Almirall, S.A.

Type	Public (Bolsa española - ALM)
Industry	Pharmaceutical industry
Founded	1943
Headquarters	General Mitre, 151 08022 Barcelona España
Products	Aceclofenac (Airtal and other trademarks)* Almagate (Almax)* Almotriptan (Almogran)* Atorvastatin (Prevencor) Candesartan cilexetil (Parapres) Ebastine (Ebastel and other trademarks)* Eflornithine (Vaniqa) Escitalopram (Esertia) Lansoprazole (Opiren) Salmeterol+fluticasone (Plusvent) Sodium diclofenac + hyaluronic acid (Solaraze) Balneum Venlafaxine (Dobupal) *Almirall R&D
Revenue	1,033,3 € million (2009)
Employees	3,100
Website	www.almirall.com

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Almirall, S.A. (formerly Almirall Prodesfarma S.A.),^[1] usually referred to simply as Almirall (BMAD: ALM), is a Spanish international pharmaceutical company. The company is headquartered in Barcelona and was the largest (by sales and employees) Spanish pharmaceutical company in 2004.^[1] It has affiliates in Austria, Belgium, France, Germany, Italy, Poland, Portugal, Switzerland, UK - Ireland and Mexico.

[edit] Summary

Almirall, an international, innovation-based pharmaceutical company whose headquarters are in Barcelona (Spain), researches, develops, produces and commercialises proprietary R&D medicines and those under licence.

Almirall was founded in 1943 in Barcelona (Spain) and began its research and development activities in the sixties. It has evolved to become a prominent pharmaceutical company within the current European panorama. One of its major achievements was to become a stock market listed company in June 2007.

Almirall has 11 affiliates (including Spain) in Europe and Latin America, 3 R&D centres and 2 units centres, 5 production centres and an overall workforce of 3,100 people, of whom around 550 work in R&D.

[edit] History

The company opened its first headquarters in a building of 50 m2 located in Martínez de la Rosa street in the Gracia area of Barcelona.

It was founded by Antonio Gallardo Carrera, with support from a small team of people. He created a small laboratory during difficult times when the country was suffering the aftermath of the Spanish civil war and while the rest of Europe was immersed in the 2nd World War. The first products were launched against this backdrop: an anthelmintic (Lombrikal), a parasiticide (Tundra) and a gynaecological antiseptic known as Leucosine. These were times of hardship and infection. Other products manufactured by Almirall at the time include an anti-flu medicine (Gripex) and the first balsam rectal treatment launched on the Spanish market (Rectopulmo) and which maintained a strong presence for over forty years.

In the spring of 1961 the laboratory was extended and by that stage it included a research department. Almirall launched a significant number of own research antibiotics and balms. However, it was from 1970 when its real policy for discovery and development of medicines got underway. It was then that the first Almirall proprietary research product was launched; an antibiotic (Sevilmine).

Work carried out during the seventies developed in the eighties into the launch of several Almirall R&D drugs and the obtaining of patents in technologically advanced countries such as the United States, Japan, Germany, the United Kingdom, the Netherlands and South Korea.

Antonio and Jorge Gallardo Ballart, sons of Antonio Gallardo Carrera, took on the responsibility left by their father on his death in 1988. They decided to merge Almirall with Prodesfarma in 1997, seeking an opportunity for growth. It was a decisive step that enabled the company to expand internationally through its own affiliates. Then Jorge Gallardo took the reins of the company being, at present, Chairman-Chief Executive Officer of Almirall.

In June 2007, Almirall was listed on the stock market. It then acquired Hermal, a German company specialised in dermatology and a portfolio of eight products from Shire, whose main products also belong to the said therapeutic area.

[edit] The company today

Almirall is the 66 highest turnover pharmaceutical company in the world and ranks 33 in Europe. Its medicines are present in over 70 countries in Europe, the United States and Japan. Almirall holds a leadership position in the Spanish pharmaceutical sector, with a market share of 5,4% (IMS TAM Dec.09).

One of Almirall’s most notable features is its commitment to R&D. In 2009, resources allocated to R&D totalled 121 million euros; approx. 15% of net sales. In terms of workforce, over 15% of its professionals work in R&D.

[edit] Global presence

Almirall medicines are present in over 70 countries and represent around 45% of total income in 2009.

