NMC sues Dubai bank in $6 billion UAE debt row

 The United Arab Emirates’ largest private healthcare provider NMC is suing a Dubai bank in Abu Dhabi courts, three sources said and a court document showed, in a dispute that could complicate the company’s multibillion-dollar debt restructuring and potentially delay payouts to creditors.

The healthcare company ran into trouble last year after the disclosure of more than $4 billion in hidden debt.

Its UAE operating businesses were placed into administration in the courts of Abu Dhabi’s international financial centre ADGM. Claims from creditors to date amount to $6.4 billion, the company has said.

The legal action by NMC’s administrator against Dubai Islamic Bank (DIB) comes after DIB filed lawsuits in neighbouring Dubai. The lawsuits pit UAE’s different legal systems against one another and risk complicating the restructuring.

“So which court takes priority now?” one of the sources said. “The problem is that none of this has ever been done before.” The sources declined to be identified because of the commercial sensitivity of the matter.

NMC’s lawsuit seeks to give its administrators, Alvarez & Marsal, power over securities claimed by DIB and possibly use them to pay other creditors, the sources and the court document seen by Reuters showed.

Pending a full account of the receivables to the administrators and payment by DIB of the proceeds, “the joint administrators shall be entitled to withhold any distribution or payment that would otherwise be due to DIB from the estate of the companies, or other property in the hands of the joint administrators,” the court document said.

That could leave DIB, which has an exposure of over $400 million to NMC, out of pocket. NMC had secured loans from DIB using collateral known as insurance receivables, which relate to payments by insurance companies for medical treatment.

DIB has already sought rights over those securities in cases filed in neighbouring Dubai, three sources close to the matter said.

ADGM told Reuters it does not comment on ongoing court proceedings. Alvarez & Marsal, which has been appointed as administrator of NMC, declined to comment. DIB did not respond to a request for comment.

LEGAL TANGLE

The UAE’s legal system has both onshore and offshore jurisdictions. The onshore courts use UAE law, while the Abu Dhabi Global Markets courts and the courts of the financial free zone Dubai International Financial Centre (DIFC) are modelled on the English judicial system.

“You have a situation where you have facilities granted by banks secured by security - for example assignment of receivables - governed by the UAE, onshore law ... and then you have the companies redomiciling in ADGM, in an English style process,” said one of the sources, speaking anonymously for commercial sensitivities.

Courts in the Dubai International Financial Centre and Abu Dhabi onshore courts have recognised Alvarez & Marsal’s role as administrator for NMC.

It is planning to submit a request to have the administration recognised in Dubai onshore courts, it said in an update last week.

The administrator has said this process would help to protect and maximise NMC’s assets for the benefit of creditors.

https://www.reuters.com/article/us-emirates-nmc-restructuring/exclusive-nmc-sues-dubai-bank-in-6-billion-uae-debt-row-sources-idUSKBN2C1277

NovoCure cut to Underperform from Neutral by Wedbush

Target to $154 from $159

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

Galectin Combo Study Shows Enhanced Tumor Response

 

• Galectin Therapeutics Inc (NASDAQ: GALT) has announced that a paper in the peer-reviewed Journal for ImmunoTherapy of Cancer (JITC) published data from an ongoing Phase 1 trial evaluating Galectin's belapectin in head & neck cancer, lung cancer, and melanoma.

• The study assessing belapectin combined with Merck's & Co's (NYSE: MRK) Keytruda (pembrolizumab) is being conducted to collaborate between Galectin and Providence Cancer Institute in Portland.

• As previously disclosed, an objective response of 50% in advanced metastatic melanoma and 33% in head and neck squamous cell carcinoma patients was observed in the study.

• It compares favorably to published response rates on pembrolizumab alone.

• The publication also noted that the combination was associated with fewer immune-mediated adverse events than anticipated with pembrolizumab alone.

• Besides, the patient's tumor tissue analysis showed reduced monocytic myeloid-derived suppressor cells and increased effector memory T-cell activation in responders compared with non-responders.

