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Covid-19 roundup: China hacked Moderna, per official; Merck prepares to put vaccines into clinic

Covid-19 roundup: China hacked Moderna, per official; Merck prepares to put vaccines into clinic

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Earlier this week, Moderna acknowledged it had removed signage around its Norwood, MA manufacturing plant due to unspecified security issues. Now, the culprit has apparently emerged, and it doesn’t come as a surprise.

Chinese-backed hackers attempted to steal some of Moderna’s Covid-19 vaccine research, according to an anonymous US security official cited by Reuters. The official did not provide further details, and the FBI and HHS declined to identify which companies had been the target of Chinese espionage.

The revelation comes a week after the New York Times reported that the US Justice Department had formally indicted a pair of Chinese nationals and accused them of plotting to steal tech IP from a wide range of American companies, including those working on vaccines. According to the indictment, the individuals “conducted reconnaissance on the computer network of a Massachusetts biotech firm publicly known to be researching a potential COVID-19 vaccine” on January 27.

Reconnaissance can mean a variety of things, per cybersecurity experts cited by Reuters, including probing websites for vulnerabilities and searching for important accounts.

Moderna removed several signs around its Norwood plant a couple months ago, but only addressed the issue after the Boston Globe reported the company had also covered up the sign on its headquarters in what appeared to be white shrink wrap. Company spokespeople responded vaguely to those inquiries.

Ray Jordan

“About two months ago, much of the signage there was either adjusted or removed out of an abundance of caution for security and for the safety of our employees once it was clear that the production facility would become a primary manufacturing point for our vaccine candidate,” chief corporate affairs officer Ray Jordan told the Globe on Tuesday. “That was without any specific security threats precipitating the action.”

Russia has also been accused by the US, UK and Canadian governments of attempting to steal Covid-19 vaccine data from western drugmakers. It remains unclear what, if any, information had been stolen, however.

Moderna this week launched a pivotal Phase III study to determine whether or not two 100 µg doses of their mRNA vaccine can prevent Covid-19 symptoms from manifesting. The company has emerged as one of the leaders in the vaccine race, and BARDA committed $472 million to help get that trial off the ground and scale up production. — Max Gelman

Merck readies vaccines for clinical trials

Merck, the latecomer to the Covid-19 vaccine race, said today that it will push its first candidate into the clinic this quarter and move the other one there by the end of the year.

After staying tight-lipped for the first 6 months of the outbreak, Merck announced on May 26 they had licensed a vaccine candidate from the International Aids Vaccine Initiative and acquired biotech partner Themis and their Covid-19 vaccine candidate. Today, in their Q2 earnings, the NJ pharma said that the Themis vaccine will move into Phase I in Q3 and the IAIVI candidate will enter later this year.

Both of the candidates are viral vectors that deliver the gene for the coronavirus antigen to cells. Themis uses a measles vector. IAVI uses a vesicular stomatitis virus, the same one used in the Ebola vaccine Merck developed with the US government and got approved last year. BARDA has backed the IAVI candidate with a $38 million grant.

Merck has declined to detail timelines for completion, but Chief Patient Officer Julie Gerberding said at a recent Congressional hearing that the company is manufacturing at-risk and they “expect to have hundreds of millions of doses available beginning in 2021.” — Jason Mast

Remdesivir buoys a down quarter for Gilead

The Covid-19 pandemic hit Gilead hard in the second quarter, but the pharma company expects that to change for the better thanks to remdesivir.

Johanna Mercier

After announcing a 10 percent drop in sales in a quarterly earnings call with investors Thursday afternoon, Gilead revised its 2020 revenue projections upward, forecasting as much as $2.8 billion more in year-end yield. Huge demand for remdesivir is the biggest reason, as CCO Johanna Mercier hopes to meet the global need by October, according to a Wall Street Journal report.

Gilead received emergency FDA approval for remdesivir to treat Covid-19 back in May, with the company donating treatments to the US government for distribution. The pharma started selling the drug this month, charging $3,120 per course in the US and $2,340 in the EU.

The department of Health and Human Services makes up for almost all of Gilead’s remdesivir sales, as HHS secretary Alex Azar announced a purchase of 500,000 courses of the drug on June 29. This accounts for all July production and 90 percent of production in each of August and September.

SVB Leerink’s Geoffrey Porges cited this HHS contract as a reason for optimism, expecting Gilead to rebound later this year.

