Swedish rare disease drugmaker Sobi to go private in $8B takeover by Advent, GIC

 After AstraZeneca’s $39 billion acquisition of Alexion, another rare disease drugmaker has become the target of a takeover.

Thursday, Swedish biotech Sobi said it has received an offer from private equity firm Advent International and Singapore’s sovereign wealth fund, GIC, to buy out the company for SEK 69.4 billion (about $8 billion).

The purchase price, at SEK 235 per Sobi share in cash, represents a 34.5% mark-up from the firm’s closing price on Nasdaq Stockholm on Aug. 25, before Bloomberg reported Advent’s interest in a potential deal for Sobi.

Sobi’s board unanimously recommends its shareholders approve the transaction partly because its largest shareholder, the Wallenberg family-controlled Investor AB, has signed off on the accord in a separate agreement with the buyer. The prominent Swedish investment shop currently holds a 35.4% stake in Sobi.

But Investor AB’s backing isn’t unconditional. Its support will become void if a competing offer emerges at a per-share price of SEK 251 or more and wins unanimous recommendation from the Sobi board, the holding company said in a separate statement.

The Sobi deal draws comparisons to AstraZeneca’s recent Alexion acquisition. In Alexion, AZ got a rare disease portfolio—including complement inhibitors Soliris and Ultomiris—and valuable scientific know-how in immunology. Sobi is also a rare disease player, with immunology being one of its two focus areas.

Sobi just so happens to be a direct competitor to AZ in its newly acquired complement inhibitor franchise. Through a licensing deal last fall, Sobi gained ex-U.S. commercial rights to Apellis’ C3 inhibitor Empaveli. The drug earned an FDA go-ahead in paroxysmal nocturnal hemoglobinuria after beating Soliris head-to-head in improving patients’ hemoglobin levels.

Elsewhere in immunology, Sobi sells IL-1Ra inhibitor Kineret for a slate of inflammatory diseases, including rheumatoid arthritis, as well as rare conditions such as cryopyrin-associated periodic syndromes. In 2020, the drug raked in sales of SEK 2.08 billion ($242 million), up 35% year over year.

Through a 2019 deal with Novimmune, Sobi gained full control of anti-interferon-gamma antibody Gamifant shortly after it won FDA approval for the rare disease of primary hemophagocytic lymphohistiocytosis (pHLH). And last year, Sobi picked up low blood platelet med Doptelet via a $915 million acquisition of Dova Pharmaceuticals to beef up the other arm of its business, hematology.

But both acquisitions suffered setbacks in 2020. The European Medicines Agency rejected Gamifant in pHLH twice, and Doptelet flopped a phase 3 testing for chemotherapy-induced thrombocytopenia. Sobi is still aiming to expand Gamifant in secondary HLH and acute graft failure.

Last year, Sobi’s revenues climbed 8% year over year at constant currencies to SEK 15.3 billion ($1.78 billion).

Sobi has been a rumored target for M&A before this buyout interest. Back in 2015, the Swedish pharma reportedly rejected buyout propositions from Pfizer and Biogen because it said the offer price was too low.

https://www.fiercepharma.com/pharma/swedish-rare-disease-drugmaker-sobi-to-go-private-8b-takeover-by-advent-gic

Former Eli Lilly job applicants say company's hiring practices favor young

 Following a high-profile chief financial officer exit earlier this year and a discrimination lawsuit filed a month later, Eli Lilly is again in the spotlight for a personnel issue—this time for alleged age bias. 

In a proposed class-action lawsuit filed this week in Indianapolis federal court, two former Eli Lilly job applicants say the company has "systematically excluded" older candidates for diabetes and primary care sales positions in favor of younger workers, even if the older applicants were "equally or more qualified." 

Lilly denies the allegations, a spokesperson said over email.

Pharma sales reps Jared Grimes, 49, and Georgia Edmondson, 55, sued Eli Lilly alleging the company recruits for certain positions only through on-campus activities and internships. The company fills those sales rep positions with interns "until there are no more interns left," the lawsuit says. 

"Only after exhausting all potential intern hires does Eli Lilly sometimes post these positions publicly," the plaintiffs claim.

