Biden Caves To Critics, Sends 20M FDA-Authorized Vaccines Abroad

 In a sign that the EU might be having second thoughts following objections from German Chancellor Angela Merkel, Brussels sent Washington a letter last week urging Biden to accelerate exports of COVID-19 vaccines to help countries like India, and many other developing economies, which are desperately lagging the developed world, and even - according to some scientists - threatening to revive COVID by allowing dangerous mutant strains to fester.

It appears President Biden as settled on a response, and in doing so, marked the latest suggestion that speeding up exports and increased supply sharing might be the compromise offered by the developed world to countries like India and South Africa, in exchange for giving up IP protections that numerous CEOs and lobbyists have warned is "the lifeblood" of the global biotech industry.

Bloomberg reports that for the first time, the US will send vaccines abroad as President Biden plans to send 20MM doses of shots from Moderna, Pfizer and J&J. This is the first time the US has voluntarily given up vaccines produced by the companies that have already received the FDA's stamp of approval (previously, Biden promised to share a 60M stockpile of AstraZeneca jabs). Mexico and Canada have already received doses of AstraZeneca, and Pfizer has already shippeddoses of its US-produced vaccine to countries including Mexico, Canada and Uruguay as part of private deals

Biden will also announce that he is putting Jeff Zients, who has served as the White House coronavirus response coordinator, in charge of his effort to beat back the global pandemic. But the appointment of Zients is more than anything a signal to the WHO and Dr. Tedros - who was warning about "vaccine apartheid" just hours ago - that Washington will make international needs a bigger priority - especially amid growing evidence that demand for vaccines in the US is waning, even though the Administration hasn't yet hit its goal of 70% of adults vaccinated, though the US is set to cross the threshold of 60% of adults having received at least one jab - while vaccination of minors below the age of 16 is just beginning.

Biden has previously promised not to share American-made jabs until he had secured enough supply for the entire US population. But as questions about demand rise, many are starting to wonder whether that threshold has already been crossed.

US caseloads have fallen dramatically, alongside hospitalizations and deaths. But fears about mutant strains that can defeat the vaccines linger. The other day, eight yankees including one player tested positive, but all but one were asymptomatic, raising questions whether tests might still be too sensitive, and reflecting too many false positives.

Source: Johns Hopkins Data

Whatever happens with the rate of vaccinations in the US, the plan is "a watershed moment in the pandemic and a pivot for Biden’s administration, BBG said. The US government, under two presidents, claimed nearly all of the first several hundred million doses of vaccines produced on its soil. That approach allowed Biden to advance what has been one of the most successful domestic vaccination campaigns in the world, with Bill Gates as his cheerleader. Now, criticism about Gates' status as unofficial global vaccine czar is intensifying (just as his divorce is being splattered across the headlines), after Washington broke with Gates by signaling support for an IP waiver.

BBG added that the issue has also been a fraught one for Biden, as he tries to absorb many of the "America First" leanings that proved to be so popular under his predecessor.

To be sure, 20M vaccines is more of a token, and won't really do all that much to help assuage the outbreak raging in India, and in other countries across at least three Continents.

So the question now is: will the US, perhaps joined by Europe, the UK and Japan, commit to regular offerings of vaccines? Or will we see Washington signal that the IP waiver will be its preferred tool for assisting developing nations?

https://www.zerohedge.com/geopolitical/biden-caves-critics-sends-20m-fda-approved-vaccines-abroad

J&J cuts vaccine deliveries to EU by half this week

 Johnson & Johnson has cut by half expected deliveries of COVID-19 vaccines to the European Union this week, an EU official told Reuters on Monday, compounding supply problems the company has faced since it began shipping doses to the bloc in April.

Under its contract with the EU, J&J has committed to shipping 55 million doses of its one-shot vaccine in the second quarter. But midway through the quarter, it had delivered less than 5 million doses, less than 10% of its target.

In addition to these initial delays, the drugmaker “is cutting deliveries this week by half,” one EU official involved in talks with vaccine makers said, adding that it is not clear how many doses will be delivered next week. The official did not say how many doses were expected this week.

J&J did not reply to a request for comment.

“We understand there is only a limited temporary reduction of deliveries which is expected to be caught up at a later stage,” a spokesman for the European Commission said, declining to say how many doses short this week’s delivery will be.

Both the EU source and the spokesman said the company was still aiming to deliver the contracted 55 million doses by the end of June.

J&J has faced production problems in the United States. The EU official said doses meant for the EU were produced both in the United States and in a factory in Leiden, in the Netherlands.

The official said J&J had not yet provided a clear schedule for its deliveries through the end of the second quarter.

The company had initially planned to begin delivering doses to the EU from April 1, but delayed the start of shipments to mid-April over production issues.

Deliveries were then interrupted just as they began over safety concerns, after use of the vaccine was temporarily paused in the United States to assess possible links with rare but serious blood clots. Deliveries resumed in Europe about a week later.

As of Monday, the company has delivered 2.6 million doses to European countries, data from the European Centre for Disease Prevention and Control (ECDC) show.

The European Commission, which has more up to date information on deliveries, confirmed that supplies have so far been below 5 million doses.

https://whbl.com/2021/05/17/jj-cuts-vaccine-deliveries-to-eu-by-half-this-week-eu-source/

Glaxo Supported by Leading Shareholders Over Elliott Management Shake-Up Bid

 GlaxoSmithKline PLC shareholders have backed the company over concerns that activist U.S. hedge fund Elliott Management is set to push for a shakeup, The Times reports.

