R&D budget (pharmaceuticals and diagnostics): CHF 11.53 billion ($11.42 billion)
Change from 2015: Up 20%
Total 2016 revenue: CHF 50.57 billion
R&D budget as percentage of revenue: 22.8%
Roche is a big R&D spender, forking out CHF 11.53 billion ($11.42 billion) last year. Although at 22.8% of its total revenue, it’s not quite top in terms of percentages.
But it did have the largest jump in R&D funding, up 20% from CHF 9.58 billion in 2015, counting both pharmaceuticals and its diagnostics division.
The biggest boost was in its pharmaceuticals R&D, up from CHF 8.3 billion two years ago to CHF 10.1 billion last year. Diagnostics saw a much smaller increase, from CHF 1.2 billion in 2015 to CHF 1.3 billion in 2016.
Overall, however, the company had a mixed bag in 2016: A key success saw the FDA approval of its I-O med Tecentriq (atezolizumab) in bladder cancer, coming third in the new PD-L1/PD-1 world after Merck and Bristol-Myers, but becoming the first PD-L1 checkpoint inhibitor to market and beating out rivals AstraZeneca and Pfizer/Merck KGaA.
The med is expected to go on and do big things, especially after it scored an FDA nod in lung cancer, despite being third to market. And the company is, like many others in this space, looking to combine its new med with other experimental drugs (such as Kite’s cutting-edge CAR-T candidate) to see if it can boost efficacy and immune responses across a range of cancers.
But the Swiss major is coming under the looming threat of biosimilars to its aging batch of superstar oncology products, and some of its attempts to offset these future sales declines saw major setbacks last year.
One of the biggest problems came out of its hemophilia test, the study of which is centered around the “game-changing” emicizumab (ACE910) that saw two thromboembolic events and two cases of thrombotic microangiopathy in patients.
But in February of this year, Roche revealed that a patient died in a phase 3 hemophilia trial of its bispecific antibody.
The trial investigator ruled the death was unrelated to emicizumab, but with the event following other reports of serious adverse reactions, it has added to questions about the safety of the experimental regimen.
The Swiss major also failed a late-stage trial pitting one of its newer drugs against an aging stalwart as it failed to help patients with an aggressive form of blood cancer live longer.
Specifically, the phase 3 GOYA study of Gazyva (obinutuzumab) used with a cocktail of chemo agents missed its primary endpoint in improving progression-free survival in patients with diffuse large B-cell lymphoma when compared to Roche’s own blockbuster cancer and autoimmune drug Rituxan (rituximab), also with a chemo regimen.
The company also dropped vanucizumab, which was intended as a follow-on to blockbuster cancer drug Avastin (bevacizumab), as a cancer monotherapy on a phase 2 trial failure.
Development of vanucizumab on its own was discontinued given that it failed to meet its primary endpoint in a key test, but it continues life in several ongoing combo trials.
>> Check out Roche’s pipeline.