Year Established: 1896
Total Revenues: $54,591 (+5%)
Pharma Revenues: $42,219 (+5%)
Net Income: $9,039 (-9%)
R&D: $11,566 (+2%)
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Roche Group’s pharmaceutical business reported solid overall results in 2017. Revenue grew 5% to $42.2 billion from $38.3 billion a year ago—good enough to move into the number two spot from four last year.
Pharmaceutical sales growth contributed $1.4 billion of new sales, representing 65% of the division’s growth. In oncology, HER2 franchise sales increased by 7% to $10.1 billion, led by Perjeta. MabThera/Rituxan sales were $7.5 billion, a growth of 1% globally, despite sales in Europe being 11% lower following biosimilar entry. Sales of Avastin were $6.7 billion, a decline of 2% due to competitive pressure. Sales in immunology grew to $7.6 billion, with Xolair and Actemra/RoActemra increasing by 16% and 14% respectively. Sales of Tamiflu fell by 33% due to competition from generics in the U.S. market.
During the year, the Swiss drug maker scored a major victory when FDA approved Ocrevus, a new multiple sclerosis (MS) drug from Roche’s Genentech unit that is poised to make a major impact on the market for MS and could prove to be a blockbuster. Since its launch, more than 30,000 prescriptions have been written and sales estimates for 2022 are projected to be more than $4 billion.
To say the FDA’s approval of the drug back in March 2017 was big news in the MS world is an understatement. Why is Ocrevus touted for being the leading new drug approval from the class of 2017? Well, there are approximately 15 other medications—known as disease-modifying treatments, or DMTs — for MS, but they only treat the most common form of MS, called relapsing-remitting multiple sclerosis (RRMS).
Ocrevus is groundbreaking because, while it has been very effective for RRMS, it is also the first medication approved to treat primary-progressive multiple sclerosis (PPMS), a less-common form of the disease. According to the National Multiple Sclerosis Society, 85 percent of people with MS have RRMS, while 10 to 15 percent are diagnosed with PPMS.
Roche was awarded several other new drug approvals during the year, some of which are highlighted here. First, FDA gave the green light to cancer drug Perjeta, in combination with Herceptin and chemotherapy—the Perjeta-based regimen—for adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence.
The drug enforcer also approved Roche’s Gazyva for previously untreated advanced follicular lymphoma. The approval marks the first treatment option to demonstrate superior progression-free survival over standard-of-care Rituxan-based therapy.
Hemlibra for haemophilia A with inhibitors was approved and is the first new medicine in nearly 20 years to treat people with haemophilia A with inhibitors. The drug was shown to substantially reduced bleeds in adults and children.
FDA also approved Zelboraf for Erdheim-Chester disease with BRAF V600 mutation. Zelboraf is the first FDA-approved treatment for Erdheim-Chester disease (ECD), a rare blood disease.
Alecensa also was approved as a first-line treatment for people with specific type of lung cancer. Approval was based on Phase III results that showed Alecensa extended the average time that people lived without their disease worsening compared to crizotinib.
Actemra/RoActemra was approved for the treatment of CAR T cell-induced cytokine release syndrome. Actemra/RoActemra is the first FDA-approved treatment for severe or life-threatening cytokine release syndrome induced by CAR T cell therapy. This marks the seventh FDA approval for Actemra/RoActemra since its U.S. launch in 2010
Lasty, FDA ok’d Roche’s Lucentis for diabetic retinopathy, the leading cause of blindness among working age adults in the U.S. It is the first and only medicine approved to treat all forms of diabetic retinopathy on the market.
Billion dollar deals
At the start of 2018 Roche made a couple of major M&A transactions. First, to boost its cancer pipeline, it paid $1.7 billion to acquire Ignyta, Inc., a U.S. based pharmaceutical company focused on developing cancer therapies. The acquisition expands Roche’s oncology portfolio globally. Ignyta is responsible for the ongoing study of entrectinib, its most advanced cancer drug being studied in a range of solid tumor types. The company also has a portfolio of drugs in early stage development that use gene therapy to kill the underlying diseases that drive cancer tumor growth. Ignyta employs an integrated “Rx/Dx” approach that combines precision medicines (Rx) and in-house molecular diagnostics (Dx) to both identify and target hard-to-treat cancers in hard-to-find patients.
Second, Roche continued its push into the personalized healthcare space with the purchase of Flatiron Health in a deal worth $1.9 billion. Flatiron is a healthcare technology and services company focused on accelerating cancer research and improving patient care. They develop oncology-specific electronic health record (EHR) systems, most notably an information exchange platform which allows researchers to access and learn from patient records. The company’s message is that large amounts of data could be used to speed up and, in some cases, replace certain clinical trials where patients are randomly assigned to a specific treatment.
