On October 20, 2016 TG Therapeutics, Inc. (NASDAQ:TGTX) reported the launch of a Phase 1/2 study to evaluate the safety and efficacy of TGR-1202, the Company’s oral PI3K delta inhibitor in combination with carfilzomib, the FDA-approved proteasome inhibitor, in patients with relapsed or refractory lymphoma (Press release, TG Therapeutics, OCT 20, 2016, View Source [SID1234515923]).

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The rationale for combining these two agents is based on extensive preclinical work conducted as part of a research collaboration supported by TG Therapeutics at the Center for Lymphoid Malignancies, Columbia University Medical Center. Portions of this work were presented in an oral presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting in December 2015, by Dr. Changchun Deng of the Center for Lymphoid Malignancies. The presentation contained data demonstrating that the combination of TGR-1202 and carfilzomib was uniquely synergistic as compared to any other combination of a PI3K-delta inhibitor and proteasome inhibitor, including the combination of idelalisib and carfilzomib and idelalisib and bortezomib. Of particular interest, the combination of TGR-1202 and carfilzomib was found to potently inhibit cap dependent translation of c-Myc in all cell lines tested, including diffuse large B-Cell lymphoma (DLBCL), mantle cell lymphoma (MCL), multiple myeloma, T-cell lymphoma, and chronic lymphocytic leukemia (CLL) cells. A more in depth presentation of the preclinical work has been submitted to a leading medical journal and is awaiting publication.

In the Phase 1 portion, the study will evaluate the safety, tolerability, and appropriate dose of carfilzomib when combined with 800mg of TGR-1202. Once a recommended Phase 2 dose is identified, the Phase 2 portion will further evaluate the safety and effectiveness of the combination at the chosen dose. TG Therapeutics will supply the TGR-1202 and assume up to 50% for the cost for the trial.

"We are very excited about the launch of this combination study, building on the extensive preclinical work completed by Dr. Deng, Dr. Owen A. O’Connor and the team from Columbia Presbyterian Medical Center, allowing us to move the science from bench to bedside and into patients in need of combination therapies. TGR-1202 continues to exhibit best-in-class safety and efficacy results and has demonstrated itself as a uniquely combinable PI3k-delta inhibitor. Our hope is that combination therapies with TGR-1202 could significantly improve the outcomes for patients with lymphoma," stated Michael S. Weiss, the Company’s Executive Chairman and Interim Chief Executive Officer."

"C-myc continues to be one of the most challenging tumor mutations to target. C-myc tumors include some of the most difficult to treat, including double hit lymphoma and triple negative breast cancer, which are generally resistant to currently available therapies leading to very poor outcomes for patients. The work we completed at Columbia appears to identify a novel mechanism for targeting c-myc by combining these two agents and we are eager to see if the work in the lab translates into helping these patients. We look forward to working with TGR-1202 and carfilzomib in this important clinical research project," stated Dr. Owen O’Connor, Director Lymphoid Malignancies at Columbia Presbyterian Medical Center.

This study is currently open to enrollment at the Center for Lymphoid Malignancies, Columbia Presbyterian Medical Center, New York, NY. More information on this clinical study can be found at www.clinicaltrials.gov.

On October 20, 2016 Advaxis, Inc. (NASDAQ:ADXS), a clinical stage biotechnology company developing cancer immunotherapies, reported the commencement of Part B of the KEYNOTE-046 clinical trial evaluating Advaxis’ Lm immunotherapy candidate, ADXS-PSA, in combination with KEYTRUDA (pembrolizumab) in patients with previously treated, metastatic castration-resistant prostate cancer (mCRPC) (Press release, Advaxis, OCT 20, 2016, View Source [SID1234515920]). In Part A of the Phase 1/2 study, 14 patients were treated with ADXS-PSA monotherapy across three dose levels, with no dose limiting toxicities, paving the way for initiating Part B of the study.

