Almirall Prodesfarma licenses in the antipsychotic agent blonanserin from Dainippon.

Broad territorial rights, including Europe and USA, obtained for the development and commercialization of the compound.

Almirall Prodesfarma, S.A. announced today the signing of a License Agreement with Dainippon Pharmaceutical Co., Ltd. that provides Almirall Prodesfarma with exclusive development and marketing rights world-wide (except Japan, China, Taiwan and South Korea) for blonanserin (AD-5423), an original antipsychotic agent from Dainippon which is under development in Japan.

"We are very pleased to work with Almirall Prodesfarma", said Kenjiro Miyatake, President of Dainippon. "Almirall Prodesfarma has a proven capability to develop and register drugs internationally which will result in the successful development and commercialization of blonanserin in broader territories". "Both companies have a long history of collaboration, that have led to the registration and commercialization of Dainippon's antibacterial agents pipemidic acid and enoxacin by Almirall Prodesfarma in Spain and to the development and launch of Almirall Prodesfarma's anti-histamine ebastine (Ebastel) by Dainippon in Japan and Taiwan. Ebastine is currently one of Dainippon's major products in the Japanese market", concluded Mr. Miyatake.

"The agreement with Dainippon is an important strategic step for expanding our international activities to new markets with innovative products and we are very pleased to have reached this agreement with Dainippon's team", said Jorge Gallardo, President and Chief Executive Officer of Almirall Prodesfarma. "It reflects our commitment to collaborate with a broad range of pharmaceutical and biotech companies to develop their products on a world-wide basis in order to complement our development pipeline".

Schizophrenia is an extremely disabling psychiatric disorder characterized by the appearance of positive symptoms, such as delusions and hallucinations as well as negative symptoms, such as blunted affect and disturbance of volition. Today several drugs are available to treat this disorder, but it still remains to be an area of clear unmet medical need, due to limited efficacy and high incidence of side effects.

Blonanserin is a novel antipsychotic agent with a chemical structure which is different from the existing antipsychotic agents available in the market. Blonanserin has dopamine 2 and 5-HT2 receptor antagonistic properties, and is expected to demonstrate efficacy on both positive and negative symptoms. Also, clinical results suggest it has fewer adverse drug reactions, such as extra-pyramidal symptoms, hypotension in comparison with typical antipsychotic agents, and weight gain, in comparison with other agents with a similar mechanism of action. Presently, Dainippon is conducting Phase III clinical trials for blonanserin in Japan.

Dainippon, as one of the pioneers of the modern pharmaceutical industry in Japan, has continuously striven to contribute to society with the research and development of better pharmaceuticals and in the supply of products to the health care world. R&D operations' objective is to create innovative, highly efficacious drugs geared to the most pressing needs in the worldwide market. To this end, discovery research efforts are focused on vascular diseases, psycho-neurological diseases, immuno-inflammatory diseases and infectious diseases.

The main aim of Almirall Prodesfarma, the first Spanish multinational pharmaceutical company, is to provide society with innovative drugs to combat discomfort and disease, thus helping to improve quality of life. To this end, it constantly devotes the maximum human and financial resources to researching new products. The company's main research fields fall within the areas related to the treatment of asthma, allergies, dermatitis, arthritis, cardiovascular diseases, gastrointestinal disorders and migraine. It has a staff of 2,300 people of whom over 300 work in R&D activities. It also has five manufacturing plants in the Barcelona area, branch offices in the main cities of Spain and subsidiaries in Europe and Latin America. Its annual output stands at 75 million units and its own R&D products are marketed in over 80 countries around the world.