2020-2022: A chronicle of the pandemic

Big Pharma Can't Get Enough Of One Class Of Cancer Drugs

AROUND THE world, dealmaking is in a rut. A combination of higher interest rates, geopolitical tensions and economic uncertainty has put a hold on joint ventures, mergers and acquisitions. One exception is targets with AI in their name. Another, less obvious one, involves a less catchy initialism: ADCs.

Makers of these antibody-drug conjugates, to give them their full name, are all the rage among the world's biggest drugmakers. Pfizer is paying $43bn for Seagen, which in turn has just teamed up with Nurix Therapeutics, a smaller biotechnology firm, to work on this class of drugs. Amgen, AstraZeneca and Merck have also placed billion-dollar bets on ADCs. In the past five years licensing deals worth $60bn have been signed for such therapies. The number of such deals tripled in that period, to 26. So far this year 18 have been signed, outpacing similar deals involving other emerging cancer drugs.

ADCs aren't new. The first was approved in 2000 for types of leukaemia. They act like guided biological missiles: a payload of toxic chemotherapy is carried by antibodies able to seek out cancer cells directly. Because they bypass normal tissue and go straight for their targets, they let patients receive higher doses that would otherwise cause too much collateral damage.

Two developments explain the frenzied stockpiling of these anti-cancer weapons of late. One is increased clinical confidence. Enhertu, an ADC developed by AstraZeneca and Daiichi Sankyo, a Japanese biotechnology company, was first approved in America in 2019. But after another set of trials in 2022 showed that it allowed breast-cancer patients to live almost twice as long without relapse as those treated with standard chemotherapy, its approval was extended to different types of breast and lung cancer. Regulators have cleared a dozen other ADCs, which are now routinely used to treat some of the deadliest cancers, including leukaemia, lymphoma and breast cancer.

More than 140 new ADCs are currently in clinical trials. Bristol Myers Squibb and Sanofi all have therapies in late-stage tests. AstraZeneca and Merck have each formed a joint-venture with biotech firms in China, to take advantage of Chinese regulators' more relaxed rules for early-stage trials, which helps accelerate the drugs' development. Susan Galbraith, who oversees oncology research and development at AstraZeneca, says that the timeline for drug testing in China has been significantly reduced in the past decade.

Clinical success has, in turn, boosted commercial confidence. Sales of Enhertu exceeded $1.2bn in 2022. Revenue from Trodelvy, a similar drug approved for advanced breast cancer and sold by Gilead Sciences, rose by 79% last year, to $680m. Kadcyla brought in $1.1bn for its Swiss developer, Roche, in the first half of this year. Evaluate, a provider of health-care data, forecasts that ADC sales could reach nearly $30bn by 2028, up from around $7.5bn last year (see chart).

Some of these wagers could misfire. It is unclear just how well the drugs will work in combination with others, such as immunotherapies. They are also complex to make. Any deals involving Chinese partners could unravel if Sino-Western tensions increase. For now, though, ADCs are a global arms race worth cheering.

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© 2023 The Economist Newspaper Limited. All rights reserved.

From The Economist, published under licence. The original content can be found on https://www.Economist.Com/business/2023/09/21/big-pharma-cant-get-enough-of-one-class-of-cancer-drugs

AstraZeneca Succession Sickness Demands Urgent Fix

By Aimee Donnellan

LONDON (Reuters Breakingviews) - Can a CEO be worth $9 billion? That's the question posed by the 4% fall in AstraZeneca's shares following an article stating boss Pascal Soriot may soon resign. The company has played down the report, and its stock has recovered, but the episode highlights its uncertain position were 64-year-old Soriot to leave. Without a clear succession plan, investors should prepare for further swings. By most measures, Soriot is a top performer. He joined the $205 billion Anglo-Swedish group in 2012 with a mandate to rebuild its empty pipeline. Barely two years in he had to fend off a 55 pound a share offer from rival Pfizer. Today AstraZeneca's shares are worth nearly twice that amount, and the group has thrived thanks to blockbusters like breast cancer treatment Lynparza, and bold M&A, such as the $39 billion purchase of rare disease specialist Alexion in the middle of the pandemic. Berenberg analysts reckon AstraZeneca's annual return on research spending has averaged 12% since 2016, comfortably exceeding its 8% cost of capital and trouncing most major pharma groups. The combination of these tactics has gifted investors with an over 400% return including dividends during Soriot's tenure, handily beating European rivals like Novartis, Sanofi and GSK. Small wonder investors and analysts wonder whether AstraZeneca will be able to find a successor capable of replicating his success. Soriot's lengthy tenure, more than double the average for a FTSE 100 chief executive, makes the issue all the more pressing.

