Two manufacturers of a decades-old malaria drug that some research has suggested may be useful in combating the novel coronavirus announced steps to provide millions of tablets over the next few weeks after the Trump administration singled out the medicine for expedited testing and broader use.
Mylan (MYL) and Teva Pharmaceuticals (TEVA) plan to jumpstart production of hydroxychloroquine, which is also approved for treating lupus or rheumatoid arthritis. The medicine has been prescribed sparingly, mostly to travelers, and was in short supply this month, according to the American Society of Health-System Pharmacists, which counted a handful of manufacturers that were not shipping tablets.
The drug has taken on new life in recent weeks after several studies indicated it may show promise as a weapon to fight Covid-19, prompting some doctors to write prescriptions. As a result, Trump administration officials want to move quickly to determine whether the drug — and a closely related medicine called chloroquine — can be effective.
As a result, Mylan plans to restart production of hydroxychloroquine tablets at a West Virginia facility to meet “potential” increased demand and is looking to begin manufacturing outside the U.S. in coming weeks, according to a statement. In explaining its decision, the company noted the World Health Organization listed the drug as being under investigation for combating the coronavirus.
The drug maker expects to begin supplying the pills by mid-April, based on existing supplies of the active pharmaceutical ingredient, and ramp up production to provide 50 million tablets and potentially treat a total of more than 1.5 million patients. The potential use of this medicine for Covid-19 related treatment is pending additional FDA and other regulatory body guidance, the company added.
Meanwhile, Teva expects to donate more than 6 million doses through wholesalers to U.S. hospitals to meet “urgent demand,” the company said in a statement. The doses will be shipped by March 31, and more than 10 million within a month. Additional production is being assessed. The drug is being studied for its ability to fight Covid-19 and Teva noted U.S. officials requested it be made available for immediate use.
“The allure of repurposing hydroxychloroquine for the treatment of Covid-19 or prophylaxis in patients who have been exposed, is obvious: it is an oral molecule that has been around for decades, has a well-established track record from a safety perspective, and would be inexpensive — it has been a commodity generic for some time,” Piper Sandler analyst David Amsellem wrote to investors.
He also pointed out that the University of Minnesota announced that it will start a multi-center study evaluating hydroxychloroquine in around 1,500 people who were exposed to Covid-19 within three days but are not symptomatic. And Amsellem also noted that studies are under way in South Korea and Spain.
Neither company would comment on why shortages existed in recent weeks, although one industry watcher pointed to published studies, such as this one in Nature. And a search of PubMed, an online database of medical papers, turns up several abstracts, including “Discovering drugs to treat coronavirus disease 2019 (COVID-19),” published by three Chinese researchers in Drug Discoveries & Therapies.
“People saw these abstracts and it didn’t take long for doctors to write prescriptions and the drugs to go on shortage,” said Erin Fox, who tracks shortages and directs the drug-information service at University of Utah Health Care, which has four hospitals. “We’re getting reports from all different kinds of hospitals across the country and we’re having trouble ordering the product, too.”
One reason may be that some prescribers wrote prescriptions for themselves, family members and colleagues, according to Scott Knoer, the chief pharmacy officer at the Cleveland Clinic. “Some healthcare professionals are acting like Walmart shoppers cleaning out the toilet paper and hand sanitizer aisles by creating personal stockpiles of potentially critical medications just in case they need them. Pharmacists and physicians need to work together to make sure that the patients who really need these drugs have access to them.”
Separately, the manufacturer of chloroquine, which is also approved to treat malaria, acknowledged a recent shortage, but had indicated previously that supplies would return by mid-March. “The product is in stock and we are actively shipping orders,” Ira Baeringer, chief operating officer at Rising Pharmaceuticals, wrote us. A recent spike in orders caused strict allocations that led to back orders.
President Trump had touted the drug as a coronavirus treatment at a Thursday media briefing, saying the tablet was “approved for prescription,” although the drug is indicated only for malaria. However, FDA Commissioner Stephen Hahn quickly added that effectiveness in combating COVID19 should be conducted “in a setting of a clinical trial.”
Rising recently cut the price of its tablet in half in response to the pandemic, but Baeringer insisted the tablets are not being marketed to fight Covid-19. The company, by the way, last December agreed to pay more than $3 million to resolve criminal and civil charges related to a far-reaching federal government probe into price fixing among generic makers.