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Friday, June 17, 2022

Merck Shows Takeover Interest In Seagen

 

  • Merck & Co Inc (NYSE: MRK) is reportedly mulling buying cancer-focused biotech Seagen Inc (NASDAQ: SGEN), Wall Street Journal reported citing people familiar with the matter.

  • If the deal happens, it would be significant, given Seagen's market value of roughly $28 billion.

  • According to the report, some people said other unnamed suitors are also eying Seagen, a perennially speculated takeover target.

  • Talks have been underway for a while, the people said.

  • Though the people cautioned that pulling off the deal could be tricky given the heightened risk of a regulatory challenge.

  • WSJ also mentioned that a marketing agreement is also possible between Merck and Seagen.

Graphite Bio started at Outperform by BMO

 Target $12

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

'U.S. Covid test makers anticipate layoffs after government reallocates funds'

 Domestic Covid test manufacturers are wrestling with the federal government’s decision to shuttle an already dwindling amount of Covid-19 funding to vaccines and treatment and away from testing.

“Testing manufacturing capacity is already heading to 65% of pre-peak production, and we estimate that we could lose thousands of additional American jobs in the coming weeks,” an HHS spokesperson said in an email to STAT.

Declining demand for tests had already caused some companies to scale back production, and some said further cuts, as well as layoffs, were probable after White House officials said last week that funding earmarked for testing and personal protective equipment would instead go to buy vaccines and Paxlovid oral antiviral treatment.

And it doesn’t look like the White House will be getting more funding to replenish their Covid-19 response accounts from Congress anytime soon. The most obvious compromise proposal has fallen apart, and the top Senate Republican negotiator, Sen. Mitt Romney (R-Utah), blasted the Biden administration as giving him “patently false” information about the urgency the situation.

Labcorp, one of the biggest U.S. test makers, said government support was crucial for the company to maintain its capacity to address demand for PCR tests.

“In response to decreasing demand for COVID-19 PCR testing due, in part, to the availability of vaccines, boosters and other testing options and the loss of government funding, Labcorp reduced its staffing levels, primarily contingent and temporary workers, dedicated to daily COVID-19 PCR testing,” Christopher Allman-Bradshaw, a Labcorp spokesman, said in an email to STAT.

Tom Inglesby, director of the Johns Hopkins Center for Health Security at the Bloomberg School of Public Health, emphasized the need to be prepared with stable testing capacity that won’t need to be rebuilt if we have another surge of cases this fall.

“We also need to develop additional tools like new vaccines that can handle the variants that have emerged and will emerge, and a testing infrastructure that doesn’t go up and down, and have to get dismantled and rebuilt when we have peaks and troughs, should we have them in the future,” Inglesby said. He previously served as the Biden administration’s Covid-19 testing coordinator.

A health care consultant who requested anonymity given that discussions on this topic are still ongoing said layoffs were likely without funding.

“Everybody is wrestling right now with what to do with no federal money, which has supported most of the tests,” the consultant said. Anticipating another surge in Covid cases, the person said that if “it becomes a more virulent and aggressive variant, we are in deep trouble.”

These events carry a sense of déjà vu. In the spring of 2021, virus cases in the U.S. plummeted, leading to fewer Covid-testing sales. Abbott Laboratories canceled contracts with suppliers, stopped production at its plants, and dismissed 2,000 employees only to hire hundreds back when there was a surge of cases with the Delta variant that fall and winter.

At the moment, funding cuts have not affected Abbott’s ability to provide testing, according to John Koval, a spokesman. But having a reliable supply of tests will depend on consistency of orders and manufacturing when case counts are still low seasonally, he said in an email statement to STAT.

“We self-invested to build our new facilities at the beginning of the pandemic in the U.S. and source nearly all of our BinaxNOW test components from diversified domestic suppliers, which protects against overseas supply chain disruptions and supports 200,000-300,000 indirect American jobs,” he said.

The companies and health officials alike said that trading off between testing and vaccines was dangerous, especially for a virus that is contagious even before or without symptoms. Investing in testing is beneficial from a monetary standpoint, too, the consultant argued. After all, an average hospitalization from Covid costs $20,000 — the cost of approximately 2,000 Covid tests, which can deter the spread of the virus.

The consultant explained that after a manufacturing line is shut down, not only is the process of rehiring tedious logistically, but also complicated by the need to find employees with very specific skills. Companies also undergo the laborious process of ensuring quality control for their manufacturing sites as per the Food and Drug Administration’s policies.

The HHS spokesperson said that at the start of the pandemic, the United States  had very little domestic manufacturing of tests. Once that increased production winds down, “it takes months to ramp up, which is too slow for fast-moving and evolving variants.”

The loss of domestic Covid-19 testing production means that the U.S. is likely to be dependent on foreign nations, like China, during future Covid surges. The current leading Covid test manufacturer, iHealth, is an example of an Asian manufacturer ramping up testing capacity as U.S. companies scale down.

