The long road to market
The process to develop a proprietary drug is long, and the road to market tends to be even longer. The Dexdor intensive care sedative is a good example of this.
The development of the first Finnish proprietary drug begins in 1979 at Farmos, a company that later merged with Orion. The research concerns the mechanisms of action of compounds that reduce blood pressure, and a new molecule is successfully synthesised at the beginning of the year.
At around the same time, the veterinary medicine department suggests that the researchers develop a synthesis method patent based on an animal sedative already on the market. The researchers discover that the adverse effects of a substance intended to be used as blood-pressure medication would be beneficial in an animal sedative. The work to develop detomidine begins, and the first Finnish proprietary drug, Domosedan, is launched in 1983.
But the story continues: the company decides to make use of the molecule for humans as well. And so, the development of dexmedetomidine begins in 1986. Abbott Laboratories in the United States soon takes an interest in the product, and Orion signs a licence agreement in 1994. Orion reserves the right to further develop and market dexmedetomidine in the Nordic countries, while Abbott has exclusive rights everywhere else in the world. The product is launched in the United States in 2000 and in Japan in 2004.
The European rights are returned to Orion in 2002. “We were not able to carry out further research at the time, as our resources were already tied up in two other projects,” says Director Päivi Aho, who was in charge of the dexmedetomidine development programme.
The situation changes in 2007. Orion begins phase 3 trials to gain marketing authorisation, and the EU authorities are impressed with the results. Orion is granted sales rights in September 2011, and the production of Dexdor packets begins at its Espoo plant in Finland. By the end of October, the sedative has also been launched in Germany, Austria, Denmark, Sweden, Great Britain and Ireland.