Headquarters: Basel, Switzerland
Year Established: 1896
Total Revenues: $49,626 (+5%)
Pharma Revenues: $38,369 (+5%)
Net Income: $9,550 (+8%)
R&D: $9,729 (+6%)
TOP SELLING DRUGS
|Activase/TNKase||acute myocardial infarction||$1,087||15%|
Roche is a pioneer and leader in biologics for oncology and beyond and with $38.4 billion in drug sales for 2016, it moved up a spot from last year to become the fourth largest drug maker in the world. Sales in Roche’s Pharmaceuticals Division were driven by strong growth of Perjeta, Herceptin and Actemra/RoActemra, while lower sales were recorded for Pegasys, Tarceva and Lucentis.
In the U.S., Pharmaceuticals sales advanced 3%, led by the respiratory medicines Xolair and Esbriet. The recently launched medicines Tecentriq and Alecensa contributed to the growth as well. Sales of eye drug Lucentis and cancer medicines Avastin and Tarceva declined due to growing use of other therapeutic options. In Europe, sales growth of 4% was driven by Perjeta, Actemra/RoActemra and MabThera/Rituxan.
Roche recently launched four new medicines: Cotellic (advanced melanoma), Alecensa (lung cancer), Venclexta (chronic lymphocytic leukemia) and Tecentriq (bladder and lung cancer). In addition, five FDA breakthrough therapy designations were granted for Roche medicines in 2016.
A major highlight was the U.S. launch of Roche’s cancer immunotherapy medicine Tecentriq. It is the first FDA-approved treatment for people with a specific type of bladder cancer in more than 30 years. In addition, the FDA cleared Tecentriq for use in previously treated metastatic non-small cell lung cancer (NSCLC). The pivotal Oak trial showed that people with this form of lung cancer who received Tecentriq live significantly longer, regardless of their PD-L1 status, compared with those receiving chemotherapy.
Additional data presented at the ECTRIMS4 congress in September showed that Roche’s ocrelizumab increased disease control in both relapsing and primary progressive multiple sclerosis (RMS and PPMS). In March, Roche received regulatory approval for this medicine in RMS and PPMS in the U.S. and the EU.
Roche also presented other important clinical results in 2016. A pivotal study in a group of people with haemophilia A (Haven 1) showed that prophylaxis with emicizumab led to a significant reduction in the number of bleeds over time. A phase III study by Chugai (J-Alex) found that first-line treatment with Alecensa significantly reduced the risk of disease worsening or death compared to crizotinib, the current standard of care, in people with ALK-positive NSCLC. While Gazyva/Gazyvaro showed positive results in a major clinical trial (Gallium) in follicular lymphoma, a separate trial (Goya) of the medicine in diffuse large B-cell lymphoma, did not reach its primary study goal.
Also on the cancer battlefront, during the year, Roche launched the global cancer immunotherapy Centers of Research Excellence (imCORE) Network. This network brings together many of the world’s leading scientific and clinical experts in cancer immunotherapy to collaborate in investigating the most promising new treatment approaches. The goal is to rapidly initiate preclinical and clinical research based on the latest scientific discoveries and to aggregate and share data to accelerate the search for cures for people with cancer. The imCORE Network will focus on identifying approaches to expand the number of people who benefit from cancer immunotherapy by exploring new ways to activate a person’s immune system to fight their cancer.
Roche will invest up to roughly $100 million to support basic and clinical research collaborations related to cancer immunotherapy. This investment is incremental to Roche’s on-going research and development of investigational medicines and treatment approaches in the field of cancer immunotherapy.
To further bolster its research efforts, Roche entered a collaboration with Catalent, through its subsidiary Redwood Bioscience, to develop next-generation molecules coupling different therapeutic modalities using Catalent’s proprietary SMARTag technology.
Roche gains non-exclusive access to the SMARTag platform and will have an option to take commercial licenses to develop molecules directed to a defined number of targets. Use of SMARTag, Catalent’s programmable protein-modification technology, combined with the highly stable hydrazino-Pictet-Spengler (HIPS) conjugation platform, will permit evaluation of alternative sites of drug conjugation so that Roche may develop molecules optimized for efficacy, safety and stability.
Roche paid Catalent an up-front fee of $1 million and is to provide additional research funding during the initial phase of the collaboration. Catalent has the potential to receive up to $618 million in development and commercial milestones, plus royalties on net sales of products, if Roche pursues commercial licenses and all options are exercised.
Restructuring small molecules network
At the end of 2015, Roche unveiled plans to restructure its small molecules manufacturing network. The plans called for the closure of four manufacturing sites in Clarecastle, Ireland; Leganes, Spain; Segrate, Italy; and Florence, SC, in the U.S. The decision was made to address current underutilization as a result of its evolving portfolio.
The transition began in 2016 and is planned to end by 2021. During the year, Roche divested two of the facilities. The 300,000 sq.-ft. API manufacturing plant in Florence was sold to Patheon. At the time of the sale Roche entered into a multi-year supply arrangement with the contract development and manufacturing organization (CDMO).
The Spanish facility in Leganes was sold to the contract manufacturing organization (CMO) Famar. In addition, the two companies at the time of sale signed a long-term manufacturing agreement that will allow Famar Leganes to supply Roche in the future from this facility with the current portfolio of products produced at the site.
With these changes Roche is responding to the evolution of its small molecule portfolio towards specialized medicines produced in lower volumes. To support the manufacture of a new generation of specialized small molecule medicines—produced in lower volumes than traditional medicines—Roche is investing roughly $310 million in a dedicated facility in Kaiseraugst, Switzerland to provide future technology requirements.