3M ramping up N95 respirators to reach 50M per month in June

3M (NYSE:MMM) says it expects to produce N95 respirators at a rate of 50M per month in June, a 40% increase from current levels.

The company says it has increased its output of the respirators to nearly 100M per month.

3M also is partnering with Ford (NYSE:F) to bolster production of powered air purifying respirators with the goal of increasing production by 6x within the next 60-90 days.

The company says it is working with law enforcement to fight “price gouging, fraud and counterfeit activity” in connection with its products, and that it has not changed its prices for respirators as a result of the coronavirus.

https://seekingalpha.com/news/3557009-3m-ramping-up-n95-respirators-to-reach-50m-per-month-in-june

FDA rallies troops to accelerate development of COVID-19 treatments

The FDA announces its Coronavirus Treatment Acceleration Program that, it says, leverages every tool at its disposal (e.g., cutting red tape, redeploying staff) to speed up the development of therapies to treat COVID-19 infection. Key points:

Staff from the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research are providing regulatory advice, guidance and technical assistance as quickly as possible, including triaging with developers and scientists to speed up the process. Examples of the new normal include reviewing study protocols within 24 hours and single-patient expanded access requests within three hours.

Medical and regulatory staff redeployed to serve on COVID-19 review teams.

Streamlined processes and operations for developers and scientists and additional resources for healthcare providers and researchers to help them file emergency requests for investigational products.

Advancing relationships with partners in the public and private sectors to rapidly collect and analyze information in areas like illness patterns and treatment outcomes.

ETFs: THW, BME, GRX, IXJ, GDNA, KMED, XLV

https://seekingalpha.com/news/3556988-fda-rallies-troops-to-accelerate-development-of-covidminus-19-treatments

InflaRx doses first COVID-19 with IFX-1; shares up 24% after hours

InflaRx N.V. (NASDAQ:IFRX) announces that dosing is underway in a randomized clinical trial evaluating IFX-1 in patients with severe COVID-19-induced pneumonia.

It says IFX-1 is a monoclonal anti-human complement factor C5a antibody designed to induce an anti-inflammatory response by blocking the biological activity of C5a.

Shares up 24% after hours.

https://seekingalpha.com/news/3556994-inflarx-doses-first-covidminus-19-ifxminus-1-shares-up-24-after-hours

Fujifilm ramps up production of flu drug Avigan as possible COVID-19 treatment

Fujifilm says it is prepared to offer Avigan to any country that wants to try it as a potential treatment for COVID-19. But even as it has restarted production, the Japanese drugmaker feels compelled to set the record straight about the influenza drug.

“Avigan has never been distributed in the market and is not available at hospitals and pharmacies in Japan or overseas,” it said in an announcement.

The drug, developed by Fujifilm unit Toyama Chemical, was approved in 2014 as an influenza treatment but only to be used if other treatments prove ineffective against a novel or re-emerging influenza virus.
The Japanese company issued the clarification Friday as interest in the drug builds. That follows reports that clinical trials of the drug in China showed it effective against COVID-19. Over the weekend, Japanese Prime Minister Shinzo Abe said the government would begin trials of the drug on COVID-19 in cooperation with other countries and ramp up production with the aim of a quick approval, the Nikkei Asia Review reports.

Fujifilm pointed out in its announcement that favipiravir, the active pharmaceutical ingredient in the tablet, has a “mechanism of action that prevents the propagation of viruses…that might  have an antiviral effect on the novel coronavirus.” COVID-19 is classified into the same type (single-stranded RNA virus) as influenza virus. To test that possibility, clinical trials are underway to seek “clear evidence of the drug’s efficacy and safety,” Fujifilm said.
Avigan has been rolled out before, including in 2015 against Ebola and in 2016 for avian influenza. At the time, the company made this prophetic observation:
“The need to develop new drugs for treating influenza has come amidst mounting concerns–in recent years that avian influenza viruses could mutate into a new type of virus, capable of human-to-human transmission. Such a mutation could potentially trigger a pandemic.”
https://www.fiercepharma.com/manufacturing/fujifilm-ramps-up-production-flu-drug-avigan-as-possible-covid-19-treatment

Gilead CEO: remdesivir to be ‘affordable,’ but it could still rake in revenue

Will Gilead Sciences make a fortune out of remdesivir if the antiviral proves effective against the novel coronavirus? Maybe—or maybe not.
The Big Biotech will “work to ensure affordability and access so that remdesivir is available to patients with the greatest need” if it’s approved, CEO Daniel O’Day wrote in an open letter Saturday. But with a large pool of potential patients, that still leaves plenty of room for revenue.
The pledge comes shortly after Gilead rescinded its request for an FDA orphan drug designation, which comes with the perk of seven-year market exclusivity. Critics lamented that it would allow Gilead to charge high prices for remdesivir for years.

President Donald Trump has highlighted remdesivir as a promising anti-COVID-19 treatment, and the World Health Organization labeled it as “the most promising” antiviral during the early days of the outbreak. But its effectiveness won’t be known until a slate of clinical trials reads out, with the first expected from China in the coming weeks.
Clinical trials represent one way patients can get the medicine before its approval, but not all can enroll in one, either because they don’t meet the enrollment criteria or can’t travel to a participating hospital. Gilead had offered the med under compassionate use and provided it for over 1,000 patients.