--Several top 20 shareholders in the British pharmaceutical company have contacted Chairman Jonathan Symonds to express support for the board and its current strategy, according to The Times.

--Elliott hasn't yet revealed its intentions to the company but has begun to engage with other leading shareholders, The Times reports.

https://www.marketscreener.com/quote/stock/GLAXOSMITHKLINE-PLC-9590199/news/GlaxoSmithKline-Gets-Support-From-Leading-Shareholders-Over-Elliott-Management-Shake-Up-Bid-The-Tim-33278916/

SCOTUS denies Sandoz petition to review biosimilar Erelzi case

  -- Decision not to review Federal Circuit July 2020 ruling continues to

      prevent Sandoz launch of more affordable Erelzi treatment option for US 
      patients 
 
   -- Sandoz is disappointed US patients affected by chronic autoimmune and 
      inflammatory disease have to wait until 2029 for availability of 
      biosimilar Erelzi 
 
   -- Sandoz remains committed to pioneering access for patients and 
      contributing to more sustainable healthcare by launching biosimilar and 
      generic medicines

https://www.marketscreener.com/quote/stock/NOVARTIS-AG-9364983/news/Press-Release-Novartis-US-Supreme-Court-denies-Sandoz-petition-to-review-biosimilar-Erelzi-R-eta-33279629/

Apellis Jumps on Blood Disease Treatment Approval

 Apellis Pharmaceuticals  (APLS) - Get Report was climbing Monday after the biotech said it had won government approval for its rare blood disease treatment. 

Shares of the Waltham, Mass. were up 18.2% to $52.31 in early trading Monday.

Apellis said that the U.S. Food & Drug Administration had approved Empaveli, which the company said was the first and only targeted C3 therapy for treatment of adults with paroxysmal nocturnal hemoglobinuria, or PNH. The C3 gene provides instructions for making a protein that plays a key role in a part of the body's immune response.

PNH is a rare, chronic, life-threatening blood disorder caused by an acquired mutation, Apellis said, which leads to uncontrolled complement activation and the destruction of red blood cells through intravascular and extravascular hemolysis.

The approval is based on the results of a head-to-head Phase 3 Pegasus study, where Empaveli demonstrated "superiority to the medication Soliris for the change from baseline in hemoglobin level at Week 16," the company said.

Hemoglobin is a protein that carries oxygen via blood.

Soliris is a $3.6 billion seller developed by Alexion Pharmaceuticals  (ALXN) - Get Report, which did not immediately respond to a request for comment. Alexion shares were up 0.5% to $174.36 on Monday morning.

Empaveli also did better compared to Soliris on the endpoint of transfusion avoidance, Apellis said.

The company said 85% of Empaveli-treated patients were transfusion-free over 16 weeks, compared with 15% for those treated with the medication Soliris.

"This approval represents a major scientific advancement as Empaveli ushers in the first new class of complement medicine in almost 15 years," Cedric Francois, co-founder and CEO, said in a statement. 

The most common adverse reactions to the treatment included injection site reactions, diarrhea and abdominal pain.

The European Medicines Agency is currently reviewing the marketing authorization application for Empaveli, with the potential for a European Commission decision in the second half of the year.

Apellis said last year that its treatment had outperformed Soliris in a comparison test.

https://www.thestreet.com/investing/apellis-jumps-on-blood-disease-treatment-empaveli-approval

DIaMedica cleared to start Phase 2/3 stroke trial

 

• Initiating ReMEDy2 – Pivotal Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study

DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical Company focused on developing novel treatments for neurological disorders and kidney diseases, announced today that the U.S. Food & Drug Administration (FDA) has accepted the Company’s Investigational New Drug (IND) application. The Company plans to proceed with a pivotal Phase 2/3 study of DM199 (recombinant human tissue kallikrein-1or KLK1) for the treatment of patients with Acute Ischemic Stroke (AIS).

The upcoming ReMEDy2 Trial follows the Phase 2 study in AIS patients that demonstrated an improvement in stroke outcomes and reduction in stroke recurrence, along with an excellent safety profile. The findings are consistent with a significant body of clinical evidence from the use of the approved urinary-sourced KLK1 (Kailikang®) in China. The upcoming pivotal ReMEDy2 trial will evaluate whether DM199, a recombinant investigational agent, can improve three-month outcomes in AIS patients without other treatment options.

https://finance.yahoo.com/news/diamedica-therapeutics-announces-fda-clearance-125400319.html

Humanigen In Manufacturing Agreement for COVID-19 Therapy Candidate Lenzilumab

 Humanigen, Inc. (Nasdaq:HGEN) ("Humanigen"), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab™, and Chime Biologics ("Chime"), a world-class contract development and manufacturing organization (CDMO), today announced that they have entered into a manufacturing services agreement to produce lenzilumab bulk drug substance and drug product for Humanigen for commercial sale following receipt of the requisite regulatory authorizations or approvals in regions outside of the United States including Europe, the United Kingdom, India and Brazil.

https://finance.yahoo.com/news/humanigen-chime-biologics-enter-manufacturing-120000963.html