Indian API Makers To Boost Output Of Antimalarial Drugs Found Effective Against Covid-19

Indian and global pharma ingredient makers plan to ramp up the production of two antimalarial medicines after a preliminary French study showed their efficacy in the treatment of people infected with Covid-19.

The effectiveness of Hydroxychloroquine Sulfate or HCQS against the new coronavirus was demonstrated in a study involving 24 subjects in France, according to results published in the International Journal of Antimicrobial Agents. In the patient pool treated with the drug, the virus impact was reduced in 75 percent of them in six days. Similarly, studies are on in China on the use of chloroquine.

Teva Pharmaceutical Industries Ltd., Mylan NV, Amneal Pharmaceuticals, Inc. announced plans to urgently ramp up manufacturing and distribution of HCQS formulations—used to treat malaria, lupus and rheumatoid arthritis. India’s Cadila Healthcare Ltd. and Laurus Labs Ltd. also said that they plan to increase capacity for the anti-malarial drugs.

In view of potential drug shortages or medical emergency, the U.S. drug regulator made an exception from import alert for India’s IPCA Laboratories Ltd.’s active pharma ingredient facility in Ratlam and formulation units in Indore and Piparia, according to its exchange filing.

Shares of IPCA and Cadila were trading higher at 1:30 p.m. even as India’s Nifty 50 was more than 10 percent down. Laurus tracked the benchmark, trading more than 9 percent lower.

If approved, the two drugs can prove to be a breakthrough in treating the pneumonia-causing novel virus that originated from China and has infected more than 3.25 lakh people and killed about 14,500. India has seen cases mount in the last week to more than 400, including seven deaths.

The US drug regulator said in a statement that it’s working with government agencies and academic centres on chloroquine to determine if it can be used to treat patients with mild-to-moderate Covid-19 to potentially reduce the duration of symptoms, as well as viral shedding, which can help prevent the spread of disease.

“If clinical data suggests this product may be promising in treating COVID-19, we know there will be increased demand for it,” Stephen Hahn, commissioner at the U.S. Food and Drug Administration, said in the statement. “We will take all steps to ensure chloroquine remains available for patients who take it to treat severe and life-threatening illnesses such as lupus.”

IPCA said in its filing that it’s gearing to produce chloroquine phosphate and HCQS APIs given the increase in the emergency demand and enquiries from several countries. It, however, said the exemption from the import alert could be reconsidered if the situation changes.

Cadila, in a conference call, said it’s also planning to increase its API capacity fivefold to 20 tonnes and, if the need arises, to 40 tonnes. Cadila has about 30 percent volume share in the U.S. for HCQS and 6-7 percent in India. The company said its fully backward integrated for both key starting material and API and uses these products in its own formulations.

Laurus Labs has been receiving enquiries, Satyanarayana Chava, founder and chief executive officer, told BloombergQuint over the phone. The company will ramp up HCQS production from mid-April from 5 tonnes a month to 15-20 tonnes.

Brokerage View

Morgan Stanley

• HCQS formulations gross sales in the U.S. stand at $220 million by volume.
• Cadila is the largest player with 32 percent share, followed by Prasco (18 percent), Sandoz (13 percent), Dr. Reddy’s Laboratories Ltd. (10 percent), Teva (10 percent) and Sun Pharmaceutical Industries Ltd. (7 percent), according to Morgan Stanely.
• If the drug is approved for use for Covid-19, the demand could increase significantly but the pricing leverage may be limited given that half a dozen players are looking to scale up production.

Credit Suisse

• While by volume the market for HCQS is already large with 5.5 million annual prescriptions, in terms of value the market size is small given the high competition among generics.
• Given the number of cases of Covid-19 so far, it should not be a significant addition to the overall volumes and demand could be met.

BofA Securities

• Clinical trials from Chinese and French researchers have shown the efficacy of CQ and HCQS.
• It’s still early to say which is more efficacious than the other but HCQS is definitely less toxic and can be prescribed for longer durations.
• For shorter periods, BofA foresees a possible increase in demand in both the drugs.