Moderna, one of the leaders in the race to develop a new Covid-19 vaccine, has come home — again.
The biotech startup, which raised a significant chunk of its initial $100m amongst a group of far-sighted Swiss investors and private bankers a decade ago, announced Wednesday that it would be establishing its first commercial hub outside of North America in Basel. The new Swiss hub, located alongside the company’s European headquarters, will be led by Dan Staner, as vice president and managing director, Switzerland.
“Switzerland has a leading biotech and pharma sector. All the conditions exist for a new leading-edge technology, such as the mRNA platform, to attract leading vaccine talents from around the world to join us in Switzerland,” Staner told Geneva Solutions.
“By the end of December, we will have around 20-30 specialists at our Swiss headquarters in Basel, where the hub for the whole of Europe is also located. By the end of 2021, we expect to have between 50 and 60 employees, mainly people who already have experience in regulatory affairs, medical, quality, manufacturing or commercial roles,” said Staner, a former executive for Eli Lilly and a Swiss national with a degree from the University of Lausanne.
Paving way to Swiss Medic Approval. One of the key missions of the new office will be to ease the way to Swiss regulatory approval for the company’s novel messenger RNA (mRNA) vaccine candidate, currently undergoing Phase III clinical trials, Staner added. Recently, the Swiss Federal Government concluded an agreement with Moderna for the procurement of 4.5 million vaccine doses of the mRNA-1273 candidate, one of nine worldwide at the advanced Phase III trial stage. However, the national regulatory agency, Swiss Medic, operates independently of the European Medicines Agency. Staner:
“My goals are firstly to work closely with the Swiss Regulatory Authorities to deliver a high quality, approved vaccine as soon as possible for the Swiss population, secondly, to build a highly effective and professional Moderna team in Switzerland; and thirdly to work closely with key healthcare stakeholders in the country, to ensure we defeat the pandemic together.”
In an interview with the Swiss business journal Bilan, Moderna CEO Stéphane Bancel predicted that the company’s vaccine could be ready for market approval as early as October, but “without a doubt” by December or January 2021. He noted that the Moderna Phase III trial had already enrolled some 21,000 participants - nearly reaching the 30,000 target set by the United States Food and Drug Administration (FDA) for participation.
Fears of ‘vaccine nationalism’.The United States, where the company is based, also has huge political and financial investments in Moderna’s development, with a pre-order of 100 million vaccine doses, announced by US President Donald Trump in an August deal, said to be worth US$ 1.5 billion. The big pre-orders have fueled fears amongst global health officials that once a safe and effective Covid-19 vaccine does become available, rich countries will have already bought up the lion’s share of available supplies - making it harder to get access to low and middle-income countries.
The US Biomedical Advanced Research and Development Agency (BARDA) also had provided Moderna with nearly US$ 1 billion in public funds for Covid-19 vaccine R&D, with the US Defense Advanced Research Projects Agency (DARPA) investing lesser amounts. Recently, that support became the focus of controversy after a medicines access group charged that Moderna had failed to report the public funding, as required, in its US patent applications - something both BARDA and DARPA said they are now investigating. Evidence of public funding is often key to leveraging lower prices among drug and vaccine manufacturers.
Lonza manufacturing agreement also key to Moderna’s Swiss choice. According to Moderna, another reason for the decision to open a Swiss commercial hub, is the agreement announced in May 2020, with the Swiss manufacturing firm, Lonza, for the large scale global manufacture of the vaccine candidate in Switzerland “and additional Moderna products in the future.”
Deep roots in Switzerland. But the strategic decision to develop a commercial outpost in Switzerland, continues a romance with the Confederation that began long before the Lonza agreement. Almost a decade ago, Bancel, head of what was then an unknown startup, Moderna Therapeutics, began raising capital along the shores of Lac Leman among a small group of private Swiss investors as described in an exclusive Geneva Solutions story.
Bancel, who had previously headed BioMérieux in nearby Lyon, won over the hearts and minds of the Swiss financiers, who were shrewd enough to see the potential in the new technology - which went on to yield a number of infectious disease vaccine candidates even before the SARS-CoV-2 virus came along and dramatically changed the company’s trajectory. Bancel:
“Switzerland is a leader in life-sciences, with a dynamic pool of industry talent, scientists, research organizations, investors and global health policymakers. Since Moderna’s founding, Switzerland has played an important role in Moderna’s development thanks to the long-term support of our Swiss investors and their business advice. Opening our first subsidiary outside North America in Switzerland is a natural step for Moderna.”