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Orion has developed Sileo® product to alleviate noise anxiety in dogs - marketing authorisation in the EU area

Press release 3 December 2015 at 9.00 a.m.

Orion has developed a prescription medicine Sileo® for dogs suffering from acute noise anxiety. Sileo® is the  first medicinal solution for this indication. Noise anxiety is one of the most common behavioural concerns in dogs with approximately 50% of dogs reacting fearfully to some type of noise. Sileo® has been clinically tested to ensure safety and efficacy and it is approved by the European Medicinal Agency for the European Union. Efficacy of Sileo® is based on a well-known and extensively researched  proprietary molecule, dexmedetomidine hydrochloride, developed by Orion.

Typical loud noises that dogs are often afraid of include fireworks, thunderstorms, gunshots, and traffic noise. On those situations dogs show signs of anxiety and fear such as panting, trembling, pacing, seeking people, hiding or trying to escape. Noise anxiety typically doesn't get better over time. It often worsens and dogs may also begin to react fearfully to normal every day sounds such as slamming of car doors, or vacuum cleaners.

Development Leader at Orion Animal Health, Mira Korpivaara, comments: "The idea for dexmedetomidine as  a medication that inhibits noise anxiety in dogs was first invented by a small group within the company, but as the evidence of its efficacy for this indication kept accumulating the development program was started. The journey to an approved product has been an utterly interesting, but at times also a challenging one."

About Sileo®
Sileo® is globally the only approved medication for the indication of alleviation of acute anxiety and fear associated with noise in dogs. It has been developed by Orion and will be produced in Orion's Turku plant.

The active substance of Sileo® is a well-known molecule dexmedetomidine hydrochloride, which at this low non-sedative dose prevents or alleviates noise induced stress reaction with the dog remaining fully functional.

Sileo® is an oromucosal gel to be applied onto the oral mucosa of the dog's cheek. The product is available as a prescription medicine from veterinarians, to be administered at home by dog owners when needed.

Further information:

Mira Korpivaara, Development Leader, R&D, Orion Pharma Animal Health +358 (0) 50 966 3885

Publisher Orion Corporation
Orionintie 1A, FI-02200 Espoo, Finland

Orion is a globally operating Finnish company developing pharmaceuticals and diagnostic tests - a builder of well-being. Orion develops, manufactures and markets human and veterinary pharmaceuticals, active pharmaceutical ingredients and diagnostic tests. The company is continuously developing new drugs and treatment methods. The core therapy areas of Orion's pharmaceutical R&D are central nervous system (CNS) disorders, oncology and respiratory for which Orion developes inhaled Easyhaler® pulmonary drugs.

Orion's net sales in 2014 amounted to EUR 1,015 million and the company had about 3,500 employees. Orion's A and B shares are listed on NASDAQ Helsinki.