Due to remdesivir’s complicated manufacturing process, Gilead has struggled to keep up with early demand for the drug. The pandemic has also affected supply chains around the world, and Gilead has not gone untouched in this regard.

During the earnings call, Gilead said it expects to sell about one million to 1.5 million remdesivir treatments in the second half of 2020. With these sales potentially offsetting second-quarter losses, Gilead projects revenue to fall between the $23.3 billion and $25 billion range, up from $21.8-22.2 billion.

The Wall Street Journal also cited an analyst from Credit Suisse who noted that Gilead is indicating full remdesivir sales to be around $3 billion and $4.5 billion.

Overall, Gilead posted a $3.34 billion loss in the second quarter, largely driven by expenses related to their $4.9 billion acquisition of Forty Seven back in March. Because Covid-19 also affected how and when patients decided to seek routine health care, sales for Gilead’s Biktarvy and Descovy were also down for the quarter. — Max Gelman

Japan purchases 120 million doses of Pfizer/BioNTech vaccine candidate

The Covid-19 vaccine candidate being developed by Pfizer and BioNTech has found a new buyer — Japan.

The two companies announced Friday morning that the Japanese government has agreed to acquire 120 million doses of their mRNA vaccine, which would cover almost 95 percent of the country’s population. Financial terms of the deal were not disclosed but are contingent on the timing of delivery and volume of doses.

The deal is also subject to the candidate’s regulatory approval. As requested by Japan, deliveries of the vaccine will start in the first half of 2021.

Pfizer is working with BioNTech on four vaccine programs, two of which have received Fast Track designation from the FDA. Earlier this week, the companies announced the start of enrollment for a Phase II/III study for the candidate BNT162b2, putting them on track for regulatory review as early as October.

That’s not the candidate most analysts expected to provide the foundation for Pfizer’s vaccine program, as BNT162b1 appeared more exciting when preliminary data dropped on July 1. But BNT162b2 demonstrated a better tolerability profile in Phase I/II, which ended up being the deciding factor along with T cell response. — Max Gelman

For a look at all Endpoints News coronavirus stories, check out our special news channel.

Social image: Daniel O’Day, Bloomberg via Getty

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Four burning questions about the future of the $16.5B Novo-Catalent deal

To build or to buy? That’s a classic question for pharma boardrooms, and Novo Nordisk is going with both.
Beyond spending billions of dollars to expand…

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To build or to buy? That’s a classic question for pharma boardrooms, and Novo Nordisk is going with both.

Beyond spending billions of dollars to expand its own production capacity for its weight loss drugs, the Danish drugmaker said Monday it will pay $11 billion to acquire three manufacturing plants from Catalent. It’s part of a broader $16.5 billion deal with Novo Holdings, the investment arm of the pharma’s parent group, which agreed to acquire the contract manufacturer and take it private.

It’s a big deal for all parties, with potential ripple effects across the biotech ecosystem. Here’s a look at some of the most pressing questions to watch after Monday’s announcement.

Why did Novo do this?

Novo Holdings isn’t the most obvious buyer for Catalent, particularly after last year’s on-and-off M&A interest from the serial acquirer Danaher. But the deal could benefit both Novo Holdings and Novo Nordisk.

Novo Nordisk’s biggest challenge has been simply making enough of the weight loss drug Wegovy and diabetes therapy Ozempic. On last week’s earnings call, Novo Nordisk CEO Lars Fruergaard Jørgensen said the company isn’t constrained by capital in its efforts to boost manufacturing. Rather, the main challenge is the limited amount of capabilities out there, he said.

“Most pharmaceutical companies in the world would be shopping among the same manufacturers,” he said. “There’s not an unlimited amount of machinery and people to build it.”

While Novo was already one of Catalent’s major customers, the manufacturer has been hamstrung by its own balance sheet. With roughly $5 billion in debt on its books, it’s had to juggle paying down debt with sufficiently investing in its facilities. That’s been particularly challenging in keeping pace with soaring demand for GLP-1 drugs.

Novo, on the other hand, has the balance sheet to funnel as much money as needed into the plants in Italy, Belgium, and Indiana. It’s also struggled to make enough of its popular GLP-1 drugs to meet their soaring demand, with documented shortages of both Ozempic and Wegovy.

The impact won’t be immediate. The parties expect the deal to close near the end of 2024. Novo Nordisk said it expects the three new sites to “gradually increase Novo Nordisk’s filling capacity from 2026 and onwards.”

