Roche: Seeking Sustained Success

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Successful R&D of new tests and medicines and improving access to the company’s medical solutions are key to the sustainable development of Roche’s business.

 

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 2015 Sales 2014 Sales
Rituxan/MabThera $7,317    $7,167
Avastin $6,942    $6,665
Herceptin $6,791    $6,517
Lucentis $1,579    $1,767
Perjeta $1,501    $953
Actemra/RoActemra $1,487    $1,271
Xolair $1,326    $1,013
Tarceva $1,227    $1,342
Activase, TNKase $971  $776
CellCept $815    $842
Kadcyla     $799    $557
Tamiflu $732    $996
Pulmozyme $677    $620
Esbriet   $585    $46
Pegasys $559    $1,054
Xeloda $533    $806

All sales are in millions of dollars and were translated using the Federal Reserve Board’s average rate of exchange in 2015: SFr 0.9628.

 

 

Financial Performance

  2015 2014
Revenue $50,005    $49,296
Net income $9,406     $9,903
EPS $10.68    $11.23
R&D expense $9,693    $9,257
  1H16 1H15
Revenue $25,989    $24,496
Net income $5,678    $5,452
EPS $6.48    $6.21
R&D expense $5,502     $4,667

All sales are in millions of dollars and were translated using the Federal Reserve Board’s average rate of exchange in 2015: SFr 0.9628.

 

 

Sales for Roche during 2015 grew strongly across the company’s two divisions, Pharmaceuticals and Diagnostics, and that performance continued during the first six months of 2016. Pharmaceuticals growth is being led by oncology and immunology product sales.

As part of the company’s strategic concentration on long-term success, Roche is conducting research in areas where probability of success is not particularly high but the medical need is all the greater. Management wants to drive the progress in medical options available to patients with neurological diseases. In this endeavour, Roche has been producing strong results from investigating multiple sclerosis treatment via the promising pipeline asset Ocrevus (ocrelizumab).

In oncology, Roche has made important advances with its cancer immunotherapy portfolio, obtaining positive outcomes for bladder and lung cancer in pivotal studies of the company’s lead candidate Tecentriq (atezolizumab). Management says it is really encouraged by the improved, sustained outcomes seen in cancer patients and Roche is investing strongly in this promising treatment approach. The company is studying more than 20 investigational cancer immunotherapy medicines, nine of which are in clinical studies.

Through the 2014 acquisition of InterMune, Roche is experiencing very good growth from Esbriet – a treatment for the fatal condition of idiopathic pulmonary fibrosis. One of the 2015 highlights was the approval of Cotellic in combination with Zelboraf for treating advanced melanoma in the United States and Europe. Roche won five major approvals and four FDA breakthrough therapy designations for its medicines during 2015. According to management, this is testament to the high level of innovation Roche is achieving in its R&D activities, which, with Genentech, Chugai and various external alliances, reflect a broad range of approaches and ideas. US based-Genentech is a wholly owned member of the Roche Group, and Roche is the majority shareholder in Chugai of Japan.

In the Diagnostics Division, Roche says the launch of new cobas instruments marks the achievement of a milestone in automated, integrated lab diagnostics. These new systems allow for substantially higher test throughput and greater flexibility. Roche is additionally facilitating and improving lab work in tissue sample staining, which is central to the study and correct diagnosis of cancer.

Roche is the world’s largest biotech company with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and CNS diseases. Roche is additionally the global leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Company leaders say the combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalized healthcare.

Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, including life-saving antibiotics, antimalarials and cancer medicines. The company has been recognized as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry eight consecutive years by the Dow Jones Sustainability Indices (DJSI). In the most recent report, Roche performed particularly well across various categories and DJSI noted that Roche has maintained its leadership in the pharmaceuticals sector via the company’s excellent sustainability strategy, which is fully embedded in its business and culture.

 

2016 Performance & Outlook

Roche reported continued growth during the first six months of 2016, with a strong performance from both of the company’s divisions. In the first half of the year, Group sales increased 4.8 percent at constant exchange rates to CHF 25.02 billion ($25.99 billion). Core EPS rose 5.2 percent at constant exchange rates, slightly faster than sales. According to the company, core EPS growth reflects the good underlying business performance, investments into the launch of new products and the product pipeline, the one-off accounting impact of changes to the Group’s Swiss pension plans, as well as an early bond redemption.

