Revolution Medicines is laying the groundwork for a broad European commercial rollout of its pancreatic cancer drug, signaling confidence in its ability to bring the therapy to market without relying on a local partner to help sell it.
Following impressive clinical data against the notoriously difficult-to-treat cancer, analysts forecast peak annual global sales of $11.5 billion for Revolution’s Rasonque, which won speedy US approval in August after an FDA expedited review.
The European Medicines Agency’s human medicines committee on Thursday recommended a marketing authorization for the oral drug, known chemically as daraxonrasib. It will now be reviewed by the European Commission.
Small biotechs such as Revolution Medicines typically strike regional licensing deals in markets where they lack the scale or expertise to negotiate with government health systems, and in some cases ultimately sell themselves to larger drugmakers.
“We are doing everything that we can practically do to make this product available on as global a basis as possible,” RevMed CEO Mark Goldsmith said in an interview last month. “But it is more complicated on a country-by-country basis.”
RevMed’s shares have more than doubled so far this year, giving it a market value of $41.5 billion.
The company is applying lessons from the accelerated US approval process to markets abroad, with its most advanced efforts in Europe. Three Wall Street analysts said they believe Revolution can succeed with a solo push in Europe, despite this being its first approved drug.
The California-based company has been building a strong presence in several key European markets, expanding its regulatory, medical, market access and commercial infrastructure, it told Reuters.
Revolution said direct commercialization would also allow it to convey its deep knowledge of the drug to health systems and doctors.
It is seeking approvals through Project Orbis, an FDA-coordinated program for simultaneous submission to the EMA, the UK’s MHRA, Health Canada, and Australia. The parallel route could help shorten approval timelines by allowing shared regulatory data instead of separate reviews by each country.
Funding supports independent European launch
CEO Goldsmith declined to comment on any takeover speculation. The company said it may work with external partners in markets where local expertise is needed, but is focused on building its own global commercial presence for the drug and the company’s broader pipeline.
“It seems doable,” said RBC Capital Markets analyst Leonid Timashev, of the company’s ability to launch the drug independently. “They have certainly been hiring in a way that would indicate that that’s something that they are going to try.”
Revolution’s deal with Royalty Pharma RPRX.O that provides the drugmaker with up to $2 billion in development and marketing funding, has largely dispelled investor expectations that it would need to pursue a commercialization partner outside the United States, analysts said.
Royalty Pharma is the world’s largest buyer of biopharmaceutical royalties, which can provide funding for drug development. Royalty also recently tied up with BeOne Medicines 688235.SS in China and certain Asian markets on an Amgen AMGN.O lung cancer drug.
Company expands hiring across Europe
Stifel analyst Laura Prendergast, who expects the drug will hit $3.2 billion to $3.3 billion in peak sales outside the US, mostly from Europe and Japan, said Revolution’s key hires over the last year and a half are focused on global infrastructure.
Anthony Mancini joined the company last year as chief global commercialization officer from Denmark’s Genmab GMAB.CO, bringing over 25 years of experience in international markets. He also spent more than two decades at Bristol Myers Squibb BMY.N.
Hiring activity on LinkedIn shows that the company has advertised for at least 50 roles across the UK and Europe in the last month. These include positions requiring commercial and regulatory expertise in countries such as Germany, Italy, France and the Netherlands.
“Germany is a big focus for RevMed right now,” said Stifel’s Prendergast. “After they get the EMA approval, eyes will likely be on where Germany prices and that’ll set the precedent for the rest of Europe.”