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KEYNOTE-046 is a multicenter, open-label, nonrandomized, dose determining, Phase 1/2 trial evaluating the safety of ADXS-PSA. Part B of the study is evaluating the tolerability of ADXS-PSA in combination with KEYTRUDA in 30 patients with mCRPC. Secondary objectives for this study are to evaluate antitumor activity and progression-free survival of ADXS-PSA. KEYNOTE-046 is the first-in-human study of Advaxis’ Lm immunotherapy candidate for prostate cancer. It is the second study initiated to evaluate the use of KEYTRUDA in the treatment of advanced prostate cancer.

Advaxis also announced initiation of its Phase 3 AIM2CERV study, a multicenter, placebo-controlled, randomized study of axalimogene filolisbac, or AXAL, administered in the adjuvant setting following chemotherapy and radiation in women with high-risk, locally advanced cervical cancer (HRLACC). The primary objective of the trial is disease-free survival, with secondary objectives including examining overall survival and safety. In July 2016, Advaxis received a Special Protocol Assessment for the AIM2CERV trial, as well as Fast Track designation for AXAL as an adjuvant therapy for HRLACC patients.

Several trial sites have been opened for both studies and locations are currently screening patients for enrollment. For more information on Advaxis clinical trials, visit clinicaltrials.gov.

On October 20, 2016 – Actelion Ltd (SIX: ATLN) reported its results for the first nine months of 2016 (Press release, Actelion, OCT 20, 2016, View Source [SID1234515938]).

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OPERATING HIGHLIGHTS

Strong Opsumit (macitentan) trajectory and quarterly net new patient gains sustained

Excellent US launch momentum for Uptravi (selexipag) – enhanced by launches in Germany and the Netherlands

Uptravi (selexipag) approvals in Switzerland and Japan (by Nippon Shinyaku) in Q3

First all-oral combination therapy with ponesimod and dimethyl fumarate (Tecfidera) to be evaluated for patients with relapsing multiple sclerosis

FINANCIAL HIGHLIGHTS

Sales growing to CHF 1,785 million (+14% at CER) – New PAH products surpass Tracleer for the first time

Opsumit sales grow to CHF 596 million (+63% at CER)

Uptravi sales reach CHF 160 million after just 9 months on the market

US GAAP operating income grows to CHF 660 million (+17% at CER)

Core operating income grows to CHF 781 million (+14% at CER)

2016 financial guidance upgraded: core operating income growth in the mid-teen percentage range, at constant exchange rates and barring unforeseen events

% variance
in CHF million
(except for per share data) 9M 2016 9M 2015 in CHF at CER(1)
US GAAP results
Net revenue 1,791 1,525 17% 14%
Operating income 660 533 24% 17%
Net income 581 452 29% 21%
Diluted EPS 5.37 3.99 35% 27%
Core performance(2)
Product sales 1,785 1,522 17% 14%
Core operating income 781 651 20% 14%
Core net income 691 560 23% 17%
Core diluted EPS 6.38 4.94 29% 23%
Cash flow 9M 2016 9M 2015
Operating cash flow 695 533
Capital expenditure (45) (17)
Free cash flow 6 (506)
Net cash position as of 30 September 411 698

CER percentage changes are calculated by reconsolidating both the 9M 2015 and 9M 2016 results at constant currencies (the average monthly exchange rates for 9M 2015).

Actelion continues to measure, report and issue guidance on its core operating performance, which management believes more accurately reflects the underlying business performance. The Group believes that these non-GAAP financial measurements provide useful supplementary information to investors. These non-GAAP measures are reported in addition to, not as a substitute for, US GAAP financial performance.


Jean-Paul Clozel, MD, Chief Executive Officer, commented: "Once again, we have delivered a very strong performance across all areas of our business. I am particularly happy with the very positive feedback we receive from physicians prescribing Uptravi. We have also made considerable progress advancing our innovative pipeline, highlighted by the recent initiation of the combination study with ponesimod in relapsing multiple sclerosis. In summary, the transformation of the company is well under way."

Otto Schwarz, Chief Operating Officer, commented: "We continue to be extremely pleased with the transformation of our PAH portfolio. For the first time, in the third quarter, more than 50% of our sales came from our new outcome-based PAH portfolio. The strong uptake of Uptravi in the US continued during the third quarter, enhanced by a strong early trajectory in Germany, resulting in a total of over 1,800 patients benefiting from this novel oral therapy at the end of September 2016."

