Year Established: 1896
Total Revenues: $48,578 (+1%)
Pharma Revenues: $37,667 (+2%)
Net Income: $9,137 (-5%)
R&D: $9,667 (-7%)
TOP SELLING DRUGS
|Activase/TNKase||acute myocardial infarction||$943||25%|
In Roche’s pharmaceuticals division sales rose 5% to $37.6 billion driven by the oncology portfolio (+8%), led by the HER2 medicines and Avastin. Sales of the immunology franchise grew by 24%, driven by the strong uptake of Esbriet, a new medicine for idiopathic pulmonary fibrosis, as well as higher sales of Actemra/RoActemra and Xolair. Sales of Pegasys declined due to competition from a new generation of treatments, while Valcyte/Cymevene and Xeloda faced generic competition as expected.
All regions contributed to the sales growth, with particularly strong performance in the U.S. (+6%) and in Europe (+4%), which was driven by strong demand for the HER2 medicines along with the strong uptake of Esbriet. Growth in the International region (+5%) was driven by key markets including Brazil (+10%) and China (+4%). In Japan, sales grew by 6%, driven by Avastin, the HER2 franchise and the new lung cancer medicine Alecensa.
Roche made positive pipeline progress in 2015. For its investigational medicine ocrelizumab, Roche announced strong data in both relapsing and primary progressive forms of multiple sclerosis. In addition, the company presented promising results for its lead investigational cancer immunotherapy medicine atezolizumab in bladder and lung cancer. Roche also received EU and U.S. approval for Cotellic plus Zelboraf to treat metastatic melanoma, and U.S. approval for the cancer medicine Alecensa for a specific form of lung cancer.
Towards the end of 2015 Roche announced plans to restructure its small molecule manufacturing network, prompting it to close four sites, affecting 1,200 positions. The affected sites are in Clarecastle, Ireland; Leganes, Spain; Segrate, Italy; and Florence, U.S. The company said the closures were necessary to address current underutilization as a result of its evolving portfolio and to support the manufacture of a new generation of specialized small molecule medicines—produced in lower volumes than traditional medicines. For this effort Roche is investing 300 million Swiss francs in a dedicated facility in Kaiseraugst, Switzerland to provide future technology requirements. The transition began in 2016 and is planned to end by 2021. Restructuring costs are estimated to be CHF 1.6 billion until 2021, of which as much as CHF 600 million will be in cash.
Bolstering its portfolio
Early in 2015 Roche expanded its portfolio in neuromuscular disease when it acquired Trophos, a privately held biotechnology company based in Marseille, France. Trophos’s proprietary screening platform generated olesoxime (TRO19622), which is being developed for SMA, a rare and debilitating genetic neuromuscular disease that is most commonly diagnosed in children. Results from a pivotal Phase II clinical trial with olesoxime in SMA showed a beneficial effect on the maintenance of neuromuscular function in individuals with Type II and non-ambulatory Type III SMA, as well as a reduction in medical complications associated with the disease. U.S. and EU regulatory authorities have granted orphan drug designation to olesoxime. The acquisition highlights Roche’s commitment to developing medicines for spinal muscular atrophy, a serious disease with no effective treatment.
Roche acquired Kapa Biosystems to strengthen its next-generation sequencing product offerings. Kapa is a provider of genomic tools in the life sciences sector that employs proprietary technologies to optimize enzymes for next-generation sequencing (NGS), as well as polymerase chain reaction (PCR) and real-time PCR applications. The company’s proprietary protein engineering technology is highly customizable and allows for the generation and screening of large numbers of enzyme variants. Tailored enzymes with improved performance for specific applications can be rapidly selected, expediting product development timelines. Kapa’s portfolio of NGS reagents includes enzymes such as novel DNA polymerases, with the potential to improve the performance of the entire sequencing workflow.
Key approvals and breakthroughs
In 2015, the FDA and the European Commission approved Cotellic in combination with Zelboraf for the treatment of people with BRAF mutation-positive metastatic melanoma. Updated pivotal data showed that the combination helped people to live significantly longer, with a median of two years, compared to Zelboraf alone.
The FDA also approved Alecensa for people with advanced ALK-positive NSCLC whose disease had progressed following treatment with crizotinib. This is the second approval for this medicine, which was created by Chugai, a member of the Roche Group, and approved in Japan in 2014.
Roche was granted FDA breakthrough therapy designation to ACE910 (RG6013, RO5534262) for the prophylactic treatment of people who are 12 years or older with haemophilia A with factor VIII inhibitors. In a Phase I study, ACE910 showed promising results as a prophylactic treatment administered as a weekly subcutaneous injection in people with severe haemophilia A with and without inhibitors to factor VIII.
Roche also received breakthrough status for Actemra/Actemra in systemic sclerosis. According to the company, Actemra/Actemra monotherapy and combination treatment regimens almost double sustained remission rates in people with early rheumatoid arthritis. In addition, five-year sustained efficacy of Actemra/Actemra was demonstrated in children with systemic juvenile idiopathic arthritis. Roche has initiated a global Phase III clinical trial initiated in systemic sclerosis, a potentially fatal disease with limited treatment options.