At a briefing last week, the White House coronavirus coordinator, Ashish Jha, acknowledged the impasse and said there would be consequences.

“The domestic manufacturing of testing issue is really unfortunate because the U.S. government put a lot of resources and effort into building up that domestic manufacturing and what we are seeing is that day-by-day and week-by-week that is beginning to go away,” Jha said. “Companies, because the demand has fallen for these tests, are laying off workers and shutting down production lines.”

And, he warned, rebuilding production after scaling down would be more expensive and difficult.

“If we are not able to reverse it and we find ourselves in another surge without tests, we will largely rely on foreign manufacturers mostly from China to provide the tests that Americans need,” Jha said. “That is not the situation we need to be in.”

https://www.statnews.com/2022/06/17/u-s-covid-test-makers-anticipate-layoffs-after-government-reallocates-funds/

U.S. EPA ORDERED TO REASSESS GLYPHOSATE'S IMPACT ON HEALTH, ENVIRONMENT

 The U.S. Environmental Protection Agency was ordered by a federal appeals court on Friday to take a fresh look at whether glyphosate, the active ingredient in Bayer AG's Roundup weed killer, poses unreasonable risks to humans and the environment.

In a 3-0 decision, the 9th U.S. Circuit Court of Appeals agreed with several environmental, farmworker and food-safety advocacy groups that the EPA did not adequately consider whether glyphosate causes cancer and threatens endangered species.

The litigation began after the EPA reauthorized the use of glyphosate in January 2020.

Groups including the Natural Resources Defense Council, the Center for Food Safety and the Rural Coalition, which represents farmworkers, faulted the agency for rubber-stamping glyphosate despite its alleged harms to agriculture, farmers exposed during spraying, and wildlife such as the Monarch butterfly.

Circuit Judge Michelle Friedland wrote for the Pasadena, California-based appeals court that the EPA did not properly justify its findings that glyphosate did not threaten human health and was unlikely to be carcinogenic to humans. She also faulted aspects of the agency's approval process.

Bayer's Monsanto unit, which makes Roundup, opposed groups challenging the EPA reauthorization. Friday's decision does not prevent people from using Roundup or similar products.

An EPA spokeswoman said the agency will review the decision.

Bayer said the EPA conducted a "rigorous assessment" of more than 40 years of science, and believes the agency will continue to conclude that glyphosate-based herbicides are safe and are not carcinogenic.

George Kimbrell, a lawyer for the Rural Coalition, in an interview called the decision "a historic victory for farmworkers, the public and endangered species."

Bayer has faced tens of thousands of lawsuits claiming that Roundup causes cancer and other illnesses.

The U.S. Supreme Court is expected to decide soon whether to hear the German company's appeal of a $25 million damages award to Edwin Hardeman, a Roundup user who blamed his cancer on its weedkillers.

The cases are Natural Resources Defense Council et al v EPA, 9th U.S. Circuit Court of Appeals, No. 20-70787, and Rural Coalition et al v EPA et al in the same court, No. 20-70801.

https://www.agriculture.com/markets/newswire/update-1-us-epa-ordered-to-reassess-glyphosates-impact-on-health-environment

Back story: Biotech investment, deals down Q1: Q2?

 The massive $15.9 billion haul for biopharma technology deals in 2021 was always going to be tough to beat, but dealmaking in 2022 is off at a snail's pace, with M&A, IPOs and fundraising all plummeting, according to a new report.

Funding for the world’s biopharma technology companies totaled $2.8 billion in the first quarter of the year, down 10%, according to CB Insights’ State of Biopharma Tech Q1’22 Report. This was the fourth consecutive quarter with a decline in deals, with just 66 signed for the months of January through March.

We already know that M&A has been slow—just ask anyone who came out of the J.P. Morgan Healthcare Conference in January disappointed with the slew of licensing deals. But the CB Insights report has the details: There was a 60% drop in M&A exits in the first quarter, with just six recorded, compared to 15 in the fourth quarter of 2021.

And one trend that is no more? Special purpose acquisition company deals. With the abysmal count of M&A exits and just two IPOs, there were exactly zero SPAC deal exits in the first quarter.

This comes amid a broader cooling of the biopharma market, as CB Insights framed it. This market correction has claimed hundreds, if not thousands of staffers at biotechs everywhere amid massive layoffs

The two IPOs that did come off the ground were for Amylyx Pharmaceuticals and Lepu Biotechnology, which was actually an improvement from the single offering in the fourth quarter of 2021.

The majority of the first-quarter funding went to U.S.-based companies, which collected $2.3 billion in 40 deals, or 80% of the total funding. The U.S. has been the place to be for biopharma investing for the past three quarters. Companies based in the rest of the world nabbed just $560 million in 26 deals.

So-called megarounds, which involve $100 million or more, have also plummeted. With nine deals in the category, funding totals $1.6 billion so far this year, compared to $10 billion in 53 deals for all of 2021. All of the megarounds for this year have gone to U.S.-based companies.