André C. Muller, Chief Financial Officer, commented: "The excellent commercial performance has enabled us to increase our R&D effort to advance both the late and earlier stage pipeline, whilst continuing to deliver strong earnings growth. Our focus on the bottom line, coupled with strong sales enables us to increase guidance. Barring unforeseen events, we now expect 2016 core operating income growth in the mid-teen percentage range at constant exchange rates."

SALES UPDATE
Actelion’s strong performance continued during the third quarter of 2016 driven by the outstanding Uptravi launch in the US and Opsumit’s ongoing growth dynamics. For the first time, during the third quarter of 2016, sales of the company’s outcome-based PAH portfolio, Opsumit, Uptravi and Veletri, exceeded 50% of total sales, demonstrating the extent of the transformation of the PAH franchise.

In the US, sales increased by 23% at CER, driven by the strong Uptravi launch, continued Opsumit momentum and ERA market share gains. European sales were at the same level as 2015, despite increased Opsumit uptake and Tracleer use in the digital ulcer indication, but mitigated by continued pricing pressure and market erosion from generics, particularly in Spain. Sales in Japan increased by 20% at CER, mostly driven by very strong sales of Opsumit (launched in June 2015), Tracleer in digital ulcer indication, Veletri and Zavesca (Japanese trade name Brazaves).

Comparing average exchange rates for the first nine months of 2016 to the first nine months of 2015, the Swiss franc weakened, mostly against the US dollar, euro and Japanese yen, resulting in a positive currency variance of 54 million Swiss francs.
Sales by product – 9M 2016
% variance
in CHF millions 9M 2016 9M 2015 in CHF at CER
Opsumit 596 354 68 63
Tracleer 790 934 -15 -18
Uptravi 160 - nm* nm
Veletri 71 60 18 13
Ventavis 58 81 -28 -31
Valchlor 26 19 34 30
Zavesca 78 68 15 13
Others 6 5 12 14
Total product sales 1,785 1,522 17 14
*nm = not meaningful

Sales by product – Q3 2016
% variance
in CHF millions Q3 2016 Q3 2015 in CHF at CER
Opsumit 218 147 49 45
Tracleer 244 289 -16 -18
Uptravi 70 - nm nm
Veletri 23 22 7 2
Ventavis 15 24 -39 -40
Valchlor 8 7 10 8
Zavesca 26 24 11 9
Others 2 2 1 -1
Total product sales 606 514 18 15

Sales by region – 9M 2016
% variance
in CHF millions 9M 2016 9M 2015 in CHF at CER
United States 964 766 26 23
Europe* 485 475 2 0
Japan 182 132 38 20
Rest of the world 155 149 4 6
Total product sales 1,785 1,522 17 14
*Europe = EU28 and Switzerland

Sales by region – Q3 2016
% variance
in CHF millions Q3 2016 Q3 2015 in CHF at CER
United States 325 271 20 18
Europe* 163 157 3 3
Japan 66 45 45 20
Rest of the world 52 40 30 29
Total product sales 606 514 18 15
*Europe = EU28 and Switzerland

PAH FRANCHISE
Opsumit
Sales of Opsumit (macitentan) amounted to 596 million Swiss francs for the first nine months of 2016, an increase of 63% at CER compared to the first nine months of 2015. This increase continues to be driven by new patient starts with commercial availability in over 30 countries. The continued increase in patients benefitting from Opsumit is driven by referral of treatment-naïve patients together with increased use in combination with PDE-5 inhibitors, and some upgrades from Tracleer, notably in Japan.

