Almotriptan (Almogran) is licensed by the FDA for marketing in the United States.
The highest drug regulatory authority in the United States has certified that almotriptan provides important benefits for the treatment of migraine.
Over 28 million people in the United States currently suffer from this disease, most of these women. In Spain this figure totals more than 4 million people.
The development of this drug has required hard work from over 300 people during the course of more than 8 years and an investment in excess of 15,000 million pesetas (90 million Euros).
Almirall Prodesfarma, the leading Spanish multinational pharmaceutical company, announces today that the Food & Drug Administration (FDA) has for the first time licensed a chemical researched and developed in Spain, Almotriptan (Almogran), for marketing in the United States.
This is a milestone in the Spanish pharmaceutical industry as it is the first time a drug deriving from Spanish research and development has been granted such acknowledgement, thus allowing it to be prescribed to North Americans suffering from migraines with or without aura.
"We are extremely proud that the first Spanish R&D molecule approved by the highest American health authority belongs to our company", says Dr Jorge Gallardo, president and chief executive officer of Almirall Prodesfarma, "this authorisation is a recognition to our constant support of research for which we have become known".
Almotriptan, which will be marketed in the United States through Pharmacia under the trademark Axert, will be available to the more than 28 million North American migraine sufferers as from the second half of 2001. This disease is particularly common in women and costs the country over 13,000 million dollars a year in loss of working days and low workers' performance.
A unique research and development process in Spain Almirall Prodesfarma has invested more than 15,000 million pesetas (90 million Euros) in the research and development process of this new drug. "More than 300 people have worked intensely over the past 8 years in order to make this product. We have spent the last 2 years compiling all the documentation and clinical trials required by the FDA in order to meet the terms demanded by this authority, the top food and health authority in the United States", explains doctor José Mª Palacios, Almirall Prodesfarma's R&D director.
Almotriptan clinical trials
The results of the 28 clinical trials performed with almotriptan (21 in Europe and 7 in the United States) have comprised the base material analysed by the Food & Drug Administration to approve it for marketing in the United States. The documentation provided, which had to be transported in a lorry, served as testimony to the significant benefits of this new triptan: its high efficacy, quick onset of action, tolerability, bioavailability and its low pain recurrence rate, amongst other benefits. Almotriptan in Spain and the rest of Europe
Almotriptan, a drug belonging to the triptan family, has been 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. Almotriptan has been available in England, Scandinavia, Ireland and Germany since the beginning of this year.
Almirall Prodesfarma, the first Spanish multinational pharmaceutical company
The main aim of Almirall Prodesfarma, S.A., 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.