FDA also granted breakthrough therapy designation for Roche’s investigational cancer immunotherapy MPDL3280A (anti-PDL1) in non-small cell lung cancer. The designation was granted for the treatment of people with PD-L1-positive (Programmed Death-Ligand 1) non-small cell lung cancer (NSCLC) whose disease has progressed during or after platinum-based chemotherapy (and appropriate targeted therapy for those with an EGFR mutation-positive or ALK-positive tumor). This is the second FDA Breakthrough Therapy Designation for MPDL3280A following bladder cancer in 2014.
Clinical trial alliances
During the year, Roche and Celldex Therapeutics entered into a clinical trial collaboration to evaluate the safety, tolerability and preliminary efficacy of varlilumab, Celldex’s CD27 targeting investigational antibody, and MPDL3280A (anti-PDL1), Roche’s investigational cancer immunotherapy in a Phase 1/2 study in renal cell carcinoma.
Varlilumab and MPDL3280A are part of a new class of investigational medicines known as cancer immunotherapies that are designed to harness the body’s own immune system to fight cancer through separate yet complementary mechanisms of action that may enable the activation of T cells, restoring their ability to effectively detect and attack tumor cells. Preclinical data suggest the combination of these two mechanisms are synergistic and may enhance anti-tumor immune response compared to either agent alone.
In an immunotherapy alliance, Roche teamed up with Amgen to evaluate investigational candidates in cancer patients. The Phase Ib study the two firms are collaborating on is to evaluate the safety and efficacy of talimogene laherparepvec, Amgen’s investigational oncolytic immunotherapy, in combination with Roche’s investigational anti-PDL1 therapy, atezolizumab (also known as MPDL3280A), in patients with triple-negative breast cancer and colorectal cancer with liver metastases.
Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to selectively replicate in tumors (but not normal tissue) and to initiate an immune response to target cancer cells. Atezolizumab is an investigational monoclonal antibody designed to interfere with the PD-L1 protein.
The combination trial aims to activate an anti-tumor immune response with talimogene laherparepvec and to block inhibitory T cell checkpoints with atezolizumab, to potentially increase the anti-tumor activity relative to each agent alone.
Roche and Upsher-Smith Laboratories, through its wholly-owned UK subsidiary Proximagen, formed an agreement for the further development of a novel, oral small molecule inhibitor of Vascular Adhesion Protein 1 (VAP-1), a cell-adhesion molecule that may be effective in the treatment of inflammatory diseases. The VAP-1 inhibitor is currently in Phase II clinical development. Roche is granted a worldwide exclusive license to develop and commercialize the compound. In a novel collaboration model, Roche and Proximagen will conduct additional Phase II studies to further define the therapeutic potential of the VAP-1 inhibitor. Based on these data Roche will assume responsibility for late stage development and worldwide commercialization. Proximagen will receive an upfront payment, along with downstream development, regulatory and sales milestones. In addition, Proximagen will also receive tiered royalties on net sales of a potential future product containing the molecule.
On the research front, Roche entered a collaboration with Catalent, through its subsidiary Redwood Bioscience, to develop next-generation molecules coupling different therapeutic modalities using Catalent’s proprietary SmartTag 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 upfront 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.
In another alliance, Roche, Meiji Seika Pharma and Fedora formed a license agreement for the development and commercialization of OP0595, a beta-lactamase inhibitor in Phase I clinical development. Under the agreement, Roche obtains worldwide rights from both companies for development and commercialization with the exception of Japan, where Meiji will retain sole commercialization rights. Beta-lactamase inhibitors restore or potentiate the activity of beta-lactam antibiotics. The combination of OP0595 with a beta-lactam antibiotic targets severe infections caused by Enterobacteriaceae, including multi-drug-resistant strains. Roche entered the deal because it said there is an urgent need for new antibiotics able to combat the increasing resistance to antibiotics that is being seen worldwide. CP
Collaboration focuses on molecular information in oncology
In January 2015 Roche and Foundation Medicine, Inc. (FMI) entered a broad strategic collaboration to further advance FMI’s market-leading position in molecular information and genomic analysis while providing Roche the opportunity to optimize the identification and development of novel treatment options for cancer patients.
According to the companies, the emerging field of molecular information and genomic analysis will play an increasingly important role for future medicines and diagnostic solutions, in particular for cancer patients. FMI supports physicians by providing comprehensive molecular information to characterize a tumor that is being matched with approved targeted therapy options and novel treatments under development. Understanding the comprehensive genomic profile of a cancer patient’s disease will enable better personalized healthcare solutions to optimize treatment outcomes for patients.
Under the terms of the R&D collaboration agreement, Roche is committing to R&D funding of potentially more than $150 million for a minimum of five years and will contribute its expertise and breadth in oncology. FMI will continue to operate independently and will contribute its experience in the development of comprehensive genomic profiling tests for oncology. The initial focus of the R&D collaboration will be on developing genomic profile tests for cancer immunotherapies and for continuous blood-based monitoring.
Roche will be able to utilize FMI’s proprietary molecular information platform to standardize clinical trial testing. This aspect of the relationship is designed to enable comparability of clinical trial results for R&D purposes, and ultimately in the clinic.