IFRS net income for the first six months of 2016 increased 3 percent at constant exchange rates and 4 percent in Swiss francs to CHF 5.47 billion ($5.68 billion). The positive currency effect was propelled by the weakening of the Swiss franc against the US dollar, the yen and the euro, partially offset by a strengthening of Latin American currencies.

Sales in the Pharmaceuticals Division improved 4 percent to CHF 19.46 billion ($20.21 billion) compared to first-half 2015, driven by demand for oncology and immunology medicines. US sales grew 4 percent to CHF 9.27 billion ($9.63 billion), led by the immunology treatments Xolair and Esbriet, as well as Herceptin and Perjeta against HER2-positive breast cancer. There was high demand for Alecensa, which was recently introduced in the United States for a specific type of lung cancer. First-half 2016 sales of Lucentis and Tarceva decreased due to the continued impact of competition. In Europe (+5%), Perjeta, Rituxan/MabThera and Actemra/RoActemra generated strong sales growth, particularly in Germany and France. In the International region, 4 percent growth to CHF 3.79 billion ($3.94 billion) was spurred by HER2 medicines Avastin and Rituxan/MabThera. The first-half 2016 International growth was partly offset by lower Pegasys sales due to competition from a new generation of hepatitis C treatments. In Japan, sales advanced 2 percent to CHF 1.76 billion ($1.82 billion), driven by HER2 medicines Alecensa and Actemra/RoActemra.

Sales in the Diagnostics Division during the first six months of 2016 improved 6 percent to CHF 5.56 billion ($5.78 billion). All regions contributed to this growth, especially Asia-Pacific (+17%). Professional and Tissue Diagnostics grew strongly compared to the first-half 2015 results. Diabetes Care sales of CHF 998 million ($1.04 billion) were impacted by continued challenging market conditions, particularly in North America.

Among pipeline and regulatory highlights in first-half 2016, Ocrevus was submitted for US and EU approval for relapsing and primary progressive forms of multiple sclerosis. FDA granted priority review, with an action date of Dec. 28, 2016. Additionally, the cancer immunotherapy medicine Tecentriq received accelerated FDA approval for bladder cancer. Also in the 2016 first half, the cobas e801 immunodiagnostic module was launched for high-volume testing.

Based on first-half results, Roche continues to expect full-year 2016 sales to grow in low- to mid-single digits at constant exchange rates. Core earnings per share for the full year are targeted to grow ahead of sales at constant exchange rates. Roche anticipates further increasing its dividend in Swiss francs.

In the Pharmaceuticals Division for first-half 2016, the HER2-positive breast cancer medicines Herceptin, Perjeta and Kadcyla combined for 10 percent growth. Herceptin is also available for HER2-positive metastatic gastric cancer. Herceptin sales improved 5 percent to CHF 3.43 billion ($3.57 billion), driven by a rising demand in the United States due to longer duration of treatment in combination with Perjeta and in China following improved access. Perjeta growth of 34 percent amounted to CHF 906 million ($941 million) during the 2016 first half, with a strong performance in Europe and the United States driven mainly by uptake in the neoadjuvant setting and continued strong growth in the metastatic setting. Sales of Kadcyla grew 11 percent year-over-year to CHF 408 million ($424 million), mainly because of increasing demand in the International region and in Europe. Kadcyla is approved as a single agent in 80-plus countries for the second-line treatment of HER2-positive metastatic breast cancer.

Rituxan/MabThera, for common forms of blood cancer, rheumatoid arthritis and certain types of vasculitis, generated first-half 2016 sales growth of 4 percent to CHF 3.7 billion ($3.85 billion). Sales continued to grow, despite competitive pressure, with increasing demand in the US, Europe and the International region. The use of the subcutaneous formulation of Rituxan/MabThera has been expanding globally, with a recent launch in Brazil.

Avastin sales during the first six months of 2016 reached CHF 3.43 billion ($3.56 billion) via 4 percent growth. The medicine is indicated for advanced colorectal, breast, lung, kidney, cervical and ovarian cancer, and relapsed glioblastoma (a type of brain tumor). Sales during the 2016 first half were driven by the International region (+22%), especially China, where sales rose following improved access in the lung cancer setting. In Europe, Avastin sales climbed up 3 percent year-over-year due to growing use in breast and colorectal cancer, especially in Germany. Sales in the United States, where Avastin already is broadly used in its approved indications, fell 1 percent versus the first-half 2015 performance. In Japan, sales advanced 2 percent, with rising growth in all approved indications outweighing the impact of bi-annual government-mandated price cuts that took effect in April.

