'OpenAI co-founder Sutskever's new safety-focused AI startup SSI raises $1 billion'

 Safe Superintelligence (SSI), newly co-founded by OpenAI's former chief scientist Ilya Sutskever, has raised $1 billion in cash to help develop safe artificial intelligence systems that far surpass human capabilities, company executives told Reuters.

SSI, which currently has 10 employees, plans to use the funds to acquire computing power and hire top talent. It will focus on building a small highly trusted team of researchers and engineers split between Palo Alto, California and Tel Aviv, Israel.

The company declined to share its valuation but sources close to the matter said it was valued at $5 billion.The funding underlines how some investors are still willing to make outsized bets on exceptional talent focused on foundational AI research. That's despite a general waning in interest towards funding such companies which can be unprofitable for some time, and which has caused several startup founders to leave their posts for tech giants.

Investors included top venture capital firms Andreessen Horowitz, Sequoia Capital, DST Global and SV Angel. NFDG, an investment partnership run by Nat Friedman and SSI's Chief Executive Daniel Gross, also participated.

"It's important for us to be surrounded by investors who understand, respect and support our mission, which is to make a straight shot to safe superintelligence and in particular to spend a couple of years doing R&D on our product before bringing it to market," Gross said in an interview.

AI safety, which refers to preventing AI from causing harm, is a hot topic amid fears that rogue AI could act against the interests of humanity or even cause human extinction.

A California bill seeking to impose safety regulations on companies has split the industry. It is opposed by companies like OpenAI and Google, and supported by Anthropic and Elon Musk's xAI.

Sutskever, 37, is one of the most influential technologists in AI. He co-founded SSI in June with Gross, who previously led AI initiatives at Apple, and Daniel Levy, a former OpenAI researcher.

Sutskever is chief scientist and Levy is principal scientist, while Gross is responsible for computing power and fundraising.

NEW MOUNTAIN

Sutskever said his new venture made sense because he "identified a mountain that's a bit different from what I was working on."

Last year, he was a part of the board of OpenAI's non-profit parent which voted to oust OpenAI CEO Sam Altman over a "breakdown of communications."

Within days, he reversed his decision and joined nearly all of OpenAI's employees in signing a letter demanding Altman's return and the board's resignation. But the turn of events diminished his role at OpenAI. He was removed from the board and left the company in May.

After Sutskever's departure, the company dismantled his "Superalignment" team, which worked to ensure AI stays aligned with human values to prepare for a day when AI exceeds human intelligence.

Unlike OpenAI's unorthodox corporate structure, implemented for AI safety reasons but which made Altman's ouster possible, SSI has a regular for-profit structure.

SSI is currently very much focused on hiring people who will fit in with its culture.

Gross said they spend hours vetting if candidates have "good character", and are looking for people with extraordinary capabilities rather than overemphasizing credentials and experience in the field. 

"One thing that excites us is when you find people that are interested in the work, that are not interested in the scene, in the hype," he added.

SSI says it plans to partner with cloud providers and chip companies to fund its computing power needs but hasn't yet decided which firms it will work with. AI startups often work with companies such as Microsoft and Nvidia to address their infrastructure needs.

Sutskever was an early advocate of scaling, a hypothesis that AI models would improve in performance given vast amounts of computing power. The idea and its execution kicked off a wave of AI investment in chips, data centers and energy, laying the groundwork for generative AI advances like ChatGPT.

Sutskever said he will approach scaling in a different way than his former employer, without sharing details.

"Everyone just says scaling hypothesis. Everyone neglects to ask, what are we scaling?" he said.

"Some people can work really long hours and they'll just go down the same path faster. It's not so much our style. But if you do something different, then it becomes possible for you to do something special."

https://www.marketscreener.com/quote/stock/MICROSOFT-CORPORATION-4835/news/Exclusive-OpenAI-co-founder-Sutskever-s-new-safety-focused-AI-startup-SSI-raises-1-billion-47802334/

'Coke and Pepsi boycott over Gaza lifts Muslim countries' local sodas'

 Coca-Cola and rival PepsiCo spent hundreds of millions of dollars over decades building demand for their soft drinks in Muslim-majority countries including Egypt to Pakistan.

Now, both face a challenge from local sodas in those countries due to consumer boycotts that target the globe-straddling brands as symbols of America, and by extension Israel, at a time of war in Gaza.

