Roche’s newer pharmaceutical products are generating stellar performances and have  the company well-positioned for future growth.

 

roche-logo

 

F. Hoffmann-La Roche ltd.

KonzernHauptsitz
Grenzacherstrasse 124
CH-4070 Basel
Switzerland
Telephone: +41-61-688 1111
Website: roche.com

 

Best-Selling Rx Products

Product 2018 Sales 2017 Sales
Herceptin  $7,136 $7,169
Avastin $7,000 $6,836
Rituxan/MabThera $6,901 $7,551
Perjeta $2,834 $2,244
Ocrevus $2,405 $888
Actemra/RoActemra $2,208 $1,969
Xolair $1,954 $1,780
Lucentis $1,696 $1,445
Activase, TNKase $1,312 $1,246
Esbriet $1,054 $888
Kadcyla $1,001 $934
Tecentriq $789 $498
Pulmozyme $755 $746
CellCept $684 $712
Alecensa $651 $370
Tarceva $550 $862
Mircera $544 $516

All sales are in millions of dollars and were translated
using the Federal Reserve Board’s average rate of
exchange in 2018: SFr 0.9784.

 

Financial Performance

  2018 2017
Revenue $58,101 $54,476
Net income $10,732 $8,824
EPS $12.48 $10.26
R&D expense $11,291 $10,621
  1H 2019 1H 2018
Revenue $31,142 $28,732
Net income $8,809 $7,470
EPS $10.21 $8.70
R&D expense $5,684 $5,430

All sales are in millions of dollars, except EPS,
and were translated using the Federal Reserve
Board’s average rate of exchange in 2018:
SFr 0.9784.

 

Outcomes Creativity Index Score: 28
Manny Awards – 7
Cannes Lions – 12
LIA: Health & Wellness – N/A
Clio Health – 9
One Show: HW&P – N/A
MM&M Awards – N/A
Global Awards – N/A
Creative Floor Awards – N/A

 

 

Roche’s newest medical innovations are a significant reason for management’s optimistic outlook on the company’s future. Strength in innovation is reflected in Roche’s financial results. Seven percent sales growth across the entire Roche Group as well as in the company’s Pharmaceuticals Division during 2018 was fueled by key growth drivers Ocrevus (multiple sclerosis), Tecentriq (cancer immunotherapy), Alecensa (lung cancer), Perjeta (breast cancer) and Hemlibra (hemophilia). That momentum carried into 2019, with first-half Group sales improving 9 percent and the Pharmaceuticals business producing a 10 percent upswing. As a result, full-year sales are expected by Roche management to grow in the mid- to high-single digit range, with continuing strong uptake of newly introduced medicines.

“In the first half of the year (2019), we achieved very strong results, driven by high demand for our new medicines. I am very pleased with the expedited approvals health authorities granted for Polivy and Rozlytrek. These medicines represent important treatment options for patients fighting cancer. Based on the performance in the first half of the year, we are increasing the outlook for the full-year 2019,” says CEO Severin Schwan.

Roche executives say the multiple sclerosis medicine Ocrevus represents the most successful product launch in the company’s history. Ocrevus is the first drug ever to be approved for treating the primary progressive form of MS. Worldwide sales increased 172 percent to CHF 2.35 billion ($2.4 billion) for 2018, and the first-half 2019 total rose 63 percent to nearly CHF 1.74 billion ($1.77 billion).

Meanwhile, Roche’s product pipeline of roughly 67 new molecular entities covers a broad array of diseases, with highly innovative technologies being applied to create and produce the active molecules.

“Roche has one of the best product pipelines in the industry. In 2018 alone, we invested CHF 11 billion in its development,” says Chairman Dr Christoph Franz. “We are a leader in oncology, we have a growing number of neuroscience projects and immunology is performing well. Over the last six years, the U.S. Food and Drug Administration granted breakthrough therapy designations to no fewer than 24 of Roche’s active ingredients, six in 2018 alone. This is an achievement we are proud of.”

