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Many asthma and chronic obstructive pulmonary disease patients are now being treated with inhaled corticosteroid/long-acting beta2-agonist fixed-dose combinations, a lifecycle management strategy generating high sales from a relatively low investment. However, the lack of truly novel drug targets means that other unmet needs in asthma and COPD are being overlooked by the leading players.
Patients suffering from respiratory diseases like asthma and chronic obstructive pulmonary disease (COPD) are increasingly being treated with fixed-dose combination inhalers. Since GlaxoSmithKline (GSK) launched the first inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) combination in 1998, this drug class has been the leading class in terms of sales in the seven major markets.
Advantages for combination drugs
Indeed, ICS/LABA products accounted for 33% of the asthma/COPD market at about $5.7 billion in 2006 and are set to remain the leading class, with sales of $6.1 billion in 2016. The combination products are popular for several reasons, including improved patient compliance, simplified disease management and the assurance of bronchodilator and steroid co-administration. Non-adherence to treatment is a significant problem in asthma and COPD, especially in the later stages of disease, when patients have a multitude of drugs to deal with and treatment regimes can become confusing.
Patients show a specifically low compliance when it comes to their ICS medication because, unlike a bronchodilator, it does not give them immediate relief. However, the regular use of steroids is key to treating the underlying inflammatory process of asthma and COPD. The automatic intake of the ICS alongside the bronchodilator, improving disease management for both patients and physicians, is a major advantage of combination drugs.
Another benefit of these combination products is that patients always inhale their LABAs in combination with an ICS. Concerns regarding the dangers of LABA monotherapy in the treatment of asthma led to the 1996 Salmeterol Multicenter Asthma Research Trial (SMART), which investigated salmeterol (a type of LABA) in the treatment of asthma. A possibly increased mortality rate in certain subgroups of asthma patients using this drug was found, leading to safety warnings on LABA drug labels. Very few physicians now prescribe LABAs as monotherapy and non-compliance among patients using LABAs without ICS's is the main reason.
Combination products ensure revenue stream
The case of GSK's ICS/LABA combination Advair/Seretide (fluticasone/salmeterol) is a prime example of a life-cycle management strategy resulting in a first-to-market position being optimally used. For companies with a product facing the loss of patent protection, lifecycle management strategies are essential to prevent erosion of market share by generic competitors. Frequently this involves securing an extension of exclusivity through reformulation and launching a second-generation product or introducing a combination therapy.
Additionally, products that are first to market have a distinct advantage with regards to capturing market share. GSK's Advair/Seretide was launched several years before the patent expiry of either of its components Flixotide/Flovent and Serevent, allowing the company enough time to drive switching to the combination product. Indeed, Advair/Seretide became the highest-selling product in the asthma/COPD market with sales of just over $5 billion in 2006.
Unmet needs remain
Although the introduction of fixed dose ICS/LABA combination products has meant an improvement in the standard of treatment for the majority of asthma and COPD patients, there still remains a high level of unmet need, especially in the treatment of COPD. Key examples include the lack of efficacious anti-inflammatories for COPD (current therapies neither arrest nor reverse inflammation and the resulting decline in lung function), finding better ways to prevent and control asthma and COPD exacerbations, and developing therapies for the 10% of refractory asthma patients whose symptoms cannot be controlled with currently available drugs.
At the same time, the leading pharmaceutical companies' in-house R&D is having trouble finding new ways to treat asthma and COPD, despite significant investment. Part of the problem has been the lack of novel validated targets after significant delays and failures in developing classes such as PDE4 inhibitors. Key players in the asthma and COPD market therefore had to rely on a more conservative approach, investing into the lifecycle management of currently marketed drugs. However, this does not help those patients who need novel drugs to help them control their disease and stop the decrease of lung function.
As a result of R&D setbacks and the bias towards lifecycle management, genuinely novel pipeline drugs for asthma/COPD are scarce among such companies. Instead, innovation primarily comes from smaller biotech companies who often do not have the means to drive the development of new compounds as larger companies would have. This means that while increasingly more ICS/LABA combination products enter the market, the unmet needs in certain asthma and COPD patient groups are still not being addressed.
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