Boehringer Ingelheim laid out an ambitious agenda for itself over the next two years, planning more than 10 new launches of drugs in eight disease indications by 2016. The eight indications are diabetes, COPD, asthma, lung cancer, idiopathic pulmonary fibrosis (IPF), a rare form of leukaemia (AML), and the treatment and prevention of deep venous thrombosis (DVT) and pulmonary embolism (PE).
In DVT and PE, Boehringer Ingelheim received welcome news earlier this month when the FDA granted marketing approval of its candidate Pradaxa® for that new indication. The oral anticoagulant is already marketed for reducing stroke risk in patients with non-valvular atrial fibrillation (NVAF), for which it racked up €1.206 billion ($1.667 billion) in 2013 sales, up 16.2% over 2012.
Additionally, the company said it was planning to take nine new investigational compounds into phase II clinical studies, without detailing the compounds. The nine are among more than 90 research and development projects on which Boehringer Ingelheim said it was working.
“We will strengthen our therapeutic areas immunology and disorders of the central nervous system, CNS,” said Professor Andreas Barner, Chairman of the Board of Managing Directors of Boehringer Ingelheim. Prof. Barner spoke at the company’s annual press conference, held yesterday in the company’s headquarters city of Ingelheim, Germany.
During a presentation, Prof. Barner said Boehringer Ingelheim will undertake additional projects in CNS indications that include Alzheimer’s disease – a category long marked by clinical failure of numerous candidates – as well as Parkinson’s disease and schizophrenia.
The company will also pursue six clinical trial programs for six different immunology indications, including psoriasis, Crohn’s disease, and spondylarthritis, Prof. Barner added.
Boehringer Ingelheim hopes to surpass its many R&D successes during 2013-14. The company positioned Pradaxa for its eventual approval, while launching two products during its previous year, introducing Striverdi® Resplimat® (olodaterol) for COPD and launching afatinib for non-small cell lung cancer, marketed in the U.S. as Gilotrif®, and in Europe as Giotrif® . The latter product brings Boehringer Ingelheim into the oncology drug market.
Additionally, Boehringer Ingelheim won FDA’s Breakthrough Therapy status for volasertib for acute myeloid leukaemia (AML), and the agency’s Fast Track designation for nintedanib for idiopathic pulmonary fibrosis (IPF).
During 2013, the company submitted nintedanib among three drugs for international registration but under a different indication, non-small cell lung cancer. The other two submitted drugs were tiotropium for asthma, and empagliflozin for type 2 diabetes.
Prescription drugs accounted for 77% of net sales for Boehringer Ingelheim during 2013. The company saw net sales slide 4.5% to €10.891 billion ($15 billion) compared with 2012 – but those sales inched up 1.4% after adjusting for currency fluctuations, especially the weaker U.S. dollar and Japanese yen.
“The market environment for innovative medicines is not going to get any easier in the current financial year. In view of this and the impact from the expiry of patents, we expect to achieve net sales for our company in 2014 that are comparable to those in the previous year,” Prof. Barner added.