Novel combinations breathe new life into COPD market
SummaryThere are 31.2 million COPD sufferers in the US, Europe and Japan - a prevalence rate of approximately 4.4% of the general population. Thus, the development of novel dual-action, once-daily inhaled therapies will provide important new treatment options for COPD and play a major role in the expansion of the market over the next decade.
The market for the treatment of COPD had worldwide sales of $4.6 billion in 2004, which is forecast to grow to $7.5 billion by 2015. Novel dual-action, long-acting bronchodilator combinations, most likely launched by GlaxoSmithKline (GSK), Novartis or Pfizer / Boehringer Ingelheim will be the most significant development in the inhaled COPD class at the start of the next decade.
The term chronic obstructive pulmonary disease (COPD) covers a complex group of disorders characterized by a progressive development of airflow limitation. Caused primarily by smoking, it is set to become the third leading cause of death in the developed world by 2020. The most common symptoms of COPD include chronic cough, excessive sputum production, wheezing, shortness of breath and chest tightness, which slowly progress and eventually lead to a largely irreversible loss of lung function. In 2002, COPD was the fourth leading cause of death in the , with annual costs estimated to be $37.2 billion - double the costs of for asthma.
As no therapy appears to stop the progression of the disease, the strategy is to relieve acute symptoms such as breathlessness and wheezing using bronchodilators. Inhaled short-acting bronchodilators, such as Boehringer Ingelheim's Atrovent (ipratropium bromide) and GSK's Ventolin (salbutamol / albuterol), are effective at relieving bronchoconstriction and are prescribed for patients with few or intermittent symptoms.
In patients with moderate to very severe COPD whose symptoms are not adequately controlled with as-needed short-acting bronchodilators, adding regular treatment with a long-acting inhaled bronchodilator, such as GSK's long-acting b2-agonist Serevent (salmeterol), or Boehringer Ingelheim / Pfizer's long-acting anticholinergic, Spiriva (tiotropium bromide), is recommended.
Spiriva is the first once-daily inhaled antimuscarinic approved for the maintenance treatment of COPD, which is expected to register global sales of $1.5 billion by 2010. The development of a once-daily, dual-action tiotropium / long-acting beta-2 agonist combination therapy should improve adherence to correct treatment regimens, whilst providing important therapeutic benefits as these drugs have distinct and complementary pharmacological actions in the airways.
Although clinical trials with this combination product have not been performed, clinical experience with Combivent, a combination of a short-acting beta-2 agonist (salbutamol) and a short-acting anticholinergic (ipratropium), in COPD is encouraging because the bronchodilation produced is of a magnitude greater than that of either component alone.
Because salmeterol is given twice daily, and only tiotropium bromide is approved for once-daily use in COPD, the challenge for Boehringer Ingelheim / Pfizer is to develop a once-daily beta-2 agonist before competitors such as Novartis and GSK launch alternative products.
Novartis signed a licensing deal with based biotechnology company Vectura Group/Arakis in April 2005 for AD-237, a novel once-daily, long-acting antimuscarinic agent. Novartis will be responsible for developing AD-237 both as a monotherapy and in combination with QAB-149, its once-daily, beta-2 agonist currently in phase II clinical trials.
GlaxoSmithKline also has numerous compounds in early clinical development to create a once-daily, dual-action combination product, and the race is now on to see which company will launch the first-to-market dual-action combination product, expected early in the next decade.