Almirall launches the roflumilast in Spain.

-This compound reinforces Almirall respiratory product catalog

Barcelona, 2011-October Almirall has just launched in Spain the second mark of the roflumilast with the name of Libertek ®. The roflumilast, licensed from Nycomed, is a capsule of a single daily decision-making for patients with pulmonary disease (COPD) chronic obstructive. This inhibitor of the enzyme Phosphodiesterase 4 (PDE4) is the first chronic anti-inflammatory treatment for this disease by mouth.

Patients with COPD suffer from frequent exacerbations now have a new therapeutic option to alleviate their condition. Enrique Domínguez, Director General of Almirall, Spain, indicates that is a specific inflammation and underlying during any illness. The roflumilast is the first medication that is specifically the inflammation reducing the appearance of characteristic of the disease exacerbations, and improving lung function. All these benefits occur when the drug is added to the therapy is already taking the patient ”.

The roflumilast fits into the business strategy of Almirall, in the respiratory area, where the pharmaceutical company also has other products bronchodilators for the same disease, such as bromide aclidinio, composed of r & d, which stands for registration in Europe and United States recently.

The roflumilast

The roflumilast is a selective inhibitor of the enzyme Phosphodiesterase 4 (PDE4) administered by mouth, which showed inhibitory effects on inflammation by COPD by a novel mechanism of action. This compressed in a single daily decision-making, is the first drug in a new therapeutic class of treatment for severe COPD and is the first oral anti-inflammatory specifically developed for patients suffering from this disease.

Through four placebo-controlled studies, the roflumilast showed significant reductions of exacerbations and improvements in lung function as add-on therapy to maintenance of first-line therapies.

The roflumilast is generally well tolerated. In clinical studies of COPD were included in total more than 12,000 patients, the most common adverse effects were diarrhea (5.9%), weight loss (3.4%), nausea (2.9%), abdominal pain (1.9%) and headaches (1.7%). Most of these adverse efecos were mild to moderate and mainly took place during the first weeks of treatment, being resolved with the continuation of the treatment.

Other pharmacological treatments for COPD patients include the use of bronchodilators and inhaled corticosteroids.

The roflumilast has been authorised in the European Union, United States and other countries. In Europe, Nycomed sells under the brand name Daxas ® roflumilast. In Spain, Daxas ® was launched in February 2011.

COPD

The World Health Organization (who) has been described as a global epidemic COPD; It is estimated that worldwide there are 210 million people suffer from this disease and more than three million people died as a result of the same in 2005, amounting to 5% of all deaths worldwide in the year. He is expected to total deaths as a result of COPD to increase by more than 30% over the next 10 years, if there is no intervention measures to tackle the risks – in particular – exposure to tobacco smoke.

In patients with COPD lung airway usually lose their elasticity, they produce an excess of mucus and will thicken and inflamed, limiting the flow of air. The most common symptoms of COPD are shortness of breath (or need to take air ”), production of abnormal sputum (a mixture of saliva and mucus in the respiratory tract) and chronic cough. Daily activities, as upload a small flight of stairs or take a suitcase can be very difficult as the disease gets worse gradually. Medical needs are very important not covered in the treatment of COPD, including limited treatment options to improve lung function, reduce the symptoms and control exacerbations.

Almirall

Almirall is an international pharmaceutical company based on innovation and committed to health. With headquarters in Barcelona (Spain), Almirall researches, develops, produces and sells drugs own r & d and licensing with the aim of improving the health and well-being of people.

The therapeutic areas in which concentrates its resources in research are related to the treatment of asthma, COPD (chronic obstructive pulmonary disease), gastrointestinal disorders, psoriasis and other skin sintomatologías.

Almirall drugs are currently present in over 70 countries. Account with a direct presence in Europe and Latin America through 12 subsidiaries.

About Nycomed, a company of Takeda

Nycomed is a company of Takeda since end of September 2011. Takeda is a global company research, focusing primarily on pharmaceutical products. The resulting company of the Union of the two has a strong presence commercial in the therapeutic areas of Oncology, metabolic diseases, Gastroenterology, cardiovascular, central nervous system diseases, inflammatory and immune, respiratory system and pain.

The significant presence that has characterized Takeda in Japan and United States, with the strong positioning with Nycomed Europe and emerging markets is strengthened. The combined company has a presence in more than 70 countries worldwide and ranked number 12 in the world ranking of pharmaceutical companies, number 14 in the BRIC countries (Brazil, Russia, India and China) and 18 in Europe.

As the largest pharmaceutical company Japan and one of the leading companies in the industry, Takeda focuses its efforts to improve the health of patients worldwide through leading innovation in the field of medicine.