British fine chemical maker Sterling Pharma Solutions will begin mass production of hydroxychloroquine to supply the UK market at its plant in Newcastle-upon-Tyne, England.
The manufacturer made the decision to move production of the drug to the UK from abroad to combat potential shortages.
Sterling will be manufacturing the active pharmaceutical ingredient (API) with the finished product being manufactured and supplied by Accord Healthcare.
Accord Healthcare aims to produce an average of 50 million tablets per month from its facility in the UK, by October 2020, approximately 70% of the UK’s annual use of hydroxychloroquine. The move would also provide “sufficient capacity to supply European markets.”
The drug had been prescribed primarily to treat rheumatoid arthritis and lupus, but is currently being used in three UK trials across primary, secondary and intensive care.
Pharmacists have warned that the preliminary results from trials assessing the medicine’s efficacy against COVID-19 should be treated “with care” to avoid patient hoarding and misuse.
The malaria treatment has been derisively renamed President Donald Trump’s “pet drug” by opponents after he repeatedly touted its use and hailed it as a potential “gamechanger” in COVID-19 treatment.
Last month, Albany Molecular Research announced plans to increase hydroxychloroquine production in Rensselaer, New York.
The UK’s current supply of hydroxychloroquine is sourced from overseas, primarily as a result of economic pressures driving production to lower cost manufacturing regions. The new deal with Accord will establish a domestic supply of the product ensuring access for patients in the UK, should the drug prove successful.
CEO of Sterling Pharma Solutions Kevin Cook said, “While it is currently unclear whether hydroxychloroquine will be a viable treatment for COVID-19, it is vital to proactively establish a strong supply route ahead of time.
“Rapid response to a rapidly changing landscape has been key here. We have worked quickly alongside Accord Healthcare to establish a UK supply chain for this product.
“Hydroxychloroquine could potentially provide an effective treatment for COVID patients and during such an unprecedented time it’s important that the pharmaceutical industry work flexibly to achieve maximum results as quickly as possible and this partnership is a good example of that.”
Sterling has already supported Accord with the purchase of over 50 tonnes of key raw materials. It will be enough to produce 60 million tablets, which equates to “either 2 million treatments — or in prophylaxis, between approximately 2 million and up to 8 million patient months of supply — based on the various dosing schedules being trialled.”
James Burt, executive vice president of Accord Healthcare, said that if trials around the use of hydroxychloroquine prove successful, “there is likely to be a significant worldwide shortfall in the API.”
Warwick Smith, director general of the British Generic Manufacturers Association (BGMA), told The Pharmaceutical Journal that the Association “welcomes the increased capacity and certainty this specific deal will deliver.”
“Currently, around a quarter of all generic prescription medicines dispensed in the UK are manufactured here. While most manufacturers will have significant supplies of API in stock — often six months or more — much of this is sourced from Europe, or further afield in China or India,” he said.
“The current crisis has underlined the benefits, from a medicine resilience perspective, of more robust supply chains and more ingredients readily available.”
The decision from Accord Healthcare comes after generics manufacturers and the BGMA called for European leaders to move drug manufacturing out of India and China to help stabilize the drug supply chain.
An investigation by The Pharmaceutical Journal in August 2019 revealed that half of all safety warnings from European and US drug regulators are issued to drug manufacturing sites in India and China, raising concerns over the fragility of the global supply chain.
Sam Roscoe, senior lecturer in operations management at the University of Sussex, raised concerns about fragility in the drug supply chain when speaking to the House of Commons International Trade Committee in April, suggesting the UK consider “a parallel supply chain where we are able to develop manufacturing capacity to make critical drugs in the UK.”
“The cost will be very high,” he said. “For the majority of generics, there’s not a lot of profit so there will need to be government support.”
He added that a parallel supply chain “doesn’t have to make 100% of the product, it could make 30–40%, but when there’s a crisis, such as a second wave, it is able to ramp up production capacity so that the UK population has the drugs that it needs.”
The UK has already faced supply chain disruptions owing to demand from COVID-19, with pharmacies experiencing difficulties sourcing some commonly used asthma inhalers, while supplies of drugs used when intubating patients with the virus have also depleted.