There are better ways to handle a succession. Take Diageo. When Ivan Menezes passed away, he left a clear replacement in Chief Operating Officer Debra Crew. Alternatively, AstraZeneca's board could line up a number of candidate CEOs, giving it ample choice when Soriot resigns. AstraZeneca has some credible internal candidates. The success of its cancer treatments, which made up 35% of sales in 2022, would put either Susan Galbraith, executive vice president of oncology research and development, or David Fredrickson, who runs the commercial strategy for that business, in a strong position. Others could include Chief Financial Officer Aradhana Sarin. The board could also consider external candidates like Luke Miels, a former protégé of Soriot's who defected to rival GSK in 2017. It would be hard for any of those to match Soriot's returns. Still, the lingering uncertainty needs a quick fix.

Follow @aimeedonnellan on X

CONTEXT NEWS

Shares of AstraZeneca fell more than 4% on Sept. 11, following a report in the Mail on Sunday that CEO Pascal Soriot may retire as soon as next year.

The company did not explicitly deny the report, but said in a statement on Sept. 11 that it does not comment on market rumours, adding that it would make an announcement if there were any "truth in a rumour that could significantly impact" its share price.

(Editing by Neil Unmack and Streisand Neto)

Rio De Janeiro Allows Pregnant Women To Mix One Dose Of Pfizer With One Of AstraZeneca Vaccines

Wednesday, June 30th 2021 - 09:30 UTC

Full article

Soranz listed six clinical studies which would "demonstrate safety and efficacy"

Health authorities in the Brazilian city of Rio de Janeiro announced Tuesday that they had approved combination doses of Pfizer and AstraZeneca anticoronavirus vaccines on pregnant women.

Rio de Janeiro will thus become the first Brazilian regional capital to allow mixing the two drugs, a practice already endorsed or recommended in Chile, Spain, Germany, Portugal, Canada and South Korea.

Vaccination with AstraZeneca / Oxford for pregnant women has been suspended in Brazil since last May, on the recommendation of the National Health Surveillance Agency (Anvisa) due to its suspected causing serious episodes of thrombosis. After that, health care practicioners turned to either the Sinovac or Pfizer-BioNTech drugs for pregnant women.

Brazil's Health Minister had also advised patients who had received the first dose of AstraZeneca-Oxford should complete their treatment with the same formula around one and a half months after delivery.

However, based on the positive results from international studies, the Rio de Janeiro Mayor's Office authorized this Tuesday to mix the two immunizers for pregnant women.

"Following our committee's recommendation: pregnant women who took the first dose of the AstraZeneca vaccine will be able, through a risk-benefit assessment with their doctors, to take the second dose with the Pfizer vaccine 12 weeks after the first dose", Rio de Janeiro Health Secretary Daniel Soranz said on social media.

Vaccination against covid-19 began in Brazil on January 17 and five months later 34% of the population has received the first dose, but only 12% are on the full schedule. With almost 515,000 deaths and 18.5 million infected, Brazil is the country in Latin America hardest hit by the pandemic the second in the world with the most fatalities and the third with the most positives, after the United States and India.

As per the new decision, pregnant women in Rio will have to see their obstetrician and bring a certificate so that she can receive the booster dose — respecting the three-month window.

"Several pregnant women took AstraZeneca before stopping [the application]. These pregnant women could now take Pfizer as a second dose. It already has some interchangeability studies. Even the Ministry of Health itself already has data on people who took it wrong. It could complete the scheme of several people: people who had a reaction to AZ in the first one," said Ethel Maciel, epidemiologist and professor at the Federal University of Espírito Santo (Ufes).

Following Anvisa's recommendation, pregnant women were being immunized, in the first dose, only with CoronaVac or Pfizer.

But Soranz listed the following six clinical studies, with about 2,000 participants in total, which would "demonstrate safety and efficacy of heterologous application of Pfizer and AZ" — or a combination of the two:

* South Korean Government: 500 military professionals* Berlin University Hospital (Germany): 129 health care professionals between 18 and 64 years old* Carlos III Institute (Spain): 663 volunteers between 18 and 59 years old* Oxford University (United Kingdom): 463 volunteers with an average age of 57* University of Saarland (Germany): 250 health care professionals* University of Ulm (Germany): 26 health care professionals

Based on these surveys, according to Soranz, different countries sometimes recommended and sometimes authorized the mixing of doses.

Those recommending the combination are: Germany, Canada, South Korea, Chile, Denmark, France, Finland, Norway, Portugal and Sweden

Those allowing the combination are: Spain, UAE, the United Kingdom and Italy.

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