Orion's blockbuster drug enables growth and renewal
The persistent faith of Orion's development team in their own idea helped to bring a cancer drug to market that has reached the rare billion-sales class, so-called blockbuster drug. The success opens up new possibilities for the company to expand its research and commercial organization, as well as to build a pharmaceutical ecosystem in Finland from which new successes can spring.
The prostate cancer drug darolutamide, invented by Orion's researchers, is an exceptional success story: the drug surpassed the one-billion-euro annual sales mark in September 2024. Now the company has a completely new basis for developing its activities.
“Orion will become a different company because we succeeded in the development of darolutamide,” says Outi Vaarala, SVP, Innovative Medicines & Research and Development at Orion.
Conquering the world starting from the United States
Since the sales are so massive and the royalty income significant, Orion now has the financial opportunities to expand research and development and build a global commercial organization.
Thanks to the success of darolutamide, Orion has started to conquer the world from the most important pharmaceutical markets. To enter the United States, new drugs must undergo clinical studies within the country, which is why Orion is increasing its drug development there with local teams.
“The local office of Business Finland has opened doors for us there and created connections. I think this is very important activity: if Business Finland wants Finland to succeed in the world, it must be present where its clients need to succeed,” Vaarala continues.
Bayer will continue to handle darolutamide sales as a partner, but in the future, Orion will be able to take the innovative new drugs it develops further commercially on its own.
Ecosystem as the driver for drug development
According to Business Finland, darolutamide and Orion are a good example of how long-term drug development is. To ensure that similar successful drugs can continue to be developed in Finland by a larger group, Orion is leading a flagship project funded by Business Finland to create an ecosystem focused on pharmaceutical development.
"When funding large companies, we consider the project's impacts on other companies and research since it also grows the entire ecosystem's expertise. It's great that Orion has set out with their flagship project to strengthen the entire ecosystem and enhance the industry's competitiveness," says Outi Tuovila, Ecosystem Manager at Business Finland.
If you look at the successful pharmaceutical companies around the world, they all pretty much have an ecosystem around them, where the expertise of different companies comes together. Then the development of drugs is accelerated.
“So far, Orion has been pretty much alone in Finland as a big player. We are trying to change that”, Vaarala says.
Rigidity takes away the buzz
The small size of companies is not a problem in itself. According to studies, about 60 percent of new drug molecules have been developed in small companies. Perhaps innovative buzz is harder to come by in big pharmaceutical firms? Is Orion actually just the right size?
“I fully endorse that. Project work in large companies can be very rigid, while our departments talk to each other and decisions and changes in projects are made very flexibly," says Olli Törmäkangas, Orion's Chemistry Lead, whose team developed darolutamide.
All support is needed, as drug development is an expensive and slow process. Only one in five thousand new molecules ultimately makes it to market as a drug. The development process can easily take ten years or more.
Additionally, a drug is always tested for each therapeutic indication before receiving marketing authorization for that specific use. There are several different types of prostate cancer, so the testing of darolutamide for new indications is still ongoing.
Efficacy and safety
Darolutamide is an androgen receptor inhibitor, meaning it weakens the effects of male hormones, which in turn slows the growth of prostate cancer. The development of the drug began in 2005 when Orion started using computer models to search for new molecules as a basis for the medication.
“The best anti-androgens available at the time were not very effective and famously caused mutations. There was an acute need for better medication. In our own work, we paid special attention to safety", Törmäkangas states.
Orion's competitors had also noticed the unmet need, and darolutamide was not the first to market. Competition intensified quickly.
Orion succeeded in that it considered the drug from the very beginning as a whole from various angles. The team aimed not only to develop a highly effective drug but also defined right away the properties that the molecule should have.
The resulting darolutamide does not cross the blood-brain barrier that protects the nerves of the central nervous system. This is a beneficial property because drugs that reach the brain can cause troublesome side effects.
Courage to focus on one's work
In addition to considering all the desired properties of the drug, a key to Orion's success was the right attitude.
“Success requires focusing on our own work and not criticizing the structures or operating environment. A positive thinking approach should spread within Finnish companies,” Vaarala emphasizes.
Darolutamide, having surpassed billion sales, has potential to grow into even greater success. Currently, darolutamide has proven effective in three different sub-indications of prostate cancer, and two phase III studies are still ongoing, which, if successful and upon regulatory approval, could extend the indication further into new types of prostate cancer.
According to Bayer's estimate, sales of the drug could rise to as much as three billion euros.
“In Finland, we have the knowledge and ability to build something big. In the early stages of development, we didn't dare to dream of such large sales figures, but we had the courage to move things forward and also overseas. There's a demand for Finnish expertise”, Törmäkangas says.
Find out more about Business Finland's funding services
Darolutamide's development
- From 2002–2004, Orion received funding of around 2 million euros from Business Finland for research projects on the treatment of androgen receptor-mediated diseases.
- Among other things, Orion was able to procure new cell lines from its network and set up the required research methods, compare the effects of different substances, and recruit expertise. This groundwork had a major impact on the initiation of the anti-androgen project.
- The search for a new drug molecule began in 2005, and darolutamide was synthesized in 2008.
- Orion received funding of around 2 million euros from Business Finland for the optimization process of molecules in 2007-2009. In addition to the anti-androgen mechanism, the effects and metabolism of testosterone and other androgenic steroid hormones were investigated.
- After the project, the first drug candidate was selected for development at the end of 2009. In preclinical studies in the early 2010s, the drug's safety and efficacy were assessed in the laboratory and animal experiments.
- Based on the preclinical studies, Orion initiated a drug development project, leading to an effective androgen receptor function inhibitor for the treatment of prostate cancer.
- Darolutamide received its first marketing authorization in the United States in July 2019 for the treatment of non-metastatic castration-resistant prostate cancer.
- Clinical trials have continued into new therapeutic indications. By the summer of 2024, darolutamide had marketing authorization in 85 countries.