Boehringer-Ingelheim: Respimat Aims to Protect Spiriva’s Success

Boehringer-Ingelheim has developed a novel device to deliver respiratory medicines, a step that it hopes will represent a significant advancement upon traditional inhaler technologies. The reformulation of the best-selling asthma/COPD drug Spiriva in the Respimat may well be the key to differentiating Spiriva from similar drugs coming on the market from 2011.

Earlier this week, Boehringer-Ingelheim (BI) presented a study on Respimat at the 16th Annual Congress of the European Respiratory Society in Munich. The Respimat is a new device that delivers medication in a soft and slow-moving mist with a high fine particle fraction, allowing the active compound to penetrate deep into the lungs. The mist formulation also decreases deposition in the mouth and throat compared to traditional MDI devices, resulting in fewer oropharyngeal side effects.

The Respimat is currently in development for BI’s most important respiratory product Spiriva (tiotropium bromide). Importantly, the data presented in Munich showed that patients with asthma and chronic obstructive pulmonary disease (COPD) are highly satisfied with the novel Respimat Soft Mist Inhaler (SMI).

The Respimat technology is currently used in BI’s Berodual (ipratropium bromide/fenoterol hydrobromide) which was launched in January 2004 on the German market. A 12 week study evaluating the satisfaction of patients using the Berodual Respimat concluded that most patients (74%) rated the treatment with the Respimat as better or much better than their previous Berodual inhaler.

This real-life validation of the new technology provides a good platform from which to reformulate BI’s COPD-blockbuster Spiriva in the Respimat inhaler. Phase III trials for Spiriva in this device were successfully completed and BI is currently preparing the filing documents, according to the company’s 2005 Annual Report.

Currently Spiriva is the only once-daily long-acting anticholinergic (LAMA) on the market with sales of $950 million in 2005, which is forecasted to grow to $1.9 billion by 2015.

Spiriva’s only disadvantage is its current inhaler device – the Handihaler – which is said to be too complicated, especially for elderly patients. Several companies have once-daily LAMAs in their pipeline, but none is expected to be launched before 2011. Although that year will mark the end to Spiriva’s monopoly, BI appears to have chosen an excellent defence strategy. A reformulation in the novel Respimat will differentiate Spiriva from its competitors and will be key to extend its success.