Having been quietly working away on its mRNA platform for years, Moderna stepped into the limelight during the COVID-19 pandemic and became a commercial-stage outfit almost overnight with its vaccine. After generating sales of USD 18.4 billion in 2022, demand for the company’s Spikevax shot, still its only commercialized product to date, have fallen drastically. But the US-based biotech has other mRNA-based candidates in its pipeline and aims to launch an RSV vaccine later this year while sustaining its patent infringement disputes with Pfizer/BioNTech.
“We are set to launch 15 new products in the next five years”
Dan Staner, VP, GM Germany & Switzerland and head of the Middle East Region
Fast Forward
Moderna was one of the biopharma companies to come out with a COVID-19 vaccine based on mRNA – alongside Pfizer/BioNTech – producing shots in record time during the pandemic. While to many the development of the vaccine seemed like a miracle, the Cambridge Mass. company had in actual fact been working on the technology since it was founded in 2010 and continues to be focused on it today.
Yet Moderna’s Spikevax anti-COVID-19 shot is still the only product it has on the market, a product that sped Moderna forward to becoming a commercial-stage company when it perhaps still saw itself as an aspiring biotech. “The pandemic accelerated our development, and while we would probably have eventually landed in the same place, it happened more quickly than expected,” Dan Staner, VP, GM Germany & Switzerland and head of the Middle East Region says in a recent PharmaBoardroom interview.
Its explosive growth meant Moderna had to step up, create a unified company culture and build organizational elements from scratch, something Staner sees as an opportunity. “At an established Big Pharma company, all the systems are already in place, but we had a fantastic opportunity to create our own, more optimal, systems from the bottom up.”
A Pipeline Based on mRNA
The profits from its COVID-19 jab have given Moderna the horsepower to continue developing its other mRNA-based candidates. “Revenues from our COVID-19 vaccine have allowed Moderna to open many new avenues,” Staner confirms.
Yet the US-based firm continues to focus on the mRNA platform. “mRNA technology is a versatile platform with potential applications across therapeutic areas,” the Moderna VP asserts. “It can be tailored to fight various diseases, including cancer, rare disorders, and autoimmune diseases, by instructing cells to produce specific proteins that can either fight the disease directly or stimulate a strong immune response. mRNA vaccines and therapies can be developed more quickly than traditional methods, which is crucial in responding to emerging health threats.”
Moderna is aiming to launch its Respiratory Syncytial Virus (RSV) vaccine in 2024 after last year’s positive Phase III clinical study results, and is also preparing to launch multiple products per year from 2025. To this effect the biotech firm announced that it would be restructuring its commercial organization in 2024 with CEO Stephane Bancel assuming responsibility for sales and marketing in 2024 and president Stephen Hoge taking on its pipeline commercial strategy.
“We are set to launch 15 new products in the next five years, starting with our RSV, before moving on to influenza, combination vaccines, rare diseases, oncology, and latent viruses,” Staner confirms.
Beyond vaccines, Moderna is also working on therapeutics for diseases such as cancer, an area it is focusing on through a partnership with MSD, says Staner. “Together with our partner MSD and in combination with immunotherapy, we have mRNA-based products for late-stage melanoma and non-small cell lung cancer patients.”
Patent Fight
The launch of new products may be on the horizon for Moderna, but the company is currently embroiled in patent battles against Pfizer/BioNTech in Europe and the US that it began in 2022, alleging that its competitors infringed on two of its patents in their use of the mRNA platform and claiming compensation for these infringements.
In 2020, Moderna said it would not enforce intellectual property rights for vaccines that “intended to combat the pandemic,” but amended this claim in March 2022 to say that it expected competitors to “respect” its intellectual property and that it would be willing to license its technology “on commercially reasonable terms.” The biotech claims that Pfizer and BioNTech failed to seek a license.
The compensation Moderna could receive might make up for the falling sales of Spikevax, down to USD 6.7 billion last year, as the demand for COVID-19 protection fades, but more importantly it stands to have an impact on the development of future mRNA, a technology that has seen no less than 2,300 inventions as of 2021, according to the European Patent Office, with Moderna filing the highest number of any company with a total of 96 patents.
Vaccine Equity Concerns
Moderna has received its share of praise for bringing the COVID-19 vaccine forward, but has also been widely criticized for not making its shots more readily available to poorer countries, especially since the company received USD 1.3 billion in US government funding to develop the vaccine.
According to Africa CDC, the African Vaccine Acquisition Trust acquired 400 million vaccines from other companies during the pandemic because Moderna’s vaccines were not made available. In a move to step up its equity efforts and boost global pandemic preparedness, last year, the vaccine maker signed an agreement with the government of Kenya to invest USD 200 million in a facility that would produce 500 million vaccine jabs a year.
Moderna has now put the project on hold for later review while Staner stresses that the firm is “committed to using mRNA technology to address global health challenges, including neglected diseases that disproportionately affect the poorest regions of the world.”