But after Trump’s advertisement, Gilead saw an exponential increase in requests, overwhelming a system where each application needed to be reviewed individually, O’Day said. The company stopped that access program last week, but it’s now transitioning to a process where hospitals and physicians can apply for multiple patients at a time.
“While it will take some time to build a network of active sites, this approach will ultimately accelerate emergency access for more people,” O’Day said in his letter. According to him, the first sites are already available in the U.S., with more to come soon.
The first batch of clinical data could be available in April, as Chinese scientists have been testing remdesivir in two trials in mild-to-moderate and severe COVID-19 patients in Wuhan, which until recently was the epicenter of the outbreak.

However, there have been concerns about whether those trial findings will be conclusive. As the virus was quickly contained in China, there simply may not be enough patients there—especially severely sick ones—for the remdesivir trial. Plus, hundreds of clinical trials are fighting for participants, including tests of other promising antivirals such as chloroquine, Fujifilm’s flu drug Avigan and AbbVie’s HIV combo Kaletra, as well as for meds that aim to manage potentially life-threatening complications, including Roche’s IL-6 inhibitor Actemra.
As SARS-CoV-2 spreads across the globe, evidence of remdesivir’s efficacy might also come from other studies. The NIH’s National Institute of Allergy and Infectious Diseases is recruiting patients for a phase 3 at multiple sites in the U.S., Japan, South Korea and Singapore. Gilead itself is conducting two studies in mild-to-moderate and severe patients separately. And the WHO is planning a megatrial of promising drugs, including one arm for remdesivir.
https://www.fiercepharma.com/pharma/gilead-ceo-pledges-affordable-remdesivir-as-promising-covid-19-drug-expects-clinical-data

China APIs flow but India ban hinders U.S. approval of hydroxychloroquine

The production of Chinese active pharmaceutical ingredients (APIs) slipped by 10% to 20% during the early days of the COVID-19 outbreak in China but is quickly recovering. The bottleneck in the global supply chain for APIs is now shipping, particularly ocean freight.

This is the assessment of Chinese officials who held a press conference Tuesday. China is focusing its production efforts on APIs that are in highest demand, Xin Guobin, deputy minister of industry and information technology, said, according to a translated transcript of the Chinese language press conference. That includes chloroquine phosphate, which the FDA this week approved for use against COVID-19 based on anecdotal reports of its effectiveness.

Xin said production is stable at the two primary producers of chloroquine phosphate, and efforts are being focused on meeting international demand. One of those producers, Chongqing Kangle Pharmaceuticals, was able to export 4.9 tons of the API within five days, Xin said.
“We can further increase the supply in accordance with international market demand,” Xin said.

The story is different in India, perhaps the biggest producer of the chloroquine phosphate API. India last week added it to a list of more than two dozen APIs that it no longer is allowing to be exported while officials get a handle on how much will be needed for India’s COVID-19 outbreak.
India is in the beginning of a 21-day lockdown ordered by Prime Minister Narendra Modi. So far, the official count of COVID-19 cases in India is only 1,251 cases compared to 164,179 in the U.S. as of March 30. But that number is expected to skyrocket in the world’s second most populous country with about 1.4 billion people.
Trump administration officials are reportedly asking India to lift the ban on the APIs, NBC news reports, citing unnamed sources.

This comes after the FDA Tuesday approved emergency use of hydroxychloroquine, a drug already approved to treat malaria, lupus and rheumatoid arthritis. The approval came at the urging of President Donald Trump. Some small studies have suggested it can help some patients with COVID-19, but clinical trials, which experts say are essential to know its effectiveness, are just now getting underway.

That hasn’t deterred the Department of Health and Human Services from accepting 30 million donated doses from Novartis’ Sandoz unit, as well as another 1 million tablets of chloroquine phosphate, the other form of the drug. Bayer, Mylan and Amneal have each pledged donations or increased production of the drugs.

While countries try to sort out their API supplies, drugmakers and shippers are sorting out how to get them moved around the world. China’s Xin said he understands “main constraints to Chinese exports are sea freight, international shipping,” which has been hampered in the face of the outbreak, leading to much higher prices.

Finished pharmaceuticals can be shipped by air freight, but the number of flights in and out of China has fallen significantly as countries set up border restrictions, forcing drugmakers to scramble for slots to ship their products.

https://www.fiercepharma.com/manufacturing/chinese-apis-flowing-but-indian-ban-hinders-u-s-approval-hydroxychloroquine

Temperature check at Walmart

Walmart (WMT +0.3%) says it has decided to begin taking the temperatures of its associates as they report to work in stores, clubs and facilities. The retail giant will also ask reporting employees some basic health screening questions.

Employees recording a temperature of 100.0 degrees or more will be sent home with pay.

The company says it expects it to take a few weeks for all locations to have infrared thermometers.

It’s possible that when stores open back up that some retailers will do a temperature check of guests. That was the case earlier this week in Wuhan, China as one its malls opened back up for store traffic for the first time.

https://seekingalpha.com/news/3556944-temperature-check-walmart