nearly 7.5 billion euros, around 17% of the French group’s total – is pencilled into models at 14 times EBITDA.

Yet this premium is not as helpful as it looks for helping the world face down a new Covid. The stability favoured by shareholders is largely reserved for vaccines where there will be steady demand, like flu jabs. Lower-frequency but high-impact diseases – the type likely to cause pandemics – are less likely to be prized as highly by the market.

Mpox, as it happens, offers a live example of this. Denmark’s $3.1 billion Bavarian Nordic BAVA.CO, which makes a jab for the condition, has seen its shares jump by over 50% since the beginning of the year versus a 15% rise for the S&P Pharmaceuticals Select Industry Index .SPXSPH. Before that, investors gave the company little credit for having an effective treatment for a deadly disease. Last year, the Copenhagen-based business traded on just 2 times sales, whereas it now trades at over 4 times.

The post-Covid fates of stars like Pfizer and Moderna tell a similarly volatile story. Over the last three years Pfizer shares have fallen 40%, while Moderna’s are off 80%. CEOs have little cause to make big vaccine punts if the valuation sugar-rush is so brief.

Rolling the dice on a niche-condition inoculation is, in any case, a risky step. In order to get approval from regulators like the U.S. Food and Drug Administration, pharma groups need to display evidence that the drug works in most cases. Yet those sorts of threshold make it harder for other drugmakers to compete with new products. That’s because regulators tend to frown upon enrolling patients in trials for vaccines when an already effective jab is on the market.

On the face of it, governments could step in where the private sector is failing. A comprehensive global strategy would see countries cooperating on a plan to provide joint funding for new vaccines, meaning there could be some sort of strategic jab reserve against future pandemics. A version of this in train: health officials around the world have been working towards the so-called “100 day challenge” which would in the same timeframe see an unknown pathogen identified, an inoculation created and manufactured, and a public rollout.

Yet the public sector’s hopes of nailing a robust pandemic response seem just as forlorn. At the World Health Assembly in May, countries couldn’t agree on how vaccines would be doled out in a future pandemic, and plans for a treaty outlining a pandemic response protocol came to nought. The world’s hopes of devising a rapid jab in future therefore rest on ad hoc public support for individual projects. This is not nothing – U.S. state funds helped Bavarian Nordic advance its Mpox treatment, for example. But given Covid-19 is less than five years old, taxpayers might find it odd that the main strategy to avoid future equivalents is basically just to hope they don’t happen.

https://www.xm.com/fr/research/markets/stocks/reuters/big-pharma-lacks-motive-to-prep-for-new-pandemics-53921855

Hearing Aid Makers Slip After Apple Rolls Out Hearing Aid Features

 Shares in European hearing aid makers slipped in early trading on Tuesday after Apple rolled out hearing aid features.

Apple said its AirPods Pro 2 could now be "transformed" into a personalized hearing aid via an upcoming software update that would boost specific sounds in real time, including parts of speech or elements within a user's environment.

Shares in Italy's Amplifon dropped as much as 7.2% earlier in the session and were down 5.7% by 0845 GMT. Other hearing aid makers, Sonova, Demant and GN Store Nord, fell between 2% and 4%.

Shares in European hearing aid makers slipped in early trading on Tuesday after Apple rolled out hearing aid features.

Apple said its AirPods Pro 2 could now be "transformed" into a personalized hearing aid via an upcoming software update that would boost specific sounds in real time, including parts of speech or elements within a user's environment.

Shares in Italy's Amplifon dropped as much as 7.2% earlier in the session and were down 5.7% by 0845 GMT. Other hearing aid makers, Sonova, Demant and GN Store Nord, fell between 2% and 4%.

https://money.usnews.com/investing/news/articles/2024-09-10/hearing-aid-makers-slip-after-apple-rolls-out-hearing-aid-features-analysts-shrug-off-threat

Viridfian Positive Topline Results from Veligrotug (VRDN-001) Phase 3 in Thyroid Eye

