Almirall expands its horizons

Tag : tiotropium bromide
Almirall expands its horizons


Niche markets, acquisitions and a COPD candidate are all part ofthe strategy for Spain's biggest pharma company to grow beyond itshome market


Almirall has been Spain's number one pharmaceutical company forsome years, but is still little known outside its home market. Thecompany's management wants to change this by expanding its presenceacross Europe, and is banking on a portfolio of newly acquireddermatology products and a new COPD drug discovered in-house tohelp it fulfil its ambitions.
The Barcelona-based company has been in existence for 65 years andbecame the company with the largest market share in Spain in 1987,basing its success on a mixture of in-house products and drugslicensed 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 trulyinternational company with presence in more markets and with agreater 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 ofproducts. These new offices add to its existing European affiliatesin France, Belgium, Italy, Germany and Portugal.
This larger portfolio has come about through two recentacquisitions, an outright acquisition of Germany company Hermal -an established niche player in dermatology - in August 2007, andthe purchase of several dermatology products from UK company Shirein November.
Dr Jorge Gallardo, chairman and chief executive of Almirall says2007 was a "milestone year" for Almirall, and adds thatits performance as a listed company put it among the top performingstocks among European medium-sized pharma companies. He is upbeatabout further growth in Europe this year: "Almirall will becentering efforts on consolidating its international expansion,mainly in Europe, and with special focus on the evolution of [COPDlead candidate] aclidinium bromide."
A star is born?
Almirall is looking to its novel pipeline drug aclidinium bromideas a potential blockbuster treatment for chronic obstructivepulmonary disease (COPD). Currently in phase III trials, the drugcould transform the company's fortunes, with peak sales forecastsfrom analysts as high as $2billion.
The long-acting anti-muscarinic agent is being developed as aonce-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 asBoehringer Ingelheim and Pfizer's blockbuster Spiriva (tiotropium)and will have to show significant advantages over the existing drugif it is to be a major success.
Almirall says aclidinium may offer COPD patients certain advantagesover existing drugs, including speed of onset and tolerability, anda strong safety profile.
Aclidinium bromide has a different structure and pharmacologicalprofile 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 withrising mortality. It affects between 4-10% of adults and isparticularly on the rise among women, with most cases linked tocigarette smoking. COPD causes 200,000 - 300,000 deaths in Europeevery year, along with huge productivity losses because of absencefrom work.
The drug is also in phase II trials as a combination therapy withthe long-acting beta agonist formoterol, and at pre-clinicaldevelopment stage as a combination therapy with an inhaledcorticosteroid. Currently there is no combination treatment inhaleravailable for COPD that includes an anti-muscarinic therapy.
Analysts say that it is the combination of sales from thesemonotherapy and combination therapy indications which could bringglobal peak sales up to the forecast $2 billion, but the companywill undoubtedly face stiff competition, especially in theall-important US market.
To help ensure access to this market, Almirall has struck a dealwith American company Forest to co-develop and co-market the drugin the US. Although Forest has no heritage in the COPD fielditself, it does have a large US field force and experience inmarketing other primary care-focused products such asanti-depressant escitalopram and hypertension treatment olmesartan.
Almirall will retain rights for the rest of the world, and couldbecome much more widely known across Europe and elsewhere if andwhen aclidium reaches the market.
Easy-to-use inhaler
A vital component for the success for any new inhaled medicine isthe inhaler device, and Almirall acquired specialists in the fieldSofotec in 2006. The move gave Almirall access to important newrespiratory technology - a novel 'press and inhale' multidose drypowder inhaler (DPI) which it believes could make a big differenceto patients, and in turn to future sales of aclidinium.
The company say the inhaler is unique because it has a four-stageactuation process and requires no cleaning, unlike existingdevices. The inhaler is also being developed for delivering otherdrugs for inhalation in the future.
Almirall's director of pharmaceutical development CarstenNiederlander said the new 'state of the art' inhaler will appeal topatients and healthcare professionals alike because of its ease ofuse and flexibility.
"A typical COPD patient will be on lots of medication, withco-morbidities such as angina, diabetes etc. Previous inhalers haveproven complicated to use, particularly when the patient finds eventheir day-to-day existence a struggle because of the debilitatingsymptoms of COPD," he says. "This device will take thestress of self-medication out of the equation".
It is hoped that the device will give Almirall an edge in therapidly growing international COPD market, and boost the company'sglobal profile.
Key results for the phase III clinical trials are expected in thesecond half of 2008, and the company will be hoping it can matchexpectations. Chief executive Jorge Gallardo is optimistic ahead ofthe crucial results, saying: "We have no doubt that aclidiniumbromide will be a remarkable event for Almirall".
Dermatology and rheumatoid arthritis
Though COPD is the company's current main focus, drugs forconditions such as asthma, psoriasis, rheumatoid arthritis andmultiple sclerosis also form a large part of Almirall's in-houseR&D programme. Recently acquired R&D pipelines include drugs forpsoriasis, skin cancer and other skin conditions.
Two new projects for rheumatoid arthritis and multiple sclerosisentered the development phase in 2007, and Almirall announcedresults for a new compound treatment of asthma and COPD. Thecompound LAS100977 has successfully completed a daily single dosetrial that demonstrated 24 hour efficacy. Almirall also has severaldermatology candidates in development, three of which are in phaseIII.
Sales of the former Shire portfolio reached $53.8 million in 2006,and are mainly concentrated in the UK, representing over $36million of the total. The portfolio acquired includes twodermatology products and six others for the treatment of pain,inflammatory and gastrointestinal diseases.
If Almirall can increase sales of the dermatology franchise outsidethe 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 netsales (122 million euros), and 15% of the workforce is based inR&D. The company has three main R&D centres, including theirflagship headquarters opened in 2006 in Barcelona. This houses themajority of Almirall R&D - a team of approximately 400 people - andis equipped with the latest technology.
Almirall's progressive manufacturing facilities at Sant Andreu dela Barca are the company's pride in terms of the speed-enhancingtechnology used, and are seen as a benchmark for the industry interms of big value production.
Overall, 122 million units of medicine are produced by Almiralleach year, including current bestsellers Airtal (aceclofenac),Almax (almagate) and Cidine (cinitapride).
The company prides itself on its high safety standards and itssystem for workplace risk prevention management. It has won awardsfor its environmental policies and wants to be known for itscommitment to the health of its employees, providing on-site gymsand good working conditions.
Boasting a high ratio of PhDs and a successful recruitment andretention policy, the company says it is committed to pharmacologyeducation. It has taken the lead among Spanish pharma companies incollaborating with universities and other public bodies, andprovides courses to facilitate the discovery and development of newcompounds and scientific methods.
Almirall's investment for the future is particularly noticeable inR&D, where its spending rose 43% to 31 million euros for the firstthree months of 2008, and the company's total R&D workforce isexpected to hit 600 employees by the end of the year.
Text Box:
2007 was a "milestone year" for Almirall says JorgeGallardo, Almirall's chief executive. Its performance as a listedcompany put it among the top performing stocks in Europeanmedium-sized pharma companies.
Almirall's pipeline drug aclidinium bromide, now in phase IIItrials, has the potential to transform the company's fortunes, withpeak sales forecasts from analysts as high as $2 billion.
R&D spending rose 43% to 31 million euros for the first threemonths of 2008, and the company's total R&D workforce is expectedto hit 600 employees by the end of the year.
The company has 11 affiliates in Europe and Mexico, and is lookingto expand further internationally in the future, particularlywithin Europe.

Pharmafocus
E: pharmafocus@wiley.com

Thursday , July 03, 2008