Our strength lies in taking drugs in late stages of development to the market. Thanks to our extensive network, expert knowledge and efficient logistics, we can reach patients all over the world. By collaborating with a large number of research institutions and companies, we increase the chances that more new and improved drugs against rare diseases will become a reality.

A focused approach
Producing a new medicine can take more than ten years. The process of developing a drug begins with research, which is conducted at universities or in the biotech and pharmaceutical industry. This research may result in the creation of a new preparation.

Swedish Orphan International monitors research activities through close cooperation with institutions and businesses to identify potential future products. Once we have identified an interesting drug, a partnership is established with the organisation developing the preparation. This usually takes place during phase II or III of clinical development or when the drug is in the registration phase.

For the pharmaceutical industry, developing a new drug is a protracted and risky venture. A new preparation can cost more than SEK 1 billion to develop and there is no guarantee that it will eventually be approved by the regulators and offered to patients.

One of the advantages of our focus on the latter phases of development is that it reduces the financial risk.

The clinical stage is divided into three phases
When the pre-clinical studies have been completed, the clinical stage of development begins, and this stage is divided into three phases.

Phase I. Tests are carried out on healthy volunteers, who receive a single dose of the preparation. The aim is to analyse how the drug is assimilated and metabolised in the body.

Phase II. The preparation is tested on a small group of patients. One of the aims is to analyse whether the drug is effective against the disease it is intended for and to establish a suitable dosage level.

Phase III. In the third phase the test group is expanded to further demonstrate effects and safety. It is here that comparative studies with existing medicines are done, if such a medicine exist.
The further a medicine goes up the chain, the greater the chances that it will eventually reach the market. Once a medicine has been approved, followups are can be made to further confirm its safety in clinical use These are known as phase IV studies. Once the manufacturing, pre-clinical and clinical studies are completed/satisfactory, these data has to be evaluated and approved by a Regulatory Authority.

The further a medicine goes up the chain, the greater the chances that it will eventually reach the market. Once a medicine has been approved, followups are made to further confirm its safety in clinical use. These are known as phase IV studies.

In the market
The fact that an orphan drug has been approved for sale by a regulator does not mean that patients automatically get access to it. The company supplying the drug needs to have experience, a local presence and a good knowledge of regulations, pricing and other local issues. Other requirements include local monitoring of the effect and an effective, wellfunctioning logistics network. These factors are a basic prerequisite, and it is here that our strength lies in the form of collaboration with partners pharmaceutical and research companies), specialist physicians, patient organisations and government regulators.