In Egypt, sales of Coke have cratered this year, while local brand V7 exported three times as many bottles of its own cola in the Middle East and the wider region than last year. In Bangladesh, an outcry forced Coca-Cola to cancel an ad campaign against the boycott. And across the Middle East, Pepsi's rapid growth evaporated after the Gaza war started in October.  

Pakistani corporate executive Sunbal Hassan kept Coke and Pepsi off her wedding menu in Karachi in April. She said she didn't want to feel her money had reached the tax coffers of the United States, Israel's staunchest ally.

"With the boycott, one can play a part by not contributing to those funds," Hassan said. Instead, she served her wedding guests Pakistani brand Cola Next. 

She is not alone. While market analysts say it is hard to put a dollar figure on lost sales and PepsiCo and Coca-Cola still have growing businesses in several countries in the Middle East, Western beverage brands suffered a 7% sales decline in the first half of the year across the region, market researcher NielsenIQ says.

In Pakistan, Krave Mart, a leading delivery app, has seen local cola rivals like Cola Next and Pakola soar in popularity to become about 12% of the soft drinks category, founder Kassim Shroff told Reuters this month. Before the boycott, the figure was closer to 2.5%.

Shroff said Pakola, which is ice-cream soda flavored, made up most of the purchases before the boycott. He declined to provide figures for Coca-Cola and PepsiCo sales.

Consumer boycotts date back at least as far as an 18th century anti-slavery sugar protest in Britain. The strategy was used in the 20th century to fight apartheid in South Africa and has been widely wielded against Israel through the Boycott, Divestment and Sanctions movement. 

Many consumers shunning Coca-Cola and PepsiCo cite U.S. support of Israel over decades, including in the current, ongoing war with Hamas.

"Some consumers are deciding to make different options in their purchases because of the political perception," PepsiCo CEO Ramon Laguarta told Reuters in a July 11 interview, adding that boycotts are "impacting those particular geographies" such as Lebanon, Pakistan and Egypt.

"We will manage through it over time," he said. "It's not meaningful to our top line and bottom line at this point." 

PepsiCo's total revenue from its Africa, Middle East and South Asia division was $6 billion in 2023, earnings releases show. The same year, Coca-Cola's revenue from its Europe, Middle East and Africa region was $8 billion, company filings show.

In the six months following the Oct. 7 Hamas attacks on Israel that triggered the invasion of Gaza, PepsiCo beverage volumes in the Africa, Middle East and South Asia division barely grew, after notching up 8% and 15% growth in the same quarters of 2022/23, the company said. 

Volumes of Coke sold in Egypt declined by double-digit percentage points in the six months ended June 28, according to data from Coca-Cola HBC, which bottles there. In the same period last year, volumes rose in high single digits.

Coca-Cola has said it does not fund military operations in Israel or any country. In response to a Reuters request, PepsiCo said neither the company "nor any of our brands are affiliated with any government or military in the conflict." 

Palestinian-American businessman Zahi Khouri founded Ramallah-based Coca-Cola bottler National Beverage Company, which sells Coke in the West Bank. The company's $25 million plant in Gaza, opened in 2016, has been destroyed in the war, he said. Employees were unharmed, he said.

Khouri said boycotts were a matter of personal choice but didn't really help Palestinians. In the West Bank itself, he said, they had limited sales impact. 

"Only ending the occupation would help the situation," said Khouri, who supports the creation of a Palestinian state alongside Israel.

Israel's government did not respond to a request for comment.

HISTORICAL TARGETS

The big soda companies are no stranger to pressure among the Muslim world's hundreds of millions of consumers. After Coke opened a factory in Israel in the 1960s, it was hit by an Arab League boycott that lasted until the early 1990s and benefited Pepsi for years in the Middle East.

Coke still lags Pepsi's market share in Egypt and Pakistan, according to market research firm GlobalData.

PepsiCo, which entered Israel in the early 1990s, itself faced boycotts when it purchased Israel's SodaStream for $3.2 billion in 2018.

In recent years though, Muslim-majority countries with young, rising populations have provided some of the soda giants' fastest growth. In Pakistan alone, Coca-Cola says it has invested $1 billion since 2008, yielding years of double-digit sales growth. PepsiCo had similar gains, according to securities filings.

Now, both are losing ground to local brands.

