Israel reports dozens of Indian COVID strain cases

 The Health Ministry has identified 41 new cases of the Indian coronavirus variant in Israel, including four in people who have been vaccinated against COVID-19.

Israel's genomic sequencing system found that 24 of those infected with the variant, which experts say may be more contagious than other variants, had returned recently from abroad. The other 17 contracted it via community transmission, including five schoolchildren. The Health Ministry and the IDF Home Front Command are carrying out widespread testing at the schools where the children are enrolled.  

Twenty-one of the people who tested positive for the variant are foreign nationals. Last week, Israel banned entry to tourists from India over concerns about the variant's spread and the severe increase in cases there. As part of the new restrictions, only 300 Indian caregivers and students will be allowed to enter the country per month. They will be required to quarantine at coronavirus hotels designated for those coming from India, unless they have either recovered from or were vaccinated against COVID-19 in Israel.

A Health Ministry statement said that new restrictions which would forbid Israelis from traveling to countries with high infection rates (save for exceptional cases) are awaiting approval from the relevant ministries before it can be sent to government approval. Israelis returning from these countries would also need to quarantine, even if they have been vaccinated against or recovered from COVID-19. Foreign nationals from these countries would also not be allowed to enter Israel, and those who have received permission to do so would have to quarantine at designated hotels, as is the case with arrivals from India.   

Last month some 1,000 people entered Israel from India, and only about a quarter of them were vaccinated. Among those who entered, 63 tested positive for the virus, but not all of them had necessarily been infected by the Indian variant.

The Indian variant is of concern to experts because it consist of two mutations of its protein, which could make it more resistant to the coronavirus vaccine. Last month, the Indian Health Ministry reported on a strain of the virus that includes two genetic changes and constitutes a kind of “union” of two variants previously known as E484Q and L452R.

However, because samples collected from throughout India have shown that the most dominant variant in the country is the British variant, the prevailing view is that the new strain of the virus is not behind the latest outbreak in India, which is rapidly spreading across the country.

The Israeli Health Ministry also identified eight new cases of the South African variant, seven of the New York variant, two of the California variant, one of the St. Petersburg variant and one case of an additional British variant.  

Although most of the coronavirus restrictions in Israel have been rolled back in recent weeks due to the drop in infections, entrance to the country is still being controlled. Israelis who enter without a vaccination certificate must quarantine at home, while those who recovered or were vaccinated in Israel do not have to quarantine, but must receive a negative result from the rapid coronavirus test now being administered to everyone entering Israel via Ben-Gurion Airport.

https://www.haaretz.com/israel-news/dozens-of-cases-of-indian-covid-variant-found-in-israel-including-among-vaccinated-1.9758121

Bristol Myers on alert for potential immuno-oncology pricing war as 3rd launch nears

 With several new immuno-oncology drugs on their way to the U.S. from Chinese biopharma companies, the already crowded PD-1/L1 market about to get even more so. And that's put Opdivo developer Bristol Myers Squibb on notice.

While Bristol Myers isn’t paranoid about new PD-1 competition, the risk of commoditization—as newer entrants undercut established drugs on price—could be a bigger problem that “we need to stay on top of,” the company’s chief commercial officer Chris Boerner said on a conference call Thursday.

At least three Chinese-made PD-1s are looking to launch in the U.S. in the next three years, with U.S. partners in Novartis, Eli Lilly and Coherus BioSciences. Although none of the drugs has proven superior to the currently available meds, the new entrants are expected to offer discounted prices to win market share.

BMS is paying attention to the up-and-coming drugs, Boerner said, but it's not so concerned about competition on the merits. A price-driven battle might be more disruptive.

Low cost isn't the only thing that drives commoditization, Boerner said. Payers, physicians and patients also have to consider products interchangeable.

“The risk of both of these things coming together likely varies by geography, healthcare system and maybe even by therapeutic setting, but we pay very close attention to this,” he said. At least for now, the greatest risks don’t overlap with Opdivo’s largest markets, he added.

