GlaxoSmithKline is already the asthma treatment industry leader with its Advair product and 2007 sales of US $6.9 billion. It will likely remain the market leader in the current generation of asthma medication, being a combination drug consisting of a corticosteroid and a long-acting beta antagonist. However, Advair’s patent protection expires in both the United States and Europe in the next few years. Therefore, Glaxo announced this week it is pleased with clinical trial results that sees new product, Relovair, as a potential replacement for the treatment of chronic obstructive pulmonary disease, or COPD.

Over 300 million people suffer from asthma, which translates to a drug market worth over $15 billion. While drugs to manage asthma have existed for several decades, pharmaceutical companies have developed faster acting and more effective products over the years.

Both Advair and Relovair combine two types of drugs that reduce inflammation and open the breathing passages in the lungs: a corticosteroid and a long-acting beta agonist, or LABA. The corticosteroid in both products is similar but the LABA is different. Relovair is to be a daily inhaled medication.

Glaxo is comparing Relovair to Advair in a separate clinical trial for COPD, with the aim of proving Relovair more effective.

Darrell Baker, head of Glaxo’s respiratory medicine development program comments:

“Successful completion of these two studies is an important milestone in the development of Relovair for COPD. These data will be reviewed together with the larger 12-month exacerbation studies still under way, to develop a complete evaluation of Relovair in treating patients with COPD.”

Glaxo hopes Relovair can replace its best-selling asthma drug Advair, which combines two drugs in a fine powder that’s inhaled through an intricate device called a Diskus.

The two studies tested Relovair and its two components against a placebo in trials testing lung function using around 2,200 patients with moderate to severe COPD. Detailed results will be released at a conference at a later, undetermined date.

AstraZeneca has budesonide/formoterol, and was a new asthma drug that launched in the US in mid-2007, with 2007 sales of $1.6 billion. It is also a combination drug that belongs to the same drug family as Advair (ICS/LABA), but with slightly faster action. The drug is expected to overtake Singular as the second most popular asthma drug in the next five years.

So yes, there also is Merck’s Singulair or montelukast. This is a leukotriene receptor antagonist that inhibits a specific inflammatory pathway. While it is less effective than ICSs, which inhibit many pathways, Merck has been able to market it in the US successfully by playing up fears of corticosteroids and promoting Singulair for use in children. Singulair is used to help maintain chronic asthma symptoms and cannot be used to treat acute asthma attacks. It is also the last branded drug for allergic rhinitis (hay fever). The drug is Merck’s best-selling product, with 2007 sales of $4.3 billion, representing 18% of company total sales.

Sources: GlaxoSmithKline, AstraZeneca and Merck

Written by Sy Kraft