With millions of patients affected by COVID-19, the raging pandemic has put enormous pressure on safety stocks of critical medicines. Healthcare workers are using every tool available to treat COVID-19 and associated (or secondary) infections, resulting in high pressure on multiple medications, including antibiotics. The pressure on the system has been significant with increased demand for key medicines from patients and governments.
We are proud of our success so far in ensuring a reliable supply of medicines through swift action to scale up production in the face of rapidly increasing demand and multiple new barriers along the supply chain.
Richard SaynorSandoz CEO
In response to these challenges, Sandoz, the generics and biosimilars division of Novartis, has expanded its manufacturing capacity to maintain a stable supply of generic medicines for patients, while meeting a number of additional commitments to help the global response to COVID-19.
“We are proud of our success so far in ensuring a reliable supply of medicines through swift action to scale up production in the face of soaring demand and multiple new challenges along the supply chain. said Richard Saynor, CEO of Sandoz.
“This crisis is exceptional, both in the way it affects our patients and in the complexity it presents to us in the way we respond to it. Indeed, we are seeing an increase in demand combined with significant supply restrictions. Border lockdowns and limitations on trade, exports and air traffic, as well as additional demands placed on employees, both on and off site, have made the production and delivery of medicines incredibly difficult. Despite these challenges, we continue to provide quality generic and biosimilar medicines to the patients we serve, while meeting additional commitments to fight COVID-19. »
Sandoz, Europe’s largest drug supplier and a global leader, has taken early action to ensure patients can access its drug portfolio, despite the crisis. Measures such as proactively increasing inventory of antibiotics and respiratory medications are now helping the company address COVID-related supply chain issues and continue to meet patient needs. All Sandoz manufacturing sites and suppliers have continued full production and delivery throughout this crisis.
In addition to this, Sandoz pledged in February to guarantee stable prices for a basket of its essential medicines, which could help treat patients with COVID-19. Sandoz is also providing public and private partners with donations of a malaria drug with antiviral properties, currently being investigated as a potential treatment for COVID-19. Novartis has pledged to donate 130 million doses of this potential treatment, worldwide, based on government requests.
“Sandoz employees around the world are the reason we are able to meet the needs of patients, healthcare providers and researchers during this time of global crisis,” said Richard Saynor. “Without their willingness to work harder, solve problems faster, and collaborate in new ways, we wouldn’t be able to contribute in all the ways we are now.”
Manufacturing in times of crisis
Sandoz manufacturing sites in Kundl, Austria and Targu Mures, Romania are increasing stocks of key antibiotics needed to respond to the COVID crisis. The Sandoz antibiotics production facility in Kundl is the only remaining fully integrated large-scale manufacturing facility for these critical drugs in Europe, primarily serving the European market. Sandoz’s two largest businesses, Biopharmaceuticals and Anti-Infectives, both have production based primarily in Europe.
“Kundl recently set a new record for internal production, in the face of an unprecedented increase in demand due to COVID,” said Roman Burja, FDF Site Manager, Sandoz Austria. “As the global leader in generic antibiotics, Sandoz has a responsibility to do everything in its power to ensure patient access, especially in times of crisis, and I am delighted to say that the team has is mobilized in an unprecedented way to achieve this, despite a very dynamic market situation.
In China, the COVID-19 outbreak has presented unique challenges to local manufacturing, such as quarantine restrictions for all manufacturing employees. Sandoz production at Novartis’ technical operations site in Zhongshan, China, has also experienced staff shortages due to the outbreak.
“After the outbreak, the Zhongshan site (…) faced multiple challenges brought by the pandemic, such as tight supply of raw materials and shortage of personnel. Site colleagues contributed their maximum to support Sandoz China operations by overcoming challenges and seeking solutions to produce medicines at the highest quality standards,” said Francis Vaillant, Head of Greater China, Sandoz.
To go beyond
On March 20, Novartis pledged to donate up to 130 million doses of a malaria drug with antiviral properties by the end of May to support the global response to the COVID-19 pandemic. To provide this donation, Sandoz’s manufacturing site in Wilson, North Carolina, USA managed to double its production of this drug in less than a month, while continuing to produce all other drugs in its portfolio. The facility is operating in a three-five-day shift mode and is on track to manufacture 80 million doses, the equivalent of nearly two years of steady demand for the drug in the United States, in just two month. Global distribution is executed in record time.
“It’s amazing to see in these difficult days the spirit, the dedication, the tenacity of our teams to ensure the continued supply of this important medicine,” said Carlos Hernandez, director, MS&T, Sandoz US.
“Team members are coming together to dramatically increase production to meet the needs of existing patients and those in clinical trials,” said Candida Boone, director, P&O, Wilson Technical Operations.
The Sandoz Wilson site has begun shipping 30 million doses of the malaria drug to the US Department of Health and Human Services for immediate use in controlled clinical studies. Sandoz also donated 20,000 pills to the University of Washington for a clinical trial to determine the prevention of COVID-19 in 2,000 people who have previously been exposed to the disease. The trial is sponsored in part by the Bill & Melinda Gates Foundation as part of the COVID-19 Therapeutics Accelerator. The results of this clinical trial will be available at the end of 2020.
On April 30, Novartis announced its agreement with the United States Food and Drug Administration (FDA) to conduct a Phase III clinical trial with approximately 440 patients to evaluate the use of the malaria drug for the treatment hospitalized patients with COVID-19 disease. Drugs for clinical trials are supplied by Sandoz.
“We are deeply committed to the global effort to combat COVID-19 and ensure the stability of global healthcare systems,” said Carol Lynch, President of Sandoz Inc.. “Now is when our goal – pioneering access for patients – matters most, and I’m proud to see Sandoz show up with our best at this critical time,” said Richard Saynor. “In the midst of a global health crisis, our ability to continue to provide essential medicines to patients while meeting additional commitments to support the response to COVID-19 is only possible thanks to our employees.”