 Veligrotug (VRDN-001) achieved all primary and secondary endpoints in THRIVE, the largest phase 3 trial conducted to date of an anti-IGF-1R antibody in thyroid eye disease (TED), with a week 15 proptosis responder rate (PRR) of 70% and a placebo-adjusted PRR of 64% (p < 0.0001) -

- All secondary endpoints were highly statistically significant (p < 0.0001), with clinically meaningful patient outcomes, including complete resolution of diplopia in 54% of patients (placebo-adjusted rate of 43%) and reduction of Clinical Activity Score (CAS) to 0 or 1 in 64% of patients (placebo-adjusted reduction of 46%) treated with veligrotug -

- Veligrotug was generally well-tolerated with no treatment-related serious adverse events (SAEs), and a 5.5% placebo-adjusted rate of hearing impairment AEs -

- THRIVE-2 study of veligrotug in patients with chronic TED fully enrolled with topline data readout on track for year-end 2024; BLA submission anticipated in second half of 2025, as planned -

- REVEAL-1 and REVEAL-2, global phase 3 trials of VRDN-003 dosed every four (Q4W) or eight weeks (Q8W), initiated in August; VRDN-003 is a subcutaneous, half-life-extended anti-IGF-1R antibody with the same binding domain as veligrotug -

- Cash, cash equivalents, and short-term investments of $571.4 million as of June 30, 2024; provides cash runway into the second half of 2026, beyond the planned veligrotug BLA submission, expected REVEAL topline data, and multiple anticipated readouts from Viridian’s FcRn inhibitor programs -

- Conference call and webcast to be held today, September 10th at 8:00 a.m. ET -

Viridian will host a conference call today at 8:00 a.m. ET to discuss the THRIVE topline data. The dial-in number for the conference call is (800) 715-9871 for domestic participants and (646) 307-1963 for international participants. The conference ID is 8636908.

A live webcast of the conference call can be accessed through the “Events” page in the Investors section of the Viridian Therapeutics website. Following the live webcast, an archived version of the call will also be available on the website.

https://www.businesswire.com/news/home/20240910052986/en/

Blinken demands overhaul of Israeli conduct in West Bank after killing of US protester

U.S. Secretary of State Antony Blinken on Tuesday demanded an overhaul of Israeli military conduct in the occupied West Bank, bemoaning the fatal shooting of an American protester against settlement expansion, which Israel said was accidental.

Aysenur Ezgi Eygi, 26, who is also a Turkish national, was shot dead last Friday at a protest march in Beita, a village near Nablus where Palestinians have been repeatedly attacked by far-right Jewish settlers.

Israel's military said on Tuesday that it was highly likely its troops had fired the shot that killed her but that her death was unintentional, and it voiced deep regret.

In his strongest comments to date criticising the security forces of Washington's closest Middle East ally, Blinken described Eygi's killing as "unprovoked and unjustified". He said Washington would insist to the Israeli government that it makes changes to how its forces operate in the West Bank.

"No one should be shot and killed for attending a protest. No one should have to put their life at risk just for freely expressing their views," he told reporters in London.

"In our judgment, Israeli security forces need to make some fundamental changes in the way that they operate in the West Bank, including changes to their rules of engagement.

"Now we have the second American citizen killed at the hands of Israeli security forces. It's not acceptable," he said.

An Israeli government spokesperson declined to comment on Blinken's remarks.

In a statement, the Israeli military said its commanders had conducted an investigation into the incident and found that the gunfire was not aimed at her but another individual it called "the key instigator of the riot."

"The incident took place during a violent riot in which dozens of Palestinian suspects burned tyres and hurled rocks towards security forces at the Beita Junction," it said.

Israel has sent a request to Palestinian authorities to carry out an autopsy, it said.

A surge in violent settler assaults on Palestinians in the West Bank has stirred anger among Western allies of Israel, including the United States, which has imposed sanctions on some Israelis involved in the hardline settler movement.

Palestinians have held weekly protests in Beita since 2020 over the expansion of nearby Evyatar, a settler outpost. Ultra-nationalist members of Israel's ruling coalition have acted to legalise previously unauthorised outposts like Evyatar, a move Washington says threatens the stability of the West Bank and undercuts efforts toward a two-state solution to the conflict.

