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'Smarter steroid' Alvesco launched in the UK

Published on 03/02/05 at 10:06am

Alvesco, the first one puff, once-daily inhaled corticosteroid for asthma has been launched in the UK, its first European market.

Manufacturers Altana say the drug has the potential to become a blockbuster asthma treatment, offering a number of significant benefits over existing treatments.

Delivered via a metered dose inhaler, the small particle size of Alvesco (ciclesonide) means that a higher proportion of the drug reaches the lungs where it can take effect.

Significant amounts of existing inhaled corticosteroids remain in the mouth and throat where they commonly cause side-effects such as voice alteration, hoarseness and oral thrush. The small amount of Alvesco that does remain in the mouth is mainly inactive because it works only in the presence of enzymes found in the lungs, unlike other inhaled corticosteroids.

Alvesco and US co-marketers Sanofi-Aventis also hope the once-daily formulation will prove popular with doctors and with patients, many of whom fail to take their current medication frequently enough.

"Getting patients to take their asthma treatment can be quite challenging, generally because people can find inhalers inconvenient to use and they can also bring about some unpleasant oral side-effects," said Dr Brian Oonnor, consultant physician, respiratory medicine and allergy at King's College Hospital London.  "However, Alvesco offers convenient once-daily dosing, works mainly in the lung and provides good asthma control over the long term."

Despite these advantages, analysts Goldman Sachs say they are concerned that Alvesco's labelling in the EU may reduce its ability to compete with established brands.

The drug is approved to treat persistent asthma of all severities in adults in once-daily doses of 160 micrograms or 80 micrograms, but is not yet licensed for treatment in children, who represent a major part of the market.

GlaxoSmithKline's Flovent/Flixotide (fluticasone) is the current worldwide market leader, with 2003 sales of $1.13 billion, closely followed by AstraZeneca's Pulmicort (budesonide) which earned $968 million in the same period.

The UK is one of the most important global markets for asthma, its estimated 10 million sufferers making it the largest in Europe, according to IMS Health. The market for monotherapy inhaled corticosteroids was worth approximately E1 billion in 2003, of which the UK accounted for around 30%.

Products combining 'reliever' inhalers with 'preventer' inhalers in one, such as GSK's Seretide and AstraZeneca's Symbicort are, however, increasingly dominating global markets. Altana already have a combination of Alvesco with the long-acting beta 2 agonist formeterol in phase II development.

Altana is expected to gain marketing approval in Europe and the US later this year for another respiratory product, Daxas (roflumilast).

The drug is targeted at the rapidly-growing chronic obstructive pulmonary disorder (COPD) market, and is expected to benefit from the US co-marketing muscle of Pfizer, who have already made significant inroads with another COPD treatment, Spiriva, co-marketed with Boehringer Ingelheim.

 

 

 

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