Roche made a move to expand the company’s impressive pipeline during February. Roche entered into a definitive merger agreement to acquire Spark Therapeutics for $114.50 per share in an all-cash transaction amounting to $4.3 billion on a fully diluted basis. Philadelphia-based Spark Therapeutics is a leader in discovering, developing and delivering gene therapies with one commercial asset and four program undergoing clinical studies. The fully integrated commercial company is dedicated to discovering, developing and delivering gene therapies for genetic diseases, including blindness, hemophilia, lysosomal storage disorders and neurodegenerative diseases.

Spark Therapeutics’ lead clinical asset is SPK-8011, a novel gene therapy for treating hemophilia A, which was expected to begin Phase III development during 2019. Spark additionally has SPK-8016 in a Phase I/II study intended to address the hemophilia A inhibitor population.

Spark Therapeutics was the first company to receive FDA approval for a gene therapy for a genetic disease when Luxturna (voretigene neparvovec-rzyl) was cleared for U.S. marketing during 2017. The one-time gene therapy product is available for treating patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy. The European Commission granted marketing clearance for Luxturna during 2018.

Other Spark Therapeutics pipeline assets include SPK-9001, an investigational gene therapy for the potential treatment of hemophilia B in Phase III, and SPK-7001 for choroideremia in Phase I/II. The company is additionally developing SPK-3006 for Pompe disease and SPK-1001 for CLN2 disease (a form of Batten disease), with both assets anticipated to be ready for clinical development during 2019. Preclinical programs for Huntington’s disease and Stargardt disease are also in the queue for 2019.

According to Roche CEO Severin Schwan, “Spark Therapeutics’ proven expertise in the entire gene therapy value chain may offer important new opportunities for the treatment of serious diseases. In particular, Spark Therapeutics’ hemophilia A program could become a new therapeutic option for people living with this disease. We are also excited to continue the investments in Spark Therapeutics’ broad product portfolio and commitment to Philadelphia as a center of excellence.” Spark Therapeutics will continue business operations in Philadelphia as an independent company within the Roche Group.

The transaction is expected by the leadership teams from both companies to be competed by year-end 2019 after being reviewed by the U.S. Federal Trade Commission and the Competition and Markets Authority in the United Kingdom.

2019 Performance & Outlook

Roche Group sales during the first six months of 2019 increased 9 percent to CHF 30.5 billion ($31.14 billion) and core EPS advanced 13 percent, ahead of sales. According to the company, core operating profit rose 11 percent compared to the January-June 2018 results, reflecting the strong underlying business performance. IFRS net income improved 19 percent year-over-year, due to the strong underlying core results and one-time effects stemming from a remeasurement of deferred tax positions as well as the release of acquisition related provisions.

First-half 2019 sales in the Pharmaceuticals Division increased 10 percent to CHF 24.2 billion ($24.73 billion). Management says key growth drivers were the multiple sclerosis product Ocrevus, the new hemophilia medicine Hemlibra, and the cancer drugs Tecentriq, Perjeta and Avastin. The strong uptake of newly introduced products more than offset lower sales of long-time successes Herceptin and Rituxan/MabThera.

Rituxan won FDA marketing clearance in September 2019 as the first medicine approved for pediatric patients living with GPA and MPA, two potentially life-threatening blood vessel disorders that are rare in children.

U.S. sales increased 14 percent compared to the first six months of 2018, led by Ocrevus, Hemlibra, Tecentriq, Perjeta, and Avastin. Ocrevus sales were propelled by new and returning patient demand.

In Europe (-4 percent), first-half 2019 sales were impacted by competition from biosimilars for Herceptin (-45 percent) and Rituxan/MabThera (-36 percent). This decrease was increasingly offset by the strong growth of Ocrevus, Perjeta, Tecentriq, Alecensa, and Hemlibra.