Since the 1967 Middle East war, Israel has occupied the West Bank of the Jordan River, an area Palestinians want as the core of a future independent state.

Israel has built a thickening array of settlements there that most countries deem illegal. Israel disputes that assertion, citing historical and biblical ties to the territory.

https://www.usnews.com/news/world/articles/2024-09-10/blinken-demands-overhaul-of-israeli-conduct-in-west-bank-after-killing-of-us-protester


Blinken says Russia received missiles from Iran, warns of threat to European security

 Russia has received ballistic missiles from Iran and will likely use them in Ukraine within weeks, U.S. Secretary of State Antony Blinken said on Tuesday, warning that cooperation between Moscow and Tehran threatens wider European security.

At a news conference in London ahead of a visit to Kyiv he and Britain's Foreign Secretary David Lammy will make, Blinken said Washington had privately warned Iran that providing ballistic missiles to Russia would be "a dramatic escalation" and said new sanctions would be imposed later on Tuesday.

"Russia has now received shipments with these ballistic missiles, and will likely use them within weeks in Ukraine, against Ukraine," Blinken said, citing intelligence that he said has been shared with U.S. allies and partners around the world.

Blinken said Iran has trained dozens of Russian military personnel to use its Fath-360 close-range ballistic missile system, which has a maximum range of 75 miles.

Russian defense ministry representatives are believed to have signed a contract in December with Iranian officials for the Fath-360 and another Iranian ballistic missile system, Reuters reported last month.

A senior Iranian official on Monday denied reports Iran had supplied Russia with ballistic missiles, describing them as "psychological warfare". Kremlin spokesman Dmitry Peskov declined to confirm the reports but told reporters Russia was cooperating with Iran including on "the most sensitive" areas.

After two-and-a-half years of war, Ukrainian forces now find themselves stretched, fending off a steady Russian advance in Ukraine's east. Last month Kyiv sent troops into Russia on their first large-scale cross-border incursion.

The Iranian missiles can be used on closer targets, allowing Russia to use more of its own arsenal for targets that are further from the front line in Ukraine, Blinken said.

"This development and the growing cooperation between Russia and Iran threatens European security and demonstrates how Iran's destabilizing influence reaches far beyond the Middle East."

Russia, which previously signed up to United Nations restrictions on Iran, was also sharing technology sought by Tehran, he added. "This is a two-way street, including on nuclear issues as well as some space information," Blinken said.

MORE SANCTIONS

Iran is already one of the most heavily sanctioned countries in the world, and some experts have questioned the benefit of adding more economic penalties that can hurt the middle class more than the country's leaders.

Additional U.S. sanctions on Iran will include measures against the airline Iran Air, Blinken said.

France, Germany and Britain also issued a joint statement condemning Iran and Russia for what they called an escalation, and pledging to impose sanctions on Iran Air.

Britain announced seven new sanctions designations under its Iran sanctions regime and three under its Russia regime.

Ukraine welcomed further sanctions on Iran over the missiles.

Presidential chief of staff Andriy Yermak reiterated that Kyiv was seeking Washington's permission to use U.S.-supplied weapons deeper inside Russia.

The Biden administration earlier this year relaxed a policy that barred Ukraine from using U.S.-supplied weapons in attacks on targets inside Russia, but officials said those arms were only to be used to hit back against Russian forces attacking or preparing to attack across the border.

"We also need authorization to use Western weapons against military targets on Russian territory, the provision of longer-range missiles, and the enhancement of our air defense systems," Yermak said on X.

Blinken said he would use his visit to Ukraine on Wednesday to hear directly from Ukraine's leadership what their current needs and objectives are and what the U.S. can do to help them.

Blinken and Lammy will visit together in a bid to show united Western support for Kyiv. Blinken will also visit Poland on Thursday, the State Department said.

https://uk.news.yahoo.com/blinken-says-russia-received-missiles-130443433.html

Ukraine targets Moscow in biggest drone attack yet

 Ukraine targeted the Russian capital on Tuesday in its biggest drone attack so far, killing at least one and wrecking dozens of homes in the Moscow region and forcing around 50 flights to be diverted from airports around Moscow.

