Fujifilm partners with Shanghai firm to seek China COVID-19 approval for Avigan

TOKYO— Japan's Fujifilm Holdings Corp said on Thursday it has partnered with Shanghai-based Carelink Pharmaceutical Co to seek approval in China for Avigan to treat COVID-19 and influenza.

Carelink will use Fujifilm's data on Avigan's treatment of novel coronavirus infections and influenza to seek imported drug approval in China, Fujifilm said in a statement. The two companies also plan to develop an injectable form of the drug.

Fujifilm said last week it was seeking approval for Avigan as a treatment for COVID-19 in Japan. That followed results from a late-stage study in Japan that showed the antiviral drug reduced recovery time for patients with non-severe symptoms.

Avigan, originally developed as an emergency flu drug and known generically worldwide as favipiravir, has been approved in India and Russia to treat COVID-19.

Fujifilm sold global rights in July on Avigan to India's Dr Reddy's Laboratories and Dubai-based Global Response Aid. That deal excluded China, Japan and Russia.

Last month, Fujifilm said the late-stage study of 156 COVID-19 patients in Japan showed that symptoms of those treated with Avigan improved after 11.9 days, versus 14.7 days for a placebo group.

Results of the study, conducted by subsidiary Fujifilm Toyama Chemical, were found to be statistically significant. 

-reuters-

BioNTech and Pfizer's COVID-19 vaccine shows potential in human trial

FRANKFURT - A COVID-19 vaccine developed by German biotech firm BioNTech and US pharmaceutical giant Pfizer has shown potential and was found to be well tolerated in early-stage human trials, the companies said Wednesday.

The drug is one of 17 being tested on humans in a frantic global race to find a vaccine the world is counting on to end a pandemic that has infected 10.5 million people and killed more than half a million so far.

The potential treatment is the fourth early-stage COVID-19 drug to show promise in human testing, along with projects involving Moderna, CanSino Biologics and Inovio Pharmaceuticals.

BioNTech's shares were up 4.6 percent, after rising as much as 19 percent to reach their highest in more than 3 months.

Pfizer stock also gained, rising 4.4 percent to $34.13. In turn, shares in some rival vaccine developers, such as Moderna and Novavax Inc dropped.

BioNTech said testing of 2 dosages of its BNT162b1 drug on 24 healthy volunteers showed that after 28 days they had developed higher levels of COVID-19 antibodies than typically seen in infected people.

It said the higher of the 2 doses - both administered via 2 injections within 3 weeks of one another - was followed by a short fever in 3 out of 4 participants after the second shot.

A third dosage, tested at a higher concentration in a separate group, was not repeated after the first shot because of injection pain.

"These first trial results show that the vaccine yields immune activity and causes a strong immune response," said BioNTech's co-founder and Chief Executive Officer Ugur Sahin.

He said larger trials were being prepared to show whether this translates into protection against a real infection.

"While more work needs to be done, we believe the benefits appear to outweigh the risks so far, especially when considering the disease the vaccine is trying to prevent," Mizuho Securities analyst Divan Vamil said in a note.

PEER REVIEW

No COVID-19 vaccine has yet been approved for commercial use. A Massachusetts Institute of Technology analysis last year found that about 1 in 3 vaccines in the first stage of testing later gains approval.

BioNTech, which listed on the US Nasdaq in October, said the data demonstrated that BNT162b1 could be administered in a dose that was well tolerated with only temporary side effects.

Early-stage human trials of vaccines are designed to measure certain antibodies and other immune markers in the blood as an indicator of the body's readiness to fight an infection that then requires further validation.

The pharmaceutical industry is eager to launch larger follow-up trials to see how vaccinated participants react to real infections over longer periods.

BioNTech and Pfizer will now pick the most promising of 4 experimental vaccines for a trial involving up to 30,000 healthy participants, which is likely to begin in the United States and Europe in late July, if it gets the regulatory green light.

If it eventually gets marketing approval, the companies are gearing up to make up to 100 million doses by the end of 2020 and another 1.2 billion doses by the end of 2021 at sites in Germany and the United States.

Results from early-stage testing of BioNTech's 3 other potential vaccines have yet to be published.

The manuscript with the preliminary data from the clinical trials, which were launched in April and May, is under peer review for publication in a scientific journal, BioNTech said.

Singapore's state investment fund Temasek and other investors said on Monday there were investing $250 million into BioNTech for a 1.1 percent stake in company.

The Mainz-based company is using the so-called messenger RNA approach, like unlisted domestic rival CureVac and Moderna. Translate Bio and its partner Sanofi are also working on a messenger RNA vaccine for COVID-19.

Biotech investors Thomas and Andreas Struengmann, who sold their generic drugs business Hexal to Novartis in 2005, are major shareholders of BioNTech.

-reuters-

South African pharma could produce 10 million dexamethasone tablets within a month - CEO

JOHANNESBURG - South African drug company Aspen could provide 10 million dexamethasone tablets within a month, Chief Executive Stephen Saad told Reuters on Tuesday.

Results from a trial showed that dexamethasone reduced death rates by about a third compared with a placebo in severely ill hospitalized COVID-19 patients, University of Oxford scientists said last week, calling the discovery a major breakthrough.

"Aspen has looked at the short-term needs and can provide 10 million tablets in the next 3 to 4 weeks. We would look to ramp up further should there be a need for additional product," Saad said without indicating current production volumes.

South Africa's biggest supplier of drugs, with a 22 percent market share in sub-Saharan Africa, manufactures both the injectable and tablet forms of dexamethasone, which is mainly used for treatment of tumors, asthma and other respiratory ailments.