If the company does post a position publicly, "older applicants are routinely eliminated early in the process," Grimes and Edmondson say in their suit. That's because Lilly managers have an incentive to meet the company's "discriminatory quotas" to hire "millennials" and "early career professionals," the suit claims. 

The plaintiffs say the hiring practices "are no accident" but rather a priority of CEO David Ricks. After taking the position, Ricks "began to publicly stress the fact that he wanted to increase the percentage of millennial sales representatives to 40% of the overall sales force by 2020," the lawsuit claims.

Lilly does "not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status," the company's spokesperson said. "We are committed to fostering and promoting a culture of diversity and respect. We do not comment on the details of ongoing litigation."

Grimes worked for Eli Lilly from 2008 to 2017, but was laid off during a restructuring. 

The suit comes months after some high-profile controversies for the company earlier this year. In February, the company parted ways with CFO Josh Smiley after an investigation concluded he engaged in "consensual though inappropriate personal communications" with employees. As part of that departure, Smiley forfeited $24 million in cash and equity awards.

A month later, longtime biopharma lobbyist Sonya Elling sued the company under the Civil Rights Act, claiming she was wrongfully terminated and mistreated by managers on the basis that she is a "strong, assertive female," who didn't "conform to traditional gender stereotypes." The company settled that case in late June.

Lilly isn't alone in facing age discrimination claims in the pharma industry. In a recent case, an ex-AstraZeneca manager claimed she was fired for her age and for not being willing to market drugs beyond their FDA labels. In that case, a jury awarded her $2.4 million.

Aside from AstraZeneca, biopharma companies such as Biogen and Teva have been hit with claims of age discrimination in recent years.

https://www.fiercepharma.com/pharma/former-eli-lilly-job-applicants-say-company-s-hiring-practices-favor-young

NYC Teachers Union Demands City Drop Mandatory Vaccination Policy For Teachers

 With the start of the new school year less than two weeks away, Mayor Bill de Blasio's push to make sure every teacher and school worker is vaccinated is hitting another snag. The city's teacher's unions are refusing to simply allow the mayor to fire the 15,000 or so teachers who have refused to be vaccinated for medical or religious reasons.

Teachers union chief Michael Mulgrew said Thursday that City Hall had vowed to remove all unvaccinated staffers from payroll without exception, including those with legitimate religious and medical objections, which Mulgrew said doesn't make sense. Because of his opposition, negotiations with the city have gone "to a very bad place"

“Our impact negotiations with the city have gone to a very bad place,” Mulgrew told reporters after a Town Hall with members. "It’s clear that the two sides are very very far apart when it comes to this vaccine mandate."

[...]

"The city’s position is to remove them from payroll," he said. "That is disgusting as far as I’m concerned. And it does not follow the law. The law says that these accommodations and exemptions have to be in place.”

Also, as we noted earlier,a recent study showed teachers do not face an increased risk of hospital admission from COVID.

While he has urged members to get the shot, Mulgrew claims the city's position is "unreasonably rigid", and not accommodating those with legitimate medical issues.

It's not fair to financially penalize them, Mulgrew said.

To try and put more pressure on City Hall,the teacher's union is seeking to work with other labor groups as they team up to leverage their combined influence.

They're also hoping to highlight the fact that these restrictions will have an outsize impact on minorities, especially Blacks, view the vaccine with mistrust.

Not every union member is backing Mulgrew on this. Some union factions have demanded mandatory jabs for all, complaining that those who don’t get the shot are putting their colleagues and others at risk. DOE staffers have until Sept. 27 to get their first shot and an agency spokesperson said that an accord with the union is nearing completion.

"The health and safety of New York City children and the protection of our employees is at the core of the vaccine mandate," said spokesperson Danielle Filson. "We will continue to negotiate with the UFT to reach a successful agreement because that is what’s best for our school communities."

As of last week, the city said that 72% of city teachers and 63% of all school workers had already been vaccinated. And if anything, the city said, the number of vaccinated workers is probably higher, as some likely got the shot through private practitioners not through the school.

