On July 25, 2019 Perrigo Company plc (NYSE; TASE: PRGO), reported that it will release its second quarter calendar year 2019 financial results on Thursday, August 8, 2019 (Press release, Perrigo Company, JUL 25, 2019, View Source [SID1234537730]). The Company will host a conference call beginning at 8 a.m. (EDT).

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The conference call will be available live via webcast to interested parties in the investor relations section of the Perrigo website at View Source or by phone at 888-317-6003, International 412-317-6061, and reference ID 1518603. A taped replay of the call will be available beginning at approximately 12:00 p.m. (EDT) Thursday, August 8 until midnight, August 15, 2019. To listen to the replay, dial 877-344-7529, International 412-317-0088, and use access code 10133465.

On July 25, 2019 GlycoMimetics, Inc. (NASDAQ: GLYC) reported that it will host a conference call and webcast to report its second-quarter 2019 financial results on Thursday, August 1, 2019, at 8:30 a.m. ET (Press release, GlycoMimetics, JUL 25, 2019, View Source [SID1234537729]).

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The dial-in number for the conference call is (844) 413-7154 (U.S. and Canada) or (216) 562-0466 (international) and entering passcode 8268638. To access the live audio webcast, or the subsequent archived recording, visit the "Investors – Events & Presentations" section of the GlycoMimetics website at www.glycomimetics.com. The webcast will be recorded and available for replay on the GlycoMimetics website for 30 days following the call.

On July 25, 2019 LabCorp (or the Company) (NYSE: LH) reported results for the second quarter ended June 30, 2019, and updated 2019 guidance (Press release, LabCorp, JUL 25, 2019, View Source [SID1234537728]).

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"This quarter again highlighted the strength and balance of our businesses," said David P. King, chairman and CEO of LabCorp. "Revenue grew 4.1% excluding non-operational headwinds from PAMA, disposition of businesses, and currency translation. Diagnostics performed well during the quarter, with the LaunchPad business transformation initiative largely offsetting known headwinds, while Drug Development continued to deliver strong top-line growth and margin expansion. We deployed capital to share repurchase and acquisitions, returning capital to shareholders and adding to our repertoire of innovative customer solutions that deliver value our customers want. We remain well-positioned to drive growth in 2019 and the years to come."

Consolidated Results

Second Quarter Results

Revenue for the quarter was $2.88 billion, an increase of 0.5% from $2.87 billion in the second quarter of 2018. The increase in revenue was primarily due to acquisitions of 1.4% and organic growth of 1.7% (which includes the negative impact from PAMA of 0.9%), partially offset by the disposition of businesses of 1.9% and foreign currency translation of 0.7%.

Operating income for the quarter was $335.7 million, or 11.6% of revenue, compared to $369.2 million, or 12.9%, in the second quarter of 2018. The decrease in operating income and margin was primarily due to lower Medicare and Medicaid pricing as a result of PAMA, higher personnel costs, cybersecurity expenses, and higher special items from acquisition and disposition-related costs, partially offset by increased demand and LaunchPad savings. The Company recorded restructuring charges, special items, and amortization, which together totaled $111.2 million in the quarter, compared to $94.3 million during the same period in 2018. Adjusted operating income (excluding amortization, restructuring charges, and special items) for the quarter was $446.9 million,

or 15.5% of revenue, compared to $463.5 million, or 16.2%, in the second quarter of 2018. The $16.6 million decline in adjusted operating income from 2018 included the negative impact from PAMA of $27.1 million.

Net earnings in the quarter were $190.4 million, compared to $233.8 million in the second quarter of 2018. Diluted EPS were $1.93 in the quarter, a decrease of 15.0% compared to $2.27 in the same period in 2018. Adjusted EPS (excluding amortization, restructuring charges, and special items) were $2.93 in the quarter, a decrease of 1.7% compared to $2.98 in the second quarter of 2018.

Operating cash flow for the quarter was $253.5 million, compared to $387.4 million in the second quarter of 2018. The decrease in operating cash flow was primarily due to higher working capital requirements to support growth. Capital expenditures totaled $85.2 million, compared to $87.2 million a year ago. As a result, free cash flow (operating cash flow less capital expenditures) was $168.3 million, compared to $300.2 million in the second quarter of 2018.

