Successful European expansion

The past year proved to be yet another successful year in Swedish Orphan International’s 20-year history. We have shown clearly that our business model works, that we are reaching out to a growing number of patients with rare diseases, that we are able to achieve sustainable growth and profitability, and that our ability to compete is very good.

Today we know of more than 7,000 rare diseases but in the EU only about 600 drugs for treating rare diseases are currently being developed and less than 50 of these have been approved for use. This creates big opportunities for us to continue expand and generate strong returns. We are convinced that we will be able to help even more patients suffering from rare diseases or diseases for which there has been no satisfactory treatment.

Expansion going to plan

During the year we continued to expand geographically and in terms of our product offering, exactly as planned. We opened an office and established a subsidiary in Russia. An application for registration of Orfadin® was submitted and we hope to obtain approval in 2009. Russia still has no legislation on rare diseases but the issue of introducing such legislation is being discussed in the Duma, and we are optimistic about our opportunities in the country.
We have also decided to open a representative office in Switzerland covering Switzerland, Austria and Slovenia, which are currently managed from our German office. Reducing the size of the regions managed by each office will enable us to get closer to the patients and reach out to and help more people.
We have added no less than 14 new drugs to our product portfolio through partnerships.


Long-term strategy

Our long-term strategy is to also increase our portfolio of proprietary drugs and the focus over the past year has been on securing the mutual recognition procedure for our proprietary drug Multiferon®. This work has been completed successfully, and since March 2009 Multiferon® is approved in 15 European countries. Besides for the treatment of Malignant Melanoma Multiferon® is also approved for treatment of patients who do not respond to treatment with recombinant interferons. It is this second indication that is deemed to have the largest market potential as up to 40% of patients treated with recombinant interferons today, do not show sufficient effect. This indicates that there is a large unmet medical need. Focus will now be on securing registration of Multiferon® in the remaining EU countries.

Political commitment for rare diseases

The global financial crisis that began in autumn 2008 has had a very limited impact on our industry. Existing legislations in the United States and the EU protect the development of orphan drugs. The EU’s new plan establishes that “Health is our greatest wealth,” which means, in practice, that health and healthcare are priority areas in the EU. In particular, there is now a clear focus on continuing to promote the development of and improve access to orphan drugs for patients with rare diseases, which is very encouraging.

As population ages and birth rates fall, it is becoming imperative to ensure that the working-age population is able to contribute economically. It is estimated that in Europe alone there are some 30 million people with rare diseases, yet only two to three million are currently receiving treatment. Treating patients with rare diseases and enabling them to work and earn a living is thus important not only for the individuals concerned but also for society at large.

Constant focus on the patient

Since its foundation the number one success factor for Swedish Orphan International has been our constant focus on the patient. Everything we do is aimed at improving the lives of patients with rare diseases.
Today many businesses work on formulating and identifying the responsibility they have and want to assume in society. This is known as corporate social responsibility, or CSR. It is clear that since the very beginning CSR, in the true sense of the word, has been at the very core of what we do. One could even say that, for us, CSR has become what might be called CSO – corporate social opportunity! By developing and distributing effective drugs and treatments, we have been able to help people who were previously unable to work, earn a livelihood and contribute to society.
Throughout our history we have stuck to our mission: To offer products and services that meet medical needs in cases where existing treatments do not exist or are inadequate. Our aim is to provide patients, healthcare staff and the pharmaceutical industry with an international network specialising in the development, marketing and distribution of orphan drugs.

A decentralised organisation

Our mission and values inspire everything we do and are shared by all our competent and highly skilled staff, most of whom have a long business-oriented as well as scientific background. To make the most of and encourage the entrepreneurial spirit, which is one of the hallmarks of our company, we operate with a decentralised organisation. We currently have 14 subsidiaries in 11 countries around Europe, and the manager of each subsidiary has a large responsibility. Regular and frequent meetings among all country managers ensure that the company develops as planned, that our core values are implemented throughout the organisation and that experiences from different markets are shared. In addition to internal meetings, a series of international training sessions, conferences and seminars are arranged with leading experts in the industry and other professionals working with rare diseases. These gatherings are much appreciated by all those taking part and play a huge role in the exchange of experiences and spreading of knowledge.

Thanks to our successful, long-term work as pioneers in the area of rare diseases, Swedish Orphan International has a very strong reputation in the industry. We receive many enquiries about collaboration, partnerships and proposals on project acquisitions. At any given time we have 10 to 15 potential projects under evaluation and ongoing dialogues with potential partners. For us the deciding factor is that any future project or partner can make a difference for the patient and that it is consistent with our values and mission.

Invaluable contributions

When I started working at Swedish Orphan International 15 years ago, I did so with the intention of staying for only a short time. I was working as a surgeon at the same time and was in the process of completing my dissertation in urology. Yet, as time passed I became ever more divided as to which of my two occupations I wanted to devote myself to. The decision was made during a dinner in Washington with Marlene Haffner, a former director of the Office of Rare Diseases at the US Food and Drug Administration (FDA). Discussing my dilemma with Marlene, she said: “Bo, each day that you go to Swedish Orphan International you help to prolong the lives and improve the quality of life for children suffering from rare diseases thanks to the work you do.”
This feeling is something that is shared by everyone at Swedish Orphan International – our work is important and affects the lives of other human beings. I am proud to be leading a company that is so clearly focused on the well-being of patients, and I would like to thank our enthusiastic and passionate staff for their commitment and efforts for the patients as well as for Swedish Orphan International as a company. Your work is invaluable and makes a big difference for a lot of people.

Stockholm, August 2009

Bo Jesper Hansen
CEO and President
Swedish Orphan International Holding AB