• An increase in baseline expression of galectin-3 positive tumor cells correlated with clinical response was also seen.

• Belapectin (GR-MD-02) is a complex carbohydrate drug that targets galectin-3, a critical protein in NASH and fibrosis's pathogenesis. The company believes Galectin-3 has a significant role in cancer as well.

• The drug candidate binds to galectin-3 and disrupts its function.

https://finance.yahoo.com/news/galectin-therapeutics-stock-trading-higher-122827207.html

Federal Advisory Panel Meeting on J&J Vaccine

 A federal advisory panel will meet Wednesday to debate whether and how Johnson & Johnson's Covid-19 vaccine should continue to be used in the U.S., following reports of rare but severe blood clots among a few recipients.

The Advisory Committee on Immunization Practices, or ACIP, is expected to review clinical data gathered to date on six women between the ages of 18 and 48 years who developed blood clots after receiving J&J's vaccine, according to a draft agenda of the meeting posted online Tuesday.

The committee's virtual emergency meeting, scheduled for three hours Wednesday afternoon, will be open to the public.

Its findings and decisions will help determine how the federal government moves forward with the J&J vaccine at a difficult juncture in the pandemic. The U.S. is racing to vaccinate more people to damp the impact of more-infectious and rapidly spreading variants of the Covid-19 virus.

J&J has said it is aware of the cases involving blood clots and low platelet counts and is working with health authorities. It is unclear whether the vaccine is the cause. President Biden said the U.S. has sufficient supplies of other vaccines to inoculate all eligible adults in the U.S.

The ACIP advises the U.S. Centers for Disease Control and Prevention on who should get vaccines and how they should be used.

The recommendations made by its 14 voting members--medical and public-health experts from outside the agency--go to the CDC director, who decides whether to make them policy. The U.S. Food and Drug Administration will also review the committee's recommendations on the J&J vaccine.

The ACIP recommended who should be given priority for Covid-19 vaccines and in which order. After the FDA authorized Covid-19 vaccines from Pfizer Inc. and partner BioNTech SE, Moderna Inc. and then Johnson & Johnson, the panel recommended the shots.

Only a few details about the six blood-clot cases are known publicly. The patients developed symptoms including headaches, abdominal pain, nausea and neurological symptoms six to 13 days after vaccination. All six were diagnosed with blood clots in vessels draining blood from the brain; two also had clots in vessels that drain the intestines.

One of the women died and another is in critical condition, according to federal health officials.

One of the six, a woman in her late 40s from Douglas County, Neb., developed blood clots two weeks after receiving her vaccine. Nebraska public health officials announced an investigation into that case on April 9.

More than 6.8 million J&J doses have been administered to date in the U.S. The six women's cases were reported to the federal government's vaccine adverse-event reporting system in late March and early April.

The CDC issued an alert to healthcare providers Tuesday warning them to screen patients for the blood-clotting condition if they recently received the J&J vaccine and have severe headache or abdominal pain, shortness of breath, backache, leg swelling, new neurological symptoms or new or easy bruising. The condition requires a unique treatment, different from the standard protocol involving the anticoagulant heparin, the agency also warned.

The ACIP's task will be to try to establish whether the vaccine caused the blood clots, and then how it should be used going forward, said Walter Orenstein, associate director of the Emory Vaccine Center at Emory University and a former head of the CDC's U.S. Immunization Program.

That will mean weighing the benefits of protecting people against a deadly disease, particularly with new surges in the pandemic under way, against the risks posed by the vaccine, Dr. Orenstein said.

"That will be a fundamental issue," he said. "Even if they're not sure if it's causal, do the benefits outweigh the risks?"

The committee could recommend continuing vaccination with the J&J product "at full throttle," he said. It could decide that the J&J vaccine be discontinued for certain groups--such as younger adult women--or halt its use altogether, given that two other vaccines are available, he said.