At the end of the quarter, the Company’s cash balance and total debt were $265.4 million and $6.6 billion, respectively. During the quarter, the Company invested $656.4 million in acquisitions and repurchased $199.9 million of stock, representing approximately 1.3 million shares. As of June 30, 2019, the Company had $1.05 billion of authorization remaining under its share repurchase program.

Year-To-Date Results

Revenue was $5.67 billion, a decrease of 0.7% from $5.71 billion in the first half of last year. The decline in revenue was primarily due to the disposition of businesses of 1.9% and foreign currency translation of 0.8%, partially offset by acquisitions of 1.0% and organic growth of 1.0% (which includes the negative impact from PAMA of 1.0%).

Operating income was $653.9 million, or 11.5% of revenue, compared to $674.6 million, or 11.8%, in the first half of 2018. The decrease in operating income and margin was primarily due to lower Medicare and Medicaid pricing as a result of PAMA, personnel costs, disposition of businesses, cybersecurity expense, and a favorable one-time legal settlement in 2018, partially offset by organic demand, the Company’s LaunchPad initiatives, acquisitions, and a decrease in costs related to special items. The Company recorded restructuring charges, special items, and amortization which together totaled $204.4 million in the first half of the year, compared to $224.7 million during the same period in 2018. Adjusted operating income (excluding amortization, restructuring charges, and special items) was $858.3 million, or 15.1% of revenue, compared to $899.3 million, or 15.7%, in the first half of 2018. The $41.0 million decline in adjusted operating income from 2018 included the negative impact from PAMA of $54.1 million.

Net earnings in the first half of 2019 were $376.0 million, or $3.79 per diluted share, compared to $407.0 million, or $3.94 per diluted share, last year. Adjusted EPS (excluding amortization, restructuring and special items) were $5.55, a decrease of 3.5% compared to $5.75 in the first half of 2018.

Operating cash flow was $419.3 million, compared to $567.1 million in the first half of 2018. The decrease in operating cash flow was primarily due to higher working capital requirements to support growth. Capital expenditures totaled $179.4 million, compared to $159.7 million during the same period in 2018. As a result, free cash flow (operating cash flow less capital expenditures) was $239.9 million, compared to $407.4 million in the first half of 2018.

The following segment results exclude amortization, restructuring charges, special items, and unallocated corporate expenses.

Second Quarter Segment Results

LabCorp Diagnostics
Revenue for the quarter was $1.76 billion, a decrease of 2.9% from $1.81 billion in the second quarter of 2018, primarily due to the negative impact from the disposition of businesses of 2.8%, currency translation of 0.2% and lower organic revenue of 0.3% partially offset by acquisitions of 0.4%. The organic revenue decline of 0.3% includes the negative impact of 1.5% from PAMA and 0.6% due to fewer revenue days.

Total volume (measured by requisitions), excluding the disposition of businesses, decreased by 0.9%, as acquisition volume contributed 0.2% and organic volume declined by 1.2%. Organic volume was negatively impacted by approximately 2.5% from the combination of lower consumer genetics demand, managed care contract changes, and fewer revenue days. Excluding the disposition of businesses, revenue per requisition increased by 1.0%, despite the negative impact from PAMA of 1.5%.

Adjusted operating income (excluding amortization, restructuring charges, and special items) for the quarter was $345.4 million, or 19.6% of revenue, compared to $376.0 million, or 20.7%, in the second quarter of 2018. The $30.6 million decline in adjusted operating income was primarily due to the negative PAMA impact of $27.1 million. The negative impact from the disposition of businesses, managed care contract changes, cybersecurity expenses, fewer revenue days and personnel expense was predominantly offset by LaunchPad savings, other organic revenue growth, and acquisitions. The Company remains on track to deliver approximately $200 million of net savings from its three-year Diagnostics LaunchPad initiative by the end of 2021.

