After Ferozsons, Searle jumps into the remdesivir market

As the world worries about the coronavirus pandemic and how to beat back covid-19, Pakistan now apparently has not one but two drug companies that have the ability to offer a treatment for the disease, though both are linked to the same US-based pharmaceutical giant that has developed the closest thing to a cure.

On May 29, the Searle Company announced that it had entered into an exclusive agreement with Beximco Pharmaceuticals of Bangladesh to import the drug remdesivir, the broad-spectrum antiviral medication developed by US-based Gilead Sciences. That made Searle the second Pakistani drug company to acquire the ability to provide remdesivir to the Pakistani market.

Earlier, on May 15, Ferozsons Laboratories had announced that it was one among five generic drug manufacturers around the world that had been selected by Gilead to manufacture the drug for rapid distribution in 127 countries around the world. While Searle will not manufacture remdesivir, it will import the drug from Beximco, the Bangladeshi generic drug manufacturer that has already started production of remdesivir.

As the world’s pharmaceutical companies race to find both a cure and a vaccine for covid-19, Gilead appears to have taken the early lead in developing a treatment for the disease that has brought the world to a standstill. Remdesivir has been demonstrated to have reduced the amount of time it takes patients to recover from covid-19.

However, while it has been approved for emergency usage by the Food and Drug Administration in the United States, it is still undergoing testing in both the United States and the United Kingdom for more comprehensive evidence of its efficacy. The drug has been approved for use in Japan.

Gilead Sciences, the company that developed the drug, has had considerable success in recent years in developing cures for previously incurable conditions. Most notably, it developed Sovaldi and Harvoni, two drugs that cure hepatitis C rather than simply managing the condition, which is what all previous medication for the condition achieved.

Remdesivir was also originally developed to help treat hepatitis C but has since shown considerable promise in helping to treat a wide variety of other viral conditions. It has previously been demonstrated to show some promising results against Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS), and the Ebola virus, though it is not an approved treatment yet for any of these conditions.

Ferozsons has had a relationship with Gilead since at least 2015, having first signed an agreement to manufacture and distribute Harvoni and Sovaldi in the Pakistani market. So it was not entirely unexpected when Ferozsons announced that it would be among the first companies to be able to begin manufacturing another blockbuster antiviral drug from Gilead.

The agreement that Gilead has with Ferozsons, however, is not exclusive. That means that Gilead remains free to sign agreements with other pharmaceutical manufacturers in Pakistan to produce the same drugs that it has authorised Ferozsons to produce. And other pharmaceutical companies are also free to import Gilead’s drugs from manufacturers other than those based in the United States and Europe.

That second route appears to be what Searle has taken in order to be able to capitalise on the need for remdesivir as Pakistan’s coronavirus epidemic appears to be gathering steam. It is not yet clear when Ferozsons will be able to begin production of remdesivir, and by the time it starts its first shipments, Searle may have already begun distributing the imported consignments from Bangladesh into the market, which would dampen Ferozson’s advantage.

According to reporting by Reuters, Ferozsons expects that production should start “within weeks,” quoting Osman Khalid Waheed, the chief executive of Ferozsons Laboratories Ltd, which will produce the drug. Waheed said this at a news conference alongside Zafar Mirza, the advisor to the Prime Minister on health.

“Pakistan will be among the first three countries in the world where it will not only be produced but will also be exported to the whole world,” Mirza said. It will be exported to 127 countries, he said.

Yet given the speed with which the pandemic has grown in Pakistan – and the utter unwillingness of large swathes of the public to engage in meaningful social distancing or otherwise take the disease seriously – the need for remdesivir will likely continue to grow.

However, some analysts believe that – even though the drug is likely to be needed by many patients in Pakistan – all is not entirely rosy for the two companies that have been able to acquire the licence to distribute the product in the country.

“The key risk to the drug’s sales will be the introduction of a vaccine for covid-19,” wrote Hammad Akram, a research analyst at Topline Securities, a leading securities brokerage firm.

The US-based pharmaceutical company Moderna has successfully completed a phase 1 clinical trial of a vaccine for covid-19 and achieved considerable success, with all 8 patients in the trial developing antibodies for the virus. The company announced on May 29 that it is already proceeding with its phase 2 clinical trial of the drug.

Given the urgency of the pandemic and the devastation it has caused, the US FDA – the de facto global regulator for drug safety, given the importance of the United States in the global pharmaceutical market – has accelerated its approval process for the development of a covid-19 vaccine, as well as a covid-19 treatment.