Cola Next, which is cheaper than Coke and Pepsi, changed its ad slogan in March to "Because Cola Next is Pakistani," emphasizing its local roots. 

Cola Next's factories cannot meet the surge in demand, Mian Zulfiqar Ahmed, the CEO of the brand's parent company, Mezan Beverages, said in an interview. He declined to share volume figures.   

Restaurants, Karachi's private schools association and university students have all taken part in anti-Coca-Cola actions, eroding goodwill built through sponsorship of Coke Studio, a popular music show in Pakistan.

Exports of Egyptian cola V7 have tripled this year compared to 2023, founder Mohamed Nour said in an interview. Nour, a former Coca-Cola executive who left the company after 28 years in 2020, said V7 was now sold in 21 countries. 

Sales in Egypt, where the product has only been available since July 2023, were up 40%, Nour said.

Paul Musgrave, an associate professor of government at Georgetown University in Qatar, warned of long-term damage to consumer loyalty due to boycotts.

"If you break habits, it's going to be harder to win you back in the long run," he said, without giving an estimate of the financial cost to the companies.

BANGLADESH BACKFIRE

In Bangladesh, Coke launched advertising showing a shopkeeper talking about the company's operations in Palestine. 

After a public outcry over perceived insensitivity, Coke pulled the ad in June and apologized. In response to a question from Reuters, the company said the campaign "missed the mark."

The ad made the boycott worse, said one Bangladeshi advertising executive, who declined to be named because he was not authorized to speak to the media. 

Other American brands seen as symbols of Western culture, such as McDonalds and Starbucks, also face anti-Israel boycotts. 

Market share for global brands fell 4% in the first half of 2024 in the Middle East, according to NielsenIQ. But the protests have been more visible against the widely-available sodas.

As well as boycotts, inflation and economic turmoil in Pakistan, Egypt and Bangladesh eroded consumers' buying power even before the war, making cheaper local brands more appealing.

Last year, Coke's market share in the consumer sector in Pakistan fell to 5.7% from 6.3% in 2022, according to GlobalData, while Pepsi's fell to 10.4% from 10.8%. 

FUTURE PLANS

Coca-Cola and its bottlers, and PepsiCo, still see the countries as important areas for growth, particularly as Western markets slow down. 

Despite the boycotts, Coke invested another $22 million upgrading technology in Pakistan in April, it said in a press release at the time.

Coca-Cola's bottler in Pakistan said to investors in May that it remained "positive about the opportunity" the world's fifth most-populous country offers, and that it invested in the market with a long-term commitment.

In recent weeks, PepsiCo reintroduced a brand called Teem soda, traditionally lemon-lime flavored, in Pakistani market, a spokesperson confirmed. The product is now available in a cola flavor with "Made in Pakistan" printed prominently on the label.

The companies are also still injecting the Coke and Pepsi brands into the fabric of local communities by sponsoring charities, musicians and cricket teams. 

Those moves are key to Coke and Pepsi keeping a toehold in the countries long-term even as they face setbacks now, Georgetown's Musgrave said.

"Anything you can do to make yourself an ally or presence, a part of a community," helps, he said.

https://www.marketscreener.com/quote/stock/THE-COCA-COLA-COMPANY-4819/news/Coke-and-Pepsi-boycott-over-Gaza-lifts-Muslim-countries-local-sodas-47800580/

Meta oversight board asks firm not to automatically remove pro-Palestinian phrase

 Meta Platforms' Oversight Board said on Wednesday the Facebook parent should not automatically remove a phrase seen by some as displaying solidarity with Palestinians and by others as an endorsement of violence against Jews.

The board, which operates independently but is funded by the U.S. social media firm, said the phrase "From the river to the sea" has several meanings, and as such its use cannot in itself be deemed to be harmful, violent or discriminatory.

The phrase refers to the River Jordan and the Mediterranean Sea, between which lie Israel and the Palestinian territories. It is often chanted at pro-Palestinian demonstrations.

Critics of the phrase say it is antisemitic and a call for Israel's eradication. Other groups dispute that interpretation.

"Context is crucial," said Oversight Board co-chair Pamela San Martin. "Simply removing political speech is not a solution. There needs to be room for debate, especially during times of crisis and conflict."

The Oversight Board said it came to the conclusion after it had reviewed three cases involving content posted on Facebook by different users containing the phrase.