Covance Drug Development
Revenue for the quarter was $1.13 billion, an increase of 6.8% compared to $1.05 billion in the second quarter of 2018. The increase in revenue was primarily due to organic growth of 5.5% and acquisitions of 3.3%, partially offset by foreign currency translation of 1.6% and a business disposition of 0.3%.

Adjusted operating income (excluding amortization, restructuring charges, and special items) for the quarter was $141.7 million, or 12.6% of revenue, compared to $123.4 million, or 11.7%, in the second quarter of 2018. The increase in adjusted operating income and margin was primarily due to organic demand, LaunchPad savings, acquisitions, and currency translation, partially offset by higher personnel costs, cybersecurity investments, and facilities expenses to support the Company’s global expansion. The Company is on track to deliver $150 million of net savings from its three-year Covance LaunchPad initiative by the end of 2020.

Net orders and net book-to-bill during the trailing twelve months were $5.52 billion and 1.26, respectively. Backlog at the end of the quarter was $10.29 billion compared to $9.95 billion last quarter, and the Company expects approximately $4.1 billion of its backlog to convert into revenue in the next twelve months.

Outlook for 2019
The following guidance assumes foreign exchange rates effective as of June 30, 2019, for the remainder of the year and includes the estimated impact from currently anticipated capital allocation.

Revenue growth of 1.0% to 2.0% over 2018 revenue of $11.33 billion, which includes the negative impact from the disposition of businesses of approximately 1.5% and foreign currency translation of 0.5%. This is a narrowing of the range from the prior guidance of 0.5% to 2.5%.

Revenue in LabCorp Diagnostics is expected to be -3.0% to -2.0% as compared to 2018 revenue of $7.03 billion, which includes the negative impact from the disposition of businesses of approximately 2% and foreign currency translation of 0.2%. This is an improvement over the prior guidance of -4.0% to -2.0%.

Revenue growth in Covance Drug Development of 5.5% to 8.5% over 2018 revenue of $4.31 billion, a narrowing of the range as compared to the prior guidance of 5.0% to 9.0%. This guidance includes the negative impact from foreign currency translation of 0.9%.

Adjusted EPS of $11.10 to $11.40, which is an increase of 0.7% to 3.4% over 2018 adjusted EPS of $11.02, and a narrowing of the range as compared to the prior guidance of $11.05 to $11.45.

Free cash flow (operating cash flow less capital expenditures) of $950 million to $1.05 billion, which is an increase of 2.6% to 13.4% over 2018 and unchanged from the prior guidance.

Use of Adjusted Measures
The Company has provided in this press release and accompanying tables "adjusted" financial information that has not been prepared in accordance with GAAP, including adjusted net income, adjusted EPS (or adjusted net income per share), adjusted operating income, adjusted operating margin, free cash flow, and certain segment information. The Company believes these adjusted measures are useful to investors as a supplement to, but not as a substitute for, GAAP measures, in evaluating the Company’s operational performance. The Company further believes that the use of these non-GAAP financial measures provides an additional tool for investors in evaluating operating results and trends, and growth and shareholder returns, as well as in comparing the Company’s financial results with the financial results of other companies. However, the Company notes that these adjusted measures may be different from and not directly comparable to the measures presented by other companies. Reconciliations of these non-GAAP measures to the most comparable GAAP measures are included in the tables accompanying this press release.

The Company today is providing an investor relations presentation with additional information on its business and operations, which is available in the investor relations section of the Company’s website at View Source." target="_blank" title="View Source." rel="nofollow">View Source Analysts and investors are directed to the website to review this supplemental information.

A conference call discussing LabCorp’s quarterly results will be held today at 9:00 a.m. EDT and is available by dialing 844-634-1444 (615-247-0253 for international callers). The access code is 9679477. A telephone replay of the call will be available through August 8, 2019, and can be heard by dialing 855-859-2056 (404-537-3406 for international callers). The access code for the replay is 9679477. A live online broadcast of LabCorp’s quarterly conference call on July 25, 2019, will be available at View Source or at View Source beginning at 9:00 a.m. EDT. This webcast will be archived and accessible through July 24, 2020.