As for the rest of Catalent — nearly 50 other sites employing thousands of workers — Novo Holdings will take control. The group previously acquired Altasciences in 2021 and Ritedose in 2022, so the Catalent deal builds on a core investing interest in biopharma services, Novo Holdings CEO Kasim Kutay told Endpoints News.

Kasim Kutay

When asked about possible site closures or layoffs, Kutay said the team hasn’t thought about that.

“That’s not our track record. Our track record is to invest in quality businesses and help them grow,” he said. “There’s always stuff to do with any asset you own, but we haven’t bought this company to do some of the stuff you’re talking about.”

What does it mean for Catalent’s customers? 

Until the deal closes, Catalent will operate as a standalone business. After it closes, Novo Nordisk said it will honor its customer obligations at the three sites, a spokesperson said. But they didn’t answer a question about what happens when those contracts expire.

The wrinkle is the long-term future of the three plants that Novo Nordisk is paying for. Those sites don’t exclusively pump out Wegovy, but that could be the logical long-term aim for the Danish drugmaker.

The ideal scenario is that pricing and timelines remain the same for customers, said Nicole Paulk, CEO of the gene therapy startup Siren Biotechnology.

Nicole Paulk

“The name of the group that you’re going to send your check to is now going to be Novo Holdings instead of Catalent, but otherwise everything remains the same,” Paulk told Endpoints. “That’s the best-case scenario.”

In a worst case, Paulk said she feared the new owners could wind up closing sites or laying off Catalent groups. That could create some uncertainty for customers looking for a long-term manufacturing partner.

Are shareholders and regulators happy? 

The pandemic was a wild ride for Catalent’s stock, with shares surging from about $40 to $140 and then crashing back to earth. The $63.50 share price for the takeover is a happy ending depending on the investor.

On that point, the investing giant Elliott Investment Management is satisfied. Marc Steinberg, a partner at Elliott, called the agreement “an outstanding outcome” that “clearly maximizes value for Catalent stockholders” in a statement.

Elliott helped kick off a strategic review last August that culminated in the sale agreement. Compared to Catalent’s stock price before that review started, the deal pays a nearly 40% premium.

Alessandro Maselli

But this is hardly a victory lap for CEO Alessandro Maselli, who took over in July 2022 when Catalent’s stock price was north of $100. Novo’s takeover is a tacit acknowledgment that Maselli could never fully right the ship, as operational problems plagued the company throughout 2023 while it was limited by its debt.

Additional regulatory filings in the next few weeks could give insight into just how competitive the sale process was. William Blair analysts said they don’t expect a competing bidder “given the organic investments already being pursued at other leading CDMOs and the breadth and scale of Catalent’s operations.”

The Blair analysts also noted the companies likely “expect to spend some time educating relevant government agencies” about the deal, given the lengthy closing timeline. Given Novo Nordisk’s ascent — it’s now one of Europe’s most valuable companies — paired with the limited number of large contract manufacturers, antitrust regulators could be interested in taking a close look.

Are Catalent’s problems finally a thing of the past?

Catalent ran into a mix of financial and operational problems over the past year that played no small part in attracting the interest of an activist like Elliott.

Now with a deal in place, how quickly can Novo rectify those problems? Some of the challenges were driven by the demands of being a publicly traded company, like failing to meet investors’ revenue expectations or even filing earnings reports on time.

But Catalent also struggled with its business at times, with a range of manufacturing delays, inspection reports and occasionally writing down acquisitions that didn’t pan out. Novo’s deep pockets will go a long way to a turnaround, but only the future will tell if all these issues are fixed.

Kutay said his team is excited by the opportunity and was satisfied with the due diligence it did on the company.

“We believe we’re buying a strong company with a good management team and good prospects,” Kutay said. “If that wasn’t the case, I don’t think we’d be here.”

Amber Tong and Reynald Castañeda contributed reporting.

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Petrina Kamya, Ph.D., Head of AI Platforms at Insilico Medicine, presents at BIO CEO & Investor Conference

Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb….

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Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb. 26-27 at the New York Marriott Marquis in New York City. Dr. Kamya will speak as part of the panel “AI within Biopharma: Separating Value from Hype,” on Feb. 27, 1pm ET along with Michael Nally, CEO of Generate: Biomedicines and Liz Schwarzbach, PhD, CBO of BigHat Biosciences.

Credit: Insilico Medicine

Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb. 26-27 at the New York Marriott Marquis in New York City. Dr. Kamya will speak as part of the panel “AI within Biopharma: Separating Value from Hype,” on Feb. 27, 1pm ET along with Michael Nally, CEO of Generate: Biomedicines and Liz Schwarzbach, PhD, CBO of BigHat Biosciences.