The South African government has contacted Aspen to source the drug not only for its domestic market but also for rest of the continent, the company said on Monday.

The company has asked the government to indicate required volumes across the continent, Saad said. "Once they give us a sense, we can work out the supply," he added.

South Africa's health ministry on Friday said that the government had a stock of 300,000 ampules of dexamethasone and could secure supplies from local suppliers.

Saad said the recent revelation by scientists at the University of Oxford had brought in sudden demand for the drug and the company had received orders from the World Health Organization, UNICEF and other bodies.

"We are trying to make sure there is no panic-buying," he said.

-reuters-

Moderna COVID-19 vaccine appears to clear safety hurdle in mouse study

CHICAGO - A series of studies in mice of Moderna Inc's COVID-19 vaccine lent some assurance that it may not increase the risk of more severe disease, and that one dose may provide protection against the novel coronavirus, according to preliminary data released on Friday.

Prior studies on a vaccine for SARS - a close cousin to the new virus that causes COVID-19 - suggests vaccines against this type of virus might have the unintended effect of causing more severe disease when the vaccinated person is later exposed to the pathogen, especially in individuals who do not produce an adequately strong immune response.

Scientists have seen this risk as a hurdle to clear before vaccines can be safely tested in thousands of healthy people.

While the data released by the US National Institutes of Allergy and Infectious Disease (NIAID) and Moderna offered some assurance, the studies do not fully answer the question.

"This is the barest beginning of preliminary information," said Dr. Gregory Poland, an immunologist and vaccine researcher at the Mayo Clinic who has seen the paper, which has yet to undergo peer review.

Poland said the paper was incomplete and disorganized, and the numbers of animals tested were small.

The authors said they have submitted the work to a top-tier journal. Moderna's vaccine is in midstage testing in healthy volunteers. Moderna said on Thursday it plans to begin final-stage trials enrolling 30,000 people in July.

In the animal studies, mice received one or two shots of a variety of doses of Moderna's vaccine, including doses considered not strong enough to elicit a protective immune response. Researchers then exposed the mice to the virus.

Subsequent analyses suggest "sub-protective" immune responses do not cause what is known as vaccine-associated enhanced respiratory disease, a susceptibility to more severe disease in the lungs.

"Subprotective doses did not prime mice for enhanced immunopathology following (exposure)," Dr. Barney Graham of the Vaccine Research Center at NIAID and colleagues wrote in the manuscript, posted on the bioRxiv website.

Further testing suggested the vaccine induces antibody responses to block the virus from infecting cells.

The vaccine also appeared to protect against infection by the coronavirus in the lungs and noses without evidence of toxic effects, the team wrote.

They noted the mice that received just one dose before exposure to the virus seven weeks later were "completely protected against lung viral replication," suggesting a single vaccination prevented the virus from replicating in the lungs.

"At first glance, it looks promising in inducing neutralizing antibody protection in mice," Dr. Peter Hotez, a researcher at Baylor College of Medicine said in an email. He had not reviewed the paper in detail.

Poland, who was not involved with the research, said the paper leaves out "important parameters" that could help scientists judge the work.

"The results, such as they are presented, provide interesting data that are reassuring... This needs to be replicated and it needs to be peer-reviewed," he said.

-reuters-

Gilead's remdesivir shows promise in COVID-19 study on monkeys

Gilead Sciences Inc's antiviral drug, remdesivir, prevented lung disease in macaque monkeys infected with the new coronavirus, a study published in medical journal Nature showed on Tuesday.

Remdesivir is the first drug to show improvement in COVID-19 in human trials, and its progress in clinical studies is being closely watched as nations look for a treatment for the disease, which has infected more than 7 million people and killed over 400,000.

In the study, 12 macaque monkeys were deliberately infected with the new coronavirus, and half of them were given early treatment with remdesivir.

Macaques that received remdesivir did not show signs of respiratory disease and had reduced damage to the lungs, according to the study. https://go.nature.com/2Yj9xq2

Details from the trial in monkeys were previously released by the US National Institutes of Health in April, but those findings were not reviewed by peers - a step that validates a research study.

The authors of the study suggested that remdesivir should be considered as a treatment as early as possible to prevent progression to pneumonia in COVID-19 patients.

Remdesivir has been cleared for emergency use in severely-ill patients in the United States, India and South Korea. Some European nations are also using it under compassionate programs.

Trials of the drug in humans are ongoing, and early data has shown the drug helped patients recover more quickly from the illness caused by the new coronavirus.

-reuters-

Drugmaker Eli Lilly starts clinical testing of therapies for COVID-19

US drugmaker Eli Lilly & Co said on Friday it began clinical testing of therapies for the COVID-19 illness caused by the coronavirus.

The company said it had entered into an agreement with the National Institute of Allergy and Infectious Diseases to study the baricitinib drug to examine its efficacy and safety as a potential treatment for hospitalized patients diagnosed with COVID-19.

Lilly had previously been testing the Olumiant or baricitinib drug as a treatment for atopic dermatitis.

The study will start this month in the United States and will then expand to other sites in Europe and Asia, the company said in a statement, adding results from the study are expected within two months.

Lilly said it currently does not anticipate shortages for any of its medicines, including baricitinib.

US deaths due to the coronavirus topped 18,100 on Friday, according to a Reuters tally.

Earlier this week, the drugmaker lowered insulin costs, saying it has capped the out-of-pocket cost for it to $35 per month to help diabetes patients across the United States, many of whom are facing financial difficulties due to the coronavirus outbreak.

-Reuters-