Sales in Japan for the first half of 2019 grew 9 percent, driven by recently launched products, including Hemlibra, Tecentriq and Perjeta. The growth was partially offset by biosimilar competition for Rituxan/MabThera (-46 percent).

First-half 2019 sales in the International region rose 17 percent, mainly driven by China with strong sales of Herceptin, Avastin, and Rituxan/MabThera as well as launches of Alecensa and Perjeta.

Diagnostics Division sales increased 2 percent year-over-year to CHF 6.3 billion ($6.41 billion). The business area Centralized and Point of Care Solutions (+3 percent) was the main contributor, paced by the growth of the immunodiagnostics business, according to Roche. In regional terms, growth during the 2019 first half was reported in Asia-Pacific (+5 percent) and EMEA (+3 percent). Sales fell in North America (-2 percent) compared to the performance from 2018’s first six months.

Roche reported that core operating profit grew 11 percent in the Pharmaceuticals Division and 4 percent in the Diagnostics Division.

Based on the first-half results, Roche management anticipates that full-year 2019 sales will increase in the mid-to high-single digit range, at constant exchange rates. Core earnings per share are targeted to increase broadly in line with sales, at constant exchange rates. Roche expects to further increase the company’s dividend in Swiss francs.

Product Approvals/Launches and Pipeline Updates During 2019

Rozlytrek (entrectinib) was the recipient of U.S. marketing approval in August for patients with ROS1-positive, metastatic non-small cell lung cancer and NTRK gene fusion-positive solid tumors. Rozlytrek represents the first FDA-approved treatment designed to target both ROS1 and NTRK that also demonstrates response in cancer that has spread to the brain. This approval also marks Roche’s first FDA-approved tumor-agnostic drug.

The oral medicine is indicated for the treatment of adults with ROS1-positive, metastatic NSCLC, as well as for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. The selective tyrosine kinase inhibitor is designed to inhibit the kinase activity of the TRK A/B/C and ROS1 proteins, whose activating fusions drive proliferation in certain cancer. The drug can block ROS1 and NTRK kinase activity and may result in the death of cancer cells with ROS1 or NTRK gene fusions.

Rozlytrek’s first regulatory approval came by way of Japan’s Ministry of Health, Labour and Welfare (MHLW) on June 18 for treating adult and pediatric patients with NTRK fusion-positive, advanced recurrent solid tumors. Previously, the personalized medicine was granted Sakigake designation for accelerated review by the MHLW. Rozlytrek has been granted Priority Medicines (PRIME) designation by the EMA.

Polivy (polatuzumab vedotin-piiq) was granted FDA accelerated approval during June in combination with bendamustine plus Rituxan (rituximab) for people with previously treated aggressive lymphoma. Marketing clearance was based on results from the Phase Ib/II GO29365 study, which demonstrated that the new targeted medicine was able to improve clinical outcomes in people with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) versus the commonly used regimen bendamustine plus Rituxan (BR). GO29365 is the first randomized pivotal clinical study to show higher response rates over BR.

Polivy represents a first-in-class antibody-drug conjugate that specifically targets CD79b, a protein expressed specifically in the majority of B-cells. Polivy binds to CD79b and destroys these B-cells via the delivery of an anti-cancer agent, which is believed to minimize the effects on normal cells.

Developed by Roche using Seattle Genetics’ ADC technology, Polivy is being clinically studied for treating several types of non-Hodgkin lymphoma. The June U.S. approval of the medicine marked the ninth indication with Breakthrough Therapy Designation in Roche’s hematology portfolio to receive FDA marketing clearance.

As this magazine was going to press, Rituxan won FDA approval on Sept. 30 in children 2 years of age and older with two rare blood vessel disorders: granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA). This approval marks the first pediatric indication for Rituxan/MabThera.

U.S. growth of 10 percent during first-half 2019 for Lucentis was driven by sales increases in all of the medicine’s approved indications, including neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy.