First-half 2016 sales for Gazyva/Gazyvaro were up 42 percent to CHF 91 million ($95 million), which is marketed for treating chronic lymphocytic leukemia (CLL) and follicular lymphoma. Strong growth was generated in the United States and Europe despite growing competition in CLL. Gazyva/Gazyvaro is now cleared for marketing for CLL in 70-plus countries. In addition to FDA approval in February, in June this medicine was given the green light in Europe for individuals with previously treated follicular lymphoma. The initial US uptake for this indication has been encouraging, according to Roche.

Actemra/RoActemra, for rheumatoid arthritis and forms of juvenile idiopathic arthritis, was Roche’s fifth-best selling pharmaceutical product in first-half 2016 with sales up 17 percent to CHF 814 million ($845 million). Growing use of Actemra/RoActemra as a single agent, and of the subcutaneous formulation, remained key growth drivers in the United States and Europe.

Sales for the idiopathic pulmonary fibrosis medicine Esbriet grew 51 percent to CHF 358 million ($372 million) during the first six months of 2016. Roche managers say this product experienced continued good market uptake. Sales totaled CHF 261 million ($271 million) in the United States and CHF 86 million ($89 million) in Europe.

All newly launched medicines also demonstrated good sales performance in the 2016 first half, according to management. In December 2015, Alecensa received FDA approval for treating people with ALK-positive advanced non-small cell lung cancer whose disease has progressed on, or who are intolerant to crizotinib. The product has had strong uptake in the United States, driven by use in the second-line and third-line treatment settings. In Japan, where Alecensa was introduced to the marketplace during 2014 for unresectable, recurrent or advanced ALK-positive NSCLC, sales continued to grow strongly. Also late in 2015, Roche gained US and EU approvals for Cotellic in combination with Zelboraf to treat metastatic melanoma. Roche reported that Cotellic had a good start, especially in France, Germany and the United States. Following FDA accelerated approval of Tecentriq in locally advanced or metastatic urothelial carcinoma during May, the initial market uptake has been very good per Roche reports.

During first-half 2016, Professional Diagnostics (+9%) was the largest contributor to the Diagnostics Division’s sales performance with CHF 3.23 billion ($3.36 billion). The performance was led by the Asia-Pacific region, with continued strong growth in China (+25%). The immunodiagnostics business produced strong growth (+14%) and sales of the clinical chemistry business rose 6 percent compared to the first six months of 2015.

The CoaguChek INRange was launched during May in countries accepting the CE Mark. CoaguChek INRange is the first Bluetooth enabled PT/INR2 home health device that helps patients and their healthcare providers have greater control over their coagulation status and the ability to monitor Vitamin K Antagonist therapy.

The cobas e801 module was launched during June in markets accepting the CE Mark. The high-volume immunochemistry analyzer offers laboratories a significant gain in productivity and efficiency.

In Molecular Diagnostics, first-half 2016 sales rose 8 percent to CHF 903 million ($938 million), led by the Asia-Pacific region. The primary growth contributors were the sequencing and molecular businesses. Molecular business growth was led by virology (+12%), including the diagnosis and monitoring of hepatitis and HIV viral load as well as HPV screening (+16%).

A new collaboration was announced in April to increase access to testing and treatment for people infected with the hepatitis C virus in six low-income and middle-income countries. Additional members of the collaboration include the Clinton Health Access Initiative Inc. in the United States and Ministries of Health in Ethiopia, Indonesia, Myanmar, Nigeria, Rwanda and Vietnam.

The US regulatory agency during June approved the cobas EGFR Mutation Test v2 as a companion diagnostic for Tarceva in non-small cell lung cancer. This test is the first FDA-approved assay for a liquid biopsy indication, and can use plasma and tumor tissue for detection of the epidermal growth factor receptor gene.

Additionally in June, the availability of the LightMix Modular Zika Virus Assay in markets accepting the CE Mark was announced. The diagnostic test can be used on the LightCycler 480 system to analyze blood samples from individuals with signs and symptoms of Zika virus infection. This follows an FDA announcement in March enabling the use of an investigational Roche test to screen blood donations for the Zika virus.

Tissue Diagnostics sales in the 2016 first half grew 12 percent to CHF 428 million ($445 million), driven by sales in North America. Sales in the advanced staining portfolio rose 9 percent and sales in primary staining jumped up 16 percent. The strong increase in primary staining was driven by the new, fully automated Ventana HE 600 system for hematoxylin and eosin tissue staining, introduced during late 2015. Revenue from external personalized healthcare partnerships demonstrated continued strong growth (+29%).