Russia, the world's biggest nuclear power, said it had destroyed at least 20 Ukrainian attack drones as they swarmed over the Moscow region, which has a population of more than 21 million, and 124 more over eight other regions.

At least one person was killed near Moscow, Russian authorities said. Three of Moscow's four airports were closed for more than six hours and almost 50 flights were diverted.

Kremlin spokesman Dmitry Peskov told reporters that the drone attack was another reminder of the real nature of Ukraine's political leadership, which he said was made up of Russia's enemies.

"There is no way that night time strikes on residential neighbourhoods can be associated with military action," said Peskov.

"The Kyiv regime continues to demonstrate its nature. They are our enemies and we must continue the special military operation to protect ourselves from such actions," he said, using the expression Moscow uses to describe its war in Ukraine.

Kyiv said Russia, which sent tens of thousands of troops into Ukraine in February 2022, had attacked it overnight with 46 drones, of which 38 were destroyed.

The drone attacks on Russia damaged at high-rise apartment buildings in the Ramenskoye district of the Moscow region, setting flats on fire, residents told Reuters.

A 46-year-old woman was killed and three people were wounded in Ramenskoye, Moscow regional governor Andrei Vorobyov said.

Residents said they awoke to blasts and fire.

"I looked at the window and saw a ball of fire," Alexander Li, a resident of the district told Reuters. "The window got blown out by the shockwave."

Georgy, a resident who declined to give his surname, said he heard a drone buzzing outside his building in the early hours.

"I drew back the curtain and it hit the building right before my eyes, I saw it all," he said. "I took my family and we ran outside."

The Ramenskoye district, some 50 km (31 miles) southeast of the Kremlin, has a population of around a quarter of a million people, according to official data.

More than 70 drones were also downed over Russia's Bryansk region and tens more over other regions, Russia's defence ministry said. There was no damage or casualties reported there.

As Russia advances in eastern Ukraine, Kyiv has taken the war to Russia with a cross-border attack into Russia's western Kursk region that began on Aug. 6 and by carrying out increasingly large drone attacks deep into Russian territory.

DRONE WAR

The war has largely been a grinding artillery and drone war along the 1,000 km (620 mile) heavily fortified front line in southern and eastern Ukraine involving hundreds of thousands of soldiers.

Moscow and Kyiv have both sought to buy and develop new drones, deploy them in innovative ways, and seek new ways to destroy them - from using shotguns to advanced electronic jamming systems.

Both sides have turned cheap commercial drones into deadly weapons while ramping up their own production and assembly to attack targets including tanks and energy infrastructure such as refineries and airfields.

Russian President Vladimir Putin, who has sought to insulate Moscow from the grinding rigours of the war, has called Ukrainian drone attacks that target civilian infrastructure such as nuclear power plants "terrorism" and has vowed a response.

Moscow and other big Russian cities have largely been insulated from the war.

Russia itself has hit Ukraine with thousands of missiles and drones in the last two-and-a-half years, killing thousands of civilians, wrecking much of the country's energy system and damaging commercial and residential properties across the country.

Ukraine says it has a right to strike back deep into Russia, though Kyiv's Western backers have said they do not want a direct confrontation between Russia and the U.S.-led NATO military alliance.

There was no immediate comment from Ukraine about Tuesday's attacks. Both sides deny targeting civilians.

Tuesday's attack follows drone attacks Ukraine launched in early September chiefly targeting Russia's energy and power facilities.

Authorities in the Tula region, which neighbours the Moscow region to its north, said drone wreckage had fallen onto a fuel and energy facility but that the "technological process" of the facility was not affected.

https://www.yahoo.com/news/russia-destroys-ukraine-launched-drone-234940024.html

Centene stock on watch after below-consensus outlook

 Centene (NYSE:CNC) on Tuesday revised its earnings estimates for Q3 2024 to a level below consensus in line with its recent comments

https://seekingalpha.com/news/4148401-centene-stock-below-consensus-outlook