Boehringer Ingelheim is to pay $650 million after reaching a “comprehensive settlement” of US lawsuits concerning its blockbuster anticoagulant Pradaxa.

The German major has been pilloried in some sections of thje media over the extent of the bleeding risks associated with Pradaxa (dabigatran etexilate) despite the fact that regulators, scientists and Boehringer itself have consistently backed the drug's positive benefit-risk profile, when used as directed. Indeed, the US Food and Drug Administration publicly backed the therapy when it published the results of a Medicare study of more than 134,000 patients.

Nevertheless, Boehringer has decided to bite the bullet and resolve some 4,000 claims. It expects "most, if not all, of the plaintiffs to accept the terms of the settlement" and "will vigorously defend against those who do not".

Andreas Neumann, Boehringer's general counsel, said that "we continue to stand resolutely behind Pradaxa and believed from the outset that the plaintiffs’ claims lacked any merit. Notwithstanding our strong belief that we would prevail in these lawsuits, this settlement allows our company to avoid the distraction and uncertainty of protracted litigation over years and years".

He then went on the attack, saying the US litigation system "is described by some as a business where lawyers run advertising campaigns to find clients. Furthermore we have to consider that juries composed of lay people have to decide about very difficult scientific matters".

Mr Neumann concluded by saying that "all this does not allow reliable predictions for the outcome of a huge number of individual trials and that is why we came to the tough decision to settle".

Charles De Wet, medical director for Boehringer UK and Ireland, said the benefits and side-effect profile of Pradaxa “have been confirmed in trial after trial and is further backed up by real-world data analysis”. He added that “since its marketing authorisation, we have worked extremely closely with healthcare professionals and patient groups in the UK and across the world to educate and maintain their awareness about a balanced consideration of stroke risk reduction, and bleeding risk”.
Dr de Wet concluded by saying that “we are absolutely confident we have worked with all regulators and made all information available to them ensuring they too have all the information they need. We continue to stand firmly behind our medicine”.

Hikma to buy Boehringer's Bedford Labs

On a busy day for Boehringer, it was revealed that Jordanian drugmaker Hikma Pharmaceuticals is buying its troubled US generic injectables business in a deal that could be worth $300 million.

London Stock Exchange-listed Hikma will acquire Bedford Laboratories with an upfront payment of $225 million, plus a further $75 million, subject to the achievement of performance-related milestones, over five years.  In addition, Hikma has entered into an exclusivity arrangement with Boehringer "to potentially acquire substantially all of the assets" of the Ben Venue facility in Bedford, Ohio, which Boehringer said it was closing last year as it was plagued with compliance problems.
Hikma chief executive Said Darwazah said that "the large number of high value, niche and differentiated products we are acquiring will strengthen our market position in the US and will benefit patients by bringing back products to the market that are currently in short supply".

The continued manufacturing problems led to an interruption of supplies of drugs, notably of Johnson & Johnson's cancer treatment Doxil (doxorubicin) but Mr Darwazah said "I am confident that we have the technical capabilities and manufacturing expertise to successfully re-launch the acquired products over the next few years".
Hikma added that the acquisition "marks another significant step towards achieving our ambitions in injectables, adding a portfolio of 84 products to its 63 existing marketed drugs. It added that Bedford "also brings a unique and attractive R&D pipeline" of 27 products, of which 16 are pending approval from the FDA.