Case Grows For Bayer's Old Anti-Malarial To Treat COVID-19
German Major Advises Caution Over Chloroquine
Executive Summary
Bayer's anti-malaria therapy chloroquine is being touted as a cheap, safe and effective drug for coronavirus. However the company's product is only made in Pakistan and a variety of import and export agreements need to be in place for other countries to get hold of it.
With researchers around the world scrambling to find a way to tackle coronavirus using existing drugs, Bayer AG's 70-year-old antimalarial chloroquine has emerged as one of the most promising candidates but there are logistical issues that need to be overcome to getting hold of it.
There have been reports this week that Bayer is about to make a large amount of chloroquine to the US government for potential use, with the American news website, Axios, saying that its tip off came from "a senior US Health and Human Services official and another source with direct knowledge." A spokesperson for the German major told Scrip that it was not commenting on the rumors and Bayer was keen not to fuel any unrealistic expectations.
The Leverkusen-headquartered firm confirmed that the Chinese authorities have included the drug, which Bayer markets there as Resochin, in the treatment recommendations for SARS-CoV-2, the virus causing COVID-19. The company is also in discussions with the German Federal Ministry of Health to import chloroquine into the country, primarily to be tested in clinical use in infected patients "through close cooperation with the [renowned hospital] Charité in Berlin. (Also see "China Uses Old To Fight New As Repurposed Drugs Take Coronavirus Role" - Scrip, 21 Feb, 2020.)
Getting hold of the product is not straightforward however and the spokesperson told Scrip that Bayer's chloroquine is made in Pakistan. As such, export of tablets to other countries is currently only possible with a corresponding special permit from the importing state and the government agencies in Pakistan.
Importation also requires the green light from health authorities in the country acquiring the product to approve its usage. These factors need to be taken into consideration "before any expectations are raised," Bayer noted, also pointing out that "so far, an effect of chloroquine in the control of SARS-CoV-2 has only been shown in an in vitro study in China and scientific publications of clinical study results are not yet available."
The enthusiasm for chloroquine for treating COVID-19 has been growing since a letter published last month in the journal Nature from Chinese researchers who carried out the in vitro study. They said that besides its antiviral activity, chloroquine has an immune-modulating activity, which may synergistically enhance its antiviral effect in vivo, noting that it is widely distributed in the whole body, including lung, after oral administration.
Cheap, Safe And Effective
The researchers said that chloroquine is "a cheap and a safe drug that has been used for more than 70 years and, therefore, it is potentially clinically applicable" against the virus. They concluded by saying that the drug, and Gilead Sciences Inc.'s remdesivir, have proved to be highly effective in vitro and "since these compounds have been used in human patients with a safety track record and shown to be effective against various ailments, we suggest that they should be assessed in human patients suffering from the novel coronavirus disease."
Their enthusiasm has also been shared by analysts at Raymond James. In a note issued on 10 March, they wrote that "based on emerging data, chloroquine looks to be as promising a therapeutic candidate as any to treat COVID-19, and may turn out to be more effective, scalable, and affordable than either Gilead's remdesivir or AbbVie Inc.'s Kaletra/Aluvia (lopinavir/ritonavir). (Also see "Some Caution Over 'People’s Hope' Remdesivir As China Trials Progress" - Scrip, 17 Mar, 2020.)
They added that chloroquine "doesn’t directly benefit any stock", like the Gilead and AbbVie drugs, "which is probably why it seems to be getting less attention." The analysts claimed, "If we had to pick one of the three at this point that actually seems most likely to have the biggest impact on treating COVID-19 in the coming months/years, it would be chloroquine. This means other repurposing/development programs could end up having minimal net impact on their respective businesses/stocks and recent run-ups in certain stocks (Gilead) based on coronavirus candidate therapies are unsustainable."
€1m Donation For Lombardy
Meantime, Bayer has donated €1m to support hospitals in Lombardy, Italy, with the money being added to an aid fund that the regional authorities have set up to help procure urgently needed equipment for intensive care units in hospitals. Lombardy is by far the region of Italy worst affected by the coronavirus pandemic and hospitals there are reaching the limits of their capacity.
Besides Italy, where the country's regulators have made chloroquine available off label for COVID-19, Bayer noted that it had already sent considerable financial and material support to China to help contain the pandemic. The group said it will continue to provide affected regions and countries "with rapid and unbureaucratic assistance as part of its corporate social responsibility."
(Scrip's rolling coverage of the global coronavirus outbreak and the biopharma industry's response is aggregated here.)
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