The US FDA during May approved the Ventana PD-L1 (SP142) test as a complementary diagnostic for Tecentriq treatment. This test measures amounts of PD-L1 expression in patients with bladder cancer.

Diabetes Care sales decreased 4 percent compared to first-half 2015, predominantly due to continued price pressure in the United States. Improved sales were recorded in Latin America, while EMEA and Asia-Pacific regional sales were down during the 2016 first half.

 

Product Approvals/Launches & Pipeline Updates In 2016

Roche invested an industry-leading CHF 9.33 billion ($9.69 billion) in research and development during 2015. R&D expenditure increased during first-half 2016 by 18 percent year-over-year to CHF 5.3 billion ($5.5 billion). During the 2016 first half, the oncology franchise remained the primary R&D area, notably in cancer immunotherapy. In late-stage development, growth in expenditure was mainly for the oncology and CNS fields. Early-stage R&D spending grew in areas related to immunology and inflammation. As a percentage of sales, R&D core costs rose to 11.7 percent from 10.3 percent in 2015.

Roche revealed during September that Phase III efficacy results of the investigational medicine Ocrevus were reinforced by exploratory analyses in two forms of multiple sclerosis. The investigational, humanized monoclonal antibody increased disease control in patients with relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) in separate post-hoc analyses. In the analyses, two composite endpoints measured disease control using clinical and MRI outcomes: No Evidence of Disease Activity (NEDA) in patients with RMS and No Evidence of Progression (NEP) in patients with PPMS. Both of these composite endpoints are emerging as new treatment targets.

Ocrevus is designed to selectively target CD20-positive B cells, a specific type of immune cell believed to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. This nerve cell damage can result in disability in people with MS. Based on preclinical studies, OCREVUS binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, and therefore significant functions of the immune system may be preserved.

Ocrevus is the first investigational medicine to significantly reduce disability progression in individuals with relapsing and primary progressive forms of MS. The US Food and Drug Administration and European Medicines Agency have accepted marketing applications for Ocrevus, each filed for RMS and PPMS, as announced in June by Roche. If approved by the EMA and FDA for both indications, Ocrevus would be the first treatment for both forms of multiple sclerosis, which affect 95 percent of people at diagnosis.

In other late-stage news announced during September, Roche reported positive results for Tecentriq from the Phase III study, OAK. The clinical trial met its co-primary endpoints and demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) compared with docetaxel chemotherapy in people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease progressed on or after treatment with platinum-based chemotherapy.

U.S. regulators have granted Breakthrough Therapy Designation (BTD) for Tecentriq for treating people with PD-L1 (programmed death-ligand 1) positive 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). Roche’s Biologics Licence Application for NSCLC was granted Priority Review with an FDA action date of Oct. 19, 2016.

Roche is conducting eight Phase III lung trials evaluating Tecentriq alone or in combination with other treatments in patients with early and advanced stages of lung cancer. In June, the company reported that Tecentriq in a Phase II study shrank tumors of people with locally advanced or metastatic urothelial carcinoma (mUC) who have not received a prior treatment (first-line) and who were ineligible for cisplatin-based chemotherapy.

Tecentriq was granted accelerated approval in May for people with a specific form of advanced bladder cancer, thus becoming the first anti-PD-L1 cancer immunotherapy to gain U.S. marketing clearance. Tecentriq is the first FDA-approved treatment for people with a specific type of bladder cancer in more than three decades. The product is indicated for the treatment of people with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant).

The monoclonal antibody Tecentriq is designed to bind with a protein called PD-L1. Tecentriq is designed to directly bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with PD-1 and B7.1 receptors. By inhibiting PD-L1, atezolizumab may allow for the activation of T cells. Tecentriq may additionally affect normal cells.

Roche launched its innovative Accu-Chek Guide blood glucose monitoring system during August. To simplify daily diabetes routines, the Accu-Chek Guide system offers a new spill-resistant SmartPack vial and a unique strip design with a large easy-edge dosing area. Wireless connectivity to the Accu-Chek Connect mobile app and the cloud-based diabetes management system allows for easy handling of important diabetes data and remote monitoring.

The phase III GOYA trial evaluating Gazyva/Gazyvaro (obinutuzumab) plus CHOP chemotherapy (G-CHOP) in people with previously untreated diffuse large B-cell lymphoma (DLBCL) did not meet its primary endpoint of significantly reducing the risk of disease worsening or death (progression-free survival; PFS) compared to Rituxan/MabThera (rituximab) plus CHOP chemotherapy (R-CHOP). Adverse events with Gazyva/Gazyvaro and Rituxan/MabThera were consistent with those evident in previous clinical studies when each was combined with various chemotherapies.