Uptravi
Sales of Uptravi (selexipag) amounted to 160 million Swiss francs for the first nine months of 2016. Since the US launch at the beginning of January 2016, patient demand has continued to increase with sales of 126 million Swiss francs (excluding initial inventory build of 30 million Swiss francs). For the third quarter, revenues from patient demand in the US amounted to 66 million Swiss francs compared to 45 million Swiss francs in the second quarter and 15 million Swiss francs in the first quarter of 2016. Uptravi was successfully launched in Germany in mid-June 2016 with sales reaching 3 million Swiss francs in an underdeveloped market in terms of prostacyclin usage. At the end of September, about 1,800 patients were using Uptravi globally.
During the third quarter 2016, Uptravi was approved in Switzerland and Japan (where it will be co-promoted by Nippon Shinyaku, who will record the sales) pending pricing and reimbursement approval.

Tracleer
Sales of Tracleer (bosentan) amounted to 790 million Swiss francs for the first nine months of 2016, a decrease of 18% at CER compared to the first nine months of 2015, equally driven by lower underlying volume and average price. The decrease is mainly due to lower referrals of new patients as well as switches in countries where Opsumit is available, increased generic competition, notably in Spain, continued pricing pressure in Europe and lower inventories in the US.
Tracleer sales were supported by the digital ulcer indication in Europe and Japan and continued solid demand in markets where Opsumit is not yet available.

Following the Pediatric Investigation Plan (PIP) compliance statement from the European Committee for Medicinal Products for
Human Use (CHMP), applications for extension of the Supplementary Protection Certificate (SPC) were granted in 19 EU countries until the end of August 2017.

Veletri
Sales of Veletri (epoprostenol for injection) amounted to 71 million Swiss francs for the first nine months of 2016, an increase of 13% at CER compared to the first nine months of 2015. This increase was mostly driven by successful market penetration, notably in France, and also Italy, Spain and UK. Demand in Japan remained solid, but sales were impacted by a 12% price cut effective from 01 March 2016.

Ventavis
Sales of Ventavis (iloprost) amounted to 58 million Swiss francs for the first nine months of 2016, a decrease of 31% at CER, compared to the first nine months of 2015. This is due to the competitive environment, including the availability of Uptravi. Underlying units decreased by 18%.

SPECIALTY PRODUCTS

Valchlor
Sales of Valchlor (mechlorethamine) amounted to 26 million Swiss francs for the first nine months of 2016, an increase of 30% at CER, compared to the first nine months of 2015. In the US, the company is continuing its efforts to establish Valchlor as an option in the treatment algorithm for early-stage mycosis fungoides, a type of Cutaneous T-Cell Lymphoma (MF-CTCL). In France, patients benefited from the drug under a temporary nominative authorization for use ("ATU") program initiated during the second half of 2014.

The regulatory dossier is currently under review with the European Medicines Agency (under the trade name Ledaga).

Zavesca
Sales of Zavesca (miglustat) amounted to 78 million Swiss francs for the first nine months of 2016, an increase of 13% at CER compared to the first nine months of 2015. Sales in the US were strong due to a relatively low prior year base as a consequence of last year’s inventory adjustment. In Europe, sales decreased by 2% mainly due to the launch of generic miglustat (approved for the type 1 Gaucher disease indication only). Sales in Japan were 16% higher, driven by increased patient demand in the Niemann-Pick type C indication.

The global number of patients receiving therapy grew by 7% compared to the first nine months of 2015, driven by a 16% increase in Niemann-Pick type C demand.

CLINICAL DEVELOPMENT PIPELINE
The pipeline continued to strengthen with substantial progress made with several compounds:
In the third quarter, Actelion announced the initiation of the Phase III POINT study, which investigates the use of combination therapy with ponesimod, an orally active, selective sphingosine-1-phosphate receptor 1 (S1P1) immunomodulator, and dimethyl fumarate (Tecfidera) for patients with relapsing multiple sclerosis (RMS). The POINT study – which will be conducted under a Special Protocol Assessment (SPA) agreement with the FDA – is the first to assess the concurrent administration of two oral therapies in MS with the objective to improve disease control in this progressive, debilitating neurological disorder. Ponesimod is also being studied in the double blind long-term extension of the Phase II study as well as in the Phase III study OPTIMUM to compare the efficacy and safety of ponesimod with teriflunomide in patients with RMS. Enrollment for the OPTIMUM study is on target to be completed around the end of 2016.