After acknowledging that the vaccine requirement had created controversy and division within his ranks, Mulgrew added during Thursday night's meeting that members should dial back their rancor on social media, and not play into the same toxic dynamics that are leading school board members across the country to quit. “t

https://www.zerohedge.com/political/nyc-teachers-union-demands-city-hall-drop-mandatory-vaccination-policy-teachers

Health Officials Push Back Against Biden's Booster Jabs Plan

Just as President Biden was promising to unveil new federal measures for combating the delta variant next week, the NYT dropped a bombshell report claiming that the heads of the CDC and FDA had advised the White House to scale back its plan for booster shots.

During a meeting at the White House, they reportedly asked White House pandemic coordinator Jeff Zients for more time to collect data on the efficacy of booster shots, according to the NYT's sources.

Dr. Janet Woodcock, the acting commissioner of the Food and Drug Administration, and Dr. Rochelle P. Walensky, who heads the Centers for Disease Control and Prevention, warned the White House on Thursday that their agencies may be able to determine in the coming weeks whether to recommend boosters only for recipients of the Pfizer-BioNTech vaccine — and possibly just some of them to start.

The two health leaders made their argument in a meeting with Jeffrey D. Zients, the White House pandemic coordinator. Several people who heard about the session said it was unclear how Mr. Zients responded. But he has insisted for months that the White House will always follow the advice of government scientists, wherever it leads.

In response to the NYT's questions, the White House said it's merely trying to "follow the science". That this statement is blatantly untrue shouldn't require too much explanation. Let's review: pushing for mandatory masks in schools, refusing to accept natural immunity, pushing for vaccine passports etc.

Asked about the meeting, a White House spokesman on Friday said, “We always said we would follow the science, and this is all part of a process that is now underway,” adding that the administration was awaiting a “full review and approval” of booster shots by the F.D.A. as well as a recommendation from the C.D.C.

"When that approval and recommendation are made,” the spokesman, Chris Meagher, said, “we will be ready to implement the plan our nation’s top doctors developed so that we are staying ahead of this virus.”

President Biden has said the plan is for every adult to get a booster shot eight months after you got your second shot, with the president claiming it wil end the pandemic faster. Of course, in recent weeks, more doctors have spoken out against booster shots, claiming it would be better for them to go to the developing world, to people who haven't received any jabs, that way it can help protect against the emergence of a new deadlier and more infectious variant.

And they're not alone: while Israel pushes ahead with its plan for booster jabs, the EU's equivalent to the CDC has broken with the Biden Administration saying this week that booster jabs aren't necessary. And senior officials at the FDA have also stepped down over their disagreements aboout booster jabs.

Advisers to the FDA are expected to discuss two key questions when they meet on Sept. 17 to consider a COVID-19 vaccine booster campaign this fall. The first: is protection from the initial shots waning, and the second: will boosters help?

By moving ahead unilaterally, the White House usurped the CDC and FDA's authority over these types of health-related calls, Reuters added.

"The recommendation shouldn't precede the data, which is what happened here. And that's why people are so upset," said a source close to the FDA advisory panel who was not authorized to speak on the record.

Take a look at this piece of 'news analysis' published by Reuters.

Shares of Moderna skidded lower on the news, as this is the latest sign that real resistance to Biden's booster jabs for all plan is growing.

https://www.zerohedge.com/political/top-health-officials-push-back-against-bidens-booster-jabs-plan

FDA OKs Impel NeuroPharma nasal spray for migraine

 TRUDHESA Is the First and Only Therapeutic to Use POD technology to Deliver Dihydroergotamine Mesylate (DHE) to the Vascular-Rich Upper Nasal Space

TRUDHESA Is Well Tolerated and Delivers Rapid, Sustained and Consistent Symptom Relief for the Acute Treatment of Migraine

Commercial Launch of TRUDHESA is Planned for Early October 2021

Impel to Host Investor Call on Tuesday, September 7, 2021 at 8:30 a.m. ET

Conference Call Information
Impel NeuroPharma will host a live conference call and webcast on Tuesday, September 7, 2021 at 8:30 a.m. ET to discuss the FDA’s approval of TRUDHESA. The conference call may be accessed by dialing 877-295-2648 (domestic) or 470-495-9487 (international) and referring to conference ID 4387746. A live webcast of the event will be available on the Investors section of the Impel NeuroPharma website at https://investors.impelnp.com/. A replay of the webcast will be available on the Impel NeuroPharma website following the event.

https://finance.yahoo.com/news/impel-neuropharma-announces-u-fda-125000945.html

August payrolls rise by disappointing 235,000; jobless rate falls to 5.2%

 The U.S. economy added back jobs at a far slower pace in August following an early-summer jump in employment, as an initial wave of reopening hiring waned and concerns over the Delta variant increased.