"We welcome the board's review of our guidance on this matter," Meta said in a statement. "While all of our policies are developed with safety in mind, we know they come with global challenges and we regularly seek input from experts outside Meta, including the Oversight Board."

Alex Abdo, litigation director of the Knight First Amendment Institute at Columbia University that promotes free speech, called the decision by the board "thoughtful (and in my opinion, correct)."

The Anti-Defamation League, a Jewish advocacy group, said the decision was "short-sighted."

"Usage of this phrase has the effect of making members of the Jewish and pro-Israel community feel unsafe and ostracized," it said.

The board also called on Meta to improve access to data for journalists and researchers, less than a month after Meta discontinued CrowdTangle, a tool widely used to check misinformation and conduct research on content on Meta's platforms, including Instagram.

https://www.marketscreener.com/quote/stock/META-PLATFORMS-INC-10547141/news/Meta-oversight-board-asks-firm-not-to-automatically-remove-pro-Palestinian-phrase-47803653/

Job Openings Crater To Lowest Since 2021 As Data Manipulation Fails

 Last month, after the latest JOLTS report came in fractionally stronger than expected as the Kamala Department of Labor engaged in its usual data manipulation, this time by artificially inflating the number of government sector job openings, we made one prediction: expect a big drop in the next job openings report as the recent surge in government job openings quietly disappears.

That's precisely what happened because moments ago, the DOL reported that in July the number of job openings plunged sharply to 7.673 Million - the lowest since January 2021 - from a prior month unrevised June print of 8.184 Million...

which of course was revised sharply lower to 7.910 Million, which also means that what was originally reported to be a beat to estimates of an 8.00 million print has since been revised  to a miss of 7.910 million... but of course one month later nobody cares. Which is precisely how the Biden labor department has been operating all along.

In any case, since Wall Street was expecting was a much higher number based on the unrevised print, today's miss was massive, and it printed below the lowest estimate....

... and was a 4-sigma miss to the median estimate of 8.100 million, a whopping 427K miss in absolute terms. As shown in the next chart, this was the 4th miss in the past 5 months.

As for the driver behind the last months of manipulated JOLTS "beats", which as we showed was the artificially inflated number of government sector job openings, they did - as expected - tumble, from 1.016 million to 924K, while private sector job openings hit a fresh 3.5 year low.

As an aside, keep an eye on construction jobs: the number of job openings in this sector is in absolute freefall, plunging to levels not seen since late 2020.

And here is what may be the most shocking chart of the year: construction jobs openings vs construction jobs. Expect nothing less than an epic implosion of construction jobs in the coming months.

Ignoring the data manipulation, in the context of the broader jobs report, in June the number of job openings was just 510K more than the number of unemployed workers (which the BLS reported was 7.163 million), down from last month's 1.373 million and the lowest since April 2021.

Said otherwise, in July the number of job openings to unemployed dropped to just 1.07, a plunge from the June print of 1.16, the lowest level since May 2021 and now officially below pre-covid levels.

While the job openings data set was a disaster no matter how one looks at it, there was silver lining as hiring finally staged a modest rebound after last month's collapse...

... with quits also rising modestly from the lowest level since mid-2020.

Finally, no matter what the "data" shows, let's not forget that it is all just estimated, and it is safe to say that the real number of job openings remains still far lower since half of it - or some 70% to be specific - is guesswork. As the BLS itself admits, while the response rate to most of its various labor (and other) surveys has collapsed in recent years, nothing is as bad as the JOLTS report where the actual response rate remains near a record low 33%

In other words, more than two thirds, or 70% of the final number of job openings, is made up!

https://www.zerohedge.com/economics/catastrophic-jolt-job-openings-crater-lowest-2021-data-manipulation-fails

Ascendis Pricing Fiasco Prompts Guidance Cut

Shares of Ascendis Pharma (ASND) tumbled Wednesday after the biotech company cut its full-year outlook for its human growth hormone amid marketwide price struggles.

Ascendis now expects its drug, Skytrofa, to bring in 220 million to 240 million euros in sales — or roughly $243.1 million to $265.2 million. That's a 100 million euro cut from the company's previous guidance. Skytrofa treats children with human growth hormone deficiency.

"Disappointing news that Skytrofa, along with the entire growth hormone market, was subject to a broader market access reset lowering the price of growth hormone agents," Leerink Partners analyst Joseph Schwartz said in a report.