In positive news for the product, Gazyva/Gazyvaro demonstrated superior progression-free survival compared to Rituxan/ MabThera in people with previously untreated follicular lymphoma. The Phase III GALLIUM trial met the primary endpoint early, as determined by an independent data monitoring committee during May.

Gazyva/Gazyvaro is designed to attach to CD20, which is a protein expressed on certain B cells, but not on stem cells or plasma cells. The engineered monoclonal antibody is designed to attack and destroy targeted B-cells directly and together with the body’s immune system.

Gazyva/Gazyvaro is approved in 70-plus countries, in combination with chlorambucil, for people with previously untreated chronic lymphocytic leukemia. During June, the European Commission gave the green light to Gazyvaro in combination with bendamustine chemotherapy followed by Gazyvaro maintenance in people with follicular lymphoma who did not respond or who progressed during or up to six months after treatment with MabThera or a MabThera-containing regimen.

Gazyva received its second FDA approval during February, for certain people with previously treated follicular lymphoma. Approval was granted for Gazyva plus bendamustine chemotherapy followed by Gazyva alone as a new treatment for people with follicular lymphoma who did not respond to a Rituxan-containing regimen, or had their follicular lymphoma return after such treatment.

Roche’s subcutaneous formulation of MabThera received marketing approval in Europe during May for people with chronic lymphocytic leukemia. The subcutaneous version of MabThera saves time and eases treatment burden compared with intravenous formulation.

MabThera is marketed as Rituxan in the United States, Japan and Canada. Genentech, a member of the Roche Group, and Biogen collaborate on Rituxan in the United States. Roche markets MabThera in the rest of the world, except Japan, where MabThera is jointly marketed by Chugai and Zenyaku Kogyo.

Roche’s new, dedicated high-volume testing immunoassay solution, the cobas e 801 module, was made available for countries accepting the CE Mark as of June. Helping hospitals meet the demand for increased diagnostic testing, the cobas e 801 module offers more than 100 immunoassays across a wide range of disease fields.

The European Commission approved the use of Avastin (bevacizumab) in combination with Tarceva (erlotinib) for the first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR)-activating mutations. The June approval provides European physicians with a powerful combination therapy that can significantly extend progression-free survival beyond one year, representing significant progress for a group of patients who typically face a poor prognosis.

With initial FDA approval for advanced colorectal cancer during 2004, Avastin became the first anti-angiogenic therapy made widely available for treating patients with an advanced cancer. According to Roche, Avastin has made anti-angiogenic therapy a fundamental pillar of cancer treatment today. More than 2 million individual have been treated with Avastin. A comprehensive clinical program with 300-plus ongoing clinical studies is investigating the use of Avastin in more than 50 tumor types.

Tarceva is a once-daily, oral non-chemotherapy medicine for treating advanced or metastatic NSCLC. Tarceva has been demonstrated to inhibit EGFR, a protein involved in cancer growth and development of cancers. The product is developed and commercialized by Astellas Pharma in partnership with Genentech in the United States, Chugai in Japan, and Roche in the rest of the world.

A Phase III trial demonstrated Roche’s Actemra/RoActemra maintained steroid-free remission in people with Giant Cell Arteritis (GCA). The Phase III trial, the largest clinical study ever conducted in GCA, met its primary and key secondary endpoints. The study demonstrated that Actemra/RoActemra, initially combined with a six-month steroid (glucocorticoid) regimen, more effectively sustained remission through one year compared to a six or 12 month steroid-only regimen in people with newly diagnosed and relapsing GCA. There have been no new approved treatments for GCA in more than five decades.

roactemra

Actemra/RoActemra is the only approved anti-IL-6 receptor biologic, available in both intravenous (IV) and subcutaneous formulations, for treating adult patients with moderate-to-severe active rheumatoid arthritis.

Actemra/RoActemra is part of a joint-development deal with Chugai Pharmaceutical and has been approved in Japan since April 2005. Actemra/RoActemra is approved in 100-plus countries.

Roche during May introduced the CoaguChek INRange system in countries accepting the CE Mark. The system is the first Bluetooth-enabled PT/INR home health device that helps patients and their healthcare providers have greater control over their coagulation status and the ability to monitor Vitamin K Antagonist therapy. Patient self-testing with CoaguChek INRange sets a new standard of care by allowing HCPs to monitor patient PT/INR data while reducing lab visits.