Roche’s blockbuster medicine Kadcyla (trastuzumab emtansine) won U.S. marketing approval in May for a new use: for adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment taxane and Herceptin (trastuzumab)-based treatment. FDA approval is based on clinical data from the Phase III KATHERINE trial demonstrating that Kadcyla cut the risk of disease recurring by half compared to Herceptin in the adjuvant setting for specific patients with HER2-positive early breast cancer (eBC). The marketing application was approved in just over 12 weeks under the FDA’s Real-Time Oncology Review pilot program.

The antibody-drug conjugate (ADC) Kadcyla is engineered to deliver potent chemotherapy directly to HER2-positive cancer cells, potentially limiting damage to healthy tissues. The medicine combines two anti-cancer properties joined together by one stable linker: the HER2-targeting properties of trastuzumab (the active ingredient in Herceptin) and the chemotherapy agent DM1. Kadcyla is the first ADC approved as a single agent in 104 countries including the United States and European Union for treating people with HER2-positive metastatic breast cancer who have previously received Herceptin and taxane chemotherapy, separately or in combination. Roche licenses technology for Kadcyla via a business arrangement with ImmunoGen Inc.

In another May FDA approval win for Roche, the U.S. regulatory agency granted marketing clearance to Venclexta (venetoclax) plus Gazyva (obinutuzumab) for the treatment of people with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. Data show that a fixed 12-month treatment consisting of Venclexta in combination with Gazyva significantly reduced the risk of disease progression or death by 67 percent compared to a current standard-of-care, Gazyva plus chlorambucil. The marketing approval for the expanded use of Venclexta offers a new treatment option for more adults with chronic lymphocytic leukemia (CLL).

FDA rapidly reviewed the supplemental New Drug Application (sNDA) for the Venclexta-Gazyva combo under the FDA’s Real-Time Oncology Review (RTOR) and Assessment Aid pilot programs. This marks the second regimen of Roche medicines approved through the RTOR pilot program, which is exploring a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. The sNDA was additionally assigned Priority Review status. The Venclexta-Gazyva combination was previously granted Breakthrough Therapy Designation for the treatment of previously untreated CLL with co-existing medical conditions. Additional filings of the CLL14 data to health authorities around the globe are under way.

The first-in-class targeted medicine Venclexta is designed to selectively bind and inhibit the B-cell lymphoma-2 (BCL-2) protein. In certain blood cancers and other tumors, BCL-2 builds up and prevents cancer cells from dying or self-destructing, a process known as apoptosis. The drug blocks the BCL-2 protein and works to restore the process of apoptosis.

Venclexta is being developed by AbbVie and Roche. The product is jointly commercialized by AbbVie and Roche subsidiary Genentech in the United States. AbbVie is in charge of the product’s commercialization outside the United States under the trade name Venclyxto.

FDA has awarded five Breakthrough Therapy Designations to Venclexto: one for previously untreated CLL, two for relapsed or refractory CLL, and two for previously untreated acute myeloid leukemia.

The engineered monoclonal antibody Gazyva is designed to attach to CD20, a protein found only on certain types of B-cells. The drug is believed to work by attacking targeted cells both directly and in combination with the body’s immune system. In the United States, Gazyva is developed as part of a collaboration between Genentech and Biogen. Combination studies evaluating the product with other approved or investigational medicines, including cancer immunotherapies and small molecule inhibitors, are under way across a range of blood cancers.

Gazyva is available in more than 90 countries in combination with chlorambucil for patients with previously untreated chronic lymphocytic leukemia, in 80-plus countries in combination with bendamustine for people with certain types of previously treated follicular lymphoma, and in more than 70 countries in combination with chemotherapy for previously untreated follicular lymphoma. The product is marketed as Gazyvaro in the EU and Switzerland.

