FiercePharmaAsia—India restricts drug exports; Roche's Actemra fights COVID-19; Takeda assets sale

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India's drug export restrictions, Roche's Actemra and Takeda made our news this week. (Google)

The coronavirus outbreak has led India to temporarily stop exporting 26 active ingredients and drugs, including several antibiotics. To help manage a dangerous inflammatory response in serious COVID-19 patients, China has added Roche's arthritis med Actemra to its treatment guidelines. To help lower its debt load, Takeda has sold its old campus in Deerfield, Illinois, and agreed to sell off some drugs in Latin America. And more.

1. Coronavirus spurs India to restrict exports of 2 dozen drugs

India's restrictions on API exports only temporary, official says: report

As the coronavirus pressures the global drug supply chain, India has halted exports of 26 active ingredients and drugs, though a government official insisted the restrictions are temporary. These include paracetamol––the ingredient in Tylenol––plus antivirals like acyclovir for treating shingles and the antibiotic neomycin. Indian generic drug makers earlier warned of potential shortages if the outbreak drags on in China, because India also relies heavily on APIs from its neighbor.

2. China turns Roche arthritis drug Actemra against COVID-19 in new treatment guidelines

Chinese authorities now recommend Roche’s Actemra to treat COVID-19 patients with lung damage. Originally approved in rheumatoid arthritis, the drug inhibits the IL-6 receptor, a proinflammatory cytokine that Chinese scientists have fingered as responsible for the dangerous cytokine storm in serious coronavirus cases. Sanofi, which sells another anti-IL-6R drug, Kevzara, said it's “currently exploring” that med for severe COVID-19.

3. Takeda nets $940M from sales of U.S. HQ to Horizon, Latin American brands to Hypera

Takeda has finished selling its old U.S. headquarters in a Chicago suburb to Horizon Therapeutics for $115 million as it moved to join Shire in the greater Boston region. It has also agreed to offload 18 branded prescription and consumer health drugs in Latin America to Brazil’s Hypera Pharma for $825 million to help pay off debt. About 300 commercial staffers supporting the assets may join Hypera.

4. Takeda works on plasma-based COVID-19 therapy as China turns to recovered patients (release)

Takeda has made plasma-based therapy one of its five focus areas since the Shire buyout. Now, the Japanese pharma said it’s started development of such a treatment against the novel coronavirus. The drug, dubbed TAK-888, is a polyclonal hyperimmune globulin derived from antibodies from recovered patients’ plasma. Chinese health officials have urged recovered patients to donate blood to help others who are critically ill.

5. Dirty disposable socks? Cipla sterile injectables plant hit with FDA warning letter

A 38-page Form 483 slapped on Cipla’s sterile injectable plant in Goa, India, has been upgraded to a warning letter. Among the observations, the FDA found multiple cases in which product residue was found around HEPA filters. Inspectors also noted bacillus contamination that may have come from the use of dirty disposable socks.

6. Drugmakers tell analyst ingredient prices are rising as FDA reports first supply hit tied to COVID-19

On Feb. 28, the FDA reported the first shortage of a drug due to the COVID-19 outbreak. Without identifying the med or the manufacturer, the FDA said there were alternatives. The agency noted 20 products for which ingredients or finished forms are sourced entirely from China. Those makers said there hadn’t been any interruption in supply.

7. Chinese copyist of Gilead's COVID-19 hopeful remdesivir dinged by securities manager (Bloomberg)

BrightGene, a Chinese firm which claimed to have successfully copied—and started mass-producing—Gilead’s remdesivir, has been slammed by securities regulators. Shanghai Stock Exchange said the company had only been able to make the anti-COVID-19 hopeful in a small quantity for clinical research, not at commercial scale as it had suggested, ruling that the firm misled investors with “unclear, inaccurate information.”

8. Arcturus pairs with Duke-NUS to develop coronavirus vaccine (release)

Top China medical research institute teams with Cyclia on drug repurposing for COVID-19 (release)

In a new partnership formed around COVID-19, Arcturus Therapeutics is using its mRNA technology to work with Singapore’s Duke-NUS Medical School on a coronavirus vaccine. At the same time, China’s Institute of Materia Medica has inked a collaboration with Canadian biotech Cyclia, which will use its artificial intelligence engine to screen a collection of more than 6,700 FDA-approved drugs and phase 1-cleared candidates for potential COVID-19 treatments.

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