A Phase III trial of Roche’s Alecensa (alectinib) demonstrated superior efficacy versus crizotinib in Japanese people with a specific form of lung cancer. The oral anaplastic lymphoma kinase (ALK) inhibitor reduced the risk of disease worsening or death (progression free survival) by 66 percent compared to crizotinib in Japanese people with advanced or recurrent ALK-positive NSCLC. This was the first investigational head-to-head study of Alecensa compared to crizotinib in people with advanced ALK-positive non-small cell lung cancer.

Alecensa was granted accelerated approval by the U.S. Food and Drug Administration during December 2015 for treating people with ALK-positive NSCLC who have progressed on or are intolerant to crizotinib. The oral medicine (also known by the product codes RG7853/AF-802/RO5424802/CH5424802) was created at Chugai Kamakura Research Laboratories and is being developed for individuals with NSCLC whose tumors are identified as ALK+.

U.S. regulators during April granted accelerated approval to Venclexta (venetoclax) for individuals with a difficult-to-treat type of chronic lymphocytic leukemia. Venclexta is designed to help restore a cell’s ability to self-destruct and is the first medicine of its kind to be cleared for marketing. The new product is indicated for the treatment of people with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy.

Venclexta is the first approved medicine designed to help restore a process in which cells self-destruct (apoptosis) by selectively blocking the BCL-2 protein. The small molecule is also Roche’s 10th new medicine approved during the past seven years. AbbVie and Roche are jointly developing Venclexta. The drug is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the United States and commercialized by AbbVie in non-U. S. countries.

Venclexta is designed to selectively bind and inhibit the BCL-2 protein, which plays a significant role in a process known as apoptosis (programmed cell death). Overexpression of that protein in chronic lymphocytic leukemia has been associated with resistance to certain therapies. Blocking BCL-2 may restore the signaling system that tells cells, including cancer cells, to self-destruct.

Roche received regulatory approval in March to initiate testing for Zika virus at U.S. blood centers under an FDA Investigational New Drug Application protocol. The cobas Zika test for use with the cobas 6800/8800 Systems is a qualitative in vitro nucleic acid screening test for directly detecting Zika virus RNA in plasma specimens from individual human blood donors. Roche continues to work with global regulators to determine the path forward to implement the cobas Zika test for blood screening.

Roche provided an update during February on two identical phase III trials of lebrikizumab in people with severe asthma. One trial met its primary endpoint, showing lebrikizumab significantly reduced exacerbations in people with severe asthma; however, the second study did not meet this primary endpoint.

A novel, humanized monoclonal antibody, lebrikizumab is designed to specifically block the action of interleukin-13. IL-13 is a cytokine that is a key contributor to airway inflammation and asthma disease processes in some individuals. Clinical trials in asthma, COPD, atopic dermatitis and idiopathic pulmonary fibrosis continue.

Results from Roche’s TRAPID-AMI1 clinical trial were published online by the Annals of Emergency Medicine in January. The results confirmed a novel approach for a more rapid diagnosis of heart attack in patients with acute chest pain. The strategy is based on the cardiac troponin T high-sensitivity test from Roche and reduces the observation time necessary to rule-in or rule-out a heart attack from 3-6 hours to 1 hour. A fast and reliable diagnosis of heart attack is crucial because every hour of delay from the onset of symptoms to treatment increases the mortality risk.

Roche’s Elecsys cardiac Troponin T high-sensitivity (cTnT-hs) test detects cardiac troponin, which is the preferred biomarker for diagnosing a heart attack in clinical practice. In combination with an electrocardiogram (ECG), it has become the gold standard for heart attack diagnosis.

Also in January, Roche announced that the New England Journal of Medicine had published the results of PROGNOSIS. The groundbreaking clinical trial showed the prognostic value of the company’s Elecsys sFlt-1/PlGF immunoassay ratio test in predicting which pregnant women are at highest risk of developing preeclampsia, which is one of the leading causes of death and complications for mothers and their unborn babies.

PROGNOSIS is the first multi-center, large-sample study to show the prognostic value of the Roche Elecsys preeclampsia test to predict the absence of preeclampsia for one week, and the development of preeclampsia within the subsequent four weeks in women with clinical suspicion of the syndrome. The addition of the sFlt-1/PlGF ratio measurement to proteinuria and blood pressure measures allows for better prediction of preeclampsia, and can reduce hospitalization pre-diagnosis by 50 percent.