Product development pipeline

Aclidinium bromide monotherapy: Anticholinergic bronchodilator, selective M3 muscarinic antagonist for the treatment of COPD currently in phase III clinical development. Aclidinium bromide is a long acting drug, with a very clean safety profile, and administered by inhalation through a user-friendly multidose inhaler device, which is also proprietary to Almirall.

Combination of aclidinium bromide with the long acting beta agonist formoterol (LAS40464): Treatment with one or more long acting bronchodilators is recommended by the international guidelines for treatment of COPD. This combination is aimed at providing higher efficacy than each component alone, as well as the improved convenience of having the two products in the same easy to use inhalation device. LAS40464 is currently in phase II clinical development.

Combination of aclidinium bromide with an ICS (LAS40369): Combination of a bronchodilator with an anti-inflammatory agent for the treatment of COPD, currently in preclinical development. In addition to being treated with bronchodilators, the underlying inflammation process in COPD patients is currently addressed with anti-inflammatory agents such as inhaled corticosteroids (ICS). The combination of an anticholinergic bronchodilator and an ICS is expected to provide higher efficacy than each component alone.

LAS100977: Long acting beta agonist inhaled bronchodilator for the treatment of asthma and COPD which is in phase IIa of clinical development. Results obtained in asthmatic patients showed that LAS100977 is a potent bronchodilator, with duration of action compatible with once daily dosing.

LAS186368: Long acting beta agonist inhaled bronchodilator for the treatment of asthma and COPD, which is in preclinical development.

LAS186323: DHODH inhibitor for the oral treatment of rheumatoid arthritis that aims at reducing the undesirable side effects of the DHODH inhibitor commercially available at present. . This is currently in phase I clinical trials.

LAS187247: DHODH inhibitor for the oral treatment of rheumatoid arthritis. A backup development candidate for LAS186323 is also in preclinical development.

Sativex® -basically, a combination of two cannabinoids: tetrahydrocannabinol (THC) and cannabidiol (CBD)- is formulated as an oromucosal spray which is administered by spraying into the mouth. Each spray of Sativex delivers a fixed dose of 2.7mg THC and 2.5mg CBD. This medicine is indicated for the treatment of spasticity in patients with multiple sclerosis (MS). Its unique formulation brings out the therapeutic benefits of the cannabinoids whilst minimizing unwanted effects such as intoxication, sedation or psychotropic effects.

Spasticity (stiffness and muscular spasms) is one of the most common symptoms of MS occurring in approximately 75% of all MS patients and it can affect many aspects of daily life.

MS is an auto-immune, inflammatory, chronic condition in which the immune system destroys the myelin, a substance that protects neurons and permits efficient transmission of nerve signals. According to the WHO data, multiple sclerosis is one of the most common neurological disorders and causes of disability in young adults. Although some people with MS experience little disability during their lifetime, up to 60% are no longer fully ambulatory 20 years after onset, with major implications for their quality of life and the financial cost to society.

Sativex® -basically, a combination of two cannabinoids: tetrahydrocannabinol (THC) and cannabidiol (CBD)- is formulated as an oromucosal spray which is administered by spraying into the mouth. Each spray of Sativex delivers a fixed dose of 2.7mg THC and 2.5mg CBD.

The first large scale US trial, Spray Trial, for cancer patients is underway and due to complete at the end of 2009. The 336-patient, double-blind, randomized, placebo-controlled study is evaluating the effect of Sativex in relieving average daily pain, reducing the use of breakthrough opioid medications, improving the quality of sleep and relevant aspects of quality of life among other outcome measures.

LAS189913: Sphingosine-1-phosphate-1 (S1P1) receptor agonist for the oral treatment of multiple sclerosis, that aims to reduce undesirable side effects of other S1P1 agonists through an improved pharmacokinetic and safety profile. Almirall's S1P1 agonist is currently in preclinical development.

LAS 41002: Topical anti-inflammatory agent for the treatment of eczema, which is in clinical phase III in comparison studies with Ecural. LAS41002 acts on a corticosteroid receptor and its different formulations will allow treatment of different skin conditions.

LAS 41003: The combination of its anti-inflammatory and antimicrobial activity makes this topically administered product (currently in preclinical development) an interesting compound for the treatment of several types of skin infection.

LAS41004: This compound is in phase II, the goal is to confirm its anti-inflammatory activity and its capacity to inhibit cellular proliferation through topical administration for the treatment of psoriasis and/or atopic dermatitis.

LAS 41005: Compound with antimitotic action in affected cells combined with disintegration of keratinocytes. The product's topical activity is compared to Solaraze and to date its greater efficacy makes it potentially a drug of interest for the treatment of severe keratosis.

Linaclotide is a first-in-class medicine for the treatment of irritable bowel syndrome with constipation (IBS-C). It is a once daily, orally delivered peptide that acts locally in the gut with no detectable systemic exposure at therapeutic doses. Linaclotide is an agonist of guanylate cyclase type-C, a receptor found on the lining of the intestine.

Irritable bowel syndrome with constipation (IBS-C) is a chronic functional gastrointestinal disorder characterized by abdominal pain and discomfort associated with altered bowel habits. There are currently few available therapies to treat this disorder. An estimated nine million patients in Europe suffer from IBS-C. Patients can be affected physically, psychologically, socially, and economically.