Almirall R&D medicines are: almotriptan (Almogran, antimigraine - 2000), aceclofenac (Airtal and other trademarks, anti-inflammatory - 1992), ebastine (Ebastel and other trademarks, antihistamine - 1990), cinitapride (Cidine, gastroprokinetic - 1990), piketoprofen (Calmatel, anti-inflammatory - 1985), almagate (Almax, antacid - 1984) and clebopride (Cleboril, gastroprokinetic - 1979).

In the dermatology area, other products include Vaniqa (eflornithine) for facial hirsutism, and Solaraze (diclofenac sodium + hyaluronic acid) for actinic keratoses.

Almirall’s affiliates are in:

Europe:
• Austria
• Belgium
• France
• Germany
• Italy
• Poland
• Portugal
• Spain
• Switzerland
• United Kingdom-Ireland

Latin America:
• Mexico

[edit] Almirall medicines

[edit] Top 10 medicines

Around 63% of sales in 2009 correspond to Almirall’s ten highest selling products, of which three are proprietary research and development products:

- (*)Almirall R&D products

Sales per therapeutic areas

Source: (1) Annual accounts 2009 (Registro Mercantil de Barcelona and CNMV)

[edit] R&D medicines

Almirall has obtained seven new medicines from around 20,000 compounds synthesised. Almirall R&D medicines are:

• Almotriptan, for treatment of migraine. This molecule received approval from the U.S. Food and Drug Administration (FDA), the maximum health authority in North America. It was the first time that a Spanish R&D medicine has been granted approval from the FDA.
• Aceclofenac, indicated for muscular inflammations and arthritis. Aceclofenac stick was launched in 2007: a new pocket- sized format against pain and inflammation. It was the first Spanish research medicine registered in the United Kingdom.
• Ebastine, anti-histamine for the treatment of allergies. In 2005 ebastine presented its new galenic formulation Flas, a fast mouth-dissolving formula that was an innovation in the anti-histamine market.
• Cintapride, a gastroprokinetic to stimulate gastrointestinal motility.
• Piketoprofen, a topical anti-inflammatory.
• Almagate, indicated for gastric acidity which has become the antacid of reference in the Spanish market. In 2005 the new Almax Masticable 1g - soft chewable tablet was presented in Spain. This is a galenic formulation with a minty taste that does not leave residue in the mouth.
• Clebopride, a gastroprokinetic to improve gastrointestinal motility, which was the first Spanish active ingredient licensed in Japan.

[edit] Research and development

[edit] Research areas

Almirall is a company committed to research and development (R&D) of innovative medicines particularly in areas with unmet therapeutic needs.

Almirall’s R&D strategy is based on creating research teams focussed on specific therapeutic targets. By concentrating efforts on certain areas it has been able to increase knowledge, and as a result, probabilities of success. The areas on which it focuses research are related to the treatment of asthma, chronic obstructive pulmonary disease (COPD), rheumatoid arthritis, multiple sclerosis, psoriasis and other dermatologic conditions.

For example, there are many unmet needs for the treatment of COPD, including a poor number of therapeutic options for improving lung function and controlling exacerbations. In this regard, the respiratory area is progressing with two new molecules; Eklira (aclidinium bromide) a long-lasting antimuscarinic for the treatment of COPD which is in phase III, and the molecule LAS100977 (LAS is an acronym of Laboratorios Almirall Síntesis). It is a novel, long-lasting beta agonist in Phase II for the treatment of asthma and COPD, suitable to be administered once a day through inhalation). Another example is Sativex (a modulator of the endocannabinoid system, which is a medicine of vegetable origin whose formulation is basically a combination of two cannabinoids: tetrahydrocannabinol (THC) and cannabidiol (CBD)), of which Almirall acquired the marketing rights in Europe (except United Kingdom), and which represents a step forward in the treatment of spasticity and multiple sclerosis and, therefore, is an interesting incorporation to Almirall’s central nervous system area. Sativex is under regulatory submission.

[edit] R&D activity

Almirall scientists have established a broad network of external collaborators in biology, chemistry and X-ray crystallography to help generate research programmes and access new technologies that may enable new research programmes to be generated and access to new technologies that may enable new drug- seeking processes to be speeded up .

This network includes collaborations with universities, research centres and technology companies in Europe and the USA. Almirall also cultivates a close relationship with the academic world in Spain and encourages the emergency of local biotechnology companies. Examples of this is the prominent role of Almirall in the Genius Pharma project, a technological platform as well as Neogenius, a programme for the discovery and development of new painkilling medicines form patiens suffering from osteoarthritis, sponsored by the Spanish government.