Roche’s chief executive of its pharma division, Dan O’Day said the deal marks an important step in its personalized healthcare strategy for Roche. “We believe that regulatory-grade real-world evidence is a key ingredient to accelerate the development of, and access to, new cancer treatments,” he said. “As a leading technology company in oncology, Flatiron Health is best positioned to provide the technology and data analytics infrastructure needed not only for Roche but for oncology research and development efforts across the entire industry.” Previously, Roche led a Series C funding round for Flatiron in 2016.
In other precision medicine news, during the year Syapse and Roche entered into a multi-year strategic collaboration to help make precision medicine available to more cancer patients. The two companies unveiled plans to work jointly to develop software products and analytics solutions to provide the tools and insights healthcare providers need to practice precision medicine at scale, with the goal of improving patient outcomes. Roche is funding the development of these products, which aim to benefit oncologists, health systems, and stakeholders including payers. Syapse will develop and deploy these new products to the precision medicine ecosystem, beginning with its existing healthcare provider network.
The companies will initially focus on four product programs: real-world evidence, so that physicians can make better care decisions; better understanding the health economics impact and patient outcomes of precision medicine; advancing electronic patient-reported outcomes to understand precision medicine’s effect on health-related quality of life; and accelerating clinical trial enrollment by matching patients to precision trials at the point of care. Roche and Syapse will also collaborate on automated methods for measuring real-world outcomes.
On the collaboration front, during the year Roche teamed up with Confo Therapeutics for the discovery, development and commercialization of novel, small molecule agonists of an undisclosed G-protein coupled receptor (GPCR) for the treatment of neurological and developmental disorders. Roche gains exclusive rights to the compounds resulting from the collaboration and will be responsible for their development, manufacturing and commercialization. The financial terms included an upfront payment, preclinical milestones and research funding to Confo Therapeutics totaling more than $7 million over the first 30 month period with up to $96.3 million in milestone payments.
Roche’s Genentech unit was also very active in research tie-ups. At the very end of 2016 Genentech extended its exclusivity period for the research collaboration and license agreement with Phylogica Ltd. to discover novel antibiotics using Phylogica’s Phylomer drug discovery platform, including its proprietary cell penetrating peptide discovery technology.
At the beginning of 2017 Corvus Pharmaceuticals expanded its clinical collaboration with Genentech for CPI-444 in combination with atezolizumab (Tecentriq) to be evaluated in a Phase Ib/II clinical study as second-line therapy in non-small cell lung cancer (NSCLC). The study will be part of Morpheus, Genentech’s novel cancer immunotherapy platform established to develop immunotherapy combination therapies more rapidly and efficiently. CPI-444, Corvus’ lead product, is a selective and potent inhibitor of the adenosine A2A receptor. Atezolizumab, developed by Genentech, is a monoclonal antibody designed to target and bind to a protein called PD-L1 (programmed death ligand-1).
With Arvinas LLC, a private biotechnology company creating a new class of drugs based on protein degradation, Genentech expanded an existing license agreement for the development of new therapeutics using Arvinas’ Protac technology. The multi-year strategic collaboration initiated in October 2015 will now encompass additional disease targets. The Protac platform removes target proteins directly rather than inhibiting them. This differs from small molecule inhibitors, which often result in toxic side effects and eventual drug resistance. Under the revised terms of the agreement, Arvinas is now eligible to receive development and commercialization milestone payments in excess of $650 million. In addition, they are also able to receive tiered-royalties on sales of products resulting from the license agreement.
Genentech and Biothera Pharmaceuticals entered into a clinical trial collaboration agreement to assess the safety and efficacy of Biothera’s Imprime PGG in combination with Genentech’s atezolizumab, an anti-PD-L1 antibody, and bevacizumab, an anti-VEGF antibody, to treat patients with metastatic colorectal cancer. Genentech will conduct the multicenter trial, which will enroll approximately 40 patients in the initial phase of the study. Under the agreement, researchers will evaluate the potential of Imprime PGG, atezolizumab and bevacizumab to increase overall patient responses.
At the start of 2018, Genentech and Syndax Pharmaceuticals formed a new clinical collaboration to evaluate the combination of Syndax’s entinostat, an oral, small molecule, class I HDAC inhibitor, and Genentech’s programmed cell death ligand 1 (PD-L1) blocking antibody, atezolizumab (Tecentriq), in patients with second-line hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) metastatic breast cancer. The planned Phase Ib/II, open-label, multicenter, randomized trial will enroll patients with metastatic HR+, HER2- breast cancer who have experienced disease progression during or following first-line therapy. Genentech will be responsible for conducting the trial.