Opdivo is the second best-selling PD-1/L1 checkpoint inhibitor among seven existing options. Under pressure from Merck & Co.’s market-leading Keytruda, the drug has hit a growth bottleneck lately. During the first quarter, it brought in sales of $1.72 billion, down 3% year over year—after a similar year-over-year decline in 2020.

Bristol blamed COVID-19 for part of that decline, particularly internationally. In the U.S., the drug maintains a low double-digit share in the biggest area, first-line non-small cell lung cancer.

The company argues Opdivo will start growing again this year, thanks to a strategy of churning out new data and winning new approvals that can help the med defend itself against the competition.

These include a combo with Exelixis’ Cabometyx in previously untreated kidney cancer and with chemotherapy in previously untreated stomach cancer, as well as potential launches in post-surgery esophageal cancer and post-surgery muscle-invasive bladder cancer.

As most metastatic cancer fields fill up with competition, PD-1/L1 developers are looking for approvals in newly diagnosed patients before and after surgery. Boerner noted that the treatment rate for some of those uses—known as adjuvant and neo-adjuvant—remain relatively low, so even after it wins those approvals, sales will likely ramp up slowly.

Meanwhile, Bristol’s looking to introduce its third checkpoint inhibitor in addition to Opdivo and CTLA4 inhibitor Opdivo. A fixed combo of Opdivo and investigational LAG-3 antibody relatlimab recently topped solo Opdivo in first-line melanoma.

Currently, the Opdivo-Yervoy combo takes up about 35% to 40% of front-line melanoma share, and single-agent I-O use constitutes another 30%. With relatlimab, the company’s aiming to tap into the rest of the market, Boerner said.

The company’s also eyeing the front-line NSCLC market, having launched an early study adding chemotherapy to the Opdivo-relatlimab pair, with the hope of starting a phase 3 trial by the end of the year, Bristol’s chief medical officer Samit Hirawat said on the call.

In addition, Bristol recently launched two CAR-T cell therapies, CD19-targeted Breyanzi and BCMA-targeted Abecma. Both drugs require designated treatment centers for administration. So far, 55 sites for Breyanzi and more than 40 for Abecma have been activated.

All told, Bristol saw sales increase 3% year over year to $11.1 billion in the first quarter. Multiple myeloma drug Revlimid led the pack with a Q1 haul of $2.94 billion, followed by oral blood thinner Eliquis, which turned in $2.89 billion. Both drugs reported growth.

https://www.fiercepharma.com/pharma/bristol-myers-to-stay-top-potential-pd-1-pricing-war-as-its-3rd-checkpoint-inhibitor-launch

Merck's open to 'all forms' of M&A deals, incoming CEO says

 With Merck's sales dragging from the pandemic and the company becoming increasingly reliant on immuno-oncology superstar Keytruda, the pharma giant's executive team unveiled a willingness to flex its M&A muscle.

“We are open to any opportunity to add a meaningful asset,” president and soon-to-be CEO Rob Davis said on a Thursday call with investors. “We are open to all forms of deals and we have the capital” for those deals, he added.

It'll soon have some extra cash on hand, too, thanks to the spinoff of Organon, which is expected to wrap up on June 2. Once the spinoff closes, Merck expects "to receive a special tax-free dividend of $9 billion, which we hope to deploy in a value-enhancing strategic business development opportunity," chief financial officer Caroline Litchfield said.

The comments came during Merck’s first-quarter earnings call, where the drug giant reported sales for the period of $12.08 billion. Cancer mainstays Keytruda and Lynparza held the line, alongside surgery drug Bridion and the drugmaker’s animal health business. Elsewhere, pandemic disruptions took their toll.

In all, Merck missed analysts' sales estimates by around $500 million. Analysts had figured the company would generate around $12.6 billion.

Merck estimated that the COVID-19 pandemic took a roughly $600 million bite out of its pharma revenue during the first three months of the year. The company now expects the pandemic to crimp 2021 sales by around 3%.

Merck's vaccine business suffered a particularly tough period as the COVID-19 vaccine rollout reached a fever pitch in the U.S. Sales of Merck’s HPV shot Gardasil fell 16% to $917 million, while revenues for its polysaccharide pneumococcal vaccine Pneumovax 23 dropped 33% to $171 million.

