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Key therapeutic areas

Respiratory diseases

Asthma

Asthma is an inflammatory condition involving the respiratory system and one of the most common chronic conditions. It is estimated to affect around 300 million people worldwide and has a substantial overall impact in terms of morbidity, mortality, decline in quality of life and cost to society.

Anti-inflammatory treatment with inhaled corticosteroids (ICS) is the most widely used maintenance therapy. The purpose of this treatment is to control the symptoms of the disease and prevent acute episodes. The addition of long-acting beta-agonists (LABAs) provides better control through prolonged bronchodilatation. The combination of fixed doses of both components into a single inhaler ensures adequate control of the condition in most patients, while improving ease of administration and compliance by patients.

Global sales of pharmacological treatments for asthma amounted to over 16 billion dollars in 2008, with the inhaled fixed dose combination of LABA/ICS being the top-selling drug. Oral leukotriene antagonists were the second most sold product for the treatment of asthma.

Many therapeutic needs have yet to be met in this area. These include improving patients' compliance when administering the drug, which requires improving posology and developing easier-to-use inhalers; new nonsteroidal treatments, which are more effective and safer; new alternative products for acute and/or refractory asthma; new therapies that slow down or revert structural changes in airways; and innovative approaches aimed at altering the process that leads to developing the disease.

COPD

COPD (Chronic Obstructive Pulmonary Disease) is a serious health issue across the world which is mainly associated with smoking. The World Health Organisation estimates that by 2020, the disease could become the fifth most prevalent and serious disease in the world. The characteristic airflow obstruction is usually progressive and irreversible, and is accompanied by other systemic and respiratory signs that ultimately have an impact on the patient's life expectancy and quality of life.

Long-acting antimuscarinics (LAMAs) are the most effective group of bronchodilators when it comes to improving the pulmonary function, as they reduce symptoms, improve the patient's quality of living and prevent exacerbation, whilst long-acting inhaled beta-agonists (LABAs) are alternative/supplementary bronchodilators. This therapy can also be supplemented with inhaled corticosteroids (ICS) so as to diminish the frequency and seriousness of exacerbations.

Global sales of pharmacological treatments for COPD came to over 15 billion dollars in 2008, led by inhaled LAMAs and inhaled fixed dose combinations of LABA and ICS. There is a steady rise in prescriptions of fixed dose combinations of LAMA and LABA/ICS as a supplementary treatment for the most serious patients.

Many medical needs are still unmet, including alternative treatments to reduce the progress of the disease, treatment and prevention of acute episodes, improving sensitivity to inhaled corticosteroids, and finding new and effective oral maintenance therapies, as well as adequate solutions for systemic symptoms.



Autoimmune diseases

Rheumatoid arthritis

Rheumatoid arthritis is an inflammatory autoimmune condition characterised by the chronic bilateral inflammation of joints, which causes the degradation of joints and loss of functionality, thus adversely affecting the patient's quality of life. As a result of this chronic inflammation and joint destruction, the patient also suffers considerable pain.

Currently available treatments are based on disease-modifying antirheumatic drugs (DMARDs) and, more recently, on therapies with biological agents that provide some degree of control of the disease by reducing signs and symptoms, by slowing the progressive destruction of joints and by improving physical function. All of these therapies are commonly used in combination with methotrexate, the most widely used DMARD and a key component of most combinations.

In 2008 the sale of DMARDs exceeded 14 billion dollars, half of which related to prescriptions for rheumatoid arthritis and ankylosing spondylitis.

Today, R&D efforts are directed towards developing oral drugs that provide the same level of control of the disease as biological agents. In addition, since combination therapies are the main treatment option, these drugs could be added to those already existing.

Multiple sclerosis

Multiple sclerosis is a chronic autoimmune disease characterised by nervous fibre demyelination, damaging the nervous system and causing symptoms of tiredness, as well as cognitive and visual disorders. The disease is sometimes accompanied by neurological symptoms and often ends up causing physical and cognitive disabilities.

Current treatments involve disease-modifying drugs that can slow the progress of the disease and even prevent long-term disability.

In 2008 sales of disease-modifying drugs reached $8 billion for a condition that affects just over 0.1% of the population.

The market is currently dominated by injected interferons, which are considered to be moderately effective but safe. The emergence of more efficient, safer oral therapies would mark a significant advance in the treatment of this disease.



Dermatological diseases

Covering a surface area of 2m2, skin is the largest organ of our body. Skin diseases present a great variety of symptoms that require both topical and systemic treatments. There are various forms of dermatosis which, although they do not constitute a threat to life, have a significant impact on the patient's social and professional activity, as well as on their quality of life. The most common skin conditions are psoriasis, eczema, acne and skin infections.

Psoriasis

Psoriasis is a chronic inflammatory disease that affects between 1.5% and 3% of the population. It manifests itself as erythematous plaques covered with marked hyperkeratosis mostly on the elbows, knees or scalp.

Eczema

Eczema is a form of skin inflammation with different pathogenetic origins. The various subtypes of eczema are differentiated by the underlying cause of skin inflammation, such as atopic eczema, toxic contact eczema or allergic contact eczema.

Acne

Acne vulgaris appears in areas rich in sebaceous glands and is characterised by seborrhoea and the formation of comedones, inflammatory papules, pustules and cysts. Almost all teenagers suffer some form of acne during puberty. Acne usually disappears spontaneously at the beginning of adulthood.

Skin infections

The principal causes of skin infection are viruses, bacteria and fungi. Skin conditions are caused by a broad spectrum of germs that require antiviral, antibiotic and antifungal treatments.



Gastrointestinal diseases

Irritable bowel syndrome with constipation (IBS-C)

IBS is defined as a functional bowel disorder in which abdominal pain or discomfort is associated with defecation or a change in bowel habit and with features of disordered defecation.

The estimated prevalence of IBS at 10-15% of the European population puts it in line with better known conditions such as migraine (12%) and asthma (11%). It leads to a substantial reduction in quality of life, accompanied by considerable socio-economic and psychological consequences and represents a significant proportion of the burden in the gastrointestinal field with respect to both primary and secondary care.

Owing to the complex, multimodal nature of the condition there is no cure for IBS and no 'gold standard' treatment. Irritable bowel syndrome with constipation (IBS-C) is one of four clinically different subtypes of IBS: at present IBS-C is treated with various classes of drugs including antispasmodics and laxatives. One third of patients with IBS are thought to have IBS-C and, therefore, live with both abdominal pain and constipation, along with other symptoms characteristic of this syndrome.

Clinical trials

Almirall carries out its clinical trials according to local regulations in the countries where the trials are performed and following international declarations and guidelines, Declaration of Helsinki and Good Clinical Practices.

The Declaration of Helsinki objective is to guarantee the rights of the clinical trial participants.

Good Clinical Practice (GCPs) is an international ethical and scientific quality standard to ensure the safety and well being of the clinical trial participants and the quality of the results.

The GCP guideline was issued by the International Conference on Harmonisation (ICH), with Health Authority representatives from Europe, the US and Japan and the pharmaceutical industry.

Almirall performs global and complex clinical trials efficiently in terms of time and quality, relying on our scientific and ethical standards and a profound knowledge in the clinical development of new pharmaceutical products.