Boehringer Ingelheim is quietly confident that its pipeline is sufficiently well-stocked to push the firm forward in the near future.

The privately-held German group was happy to go public on the state of its late-stage pipeline at its annual press conference, led by Pradaxa (dabigatran etexilate) the first oral anticoagulant from the class of direct thrombin inhibitors. It has just been approved in European Commission in its first indication for the prevention of venous thromboembolic events in adults after elective hip and knee replacement surgery, but importantly a further four indications are currently in clinical development, notably the prevention of stroke.

Chief executive Alessandro Banchi told reporters at the press conference in Ingelheim that Pradaxa will be important for even more patients and doctors for a variety of conditions “and after more than 40 years of vitamin K antagonists being the gold standard, it will change current treatment guidelines for the prevention of venous thromboembolism”.

Aside from Pradaxa, Boehringer noted that 2008 will also be marked by the publication of various landmark studies. This process began a fortnight ago at the American College of Cardiology meeting when positive results from the massive ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) study showed that Micardis (telmisartan) is as protective as the current gold standard ramipril, but is “significantly better tolerated in a broad high-risk cardiovascular population”.

Other important results expected in 2008 for the PRoFESS study involving Aggrenox (aspirin/extended-release dipyridamole) and for the UPLIFT study involving chronic obstructive pulmonary disease blockbuster Spiriva (tiotropium bromide).

Back to the pipeline and Boehringer has high hopes for flibanserin, which is in Phase III for the treatment of pre-menopausal women with hypoactive sexual desire disorder. Andreas Barner, head of R&D< told PharmaTimes World News that the suffering and stress the condition creates makes this somewhat taboo subject an area of unmet medical need and some 5,000 people are in trials. A submission to the US Food and Drug Administration is planned for the end of the year.

Elsewhere, Boehringer has four oncology compounds in clinical development, two of which will advance into Phase III for the treatment of lung cancer. Also in diabetes, BI 1356, which is a dipeptidyl peptidase-4 inhibitor, will enter Phase III this year. By Kevin Grogan in Ingelheim