It is possible more data will become available before the meeting to help the ACIP panel make a recommendation, if more cases come to light, Dr. Orenstein said. "All of the publicity may get people to report who hadn't previously reported," he said.

Jason Schwartz, assistant professor of health policy and the history of medicine at the Yale School of Public Health, said he expects the ACIP panel to offer more medical guidance to healthcare providers about the risk of blood clots and how to treat them rather than make big changes.

"I'm not sure the committee would want to take broad steps," he said, given the small number of cases.

Additional guidance would be important, he said, because the condition the six women experienced--blood clots and low blood platelet counts--requires treatment that is different from what some doctors might typically provide.

Vaccination and infectious disease experts praised the government's quick recommendation to pause the use of J&J's vaccine and then hold an open meeting to evaluate the data.

"It shows that our regulatory agencies are working properly," said Krutika Kuppalli, assistant professor of infectious diseases at the Medical University of South Carolina. "They picked up a signal and they jumped on top of it. They want to be careful; they want to be transparent."

https://www.marketscreener.com/quote/stock/JOHNSON-JOHNSON-4832/news/Federal-Advisory-Panel-to-Meet-Wednesday-on-J-J-Vaccine-32963585/

UK trial on switching COVID-19 vaccines adds Moderna and Novavax shots

 A UK study into using different COVID-19 vaccines in two-dose inoculations is being expanded to include shots made by Moderna and Novavax, researchers said on Wednesday.

The trial, known as the Com-Cov study, was first launched in February to look at whether giving a first dose of one type of COVID-19 shot, and a second dose of another, elicits an immune response that is as good as using two doses of the same vaccine.

The idea, said Matthew Snape, the Oxford University professor leading the trial, “is to explore whether the multiple COVID-19 vaccines that are available can be used more flexibly”.

Britain and many other countries in Europe are currently using AstraZeneca’s and Pfizer’s COVID-19 vaccines in nationwide immunisation campaigns against the coronavirus pandemic.

But reports of very rare blood clots have prompted some governments - including France and Germany - to say the AstraZeneca shot should only be given to certain age groups, or that people who have had a first dose of AstraZeneca’s vaccine should switch to a different one for their second dose.

In a briefing about the expansion of the study to include Moderna’s and Novavax’s COVID-19 vaccines, Snape, an associate professor in paediatrics and vaccinology at Oxford, said it will seek to recruit adults aged over 50 who have received their first, or “prime” vaccination in the past 8-12 weeks.

These volunteers, who will have received either the AstraZeneca or Pfizer vaccine, will be randomly allocated to get either the same vaccine, or the Moderna or Novavax vaccine, for a second dose.

The six new arms of the trial will each involve 175 people, adding a further 1,050 recruits in total, Snape said.

“If we can show that these mixed schedules generate an immune response that is as good as the standard schedules, and without a significant increase in the vaccine reactions, this will potentially allow more people to complete their COVID-19 immunisation course more rapidly,” Snape said.

“This would also create resilience within the system in the event of a shortfall in availability of any of the vaccines.”

Results from the original mixing trial, using AstraZeneca and Pfizer shots only, are expected as early as April or May, while results of the second phase should come in July.

https://www.reuters.com/article/us-health-coronavirus-britain-vaccines/uk-trial-on-switching-covid-19-vaccines-adds-moderna-and-novavax-shots-idUSKBN2C0317

CanSinoBIO says no serious blood clots from its vaccine

 China’s CanSino Biologics Inc said on Wednesday that no serious blood clot cases had been reported in people inoculated with its single-dose COVID-19 vaccine.

U.S. federal health agencies recommended on Tuesday that use of a similar one-shot vaccine from Johnson & Johnson be paused after six women developed rare blood clots.

CanSinoBIO’s shares fell as much as 13.7% and 18.4% in Shanghai and Hong Kong respectively.

They pared losses to close down 6.3% and 7.7% each after the company issued a statement in which it said: “No blood clot related serious adverse events have been reported in around one million vaccinations of Ad5-nCoV.”