Additional combo studies investigating Gazyva/­Gazyvaro with other approved or investigational medicines, including cancer immunotherapies and small molecule inhibitors, are under way across a range of blood cancers.

FDA issued Breakthrough Therapy Designation for Gazyva in lupus nephritis in September. If cleared for marketing, Gazyva would represent the first FDA-approved medicine for lupus nephritis. The designation is based on the results of the phase II NOBILITY trial that demonstrated Gazyva, in combination with standard of care, helped more people achieve a complete renal response than standard of care alone.

Roche reported longer-term data for Ocrevus (ocrelizumab) from the Phase III open-label extension trials of OPERA I, OPERA II and ORATORIO in September. The clinical studies demonstrated that patients who were treated with the medicine continuously for six years or more had reduced risk of disability progression in relapsing MS (RMS) and primary progressive MS (PPMS). These study results suggest earlier treatment with Ocrevus reduced the risk of disability progression and this effect was sustained over time, according to Roche. In addition, new safety data as of January were announced representing 4,611 patients with RMS and PPMS and 14,329 patient years of exposure to Ocrevus across all of the product’s clinical trials, and remain consistent with the drug’s favorable benefit-risk profile.

More than 120,000 people have been treated with Ocrevus around the world in clinical trial and real-world settings. Ocrevus represents the first therapy approved for both RMS (including relapsing-remitting MS (RRMS) and active, or relapsing, secondary progressive MS, in addition to clinically isolated syndrome in the U.S.) and PPMS. The product is administered every six months. Ocrevus has been cleared for marketing in at least 89 countries across North America, South America, the Middle East, and Eastern Europe, as well as in Australia, Switzerland and the European Union.

New Ocrevus biomarker data that increase understanding of disease progression in multiple sclerosis were presented during September by Roche at ECTRIMS. Results showed that blood neurofilament light chain (NfL) levels were significantly lowered following Ocrevus treatment in analyses of Phase III trials in RMS and PPMS. New data demonstrate that NfL may be a biomarker for predicting future disability outcomes. Separate analyses were presented from one of the first clinical studies that show NfL levels are correlated with active MRI lesions in PPMS.

The Phase III FeDeriCa study for the fixed-dose subcutaneous combination of Perjeta and Herceptin met the primary endpoint, as reported by Roche in September. The clinical trial demonstrated a new investigational fixed-dose combo of Perjeta (pertuzumab) and Herceptin (trastuzumab), administered by subcutaneous (SC) injection in combination with intravenous (IV) chemotherapy, showed non-inferior levels of Perjeta in the blood (pharmacokinetics) compared to standard IV infusion of Perjeta plus Herceptin and chemotherapy in people with HER2-positive early breast cancer (eBC). According to the results, the safety profile of the FDC of Perjeta and Herceptin was consistent with that of Perjeta and Herceptin administered intravenously. The clinical data from this study will be submitted to health authorities globally, including the U.S. FDA and European Medicines Agency.

The Perjeta-Herceptin FDC represents a new SC formulation using Halozyme Therapeutics’ Enhanze drug delivery technology, which may enable and optimize SC drug delivery for appropriate co-administered therapeutics. Roche says the technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that temporarily degrades hyaluronan – a glycosaminoglycan or chain of natural sugars in the body, to aid in the dispersion and absorption of other injected therapeutic drugs.

The mechanisms of action of Perjeta and Herceptin are thought to complement each other as each drug binds to the HER2 receptor, but to different places. The product combo is believed to provide a more comprehensive, dual blockade of the HER signaling pathways.

The standard IV formulation of Perjeta in combination with IV Herceptin and chemotherapy (the Perjeta-based regimen) is available in more than 100 countries for treating early and metastatic HER2-positive breast cancer. In the neoadjuvant eBC setting, the Perjeta-based regimen has been shown to almost double the rate of pCR versus Herceptin and chemo. The combination has been demonstrated to significantly reduce the risk of recurrence of invasive disease or death in the adjuvant eBC setting. In the metastatic setting, the drug combo has shown an unprecedented survival benefit in previously untreated (first-line) patients with HER2-positive metastatic breast cancer.