On July 25, 2019 Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing personalized cancer immunotherapies, reported its operating and financial results for the quarter ended June 30, 2019 (Press release, Genocea Biosciences, JUL 25, 2019, View Source [SID1234537727]). Genocea has initiated Part B of its Phase 1/2a clinical trial testing the safety, immunogenicity, and efficacy of its lead neoantigen vaccine candidate GEN-009 in combination with standard-of-care checkpoint inhibitors. The company also announced plans to present additional GEN-009 immunogenicity data at this year’s meeting of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper), taking place from September 27th through October 1st, 2019 in Barcelona, Spain.

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"Our presentation of GEN-009 immunogenicity data at ASCO (Free ASCO Whitepaper) 2019 marked a significant milestone for Genocea," said Chip Clark, Genocea president & CEO. "These best-in-class data showcased our unique ATLAS platform and its ability to identify each patient’s neoantigens of pre-existing T cell responses, as well as the amplification of anti-tumor cytokine responses to these neoantigens with GEN-009. These data gave us confidence to initiate Part B of our Phase 1/2a clinical trial, which we designed to demonstrate that such broad and strong anti-tumor immune responses lead to tumor shrinkage in cancer patients treated with GEN-009 and a checkpoint inhibitor."

Second Quarter 2019 Operational Highlights

Completed a public equity financing, raising $42.3 million, including the full exercise of the underwriters’ over-allotment option.

Presented best-in-class immunogenicity results for GEN-009 at the annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (ASCO 2019); the poster presentation was selected by ASCO (Free ASCO Whitepaper)’s Journal of Clinical Oncology as one of the Top 10 Featured Immuno-oncology Abstracts.

Entered into a research collaboration with Iovance exploring the use of Genocea’s ATLAS neoantigen screening platform in the development of neoantigen-targeted TIL (tumor-infiltrating lymphocyte) products.

Presented additional ATLAS data at the 2019 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (AACR 2019). The poster highlighted the potential use of ATLAS as a tool to predict the advanced melanoma patients for whom checkpoint therapy might prove beneficial.

Second Quarter 2019 Financial Results

Cash position: As of June 30, 2019, cash and cash equivalents were $58.7 million versus $26.4 million as of December 31, 2018.

Research and Development (R&D) expenses: R&D expenses were $6.8 million for the quarter ended June 30, 2019, compared to $5.3 million for the same period in 2018.

General and Administrative (G&A) expenses: G&A expenses were $3.2 million for the quarter ended June 30, 2019, compared to $4.5 million for the same period in 2018.

Net loss: Net loss was $6.5 million for the quarter ended June 30, 2019, compared to a net loss of $4.4 million for the quarter ended June 30, 2018.

Guidance
Genocea expects that its existing cash and cash equivalents are sufficient to support its operations into the first quarter of 2021.

Conference Call
Genocea will host a conference call and webcast today at 8:30 am ET. Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 7395079. To join the live webcast, please visit the presentation page of the investor relations section of the Genocea website at View Source A webcast replay of the conference call will be available on the Genocea website beginning approximately two hours after the event and will be archived for 90 days.

On July 25, 2019 Roche CEO Severin Schwan said: "In the first half of the year, we achieved very strong results, driven by high demand for our new medicines (Press release, Hoffmann-La Roche, JUL 25, 2019, View Source [SID1234537726]). 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."

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Outlook raised for 2019
Sales are now expected to grow in the mid- to high-single digit range, at constant exchange rates. Core earnings per share are targeted to grow broadly in line with sales, at constant exchange rates. Roche expects to further increase its dividend in Swiss francs.

Group results
In the first half of 2019, Group sales rose 9% to CHF 30.5 billion and core EPS grew 13%, ahead of sales. Core operating profit increased 11%, reflecting the strong underlying business performance. IFRS net income increased 19%, due to the strong underlying core results and one-time effects resulting from a remeasurement of deferred tax positions as well as the release of acquisition related provisions.

Sales in the Pharmaceuticals Division increased 10% to CHF 24.2 billion. Key growth drivers were the multiple sclerosis medicine Ocrevus, the new haemophilia medicine Hemlibra and cancer medicines Tecentriq, Perjeta and Avastin. The strong uptake of newly introduced medicines more than offset lower sales of Herceptin and of MabThera/Rituxan.