The Labor Department delivered its monthly jobs report at 8:30 a.m. ET Friday morning. Here were the main metrics from the report compared to consensus estimates compiled by Bloomberg:

• Change in non-farm payrolls: +235,000 vs. +733,000 expected and +943,000 in July

• Unemployment rate, August: 5.2% vs. 5.2% expected and 5.4% in July

• Average hourly earnings, month-over-month: 0.6% vs. 0.3% expected and 0.4% in July 

• Average hourly earnings, year-over-year: 4.3% vs. 3.9% expected and 4.0% in July

Following back-to-back months of non-farm payroll gains of more than 900,000, employers added back the fewest jobs since January. Still, this marked an eighth consecutive month of net job growth, and brought total employment closer to pre-pandemic levels. The unemployment rate also dipped further to reach a pandemic-era low of 5.2%, while holding above the 50-year low of 3.5% from early 2020.

As of July, the civilian labor force was still down by more than 3.1 million members since February 2020. And the economy has shed a net total of 5.7 million payrolls since the start of the pandemic, with these losses getting recovered at a sluggish pace compared to the swift drop in jobs during the spring last year. 

Some of the industries that were expected to still post strong — if slowing — job gains were those within the U.S. services sector. Though the Delta variant may have deterred some from taking high-contact jobs in the past month, bars, restaurants and other services industries have seen some of the strongest consumer demand, and employers have looked to hire to keep pace. Education will also likely offer another strong boost to employment, given that schools have begun to reopen more fully after last year's closures. Local government and private education together added back 261,000 jobs in July.

For the labor market at large, one of the biggest concerns has been around bringing back jobs quickly enough to meet consumer demand and fill widespread vacancies among employers. As of the latest data, job openings were at a record high of 10 million in June, underscoring the supply and demand mismatches still present in the recovering economy. 

"There are a lot of jobs but not necessarily a lot of desirable jobs," Peter Quigley, CEO of Kelley Services, told Yahoo Finance ahead of the release of Friday's jobs report. "And while employers are pounding the table wanting workers, workers are frankly taking their time, trying to figure out what jobs are the right fit for them. Job priorities have changed over the last 18 months.

"Employees are looking for something different. They're looking for flexible time. They're looking for remote opportunities. They're looking for enhanced stability in their job. They're looking for well-being programs," he added. "They're looking for up-skilling and career development opportunities. And of course, being in a safe environment and being in a welcoming environment." 

And for investors, Friday's jobs report will serve as a critical piece of data informing the Federal Reserve's next move on monetary policy. Many Fed officials have suggested they are looking especially closely at labor market data to determine when they will formally announce and then begin tapering their crisis-era asset purchase program. Another stronger-than-expected jobs report could signal the economy has garnered enough momentum to further progress without the help of a highly accommodative monetary policy tilt. 

"On balance, we look for the August employment report to unfold in a manner that would likely count as 'substantial further progress' for many Fed officials," Sam Bullard, senior economist for Wells Fargo, wrote in a note. "Our base case is that we do not look for the Delta variant to derail the economic recovery, and that economic conditions will continue to evolve to the point where officials announce the tapering plan by the December FOMC policy meeting, kicking off the tapering of asset purchases in late 2021 or early 2022."

https://finance.yahoo.com/news/august-jobs-report-nonfarm-payrolls-labor-department-coronavirus-194347179.html

EU reviewing cases of rare body inflammation after COVID-19 shots

 Europe's medicines regulator said on Friday it was reviewing cases of multisystem inflammatory syndrome after inoculation with COVID-19 vaccines, following a report of a similar case with Pfizer/BioNTech's shot.

The European Medicines Agency's safety committee is also looking into cases of blood clots in the vein with Johnson & Johnson's COVID-19 vaccine, the regulator said, adding that the issue was distinct from a rare side-effect identified earlier.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-EU-reviewing-cases-of-rare-body-inflammation-after-COVID-19-shots-36317887/