Almirall collaborates in clinical development with private universities and hospitals in Europe, the USA and other countries.

In 2008, Almirall incorporated into the Innovative Medicines Initiative (IMI), a joint project between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA, the European management of the pharmaceutical industry) to increase R&D in the pharmaceutical sector on a European level.

[edit] Research centres

To fully develop its R&D work, Almirall has infrastructures such as the R&D centre in Sant Feliu de Llobregat (Barcelona) inaugurated in 2006, which has a workforce of about 350 employees, including pharmacists, chemists, biologists, physicians and other highly qualified specialists. By housing the majority of the Almirall R&D structure under one roof, synergies can be fully exploited. Almirall also has two R&D units in the Barcelona area: Chemical Synthesis and Active ingredient scaling-up (it implies modifying the obtaining of a few grams of substance in the laboratory to adapt it to industrial equipment able to produce product quantities of tens or hundreds of kilograms).

Moreover, Almirall also has a centre of excellence for inhalation technology, located in Bad Homburg (near Frankfurt, Germany), and made up of a team of technical experts in pharmaceutical innovation for the administration of medicinal products by inhalation. From here Almirall has patented a multiple dose dry powder inhaler (Genuair).

As a result of its acquisition of Hermal in August 2007, Almirall also has a team located in Reinbek (Germany) that focuses on dermatology R&D: the center of excellence in dermatology.

[edit] The process of a medicine

Almirall controls all factors involved in the process from molecule discovery to marketing of the resulting pharmaceutical product

The entire R&D process is performed in line with deontological standards and by applying criteria established in Good Clinical Practice (international ethical and scientific quality standards for pharmaceutical product research) and International Harmonisation Conference (it established technical requirements of pharmaceutical medicines for human use. They were adopted in 1996 by the USA, Japan, the European Union, Australia, Canada and the Nordic Countries).

The production sites comply with international manufacturing standards (Good Manufacturing Practice).

[edit] Production centres

Almirall has five production centres: three pharmaceutical plants (two in Spain and one in Germany) and two chemical plants (in the Barcelona area). The facilities have cutting-edge technology and adhere to international manufacturing standards. In 2009, production exceeded 122 million pharmaceutical units and a volume of 133 tonnes in chemical plants, with a workforce of around 600 people.

[edit] Quality policies

Safety in the workplace is one of the values that underpin the resources available to a company like Almirall. Almirall received the TÜV Rheinland certificate in March 2007, endorsing the conformity of its System for Risk Prevention Management with the international standard OHSAS 18001, and recognising that its criteria for health and safety in the workplace are higher than the standards of the legislation in force in Spain. Moreover, the Almirall fine chemistry business unit (Ranke Química, S.L.) was recognised in 2008 for its low accident rate by the Autonomous Commission for Safety and Hygiene at work in the Chemical and Related Industries (COASHIQ).

Almirall applies a strict environmental policy with a commitment to continuous improvement. In Spain, it has been awarded the environmental management certificate ISO 14001.

In short, the company has a network of resources and infrastructures in which professional experts from over 20 different nationalities work side by side to offer society therapeutic solutions to improve people’s health and quality of life.

[edit] References

- Annual report 2009
- Book Almirall 50 years of pharmaceutical research
- Web: www.almirall.com
- Press dossier
- Annual accounts 2009
- Press releases
- Company triptych

[edit] Quick facts

• Turnover 2004: €700 million (on sales of €956 million)^[1]
• Turnover 2005: €736 million
• Turnover 2006: €758 million
• Turnover 2007: €793 million
• Turnover 2008: €903 million
• Turnover 2009: €925,5 million

Almirall acquired a portfolio of products from both Shire (Solaraze and Vaniqa) and Hermal (Balneum range, Unguentum M and other dermatology products) in December 2007.

Almirall now have a large dermatology sales force in the UK.

[edit] Proprietary products

products that have been developed by Almirall^[1]

• Aceclofenac (NSAID)
• Almagate (antacid)^[2]
• Almotriptan (antimigraine drug)
• Clebopride (antiemetic, prokinetic)
• Ebastine (antihistamine)
• Thiomucase anticellulite

[edit] References and notes

[edit] External links

• [1] (Almirall company website)
• [2] (Comisión Nacional del Mercado de Valores website)
• [3] (IMS 2008)
• [4] (Registro Mercantil de Barcelona website)
• Global website - Principal - Almirall
• Global website - Figures

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