But when you break out of the overall trend data, some exciting companies and emerging technologies come into focus. CB Insights ranked Freenome as the No. 1 equity deal of the year so far, with its $290 million series E, which included the Roche Venture Fund. The company also collected a megaround in 2021 with a $300 million series D. The company is developing a colorectal cancer screening test and diagnostic technology for other cancers.

Kallyope wouldn’t have made the No. 2 slot on the list if the company had gone with its original IPO plans earlier this year. Reading the tea leaves on the biotech markets, however, the company opted for a series D in February, raising $236 million to support three compounds in development for Type 2 diabetes, obesity and inflammatory bowel disease. CEO Jay Galeota, formerly Merck's chief development officer, told Fierce Biotech that he’s still eyeing that IPO: It just may take until 2024.

Fungi specialist LifeMine Therapeutics landed at No. 5 for its $175 million series C in March that also included a $70 million deal with GSK to develop three therapeutic candidates.

Others on the top equity deal list include Maze Therapeutics’ $190 million financing and Celsius Therapeutics’ $83 million series B.

Earlier-stage deals of note include Seismic Therapeutics’ $101 million series A in February and TrialJectory’s $20 million series A from the same month.

https://www.fiercebiotech.com/biotech/investment-ma-ipos-its-all-down-new-report-surveys-damage-boring-quarter-deal-action

Acadia antipsychotic snubbed by FDA panel

 https://seekingalpha.com/news/3849717-acad-stock-on-watch-as-fda-panel-snubs-antipsychotic-therap

Fed could 'break' the economy with aggressive rate hike campaign: analyst

 Wall Street is increasingly skeptical that the Federal Reserve can crush inflation without also triggering an economic recession as the U.S. central bank hikes interest rates at the fastest pace in decades. 

Central bank policymakers on Wednesday approved a 75 basis point interest rate hike for the first time since 1994 as they race to catch up with runaway inflation. 

Another hike of that magnitude could be on the table in July amid signs of stubbornly high inflation, Chairman Jerome Powell told reporters after the meeting, prompting investors to reassess the economic outlook.

"The Federal Reserve is going to hike interest rates until policymakers break inflation, but the risk is that they also break the economy," Ryan Sweet, the head of monetary policy research at Moody’s Analytics, said in an analyst note. 

"Growth is slowing, and the effect of the tightening in financial market conditions and removal of monetary policy has yet to hit the economy."

Federal Reserve Chairman Jerome Powell

U.S. Federal Reserve Chair Jerome Powell speaks during a news conference on interest rates, the economy and monetary policy actions at the Federal Reserve building in Washington, D.C., June 15, 2022. (Oliver Douliery/AFP via Getty Images) / Getty Images)

The Fed could confront a difficult decision in coming months, Sweet said, as officials determine whether to induce a recession or wait to see if inflation subsides but risk a deeper recession and "stagflation" scenario. Hiking interest rates tends to create higher rates on consumer and business loans, which slows the economy by forcing employers to cut back on spending.

"The Fed could be faced with a Hobson’s choice: Push the economy into a mild recession, similar to our scenario, to tame inflation, or wait and cause a more significant recession, since a stagflation scenario is possible next year if the Fed isn’t aggressive enough," Sweet wrote.

Inflation food prices

A man shops at a Safeway grocery store in Annapolis, Md., May 16, 2022, as Americans brace for summer sticker shock and inflation continues to grow.  (Jim Watson/AFP via Getty Images / Getty Images)

Moody's Analytics is not the only firm lowering its outlook and raising the odds of a recession after the Fed's super-sized interest rate hike this week. Bank of America raised the odds of a recession next year to 40%, while JPMorgan Chase strategists said the S&P sell-off suggests an 85% chance of a downturn. 

Officials also laid out an aggressive path of rate increases for the remainder of the year. New economic projections released after the two-day meeting showed policymakers expect interest rates to hit 3.4% by the end of 2022, which would be the highest level since 2008. 

But the economic projections, known as the "dot plot," show that while policymakers expect rate hikes to conclude in 2023 at a peak of 3.8%, they have also forecast several modest interest rate cuts in 2024, a sign that the Fed could be bracing for a slowdown in coming years.  

recession diagram

The U.S. could be facing a recession. (iStock / iStock)

"The downward revision of the growth path, increase in unemployment and inflation remaining (at) elevated   levels imply that the probability of a recession is rising," said Joe Brusuelas, RSM chief economist. "And we think the first real possibility of the economy falling off a cliff resides in the first quarter of next year."

Although Powelll has said the central bank is not trying to induce a recession, he has not ruled out the possibility of a downturn and has admitted the odds of a successful "soft landing" are getting narrower.

"There’s a path for us to get there," Powell said Wednesday, referring to a soft landing. "It’s not getting easier. It’s getting more challenging." 

https://www.foxbusiness.com/economy/fed-could-break-economy-aggressive-rate-hike-campaign-analyst-says