Also in the third quarter, the company advanced its new dual orexin receptor antagonist (DORA) into Phase II development in patients with insomnia. The Phase II program consists of two studies, one in adult and one in elderly patients, and is designed to evaluate the effect of Actelion’s DORA versus placebo on sleep maintenance and sleep initiation, as well as next-day residual effect and next-day performance. The study in adults also includes a zolpidem reference arm. The decision to move into a Phase II program was based on excellent data collected from the preclinical and Phase I clinical program, as well as a thorough understanding of the potential of dual orexin receptor antagonism on sleep efficacy and architecture.

With macitentan (Opsumit), we are entering into a pediatric study, TOMORROW, to evaluate the effect of macitentan on delaying disease progression in children with PAH using a pediatric formulation of macitentan. The global trial design has received endorsement from the US FDA (through a pediatric Written Request) and in the EU (through a Paediatric Investigation Plan). Enrollment is expected to start around the end of 2016.

A Phase II study, MERIT, assesses the efficacy, safety and tolerability of macitentan in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH). The study is on schedule to deliver results by the end of the year.
Enrollment of participants in the ongoing Phase III program IMPACT investigating cadazolid treatment in patients suffering from Clostridium difficile-associated diarrhea is progressing well and is on target to be completed around the end of 2016.

Compound Indication Study Status
Phase III Cadazolid Clostridium difficile-associated diarrhea IMPACT Ongoing
Macitentan Eisenmenger syndrome MAESTRO Ongoing
Macitentan Pediatric PAH TOMORROW Initiating


Ponesimod

Multiple sclerosis OPTIMUM Ongoing
Ponesimod Multiple sclerosis POINT Initiating
Phase II Cenerimod Systemic lupus erythematosus - Ongoing
Clazosentan Reversal of vasospasm associated with aneurysmal subarachnoid hemorrhage REVERSE Ongoing
Dual Orexin Receptor Antagonist Insomnia - Ongoing
Endothelin Receptor Antagonist Specialty cardiovascular disorders - Ongoing
Macitentan Chronic thromboembolic pulmonary hypertension MERIT Ongoing
Macitentan Combined pre- and post-capillary pulmonary hypertension MELODY Complete
Ponesimod Graft-versus-host disease - Ongoing
Phase Ib Lucerastat Fabry disease - Complete
Phase I New Chemical Entity Cardiovascular disorders - Ongoing
New Chemical Entity Inflammatory disorders - Ongoing
Selective Orexin 1 Receptor Antagonist Neurological disorders - Ongoing
T-type Calcium Channel Blocker Neurological disorders - Ongoing

RESULTS DAY CENTER
Investor community: To make your job easier, we provide links to all relevant documentation, such as a full financial review, reconciliation US-GAAP to Core results and geographical breakdown by product, from the Results Day Center on our corporate website: www.actelion.com/results-day-center.

On October 20, 2016 Roche reported good sales growth in the first nine months of 2016 (Press release, Hoffmann-La Roche , OCT 20, 2016, View Source [SID1234515921]).

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Group sales increase 4%1 at constant exchange rates, 6% in Swiss francs

Pharmaceuticals Division sales up 4%, driven by oncology and immunology medicines

Diagnostics Division sales grow 7%, primarily due to immunodiagnostic products

US FDA approves Tecentriq, the first anti-PD-L1 cancer immunotherapy for metastatic non-small cell lung cancer

Successful launch of cobas e 801, high-throughput immunodiagnostic module

For the eighth year running, Roche ranked as the most sustainable healthcare company in the Dow Jones Sustainability Index (DJSI)

Outlook for 2016 confirmed

Commenting on the Group’s first nine months, Roche CEO Severin Schwan said: "We had continued good sales growth in both Pharmaceuticals and Diagnostics driven by our newly launched products, and our product pipeline is developing very well. Our cancer immunotherapy medicine Tecentriq has been performing strongly since May, when it was first approved in the US for people with advanced bladder cancer, and it has just received US FDA approval for previously treated metastatic non-small cell lung cancer. Based on our performance so far, I am confident that we will meet our full-year targets for 2016."

