Orexo completes clinical study with positive results

Orexo has completed an efficacy study for OX 22, with positive results. OX 22 is a pharmaceutical product for the treatment of temporary insomnia, a product which is considered to have substantial medical and commercial potential. Negotiation with potential partners for commercialisation of OX 22 has been initiated.

Insomnia and/or other sleep disorders is a widespread and growing problem. OX 22 offers the patient fast and effective sleep aid, which is a significant improvement compared with existing drugs, in which the time to effect is longer and difficult to predict. In the completed clinical study, unbroken night’s sleep without any day-after side effects also could be confirmed. Global sales of pharmaceuticals for sleep disorders were estimated in 2003 at USD 2.4 billion (slightly more than SEK 16 billion). “Sleep problems is a rapidly growing and widespread disorder,” says Zsolt Lavotha, President and CEO of Orexo. “The market for rapid and predictable sleep – a full night’s sleep and waking without any “hangover” (day-after effects) – is large. Therefore we believe OX 22 has substantial medical and commercial potential.” OX 22 contains a well-documented active substance and is based on Orexo’s sublingual technology –a rapidly dissolving tablet placed under the tongue for fast, effective and predictable absorption of the active substance through the mouth’s mucous membranes. Among other countries, the technology is patent protected in the US, Japan and Australia. Patent applications have also been submitted in other major markets. Work with finding a commercialization partner for marketing and sales of the product on all main markets have been initiated. For further information, please contact: Zsolt Lavotha, President & CEO, Orexo AB +46 (0)18 780 88 12. E-mail: zsolt.lavotha@orexo.se Johan Tamsen, Corporate Communications +46 (0)733 25 40 10, E-mail: info@orexo.se About Orexo Orexo is a pharmaceutical company based in Uppsala, Sweden that is active in drug delivery. The company develops, documents and registers its own, patented pharmaceutical products. This is carried out on a proprietary basis as well as in cooperation with researchers and partnering with other companies. Orexo specializes in various forms of tablet preparations, in which the sublingual form – which means the patient places a rapidly dissolving tablet under the tongue – is currently one of the company’s most important technology platforms. www.orexo.se About insomnia Sleep is essential to life. It is when the body recovers and the brain processes and stores information. Much of all learning also occurs during sleep. Moreover, the stress hormone cortisol is reduced in the body. Lack of sleep results in stress which, in turn, leads to worse sleep, which can transgress into anxiety, sensitivity for pain and over time, also into exhaustion depression. Among other effects, loss of sleep can affect the ability to perform normal tasks that require attentiveness, mental effort or decisiveness. Other effects of the lack of sleep are mood swings, difficulties with coordination and pain. About clinical studies •Phase I clinical studies are initial studies of a new drug carried out with healthy test patients •Phase II clinical trials are carried out to determine if the new drug has the desired effect on patients suffering from the disease or condition. Phase II studies also attempt to determine the proper dosage and evaluate any possible side effects. •Phase II clinical studies are carried out to determine the candidate drug’s long-term effectiveness and safety with the final determined dosage and composition. After conclusion of Phase III clinical studies, an application for registration of the product is submitted to the pharmaceutical control authorities.