Those products could perform better in the back half of the year, once a majority of people in the U.S. have received their COVID shots and routine vaccinations resume, execs said. The CDC recommends people don't receive other vaccines within two weeks of their COVID-19 shots.

Considering those struggles, it's a good thing for Merck that its cancer stalwart Keytruda continued its ascent. The drug pulled in a whopping $3.9 billion during the quarter—up around 19% versus the same period last year.

But Merck likely won’t be able to count on Keytruda's use in third-line stomach cancer soon. An external panel summoned by the FDA voted 6-2 recommending the agency remove that accelerated approval from Keytruda’s label. The “no” voters all pointed to the change in treatment landscape as a reason to pull the nod. The FDA doesn’t have to follow the committee’s opinion, but it often does.

On the flip side, FDA panelists voted to maintain Keytruda's second-line approval in patients with hepatocellular carcinoma while additional trials play out.

Looking forward, while Merck says M&A isn’t off the table, one team of analysts figure there’s plenty to like in the company’s existing portfolio and pipeline.

“[W]e still believe there is a lot of value to be unlocked in [Merck's] products as well as its pipeline,” Cantor Fitzgerald analysts wrote in a note to clients Thursday morning. Growth across oncology, vaccines, animal health and select hospital and specialty care products remain “underappreciated,” the analysts wrote.

Plus, the company snagged recent approvals for Keytruda in esophageal cancer, and for new med Verquvo in chronic heart failure.

The other positive, to hear Bernstein's Ronny Gal tell it, was that Merck's new management seems to be more active "on both business development (the $9B from Organon will be spent on BD) and promise to communicate more clearly with the market about its pipeline and growth expectations."

All told, the company now forecasts between $51.8 billion to $53.8 billion in 2021 sales.

https://www.fiercepharma.com/pharma/merck-says-m-a-isn-t-off-table-as-q1-sales-take-pandemic-hit

Community Health: $68M loss in Q1 amid 14% admissions drop due to pandemic

 Community Health Systems posted a net loss of $64 million for the first quarter of 2021 as the hospital chain faced a 14% decline in admissions due to the pandemic.

The hospital chain posted net operating revenues of $3.01 billion for the first quarter in earnings results released late Wednesday. It also posted adjusted earnings before interest, taxes, debt and amortization of $495 million. The net loss was compared to net income of $18 million for the first quarter of 2020 before the onset of the COVID-19 pandemic.

“Our market leadership teams continue to adjust their operating models as COVID cases fluctuate, by managing shifts in volumes, revenue and expenses to achieve the best possible results,” said Tim Hingtgen, CEO of CHS, in a statement.

CHS reported a 14% decrease in admissions and a 15.8% decline in adjusted admissions compared to the first quarter of 2020.

“On a same-store basis, admissions decreased 4.9% and adjusted admissions decreased 7.2% for the three months ended March 31, 2021, compared with the same period in 2020,” CHS said in its earnings release.

But net operating revenues did increase nearly 10% for the quarter thanks to changes in the “mix of services provided and payor mix compared to the prior period."

CHS had 9,400 COVID-19 admissions in the first quarter as the hospital faced winter surges of the virus, a major boost from the 8,000 admissions it posted for the fourth quarter of 2020, said Hingtgen in an earnings call Thursday.

But the surge in cases started to dissipate in March.

"We experienced various waves of new COVID-19 cases from month to month," he added. "Our hospital leadership teams have continued to adjust extremely well to the continuing business environment."

CHS, like other hospitals across the country, has faced increased expenses for staffing and supplies due to the pandemic. Hingtgen expects those costs to dissipate in the near future as COVID-19 cases decline with the spread of vaccinations. 

"As we looked at the rest of the year, [we] expect cash flow operations to improve," he said.

