Why the generics industry has become crucial in helping fight Covid-19

The generics industry is a crucial partner in the fight against Covid-19 where cross-industry partnerships and alliances are creating a new normal, writes Tony Cordrey, VP Operations, Accord Healthcare EMENA.

As the world has had to unite in common purpose to fight Covid-19, the pharmaceutical industry has joined together to play a key role in ensuring that vital medicines reach sick patients at their point of need. No longer the Cinderella of the pharma industry, the specialist manufacturing of generic drug suppliers has come into sharp focus on the frontline of a pan-industry effort during the pandemic. 

The industry has always thrived on the symbiotic relationship between large pharmaceutical companies, with their undisputed strength in global research and development of innovator molecules and the generics industry, filling the post-patent gap by producing primarily small molecules and, increasingly, more complex biosimilars. However, research is not solely the domain of the larger companies. Increasingly the generics industry has started to initiate research into off-patent molecules that, based on their mode of action, can be repurposed to treat diseases that are different from the original licensed disease. Repurposing off-patent medicines has played an important part in the global search for a treatment for Covid-19 and it is this activity that has brought generics manufacturers into sharp focus as a keystone of our efforts. Accord’s scientists were able to very quickly identify five molecules that could possibly be repurposed; one of these very early discoveries was hydroxychloroquine (HCQ), a promising agent in the potential prophylactic and therapeutic use of combatting Covid-19. However, obtaining sufficient quantities for research purposes has not proved an easy task; supply chains are long and diverse and predictions of future demand are difficult to establish.

Most of the world’s raw chemicals from which our industry creates active pharmaceutical ingredient (API) are derived from Asia (much of these off-shored to low cost countries over 30-40 years ago) and shipped primarily to India or to Europe where API is created. 74% of the world’s HCQ API comes out of India and 80% of shipments of cargo occur by air using scheduled passenger airlines. With the start of Covid-19 impacting raw materials ex-China, the collapse of logistics routes, closed ports, loss of airline passenger cargo, and countries imposing export bans, the fragility of the supply chain has been exposed.  Accord has been working to overcome many of these challenges in obtaining API to meet the needs of patients, as the global infrastructure ground to a halt in March and April this year. 

Unable to rely on delivery of HCQ API and with Covid-19’s grip on Europe tightening, it was obvious that Europe would soon have difficulties in obtaining materials. Accord took a two-pronged approach to the situation. Firstly, to get API out of India – only days before the exportation ban was imposed and through a myriad of logistics challenges – to fly the material to our Barnstaple facility. Secondly, to take the unprecedented step of shipping the raw chemicals for HCQ out of Asia; recognising the deteriorating situation within days of the border controls and travel restrictions, to allow for future manufacture of HCQ API. The initial stocks of API allowed production in Accord’s UK manufacturing plant for donation into critically important clinical trials of HCQ (as treatment and as prophylaxis). Astonishingly, it took Accord just 22 days to identify stock and ship the API to its manufacturing plant in Barnstable, Devon, fast track the tech transfer, re-tool its lines (with change parts donated by a previous manufacturer), and see the first batch of validated and approved HCQ roll off the line. Indeed, the authorities played their part in the expedition of an approval of the MAH licence. In parallel, working closely with Medicines for Europe, European HCQ licenses were expedited, which allowed Accord to establish additional HCQ packaging at its site in Fawdon, Newcastle upon Tyne. The rush to make this stock was to honour a promise made to donate two million doses of HCQ to the world’s largest interventional study for the treatment of 40,000 frontline healthcare workers across Europe and Asia (COPCOV). Accord is supporting this study with active drug, matched placebo and scientific advice; a real ‘coming of age’ activity for any generic manufacturer and one that Accord is particularly proud of. 

When drug shortages cannot be ameliorated by switching production continents, we have had to try alternative approaches, for example addressing the current shortages of the drugs that are used in intensive care unit (ICU) ventilators. The generics industry, along with our colleagues in innovator companies, have all been trying to determine future demand driven by Covid-19 so that we produce enough to meet the needs; historical sales and production forecasts simply cannot provide an accurate forecast for a pandemic situation.  A new cross-industry collaboration led by Medicines for Europe and involving European and national regulatory and legal authorities has been established. Its aim is to enable participants to work closely with one-another through a clean room to pool supplies and manufacturing capacities to ensure stock of vital ICU drugs are delivered optimally to hospitals and patients in need. 

In regard to being able to forecast the demand, the industry has also been working very closely with Medicines for Europe to try and calculate this requirement for vital, high quality drugs at the same time as ensuring the supply chain is expedited to meet the demand. This has been made possible through a genuine spirit of cooperation alongside use of a demand forecast model that Accord created and that was adopted as a guiding standard by Medicines for Europe. Activities to date have included fast-tracking of new medicine marketing authorisation applications alongside fast turnaround of new manufacturing capabilities. This is a wonderful example of the new style of cross-industry cooperation that is helping to expedite medicines to patients; everything from procurement of raw chemicals and API, adapting production to meet demands, packing, quality testing, releasing and shipment to the front line. 

As temporary keepers of a world interrupted by Covid-19, we have all learned to work closely together for the greater good. As this pandemic recedes, I hope this new normal we have created will continue.