With millions of patients affected by COVID-19, the raging pandemic has put enormous pressure on critical medicine safety stocks. Healthcare workers are using every tool available to treat COVID-19 and related (or secondary) infections, resulting in a heavy pull on several medicines, including antibiotics. The pull on the system has been significant with increased demand for key medicines from patients and governments.
We are proud that we have so far managed to ensure a dependable supply of medicines through swift action to increase production in the face of rapidly surging demand and multiple new obstacles throughout the supply chain.
Responding to these challenges, Sandoz, the Novartis generics and biosimilars division, has expanded its manufacturing capacity to maintain a stable supply of generic medicines for patients, while also delivering on a number of additional commitments to contribute to the global COVID-19 response.
“We are proud that we have so far managed to ensure a dependable supply of medicines through swift action to increase production in the face of rapidly surging demand and multiple new obstacles throughout the supply chain,” said Richard Saynor, Sandoz CEO.
“This crisis is exceptional, both in how it impacts our patients and the complexity it presents to us in how we respond. This is because we see a demand surge combined with major supply restrictions. The lockdown of borders and limitations on trade, export and air traffic, as well as the additional demands placed on employees both at sites and elsewhere, have made the production and delivery of medicines incredibly hard. Despite these challenges, we continue to deliver quality generic and biosimilar medicines to those patients we serve, while also meeting additional commitments to fight COVID-19.”
Sandoz, the single largest medicines provider in Europe and a leading player globally, took early action to ensure patients could access its portfolio of medicines, despite the crisis. Measures such as proactive increases in inventory of antibiotics and respiratory medicines are now helping the company navigate 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 committed in February to ensuring stable pricing for a basket of its essential medicines, which may help to treat COVID-19 patients. Sandoz is also supplying 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 committed to donate 130 million doses of this potential treatment, world-wide, based on government requests.
“Sandoz employees around the globe are the reason we are able to meet the needs of patients, healthcare providers, and researchers at this time of global crisis,” said Richard Saynor. “Without their willingness to work harder, problem solve faster, and collaborate in new ways, we would not 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 supplies 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 plant for these critical medicines in Europe, primarily serving the European market. The two largest Sandoz businesses, Biopharmaceuticals and Anti-Infectives, both have production based primarily in Europe.
“Kundl recently set a new internal production record, in the face of an unprecedented COVID-driven demand surge,” said Roman Burja, Site Head FDF, Sandoz Austria. “As the global leader in generic antibiotics, Sandoz has a responsibility to do everything it can to ensure patient access, particularly in times of crisis, and I am delighted to say that the team has pulled together in an unprecedented way to make that happen, despite a highly dynamic market situation.”
In China, the COVID-19 outbreak presented unique challenges to local manufacturing, such as quarantine restrictions for all manufacturing employees. Sandoz production at the Novartis Technical Operations site in Zhongshan, China 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 staff. Colleagues at the site have contributed the utmost to support Sandoz China operations by overcoming difficulties and seeking solutions to produce drugs per the highest quality standards,” said Francis Vaillant, Head of Greater China, Sandoz.
Going above and beyond
On March 20th, Novartis committed to donate up to 130 million doses of a malaria drug with antiviral properties by end of May to support the global COVID-19 pandemic response. To supply this donation, the Sandoz manufacturing site in Wilson, North Carolina, USA has successfully doubled its production of this medicine in less than a month, while continuing to produce all other medicines in its portfolio. The facility is operating in a three-shift, five-day modus and is on track to make 80 million doses, the equivalent of almost two years regular demand for this medicine in the US, in just two months. Worldwide distribution is being executed in record time.
“It has been amazing to see in these challenging days, the spirit, the dedication, the tenacity of our teams to ensure the continued supply of this important medication,” said Carlos Hernandez, Director, MS&T, Sandoz US.
“Team members are pulling together to significantly 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 shipment of 30 million doses of the malaria medicine to the US Department of Health and Human Services for immediate use in controlled clinical studies. Sandoz also completed a 20,000 tablet donation to the University of Washington for a clinical trial to determine 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. Results of this clinical trial will be available in late 2020.
On April 30th, Novartis announced its agreement with the US Food and Drug Administration (FDA) to proceed with a Phase III clinical trial with approximately 440 patients to evaluate the use of the malaria drug for the treatment of hospitalized patients with COVID-19 disease. The clinical trial drug supply is provided by Sandoz.
“We are deeply dedicated 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 Purpose – pioneering access for patients - matters most, and I am proud to see Sandoz showing up with our best at this critical time,” said Richard Saynor. “In the midst of a global health crisis, our ability to continue supplying essential medicines to patients while also delivering on additional commitments to support the COVID-19 response, is only possible because our employees.”