Almirall expands its horizons
pharmafile | July 3, 2008 | Feature | Research and Development, Sales and Marketing |Â Â Almirall, COPD, SpainÂ
Almirall has been Spain's number one pharmaceutical company for some years, but is still little known outside its home market. The company's management wants to change this by expanding its presence across Europe, and is banking on a portfolio of newly acquired dermatology products and a new COPD drug discovered in-house to help it fulfil its ambitions.
The Barcelona-based company has been in existence for 65 years and became the company with the largest market share in Spain in 1987, basing its success on a mixture of in-house products and drugs licensed from other companies.
Four of the company's top 10 products were discovered in-house, such as anti-histamine ebastine, migraine drug almotriptan, anti-inflammatory aceclofenac and the antacid almagate.
But Almirall is now looking to take a step up to becoming a truly international company with presence in more markets and with a greater proportion of its revenues derived from in-house products.
In 2007 and early 2008 Almirall opened affiliates in Austria, Poland, the UK and Ireland and Switzerland for the first time, where it will be able to market a newly expanded portfolio of products. These new offices add to its existing European affiliates in France, Belgium, Italy, Germany and Portugal.
This larger portfolio has come about through two recent acquisitions, an outright acquisition of Germany company Hermal – an established niche player in dermatology – in August 2007, and the purchase of several dermatology products from UK company Shire in November.
Dr Jorge Gallardo, chairman and chief executive of Almirall says 2007 was a "milestone year" for Almirall, and adds that its performance as a listed company put it among the top performing stocks among European medium-sized pharma companies. He is upbeat about further growth in Europe this year: "Almirall will be centering efforts on consolidating its international expansion, mainly in Europe, and with special focus on the evolution of [COPD lead candidate] aclidinium bromide."
A star is born?
Almirall is looking to its novel pipeline drug aclidinium bromide as a potential blockbuster treatment for chronic obstructive pulmonary disease (COPD). Currently in phase III trials, the drug could transform the company's fortunes, with peak sales forecasts from analysts as high as $2billion.
The long-acting anti-muscarinic agent is being developed as a once-daily monotherapy and could be filed with regulators by 2009. But the drug has still a lot to prove – it is in the same class as Boehringer Ingelheim and Pfizer's blockbuster Spiriva (tiotropium) and will have to show significant advantages over the existing drug if it is to be a major success.
Almirall says aclidinium may offer COPD patients certain advantages over existing drugs, including speed of onset and tolerability, and a strong safety profile.
Aclidinium bromide has a different structure and pharmacological profile to tiotropium, with very low and transient plasma levels, and therefore a potentially low risk of systemic side effects.
The growing COPD market
COPD is currently the fourth biggest killer in Europe and with rising mortality. It affects between 4-10% of adults and is particularly on the rise among women, with most cases linked to cigarette smoking. COPD causes 200,000 – 300,000 deaths in Europe every year, along with huge productivity losses because of absence from work.
The drug is also in phase II trials as a combination therapy with the long-acting beta agonist formoterol, and at pre-clinical development stage as a combination therapy with an inhaled corticosteroid. Currently there is no combination treatment inhaler available for COPD that includes an anti-muscarinic therapy.
Analysts say that it is the combination of sales from these monotherapy and combination therapy indications which could bring global peak sales up to the forecast $2 billion, but the company will undoubtedly face stiff competition, especially in the all-important US market.
To help ensure access to this market, Almirall has struck a deal with American company Forest to co-develop and co-market the drug in the US. Although Forest has no heritage in the COPD field itself, it does have a large US field force and experience in marketing other primary care-focused products such as anti-depressant escitalopram and hypertension treatment olmesartan.
Almirall will retain rights for the rest of the world, and could become much more widely known across Europe and elsewhere if and when aclidium reaches the market.
Easy-to-use inhaler
A vital component for the success for any new inhaled medicine is the inhaler device, and Almirall acquired specialists in the field Sofotec in 2006. The move gave Almirall access to important new respiratory technology – a novel 'press and inhale' multidose dry powder inhaler (DPI) which it believes could make a big difference to patients, and in turn to future sales of aclidinium.