Roche’s satralizumab significantly reduced relapse risk in a second positive Phase III trial for neuromyelitis optica spectrum (NMOSD), according to the company in September. The pivotal Phase III SAkuraStar trial demonstrated a 55 percent reduction in the risk of relapse for satralizumab monotherapy compared to placebo. In the large (~67 percent) subgroup of patients seropositive for AQP4-IgG antibodies, the effect was higher with a 74 percent reduction in the risk of relapse. Satralizumab showed a similar safety profile versus placebo in two Phase III trials across a broad population.

The investigational humanized monoclonal antibody satralizumab targets the interleukin-6 (IL-6) receptor, a key driver of NMOSD, triggering the inflammation cascade and resulting in damage and disability. Roche says positive Phase III results for satralizumab, as both monotherapy and in combination with baseline therapy, suggest that IL-6 inhibition may be an effective therapeutic approach for NMOSD. The Phase III clinical development program for satralizumab includes the SAkuraStar and SAkuraSky studies. SAkuraSky is assessing the efficacy and safety of satralizumab added to baseline immunosuppressant therapy in patients with NMOSD.

The European Commission on Sept. 6 approved Tecentriq (atezolizumab) in combination with chemotherapy for the initial treatment of people with extensive-stage small cell lung cancer. Tecentriq in combination with chemotherapy (carboplatin and etoposide) represents the first cancer immunotherapy approved by the European Medicines Agency for the initial treatment of extensive-stage small cell lung cancer (ES-SCLC). The combination drug significantly improved overall survival (OS) and progression-free survival (PFS) for the first time in more than 20 years.

Additionally on Sept. 6, the EC gave a green light to another Tecentriq-based combination therapy as an initial treatment for the most common form of advanced lung cancer. The marketing authorization of the new combination containing atezolizumab with chemotherapy (carboplatin and Abraxane) expands the treatment options for people across Europe affected by non-squamous non-small cell lung cancer. The approval decision is based on data demonstrating that the Tecentriq plus chemotherapy combination showed a significant OS and PFS benefit.

During late August, the European Commission granted approval for Tecentriq in combination with Abraxane for individuals with PD-L1-positive, metastatic triple-negative breast cancer. This is the first cancer immunotherapy regimen to be launched in Europe for triple-negative breast cancer – an aggressive and difficult-to-treat disease. In conjunction with that approval, Roche launched the VENTANA PD-L1 (SP142) Assay in CE markets as the first companion diagnostic to identify triple-negative breast cancer patients eligible for treatment with Tecentriq plus chemotherapy (nab-paclitaxel). FDA granted approval of the assay during March 2019.

According to results from a Phase III study reported in August, Tecentriq in combination with platinum-based chemotherapy reduced the risk of disease worsening or death in people with previously untreated advanced bladder cancer. IMvigor130 is the first positive Phase III trial of a cancer immunotherapy combination in previously untreated advanced bladder cancer.

Roche unveiled positive data during September from the Phase III IMpower110 trial studying Tecentriq as a first-line (initial) monotherapy compared with cisplatin or carboplatin and pemetrexed or gemcitabine (chemotherapy) in advanced non-squamous and squamous non-small cell lung cancer (NSCLC) without ALK or EGFR mutations (Wild-Type or WT). The clinical trial met the primary endpoint in an interim analysis showing that Tecentriq monotherapy demonstrated a statistically significant OS benefit in people with high PD-L1 expression (TC3/IC3-WT), versus chemotherapy alone. Safety for Tecentriq appeared to be consistent with the medicine’s known safety profile and no new safety signals were identified. Roche says the clinical trial will continue to final analysis for patients with lower levels of PD-L1 expression. Roche will file these data to global health authorities, including the FDA and EMA.

