Boehringer Ingelheim has been reflecting on a pretty tough 2013, hurt by manufacturing woes and Pradaxa lawsuits, but its financials were strong and the future looks bright with a raft of product launches coming up.
Sales of prescription medicines were down 4.5% (or up 1.4% taking into account currency impact) to 10.89 billion euros, driven by the chronic obstructive pulmonary disease drug Spiriva (tiotropium), which brought in 3.55 billion euros, a slip of 0.3%. The blood pressure drug Micardis (telmisartan) fell 15.4% to 1.37 billion euros, while the anticoagulant Pradaxa (dabigatran etexilate) climbed 8.8% to just over 1.20 billion euros.
However, safety questions about Pradaxa have meant that lawsuits against Boehringer continue to mount in the USA. Speaking at the company’s annual press conference in Ingelheim, chairman Andreas Barner said “we are…very confident that we will be able to demonstrate in all court cases that, during the clinical development and marketing of Pradaxa “we have always acted in an appropriate, legally correct, and responsible manner, and that any claims for damages are not justified”.
He also mentioned the “difficult decision” of having to close Ben Venue, its US facility for sterile injectables, and the criticism received from the US Food and Drug Administration regarding quality concerns at its facility in Ingelheim. Regarding the latter, Dr Barner says that since May 2013, “we have addressed the FDA’s key issues,” and “we have made investments in the sustainable quality of our products and in quality assurance”.
He acknowledged that “2013 was a difficult year that was marked by some challenges…but it was also a year with many successes”. The biggest of those was the launches on both sides of the Atlantic of the targeted lung cancer drug Gilotrif/Giotrif (afatinib) and the launch of Striverdi Respimat (olodaterol) for COPD.
In the next two years, Boehringer is planning more than ten new launches in eight indications and in the current financial year, it hopes to put nine new investigational compounds into Phase II. Arguably of most interest is a combination of Spiriva and Stiverdi and first trial results will be unveiled at the American Thoracic Society conference in San Diego next month.
Dr Barner concluded by saying that “we are advocating more transparency in R&D…and now want to be more open to scientific discussion”. He added that “we have joined up with several research-based pharmaceutical companies in order to make clinical trials data and documents available to a wider public”.
