By Gil Roth07.18.12
#13 Boehringer-Ingelheim
Binger Strasse 173
55216 Ingelheim, Germany
Tel: (49) 6132 77 0
Fax: (49) 6132 77 3000
www.boehringer-ingelheim.com
Headcount 44,094
Year Established 1817
Pharma Revenues $14,058 9%
Total Revenues $18,339 10%
Net Income $2,055 74%
R&D Budget $3,303 8%
PROFILE
Top-Selling Drugs
Drug | Indication | $ | (+/- %) |
Spiriva | COPD | $4,390 | 16% |
Micardis | hypertension | $2,218 | 8% |
Combivent | COPD | $1,067 | 11% |
Pradaxa | atrial fibrillation | $876 | 965% |
Account for 61% of total pharma sales, up from 54% in 2010
PROFILE
Boehringer Ingelheim’s oral anticoagulant Pradaxa had one of the great launches in recent memory, posting $872 million in revenues in its first full year. That success offset the loss of Mirapex revenues ($887 million in 2010, unreported in 2011), but how long will it last?
Not only is Pradaxa going to face competition from Xarelto and (presumably) Eliquis, the drug’s safety has been questioned by the FDA and EMA. BI has argued that the rate of serious adverse events (particularly fatal bleeding) among Pradaxa patients has been lower than would have been experienced had the patients been using Warfarin, the standard of treatment, but both regulatory bodies are considering adding guidance for doctors and patients on lowering bleeding risks. This may include a change in dosing. Xarelto has already received a black box on its label and received a negative recommendation to expand its label; it remains to be seen whether Pradaxa will have similar problems.
BI is also optimistic that Tradjenta, the DPP-4 inhibitor it launched with Lilly in May 2011, will take off, especially in a combination form with Metformin to compete with Merck’s Janumet. For now, neither BI nor Lilly revealed Tradjenta revenues in their 2011 statements, and Lilly didn’t report numbers for it in 1Q12. Onglyza, BMS and AZ’s DPP-4 inhibitor, took some time to build momentum in the market, reaching $475 million in revenues in its second full year on the market.
BI and Lilly will have to find that momentum outside of BI’s home country. Germany’s new pricing policy, based on comparator cost-effectiveness, has put the kibosh on Tradjenta’s launch there.
While BI develops these two new products, as well as its late-stage pipeline, like lung cancer treatment afatinib, the company also has to keep an eye on its top moneymaker, Spiriva. A meta-analysis in British Medical Journal last year found an increase in mortality risk for people using Spiriva in its Respimat mist form (a dosage that’s not approved in the U.S.). A more recent meta-study published in BMJ Open in May 2012 found a lower mortality risk for Spiriva, but an increase in stroke, angina and myocardial infarction.
For the moment, Pradaxa will let Boehringer Ingelheim breathe a little easier.