The session will look at how the latest artificial intelligence (AI) tools – including generative AI and large language models – are currently being used to advance the discovery and design of new drugs, and which technologies are still in development. 

The BIO CEO & Investor Conference brings together over 1,000 attendees and more than 700 companies across industry and institutional investment to discuss the future investment landscape of biotechnology. Sessions focus on topics such as therapeutic advancements, market outlook, and policy priorities.

Insilico Medicine is a leading, clinical stage AI-driven drug discovery company that has raised over $400m in investments since it was founded in 2014. Dr. Kamya leads the development of the Company’s end-to-end generative AI platform, Pharma.AI from Insilico’s AI R&D Center in Montreal. Using modern machine learning techniques in the context of chemistry and biology, the platform has driven the discovery and design of 30+ new therapies, with five in clinical stages – for cancer, fibrosis, inflammatory bowel disease (IBD), and COVID-19. The Company’s lead drug, for the chronic, rare lung condition idiopathic pulmonary fibrosis, is the first AI-designed drug for an AI-discovered target to reach Phase II clinical trials with patients. Nine of the top 20 pharmaceutical companies have used Insilico’s AI platform to advance their programs, and the Company has a number of major strategic licensing deals around its AI-designed therapeutic assets, including with Sanofi, Exelixis and Menarini. 

 

About Insilico Medicine

Insilico Medicine, a global clinical stage biotechnology company powered by generative AI, is connecting biology, chemistry, and clinical trials analysis using next-generation AI systems. The company has developed AI platforms that utilize deep generative models, reinforcement learning, transformers, and other modern machine learning techniques for novel target discovery and the generation of novel molecular structures with desired properties. Insilico Medicine is developing breakthrough solutions to discover and develop innovative drugs for cancer, fibrosis, immunity, central nervous system diseases, infectious diseases, autoimmune diseases, and aging-related diseases. www.insilico.com 


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Another country is getting ready to launch a visa for digital nomads

Early reports are saying Japan will soon have a digital nomad visa for high-earning foreigners.

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Over the last decade, the explosion of remote work that came as a result of improved technology and the pandemic has allowed an increasing number of people to become digital nomads. 

When looked at more broadly as anyone not required to come into a fixed office but instead moves between different locations such as the home and the coffee shop, the latest estimate shows that there were more than 35 million such workers in the world by the end of 2023 while over half of those come from the United States.

Related: There is a new list of cities that are best for digital nomads

While remote work has also allowed many to move to cheaper places and travel around the world while still bringing in income, working outside of one's home country requires either dual citizenship or work authorization — the global shift toward remote work has pushed many countries to launch specific digital nomad visas to boost their economies and bring in new residents.

Japan is a very popular destination for U.S. tourists. 

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This popular vacation destination will soon have a nomad visa

Spain, Portugal, Indonesia, Malaysia, Costa Rica, Brazil, Latvia and Malta are some of the countries currently offering specific visas for foreigners who want to live there while bringing in income from abroad.

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With the exception of a few, Asian countries generally have stricter immigration laws and were much slower to launch these types of visas that some of the countries with weaker economies had as far back as 2015. As first reported by the Japan Times, the country's Immigration Services Agency ended up making the leap toward a visa for those who can earn more than ¥10 million ($68,300 USD) with income from another country.

The Japanese government has not yet worked out the specifics of how long the visa will be valid for or how much it will cost — public comment on the proposal is being accepted throughout next week. 

That said, early reports say the visa will be shorter than the typical digital nomad option that allows foreigners to live in a country for several years. The visa will reportedly be valid for six months or slightly longer but still no more than a year — along with the ability to work, this allows some to stay beyond the 90-day tourist period typically afforded to those from countries with visa-free agreements.

'Not be given a residence card of residence certificate'

While one will be able to reapply for the visa after the time runs out, this can only be done by exiting the country and being away for six months before coming back again — becoming a permanent resident on the pathway to citizenship is an entirely different process with much more strict requirements.

"Those living in Japan with the digital nomad visa will not be given a residence card or a residence certificate, which provide access to certain government benefits," reports the news outlet. "The visa cannot be renewed and must be reapplied for, with this only possible six months after leaving the countr

The visa will reportedly start in March and also allow holders to bring their spouses and families with them. To start using the visa, holders will also need to purchase private health insurance from their home country while taxes on any money one earns will also need to be paid through one's home country.

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