Group
Both divisions showed continued growth

Group sales increased 4% to CHF 37.5 billion. Sales in the Pharmaceuticals Division were up 4% to CHF 29.1 billion, driven by demand for breast cancer medicines Perjeta and Herceptin as well as for Actemra/RoActemra for rheumatoid arthritis. Sales in the US rose 3%, led by three immunology treatments Xolair, Esbriet and Actemra/RoActemra, as well as Activase/TNKase, and Perjeta and Herceptin for HER2-positive breast cancer. The recently launched medicines Tecentriq in bladder cancer and Alecensa in lung cancer have had a strong uptake. US growth was partly offset by a decline in sales of Tamiflu, Lucentis, Avastin and Tarceva. In Europe, sales increased 5% with Perjeta, Actemra/RoActemra and MabThera/Rituxan recording strong growth, especially in Germany and France. In the International region, the 4% growth was driven by the strategic cancer medicines portfolio. In Japan, sales were stable; mandated price cuts for reimbursed products were compensated by strong growth from Alecensa, HER2 cancer medicines and Actemra/RoActemra.

Sales in the Diagnostics Division grew strongly (+7%) to CHF 8.4 billion. All regions contributed to this growth, particularly Asia-Pacific (+17%). Professional, Molecular and Tissue Diagnostics experienced continued good sales development. Diabetes Care sales continue to be impacted by challenging market conditions, especially in North America.

Confirming data for key investigational Roche medicines
Two Roche medicines were granted breakthrough therapy designations (BTD) by the US FDA in October. BTD was granted to Actemra/RoActemra for giant cell arteritis (GCA), a chronic, potentially life-threatening autoimmune condition. In addition, Alecensa received BTD for the treatment of adult patients with advanced ALK-positive non-small cell lung cancer (NSCLC) who have not received prior treatment with an ALK inhibitor. Also in October, the FDA approved the Lucentis prefilled syringe as a new method of administering the medicine to people with wet age-related macular degeneration and to people with macular edema after retinal vein occlusion.

In September, Roche presented new post-hoc analyses from three pivotal Ocrevus (ocrelizumab) studies at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The new data showed that Ocrevus consistently increased disease control both in patients with the relapsing form of multiple sclerosis and in those with the primary progressive form.

At the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) annual meeting in October, Roche presented results from the phase III OAK trial with Tecentriq in metastatic NSCLC. The study met its primary endpoint, having established a survival benefit over chemotherapy, even in people with low or no observed levels of PD-L1 expression. These results add to the growing body of evidence that supported the FDA approval of Tecentriq as a new treatment for specific types of advanced NSCLC. In addition to OAK, Roche has seven phase III lung studies underway evaluating Tecentriq alone or in combination with other treatments in patients with early and advanced stages of lung cancer.

Portfolio progress in Diagnostics
In August, the FDA granted a premarket clearance and CLIA (Clinical Laboratory Improvement Amendments) waiver for the cobas Influenza A/B & RSV test for use on the cobas Liat System. This test also identifies the Respiratory Syncytial Virus (RSV), which causes more than 80% of acute lower respiratory tract infections in infants under one year old. The FDA also issued an Emergency Use Authorization for the LightMix Zika rRT-PCR test for use in patients meeting clinical and/or epidemiological criteria developed by the Center for Disease Control. These tests further expand the rich menu of Roche products.

Also in August, the Accu-Chek Guide was launched in the EU. This next-generation blood glucose monitoring system is designed to make everyday blood glucose monitoring easier for people with diabetes. The Accu-Chek Guide system also provides advanced accuracy, which enables reliable diabetes management.

Roche the most sustainable healthcare company
The Dow Jones Sustainability Index (DJSI) recognised Roche as the most sustainable company in the healthcare industry for the eighth consecutive year. This year’s DJSI assessment emphasised that by focusing on access to healthcare, compliance and transparency, a diverse work culture and collaboration with a variety of partners, Roche is committed to creating value for all its stakeholders.