During the June quarter, Skytrofa generated 26.2 million euros in sales — about $28.7 million. Sales plummeted 27% year over year and widely lagged expectations for 73.9 million euros, according to FactSet. This was despite a 134% increase in prescriptions vs. the year-ago period

 https://www.investors.com/news/technology/ascendis-pharma-skytrofa-price-q2-2024/

Gene Editing Patent Landscape Remains ‘Clear as Mud,’ Say Patent Attorneys

 

The intellectual property landscape for newer gene-editing technologies, like that for CRISPR-Cas9, remains unclear and hard to navigate.

Years of litigation around ownership of CRISPR-Cas9 have muddled the patent landscape for the Nobel Prize–winning technology. Meanwhile, hopes that newer gene editors would avoid this uncertainty have been dashed, as even here, the intellectual property around them remains “clear as mud,” Matthew Ferry, a partner at Morrison Foerster’s San Diego office, told BioSpace.

Nevertheless, these uncertainties have not deterred companies from developing gene editors, and specifically from pursuing Cas9 alternatives in the hopes of avoiding the IP conflicts that currently center on the original CRISPR system.

“Whether that’s true or not isn’t so clear; it depends on how you read the claims of this,” Ferry said. “And the problem is we just don’t have a lot of data from courts interpreting what the claims really mean here.”

Appetite For Risk

The case all CRISPR companies have their eyes on is one that has been waging for over a decade between the Broad Institute, the current holders of key CRISPR-Cas9 patents in the U.S., and what is known collectively as the CVC group. The case is currently pending appeal, with a ruling expected from a federal court in the second half of this year. A clear victory will chart a path to Cas9 licensing for companies seeking to develop therapies using the technology. On the other hand, for investors not much may change, with any licensing fees they have to pay viewed as the cost of doing business offset by lucrative returns.

As a result of the legal uncertainty, Ferry said some companies are waiting to see the outcome of the interference case between Broad and CVC while others are moving forward anyway.

“You have others who are taking a much more risk hard approach, of just saying, ‘There hasn’t been a lot of litigation so I don’t think I’m going to get sued. I’m just going to do what I need to do,’” Ferry said.

Michalski Hüttermann & Partner patent attorney Ulrich Storz agreed that the patent landscape remains unclear for newer CRISPR technologies. However, he said that matters surrounding Cas9 became particularly complicated because around five different entities are claiming they made roughly the same invention in the same year.

“Cas12a or Cpf1 is a little less messy because you don’t have like five entities,” Storz told BioSpace. “It’s pretty clear that the main player in Cas12a is the Broad Institute with Feng Zhang.”

However, Storz said that the Broad Institute’s patents do not provide a sufficient definition of what they consider to qualify as the Cas12a endonuclease. With several companies claiming that their nucleases don’t fall under the patents’ scope, Storz said the lack of clarity in Broad’s IP makes it hard for patent practitioners to verify such claims.

“I am a little bit concerned and surprised that the patent authorities let Broad run away with patents in which the enzyme that was actually the subject matter of the claims was so poorly defined,” Storz said. He contrasted his view with what he described as “a really strong position” by the U.S. Patent and Trademark Office to demand that antibodies in patent claims are defined by their precise sequences and not solely by their function.

The Broad Institute did not respond to BioSpace’s requests for comment by deadline.

On the other hand, Ferry believes companies are distinguishing themselves more in their patent filings. “You have to show that your invention is novel and non-obvious over the prior art,” Ferry said. “So to do that, you become much more fragmented and find much more niche areas that either have unexpected results or have a completely new way of doing something.”

One of the lessons learned so far, Ferry noted, was that it’s easier to secure IP on the physical technology than the application of the natural biology. “There have been some claims out there that were more abstract that were shown to be not patentable. So they have taken a lesson from that and tied it to the physical embodiments.” Ferry explained that because products of nature are generally not patentable in the U.S., there’s been a stronger focus on distinguishing what is a human-made invention and what is a discovery of a natural phenomenon.

The complicated licensing situation is still top of mind for many companies working in this space, Ferry said, noting that right now, the companies he’s in contact with still want to know what their competitors are doing in terms of obtaining licenses.

“It is a patent thicket that’s out there, but they have a business to run at the end of the day,” Ferry said. “And you can’t be so risk intolerant that you no longer have a business to worry about.”

