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Orion Pharma inlicenses Deramciclane from Egis Pharmaceuticals. Phase 3 program in anxiety has started

Orion Corporation, Finland and Egis Pharmaceuticals, Hungary, have entered into a license agreement for deramciclane, a new chemical entity discovered and patented by Egis. Orion Pharma has initiated a comprehensive Phase 3 clinical program aiming at global registration of deramciclane in anxiety disorders.

The license agreement with Egis provides Orion Pharma with the exclusive rights to further develop, register and market the product globally, excluding certain East European territories. Orion has also the right to grant sublicenses. Egis will manufacture the active ingredient for Orion. Orion will pay Egis an upfront fee in association with the signing of the agreement, and further milestone payments in accordance with the progress of the clinical development and registration. All these cost items will be included in Orion Pharma's R&D expenses. At a later stage Egis will receive royalties on sales. The basic patent for deramciclane will be in force until December 2000. Both Orion Pharma and Egis have a number of additional patent applications pending.

Anxiety has high prevalence among adult population

Anxiety in its many different forms is one of the most common psychiatric disorders. Estimates for the number of people affected world-wide are in the range of 40-80 million.

Typically, anxiety is characterised by expressions of nervousness, restlessness, fear, excessive worry, fatigue, concentration difficulties, irritability, muscle tension and sleep disturbances. The onset of the disorders is usually in the 20s and their course is typically chronic and recurrent. The symptoms can be disabling enough to lead to decreased ability to work and perform normal daily tasks. The costs related to anxiety are considerable, due to high utilisation of healthcare resources, but mainly due to impairment, such as loss of productivity.

Only a fraction of patients with anxiety receive drug therapy today, partly because the disorder is often not diagnosed or because of the lack of drugs with an optimal profile.

Treatment of anxiety

Usually the treatment of anxiety consists of medication, psychotherapy or a combination of both. Very few breakthrough drugs have been introduced in this indication during the recent years.
Benzodiazepines, such as diazepam and alprazolam among others, are the most commonly used anti-anxiety agents, but their suitability for the treatment of chronic anxiety has been questioned. They may also cause drowsiness, tolerance, dependence and withdrawal symptoms. Other drugs are buspirone, venlafaxine, and some SSRIs (selective serotonin reuptake inhibitors), the latter two having been registered originally as antidepressants.

Findings to-date predict that deramciclane
could be an effective anxiolytic

It has been shown that disorder of the serotonin, or 5-HT neurotransmitter system is associated with anxiety.

Deramciclane has a new mode of action. It is not acting through BDZ, GABA, 5-HT1 or 5-HT3 receptors but its anxiolytic effects are predominantly due to the blockade of 5-HT2 receptors.

Orion Pharma has been investigating deramciclane for several years. Research results from various preclinical models show that deramciclane has anxiolytic properties. Phase 1 and Phase 2 clinical studies in humans conducted by Orion Pharma so far also suggest that deramciclane could be a promising new medication for anxiety.

According to the research to-date, the compound is efficient and well tolerated. It seems that deramciclane may have better tolerability than the commonly used medications. Moreover, the compound seems to be free of sedative or muscle relaxant effects, abuse or dependency potential, or adverse withdrawal symptoms. It thus might provide clear advantages over the current treatments.

Phase 3 program ongoing

Orion has initiated large Phase 3 clinical studies with deramciclane, with the aim of confirming the efficacy and safety of the compound in the treatment of anxiety. Anxiety being a chronic disorder, the clinical development program includes several long-term studies.

World market for medications used in anxiety USD 2.6 bn

The total sales of CNS drugs were in the class of USD 37 billion in 1998 (ex-factory sales). Psychiatric pharmaceuticals accounted for approximately USD 19 bn. The market for anxiolytics was of the order of USD 2.6 bn while anti-depressants accounted for USD 9.4 bn.

Orion Pharma, a research-oriented pharmaceuticals division, is the core of the Orion Group, Finland's leading company for pharmaceuticals and non-medicinal healthcare products. With 1999 net sales of MFIM 2,603 Orion Pharma accounts for almost one half of the Orion Group net sales and for two thirds of the Group operating profit. Over one half of the total net sales comes from international operations. With a broad portfolio of products, Orion Pharma is the leader in the pharmaceutical market in Finland with an 19% market share. Orion Pharma has marketing subsidiaries in nine European countries.

Original proprietary drugs account for an increasing share of Orion Pharma's sales. The CNS portfolio was recently supplemented by Comtess, also available as Comtan (entacapone), Orion's own NCE for Parkinson's disease, now registered and launched in about 30 countries including the EU and the U.S.

Egis Pharmaceuticals is the second largest pharmaceutical company in Hungary, with MUSD 150 net sales in 1999 and over 50% international sales. Egis concentrates on cardiovascular and CNS drugs. Egis is listed on the Budapest Stock Exchange. The French pharmaceutical company Servier owns 51% of Egis' shares.

Orion Corporation

Markku Talonen
President and CEO

Pauli Torkko
Executive Vice President

dealing with deramciclane will be held by Orion on Monday 20 March, 2000 at 1.00 pm at the Conference Room of the Hotel Palace, address Eteläranta 10, 10th floor.
The language will be partly in Finnish, partly in English.

Contact person:
Jyrki Mattila, President, Orion Corporation Orion Pharma,
phone +358 9 429 3003, NOT EARLIER THAN 3 o'clock P.M.