In the US, sales increased 14%, led by Ocrevus, Hemlibra, Tecentriq, Perjeta and Avastin. Ocrevus sales were driven by both new and returning patient demand.

In Europe (-4%), sales were affected by the competition from biosimilars for Herceptin (-45%) and MabThera/Rituxan (-36%). This decline was increasingly offset by the strong growth of Ocrevus, Perjeta, Tecentriq, Alecensa and Hemlibra.

In Japan, sales increased 9%, driven by recently launched products, including Hemlibra, Tecentriq and Perjeta. The growth in Japan was partially offset by biosimilar competition for MabThera/Rituxan (-46%).

In the International region sales grew 17%, mainly driven by China with strong sales of Herceptin, Avastin and MabThera/Rituxan as well as launches of Alecensa and Perjeta.

Diagnostics Division sales increased 2% to CHF 6.3 billion. The business area Centralised and Point of Care Solutions (+3%) was the main contributor, led by the growth of the immunodiagnostics business. In regional terms, growth was reported in Asia-Pacific (+5%) and EMEA2 (+3%). Sales declined in North America (-2%).

Core operating profit increased 11% in the Pharmaceuticals Division and 4% in the Diagnostics Division.

Important milestones for Roche medicines
In the second quarter, health authorities granted several approvals for Roche medicines. The US Food and Drug Administration (FDA) granted accelerated approval for Polivy (polatuzumab vedotin-piiq) in combination with bendamustine plus Rituxan for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma who have received at least two prior therapies. The FDA’s Accelerated Approval Program allows the conditional approval of a medicine that fulfils an unmet medical need for a serious condition.

In Japan, the Ministry of Health, Labour and Welfare (MHLW) approved Rozlytrek (entrectinib) for the treatment of adult and paediatric patients with neurotrophic tyrosine receptor kinase (NTRK) fusion-positive, advanced recurrent solid tumours. Rozlytrek is the first tumour-agnostic medicine to be approved in Japan that targets NTRK gene fusions, which have been identified in a range of hard-to-treat solid tumour types, including pancreatic, thyroid, salivary gland, breast, colorectal, and lung.3 Separately, the MHLW approved the FoundationOne CDx Cancer Genomic Profile as a companion diagnostic for Rozlytrek.

Kadcyla received FDA approval for adjuvant (after surgery) treatment of people with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant (before surgery) taxane and Herceptin-based treatment. Kadcyla was reviewed and approved under the FDA’s Real-Time Oncology Review (RTOR) and Assessment Aid pilot programmes, leading to an approval in just over 12 weeks after completing the submission. Kadcyla is the first Roche medicine approved under the RTOR pilot programme, which is exploring a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible.

The FDA also approved Venclexta/Venclyxto in combination with Gazyva/Gazyvaro for the treatment of people with previously untreated chronic lymphocytic leukaemia or small lymphocytic lymphoma, also under the FDA’s new RTOR and Assessment Aid pilot programme. The approval is based on the results of the randomised phase III CLL14 study, which evaluated 12-month, fixed-duration treatment with Venclexta plus Gazyva compared to Gazyva plus chlorambucil. The results showed that the combination of Venclexta plus Gazyva produced a durable and significant reduction in the risk of disease worsening or death (progression-free survival [PFS], as assessed by Independent Review Committee) by 67% compared to Gazyva plus chlorambucil, a current standard-of-care.

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended the approval of Tecentriq plus chemotherapy (Abraxane; nab-paclitaxel) for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer whose tumours have PD-L1 expression (≥ 1%) and who have not received prior chemotherapy for metastatic disease.

Progress in the product pipeline
New data from the Ocrevus studies showed higher exposure to the medicine correlated with a lower risk of disability progression and lower B-cell levels in patients with MS. Importantly, safety findings remained consistent across all exposure levels.

Long-term data from the phase III Opera and Oratorio open-label extension (OLE) trials in RMS and PPMS show that earlier treatment with Ocrevus significantly reduced the risk of permanent disability progression and this effect was sustained over time.

