Boehringer Ingelheim has been outlining its R&D plans for the coming years, specifically in the respiratory area where the German group's chronic obstructive pulmonary disease blockbuster Spiriva will continue to play a major part.

At a press conference in Biberach, BI chairman Andreas Barner noted that despite ever-increasing hurdles in terms of approvals and market access, plus increasing costs and complexity, R&D is and will continue to be the company's "backbone". Its research budget is around 24% of sales, way above the industry average and of the 7,000 employees in R&D (and medicines), some 200 are involved in respiratory drug discovery alone.

The late-stage respiratory compounds include olodaterol, a once-daily, long-acting beta2 agonist (LABA), for COPD which was developed as "an ideal combination partner" for Spiriva (tiotropium), BI's big-selling and long-acting, once-daily muscarinic antagonist (LAMA).

The company also recently announced data from a Phase III  study which revealed that tiotropium significantly reduced severe asthma attacks. While its scientists were anticipating improvements in lung function when adding Spiriva to usual care (ie inhaled corticosteroids/LABAs), BI says that the significant reduction in the risk of exacerbations "came as a surprise", especially given that the patients were already receiving optimal maintenance treatment.

When asked by PharmaTimes World News why the company had taken so long to look at Spiriva in asthma, Prof Barner said that some studies had indeed been conducted earlier but the results were not promising.

However, given the fact that doctors were prescribing Spiriva off-label for asthma and insistence from individual researchers within BI that the firm should persevere with the compound, the board decided to proceed. Prof Barner added that the case shows the power that scientists have within the group.

Promising IPF compound

As well as COPD and asthma (BI is also conducting Phase II studies focusing on a new mode of action, the blockade of the CRTH2 receptor, involved in asthma pathogenesis), the company highlighted nintedanib for the treatment of idiopathic pulmonary fibrosis. There are currently no treatments for IPF which affects between 14-43 people per 100,000 worldwide and 50% of patients die within two-three years after diagnosis.

Nintedanib is a small molecule tyrosine kinase inhibitor which targets growth factor receptors that have been shown to be involved in pulmonary fibrosis and recruitment into Phase III trials has been completed. Results are expected in 2014.

Klaus Dugi, global head of medicine at BI, stated that the firm has introduced "thorough testing methods often many years prior to such methodology being requested by guidelines", adding that "we also heavily invest in landmark studies to assess 'real world conditions' in which patients receive additional investigational compounds on top of their standard medication". He went on to say that "clearly this may make outstanding clinical trial results more difficult to achieve, in contrast to comparing new compounds with placebo only".

No increased bleeding risk with Pradaxa - FDA

Meantime, BI has received a boost from regulators in the USA who said that its new blood thinner Pradaxa (dabigatran) does not appear to increase risk of bleeding compared with warfarin.

The Food and Drug Administration began a safety review of the drug last year after receiving reports of serious bleeding events in patients using Pradaxa. It has conducted a new assessment of the treatment using insurance claims and administrative data which indicates that bleeding rates associated with new use of Pradaxa do not appear to be higher than bleeding rates associated with new use of warfarin, "which is consistent with observations from the large clinical trial used to approve" the anticoagulant.