Is the Non-Cas9 Landscape More Straightforward?

Mammoth Biosciences, a biotech company co-founded by Jennifer Doudna who won the Nobel Prize in Chemistry for developing the CRISPR-Cas9 system, is one of the companies banking on it being easier to secure IP for non-Cas9-based gene editors.

“We see the non-Cas9 landscape of truly differentiated systems, like those we’re building at Mammoth, as much more straightforward than Cas9 and Cas9-adjacent large systems, no matter the name,” a spokesperson for Mammoth Biosciences told BioSpace.

Mammoth is specifically using ultracompact systems distinct from Cas9 and has an extensive portfolio of wholly owned and licensed IP that is foundational to the non-Cas9 space, including Cas12f (CasZ), Cas12j (CasPhi), and NanoCas. MB-111, Mammoth’s lead therapeutic in development, is targeting familial chylomicronemia syndrome, a rare life-threatening disease that prevents the body from digesting fats and severe hypertriglyceridemia, which can lead to fatal pancreatitis. The research is in the lead optimization stage.

But, Ferry explained, just because an enzyme is not based on Cas9 doesn’t necessarily mean it’s free from the Broad or CVC portfolios. “That assumes a clear delineation between the IP portfolio and the enzyme, which isn’t always true,” he said. “There’s overlap between patents and a technology, but a patent can be broader than the specific technology that was the basis for it.”

In sum, he added, “it’s not clear. But you have a lot of people who think it is.”

https://www.biospace.com/business/gene-editing-patent-landscape-remains-clear-as-mud-say-patent-attorneys

Roche and Regeneron Square Off in Lucrative Eye Disease Market

 

Analysts expect the companies’ Vabysmo and Eylea HD to generate a combined $13.2 billion by 2030 in the vascular endothelial growth A therapy market, as healthcare providers and patients switch from older products.

The competition between Roche and Regeneron to dominate the ophthalmology market is heating up. With their successful launches of anti-vascular endothelial growth factor A (VEGF-A) drugs for the treatment of retinal diseases, GlobalData analysts expect the two companies to capture more than 60% of the sector by 2030.

GlobalData’s forecast reflects the respective launch trajectories of Roche’s Vabysmo and Regeneron’s Eylea HD. Vabysmo, a bispecific antibody that blocks Ang-2 and VEGF, shook up the wet age-related macular degeneration (AMD) and diabetic macular edema markets when it won FDA approval in 2022. Regeneron hit back with an August 2023 approval of Eylea HD, a high-dose version of the original version Eylea, approved in 2011 VEGF-A inhibitor, approved in 2011.

If Eylea HD maintains its current performance over the second half of 2024, both Roche’s and Regeneron’s new drugs will have become blockbusters in their first full years on the market. Eleni Tokali, pharma analyst at GlobalData, explained to BioSpace that physicians have been quick to adopt the products, which require regular injections into the eye, in large part because they don’t have to be dosed as frequently as the original Eylea.

“The main thing is their dosing flexibility. That makes them really good drugs, and that’s why we expect them to be top selling,” Tokali said. “Both drugs have this dosing flexibility that is really good and obviously healthcare providers and patients would opt to go for. At the same time, they are both very efficient as well.”

Eylea HD is initially given every four weeks. After three doses at that schedule, patients receive the drug every eight to 12 weeks or every eight to 16 weeks, depending on the indication. Patients starting on Vabysmo receive the first four doses four weeks apart. Beyond that, the gap between doses depends on how the patient responds. Patients can go 16 weeks between doses.

Both dosing schedules improve on the administration of Eylea, which has the same active ingredient as Eylea HD but is given more frequently. Physicians typically administer maintenance doses of Eylea every eight weeks, although some patients need treatment every four weeks. The label includes dosing every 12 weeks as an option but cautions the schedule is not as effective as the recommended eight weeks.

Blockbuster Launches

Vabysmo’s dosing advantage over Eylea helped Roche to quickly grow sales after winning the FDA’s approval in January 2022. Sales hit 591 million Swiss francs ($685 million) in 2022. Vabysmo became a blockbuster in its first full year on the market, with sales rising to 2.4 billion Swiss francs ($2.8 billion) in 2023. Tokali is forecasting Vabysmo sales will climb to $3.7 billion in 2024 and reach $7.7 billion by 2030.

