Almirall has taken the strategic decision of registering Almotriptan in Japan

ALMIRALL HAS TAKEN THE STRATEGIC DECISION OF REGISTERING ALMOTRIPTAN IN JAPAN

Almirall, the first Spanish multinational pharmaceutical, has announced its intention to initiate clinical development in Japan of its own R&D product Almotriptan, for the acute treatment of migraine

Barcelona, June 9, 2004.-Almirall has obtained approval to initiate the clinical development of Almotriptan in Japan during the first meeting with consultants of the Japanese Health Authorities, KIKO. The Phase I trial, that is planned to start in 3^rd quarter 2004, is the commencement of the clinical development for the registration of the product.

As for other triptans, it is proposed to follow a bridging registration strategy with Almotriptan and to obtain approval utilizing major trials already completed in the US and Europe. Expected market entry is 2008 / 2009. The prevalence of migraine in Japan is estimated in more than 8% of the population (Datamonitor 05/2002).

Currently Almirall is in discussion for licensing opportunities in Japan with various pharmaceutical companies.

Almirall already markets two other R&D products in the Japanese market through local partners: The antihistamine Ebastel (Ebastine) and the gastroprokinetic agent Cleboril (Clebopride).

Almotriptan

Almotriptan, a drug researched and developed by Almirall for the acute treatment of migraine headaches with or without aura, is available in Spain since September 2000 under the trademark Almogran. Its international expansion process started in July 2000, when the European Drug Agency approved it for marketing in 16 European countries through the Mutual Recognition process. Also, Almotriptan was approved by the Food and Drug Administration (FDA) in the USA in May 2001.

In clinical trials made, Almotriptan has been more effective than placebo and as effective as sumatriptan, being also associated with a better tolerability and greater patient satisfaction. Also, in the recently published landmark study of the triptan meta-analysis, the authors stated that "… Almotriptan 12.5 mg shows similar efficacy at 2 hours to Sumatriptan 100 mg in relieving migraine headaches but with better sustained pain relief, response in multiple attacks, and tolerability".

 

Migraine is a frequent and very disabling disease classified by the WHO as a major public health problem. In spite of that, migraine is still little recognized, underdiagnosed and not always well treated. With the best combination of efficacy and tolerability, almotriptan has been recognized by world experts as a first line option for the treatment of migraine.

Almotriptan is marketed in the United States, and in the main European countries through Almirall's own affiliates or through strategic alliances with other partners.

Almirall, the first Spanish multinational pharmaceutical company

The main aim of Almirall, the first Spanish multinational pharmaceutical company, is to provide society with innovative drugs to combat discomfort and disease, thus helping to improve health and 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, bronchitis, atopic dermatitis, arthritis and gastrointestinal disorders.

The company plans to invest some 500 million euros in R&D during the next five years, and the total sales forecasts for 2004 are projected to reach 956 million euros. Its estimated staff for 2004 is 3.321 people, of whom 518 are related to R&D activities.

The company also has four R&D centres and six manufacturing plants, as well as branch offices in the main cities of Spain and subsidiaries in Europe and Latin America.

Its annual production forecast for this year is over 88 million units, and products resulting from its own R&D are marketed in over 80 countries around the world.