Several other for-profit hospital chains such as HCA and Tenet Healthcare have been able to post profits during the first quarter on the backs of higher acuity from treating COVID-19 patients.

https://www.fiercehealthcare.com/hospitals/chs-posts-68m-loss-q1-after-steep-volume-declines-stemming-from-pandemic

Community Health Systems upped to Neutral by UBS

 From Underperform; target to $10 from $4.10

https://finviz.com/quote.ashx?t=CYH&ty=c&ta=1&p=d

UK Study: 1st Dose of Pfizer Vax Doesn't Offer 'Full Protection' From Mutant COVID Strains

 As shortages of COVID-19 vaccine supplies force more countries stretch the time between the first and second vaccine doses to try and vaccinate more people, the latest data out of a UK study of vaccination rates has stumbled on a disturbing finding: the study found that people who have had one dose are still at risk from mutated strains of the virus.

The study, published Friday afternoon in London by Imperial College London and published in the journal Science, examined the immune responses of health-care workers following their first dose of the Pfizer jab.

It found that people who had previously been infected saw significantly enhanced protection against mutant strains of the virus typically referred to as "variants". Those who only received the jab, but weren't previously infected, showed an immune response that was "less strong after a first dose, potentially leaving them at risk from variants." The findings show that those who have received the Pfizer jab aren't "fully protected" from COVID-19 variants.

Professor Rosemary Boyton, Professor of Immunology and Respiratory Medicine at Imperial College London, who led the research, said: “Our findings show that people who have had their first dose of vaccine, and who have not previously been infected with SARS-CoV-2, are not fully protected against the circulating variants of concern. This study highlights the importance of getting second doses of the vaccine rolled out to protect the population.”

Imperial College published the results in full on its website.

Meanwhile, another study released Friday came to a similar conclusion, showing that some patients who have received their first dose still wind up in the hospital with COVID symptoms.

The news appeared to weigh on US stocks, which tumbled to their lows of the session shortly after the news broke. Analysts claimed the study is a problem for the global growth outlook - which has already taken a hit thanks to to the latest data out of China - as countries like Canada aim to stagger doses by months to try and make the most out of limited supplies.

According to the latest data released on Friday, 65% of British adults have already received at least one dose, while 3,736,654 people were vaccinated in the past 7 days. More than 25% of adults in the country, meanwhile, have received both doses. 48,748,962 doses of COVID-19 vaccine have now been administered in the UK, while the US just announced that 100M Americans have now been fully vaccinated.

But the latest study data available suggests that patients who have received only one shot are still vulnerable. Researchers say the findings are reassuring because vaccines are never 100% perfect and failures are expected. But others have said that the most vulnerable patients may be letting their guard down too soon after one vaccine.

The study analyzed a quarter of all hospital patients in England, Scotland and Wales between early December and early April, and is one of the first to look at the impact of vaccinations on the numbers of people subsequently admitted to hospital.

Prof Calum Semple, study leader from the University of Liverpool, told the BBC that this data represented strong real-world evidence of few vaccine failures.

"It's reassuring that the numbers admitted are very, very small - and mostly in those at risk of severe disease," he said.

Meanwhile, Dr. Annemarie Docherty, a study co-author and honorary consultant in critical care, warned that this is just the latest sign that patients are assuming they're "safe" immediately after being vaccinated, rather than weeks later.

"It's entirely possible that elderly people will catch coronavirus again and may die," she said.

In the study, 526 people who tested positive for coronavirus were admitted to hospital from 21 days after one vaccine dose, and 113 died - out of more than 3,500 hospitalised patients in the study. The data comes from the ISARIC/CO-CIN study, which has been presented to the government's scientific advisers, Sage, but not yet reviewed by other experts. More complete NHS hospital data is set to be released in due course.

https://www.zerohedge.com/covid-19/uk-study-finds-pfizer-vaccine-doesnt-offer-full-protection-mutant-covid-strains

Vaccitech, startup behind Oxford COVID vax tech, falls 20% in Nasdaq debut

American depositary shares of Vaccitech, which co-invented the COVID-19 vaccine developed by AstraZeneca Plc and Oxford University, fell nearly 20% in their market debut on Friday, giving the biotech firm a market value of about $464 million.

The company’s shares opened at $13.62, below the initial public offering price of $17.

https://www.reuters.com/article/vaccitech-ipo/vaccitech-startup-behind-oxford-covid-19-vaccine-tech-falls-20-in-nasdaq-debut-idUSL4N2MN4F2