Sales of the original Eylea fell as Vabysmo won market share. Regeneron reported 6% and 7% decreases in U.S. Eylea net product sales, respectively, in the first and second quarters of 2023. The FDA approved Eylea HD in the third quarter of 2023, and the new treatment generated $504 million in sales in the first half of 2024. This enabled Regeneron to maintain revenues from the overall Eylea franchise at a similar level to the first half of 2023. Combined, the Eylea products held 45% of the market, Regeneron said. Tokali is forecasting Eylea HD sales will reach $1.4 billion in 2024 and keep climbing to hit $5.5 billion in 2030.

The Eylea HD launch received a boost in April 2024 when Regeneron secured a permanent J-code, which may help streamline billing and reimbursement for the product. Even so, Marion McCourt, executive vice president of commercial at Regeneron, fielded a question about access barriers, specifically among Medicare Advantage plans, on the company’s Q2 earnings call in August 2024.

“We continue to work through situations where physicians might be having some utilization management or step edits. Those are often easily managed when the physician and office staff provide information,” McCourt said. “Overall, the takeaway message should be that Eylea HD has very strong payer coverage and, again, 80% of the market where reimbursement is in place.”

Despite facing payer constraints, the Roche and Regeneron treatments are gaining market share and preference among ophthalmologists, according to June 2024 research from Spherix Global Insights on diabetic macular edema prescribing.

Increasing Dose Convenience

With Roche and Regeneron both clearing barriers to access, the fight for market share could increasingly center on the attributes of Vabysmo and Eylea HD. However, Spherix concluded that the product category “is starting to look like a coin flip between Vabysmo and Eylea HD as they are rated similarly in terms of duration of action, drying effect and other efficacy perceptions” and that payer approval and access remain “critical for deciding what gets prescribed to the patient.”

McCourt said patients are switching to Eylea HD from Eylea, Vabysmo and Roche’s Avastin, an anti-VEGF drug approved for various types of cancer but also given off-label via eye injection to treat neovascular AMD. In addition, use of Eylea HD in the treatment-naive population doubled between the first and second quarters of 2024, according to the Regeneron executive.

Earlier this month, BMO Capital Markets analyst Evan Seigerman in a Q2 earnings note to investors similarly observed that patients are switching to Eylea HD from both Eylea and Vabysmo. Seigerman said that sales for Eylea HD have grown 67% quarter over quarter (QoQ), which he said is “the fastest growing product in the category, with utilization among treatment naive patients doubling QoQ.”

Still, Roche is strengthening its hand. The Swiss drugmaker won FDA approval for a prefilled syringe form of Vabysmo in July 2024, giving physicians a ready-to-use treatment option that is designed to simplify administration of the drug.

The FDA approval gives Roche an advantage over Regeneron. Currently, Eylea HD is only available in a single-dose vial. Using aseptic technique, healthcare professionals need to attach a needle and syringe, withdraw the contents of the vial and switch to a different needle before administering Eylea HD. The prefilled syringe format of Vabysmo eliminates the need to pull liquid from a vial or switch needles.

Regeneron is aiming to launch a prefilled syringe version of Eylea HD in early 2025 and CEO Leonard Schleifer talked down the chances of Roche’s head start moving the market on the Q2 earnings call earlier this month.

“I’m not sure what the competition is actually going to do about launching, but we’re a matter of months, I think, apart if they launch ahead of us,” Schleifer said. “I don’t think that’s going to have a significant impact in the marketplace where people really are focused, I think, on the profile of our drug, the durability of our drug, the safety experience they’ve had with aflibercept, the active ingredient.”

Those attributes inform Tokali’s forecast that Eylea HD will be one of two drugs, alongside Vabysmo, that dominate the market by 2030.

One outstanding question is how Eylea biosimilars will affect the market. The FDA approved interchangeable Eylea biosimilars in May 2024. Regeneron is in disputes over Eylea patents with companies including Samsung Bioepis and the timing of biosimilar launches is unknown. In June, Samsung was hit with a preliminary injunction from a West Virginia federal court blocking its Eylea biosimilar. The same judge granted a permanent injunction against Mylan Pharmaceuticals and Biocon Biologics.

https://www.biospace.com/business/roche-and-regeneron-square-off-in-lucrative-eye-disease-market