The company say the inhaler is unique because it has a four-stage actuation process and requires no cleaning, unlike existing devices. The inhaler is also being developed for delivering other drugs for inhalation in the future.
Almirall's director of pharmaceutical development Carsten Niederlander said the new 'state of the art' inhaler will appeal to patients and healthcare professionals alike because of its ease of use and flexibility.
"A typical COPD patient will be on lots of medication, with co-morbidities such as angina, diabetes etc. Previous inhalers have proven complicated to use, particularly when the patient finds even their day-to-day existence a struggle because of the debilitating symptoms of COPD," he says. "This device will take the stress of self-medication out of the equation".
It is hoped that the device will give Almirall an edge in the rapidly growing international COPD market, and boost the company's global profile.
Key results for the phase III clinical trials are expected in the second half of 2008, and the company will be hoping it can match expectations. Chief executive Jorge Gallardo is optimistic ahead of the crucial results, saying: "We have no doubt that aclidinium bromide will be a remarkable event for Almirall".
Dermatology and rheumatoid arthritis
Though COPD is the company's current main focus, drugs for conditions such as asthma, psoriasis, rheumatoid arthritis and multiple sclerosis also form a large part of Almirall's in-house R&D programme. Recently acquired R&D pipelines include drugs for psoriasis, skin cancer and other skin conditions.
Two new projects for rheumatoid arthritis and multiple sclerosis entered the development phase in 2007, and Almirall announced results for a new compound treatment of asthma and COPD. The compound LAS100977 has successfully completed a daily single dose trial that demonstrated 24 hour efficacy. Almirall also has several dermatology candidates in development, three of which are in phase III.
Sales of the former Shire portfolio reached $53.8 million in 2006, and are mainly concentrated in the UK, representing over $36 million of the total. The portfolio acquired includes two dermatology products and six others for the treatment of pain, inflammatory and gastrointestinal diseases.
If Almirall can increase sales of the dermatology franchise outside the UK, the purchase could be a major boost for the company.
But the formulation patents on two of the biggest products, Solaraze (keratosis) and Vaniqa (facial hirsutism) expire in 2013, so the company has just five years to maximise their sales.
R&D investment
In 2007, Almirall's R&D investment represented 15% of annual net sales (122 million euros), and 15% of the workforce is based in R&D. The company has three main R&D centres, including their flagship headquarters opened in 2006 in Barcelona. This houses the majority of Almirall R&D – a team of approximately 400 people – and is equipped with the latest technology.
Almirall's progressive manufacturing facilities at Sant Andreu de la Barca are the company's pride in terms of the speed-enhancing technology used, and are seen as a benchmark for the industry in terms of big value production.
Overall, 122 million units of medicine are produced by Almirall each year, including current bestsellers Airtal (aceclofenac), Almax (almagate) and Cidine (cinitapride).
The company prides itself on its high safety standards and its system for workplace risk prevention management. It has won awards for its environmental policies and wants to be known for its commitment to the health of its employees, providing on-site gyms and good working conditions.
Boasting a high ratio of PhDs and a successful recruitment and retention policy, the company says it is committed to pharmacology education. It has taken the lead among Spanish pharma companies in collaborating with universities and other public bodies, and provides courses to facilitate the discovery and development of new compounds and scientific methods.
Almirall's investment for the future is particularly noticeable in R&D, where its spending rose 43% to 31 million euros for the first three months of 2008, and the company's total R&D workforce is expected to hit 600 employees by the end of the year.
Text Box:
2007 was a "milestone year" for Almirall says Jorge Gallardo, Almirall's chief executive. Its performance as a listed company put it among the top performing stocks in European medium-sized pharma companies.
Almirall's pipeline drug aclidinium bromide, now in phase III trials, has the potential to transform the company's fortunes, with peak sales forecasts from analysts as high as $2 billion.
R&D spending rose 43% to 31 million euros for the first three months of 2008, and the company's total R&D workforce is expected to hit 600 employees by the end of the year.
The company has 11 affiliates in Europe and Mexico, and is looking to expand further internationally in the future, particularly within Europe.
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