Boehringer dogged by doubts as it touts a growing PhIII pipeline

Courtesy of Boehringer Ingelheim GmbH

Boehringer Ingelheim wants to be considered part of the major league in global drug R&D. And it's been spending some blockbuster cash on a bid to win a big slate of new drug approvals that could eclipse even the biggest rivals. But recent stumbles in R&D have raised doubts about just how successful the German pharma company will be in achieving its goals.

This week Boehringer made a bold prediction: It has the programs needed to win 10 new drug approvals over the next two years in 8 disease fields, including cancer, diabetes, idiopathic pulmonary fibrosis, asthma and COPD. Boehringer spent more than $3 billion on R&D last year, close to a 20% increase over the year before. And it's got the pedal to the metal as it aggressively pushes ahead on 90 R&D programs with plans for 9 new Phase II programs this year.

"We will strengthen our therapeutic areas immunology and disorders of the central nervous system, CNS," says Chairman Andreas Barner.

Boehringer Chairman Andreas Barner--Courtesy of Boehringer Ingelheim GmbH

So far so good. But this is the same pharma company that eked out a meager 1.4% increase in net sales last year. Just a few weeks ago Boehringer suffered as analysts unfavorably compared its IPF drug nintedanib to InterMune's ($ITMN) pirfenidone after one of its late-stage studies came up short on a key secondary goal. And an ambitious partnership to develop new diabetes drugs with Eli Lilly ($LLY) has been afflicted by a delay on the SGLT2 drug empagliflozin after regulators cited one of Boehringer's European manufacturing sites. 

Even if it does win U.S. approval, empagliflozin (which is getting green lighted in Europe) will also face a crowded field of rivals in the diabetes market, demonstrating yet again that all new drug approvals are not alike in terms of market potential.

Rivals to its clot-fighting drug Pradaxa, which has been hit with a host of liability suits, have also pushed its big new drug to the back of the pack, potentially a sign of things to come as the pharma company angles to get more new products out into the market.

With the numbers this tight, any further slip-ups are likely to be severely punished. But a steady stream of new approvals would go a long way to winning over the skeptics.

- here's the release