CanSinoBIO’s Ad5-nCoV vaccine is approved in China, Hungary, Chile and Pakistan.

European regulators this month said they had found a possible link between AstraZeneca Plc’s vaccine and a similar rare blood clotting problem.

Several countries have since limited the AstraZeneca vaccine’s use to certain age groups, while the European Medicines Agency (EMA) said the benefits outweigh the risks.

Experts said clotting risks for both vaccines remain extremely low and they are highly effective in providing protection against COVID-19, amid concern that reports of the rare side effects could deter people from getting their shots.

“There are other vaccines in clinical use where rare side effects are reported – rotavirus, measles, yellow fever. Yet the vaccines save hundreds of thousands of lives,” said Jerome Kim, director general of the International Vaccine Institute.

“We are looking at rare events ... Countries need to assess the risk of vaccination against the known risk of not vaccinating.”

COVID-19 vaccines from J&J, AstraZeneca, CanSinoBIO and Russia’s Gamaleya Institute uses an adenovirus, a harmless cold virus, as a vector to deliver instructions for human cells to produce part of the coronavirus that can spur the immune system to recognise and attack the actual virus.

https://www.reuters.com/article/us-health-coronavirus-cansinobio/cansinobio-says-no-serious-blood-clots-from-its-vaccine-idUSKBN2C10FF

Elderly show similar antibody response to 1st dose of Astra, Pfizer COVID-19 shots: UK study

 The first study to directly compare immune reactions between Pfizer’s and AstraZeneca’s COVID-19 vaccines found strong and broadly similar antibody responses in over-80-year-olds after a first dose of either shot, scientists said on Wednesday.

The UK study also found that a critical component of the immune system known as T cells showed a more enhanced response in those who got the AstraZeneca/Oxford University vaccine than in those who got the Pfizer/BioNTech one.

The scientists behind the study, which analysed blood samples from 165 people in Britain aged between 80 and 99 who had been given a first COVID-19 vaccine dose, said that finding merited further investigation.

While antibodies can block the coronavirus’ ability to enter human cells, T cells can act as broader protection by attacking and killing any cells that have been infected with the virus.

“These vaccines are both equivalent and effective at inducing antibody responses in the great majority of people (in this study), even after one dose,” said Paul Moss, a professor of haematology at Britain’s Birmingham University who co-led the research.

“Both vaccines are good,” he told a briefing on the findings.

The researchers also found that immune responses were “markedly enhanced” by prior infection with SARS-CoV-2. Across the whole cohort of 165, evidence of previous natural infection was seen in 8 donors and associated with 691-fold and 4-fold increase in humoral and cellular immune responses, according to the report.

The study was published online as a Lancet preprint before being peer reviewed. It found that key antibodies were present and at similar levels in 93% of the 76 study participants who got the Pfizer single COVID-19 vaccine dose, and 87% of the 89 participants who got the AstraZeneca shot.

Helen Parry, clinical lecturer at Birmingham University who co-led the study, said the tests also showed that a larger proportion of those who got the AstraZeneca vaccine had a detectable T cell response.

That finding adds to other emerging evidence from COVID-19 studies suggesting that antibodies - which stop the coronavirus from being able to attach to human cells - may not be the only important element of immunity, and that T-cells may also have an important protective role.

“We now need to carry out further research to understand what this difference in T cell responses means,” said Parry.

Around half of the UK population have had at least one dose of a COVID-19 vaccine, one of the highest rates of inoculation in the world. The vast majority have received either the Pfizer or the AstraZeneca shot.

SOURCE: bit.ly/3mLQhxb Preprints with The Lancet, online April 13, 2021.

https://www.reuters.com/article/us-health-coronavirus-vaccines-antibodie/elderly-show-similar-antibody-response-to-1st-dose-of-astra-pfizer-covid-19-shots-uk-study-idUSKBN2C11KO