As of September, Roche had nine Phase III lung cancer trials under way testing Tecentriq as a monotherapy or combined with other medicines across different types of lung cancer. The company has an extensive development program for Tecentriq, including multiple continuing and planned Phase III studies, across lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers. The program includes studies assessing Tecentriq alone and in combination with other drugs.

The monoclonal antibody Tecentriq is designed to bind with a protein called PD-L1, which is expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with PD-1 and B7.1 receptors. By inhibiting PD-L1, the medicine may enable the activation of T cells. The cancer immunotherapy (CIT) Tecentriq has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a wide range of cancers. The development of Tecentriq and the product’s clinical program is based on Roche’s greater understanding of how the immune system interacts with tumors and how harnessing a person’s immune system fights cancer more effectively.

Tecentriq is marketed in the United States, EU, and other countries either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer, and in PD-L1-positive metastatic triple-negative breast cancer.

In other promising news for Roche, positive Phase III results were reported in September demonstrating Xofluza reduces the risk of developing flu after contact with an infected person by 86 percent. The BLOCKSTONE clinical trial reached the primary endpoint of fewer people testing positive for flu, with fever and at least one respiratory symptom, when treated with Xofluza versus placebo. Xofluza potentially represents a significant and convenient treatment for reducing the burden of seasonal flu and limiting the impact of a pandemic.

The first-in-class, one-dose oral medicine Xofluza with a novel proposed mechanism of action has shown efficacy in a wide range of influenza viruses, including in vitro activity against oseltamivir-resistant strains and avian strains (H7N9, H5N1) in non-clinical studies. Unlike other available antiviral treatments, Xofluza represents the first in a new class of antivirals designed to inhibit the CAP-dependent endonuclease protein, which is essential for viral replication.

Xofluza is available in several countries, including the United States, for treating acute, uncomplicated influenza in people 12 years of age and older. A supplemental New Drug Application (sNDA) for Xofluza as a one-dose oral treatment for individuals at high risk of complications from flu is under U.S. regulatory review with a decision anticipated by Nov. 4, 2019.
The influenza product is being further evaluated in a Phase III development program, including children under the age of 1 (NCT03653364); severely ill, hospitalized patients (NCT03684044); and to assess the potential to reduce transmission of flu from an infected person to healthy people (NCT03969212).

Xofluza was discovered by Shionogi & Co. Ltd. and is being further developed and commercialized around the world in collaboration with the Roche Group. Roche holds global rights to Xofluza excluding Japan and Taiwan, where rights are exclusively retained by Shionogi.

Diagnostics

Roche and GE Healthcare launched their first collaboration product in May. NAVIFY Tumor Board 2.0 enables tumor boards to have a more comprehensive view of each patient in one place. The product’s medical imaging capabilities enable more personalized treatment decisions in cancer care, and radiologists can now upload patient records to the same dashboard as patient files from other disciplines. This market introduction represents a significant step in Roche’s personalized healthcare strategy to fit treatments to patients who can benefit most from a specific therapy.

Roche’s first whole blood test for donor screening, cobas Babesia, received FDA marketing clearance in September. Approval was granted for the cobas Babesia test for use on the cobas 6800/8800 Systems for individual blood donation testing. The marketing clearance follows May 2019 FDA-updated industry guidance recommending screening and testing for Babesia, to reduce the risk of transmitting the parasite through transfusions.

Roche also won FDA clearance during September for cobas pro integrated solutions, designed to help laboratories deliver faster results to patients. Roche Diagnostics’ cobas pro integrated solutions – a new generation of Serum Work Area (clinical chemistry and immunochemistry) laboratory solution – improves productivity in the lab and enhances reliability and turnaround times in delivering patient results. By simplifying operations in the laboratory, Roche is in turn helping physicians provide evidence-based diagnostic and treatment decisions more cost effectively and quickly for every patient.