With more than 100,000 patients now treated globally, real-world and study experience with Ocrevus is rapidly growing. Ocrevus safety remains in line with the benefit-risk profile assessed in pivotal studies and assigned in the label.

Positive additional results of a prespecified exploratory analysis from the phase III IMpower150 study demonstrated that the combination of Tecentriq, Avastin, carboplatin and paclitaxel (chemotherapy) gave patients with chemotherapy-naïve, metastatic non-squamous non-small cell lung cancer (NSCLC), with baseline liver metastases an overall survival (OS) advantage compared with the combination of Avastin and chemotherapy. In addition, Tecentriq, Avastin and chemotherapy reduced the risk of disease worsening or death (PFS) by 59% in patients with baseline liver metastases, compared with Avastin and chemotherapy.

Results from the pivotal phase III CLL14 study in previously untreated chronic lymphocytic leukaemia (CLL) show that Venclexta/Venclyxto plus Gazyva/Gazyvaro met the primary endpoint of investigator-assessed PFS. The 12-month, fixed-duration, chemotherapy-free combination reduced the risk of disease worsening or death by 65% compared to Gazyva/Gazyvaro plus chlorambucil, when given to people with previously untreated CLL who have co-existing medical conditions.

The phase I/II Startrk-NG study showed entrectinib shrank tumours (objective response rate; ORR) in all children and adolescents who had NTRK, ROS1 or ALK fusion-positive solid tumours (11 of 11 patients), including two patients achieving a complete response. The study evaluates the investigational medicine entrectinib in children and adolescents with recurrent or refractory solid tumours with and without NTRK, ROS1 or anaplastic lymphoma kinase (ALK) gene fusions.

In spinal muscular atrophy (SMA) data from the dose-finding part 1 of the pivotal Firefish trial showing infants with type 1 SMA achieved key motor milestones after one year of treatment with investigational risdiplam. Furthermore, data from part 1 of the pivotal Sunfish trial in people aged 2 -25 years with type 2 or 3 SMA were presented at the AAN meeting.4 A sustained median increase from baseline in SMN protein of greater than two-fold, as measured in blood, was seen after 12 months of treatment with risdiplam. Roche is planning to include these new data in regulatory filing with the FDA.

The Xofluza phase III Ministone-2 study met its primary endpoint, demonstrating that Xofluza was well tolerated in children with flu. The study also showed that Xofluza is comparable to oseltamivir – a proven effective treatment for children with flu – at reducing the duration of flu symptoms, including fever. The study assessed Xofluza versus an active comparator (oseltamivir) in children aged between one and less than 12 years old with flu. Additionally, the phase III Blockstone study showed Xofluza is effective at preventing influenza infection in healthy people compared with placebo after exposure to an infected household member.

In February 2019, Roche announced that it had entered into a definitive merger agreement to fully acquire Spark Therapeutics, Inc. (‘Spark Therapeutics’). Regulatory review of the transaction is ongoing, and the parties are actively working with the US and UK authorities to facilitate that process. The closing of the transaction is currently expected to take place in 2019. Spark Therapeutics, based in Philadelphia, Pennsylvania, USA, is a fully integrated company committed to discovering, developing and delivering gene therapies for genetic diseases, including blindness, haemophilia, lysosomal storage disorders and neurodegenerative diseases.

Roche Diagnostics – next generation solutions for individualised treatments
The Navify Tumor Board 2.0, the first collaboration product with GE Healthcare, was released for the markets. Incorporating medical image viewing and storage capabilities with other patient data, the product enables tumour boards – multi-disciplinary teams who determine treatment plans for cancer patients – to have a more comprehensive view of each patient in one place. The integration of GE Healthcare’s medical image viewer into Navify Tumor Board 2.0 enables radiologists to upload their patient records to the same dashboard where patient files from other disciplines in the cancer care team are stored. Having complete patient diagnostic information in one location helps specialists use the limited time they have during tumour boards to review all relevant files quickly and agree on the best possible treatment plan for each cancer patient.

Roche launched the Ventana HER2 Dual ISH DNA Probe Cocktail companion diagnostic test for breast and gastric cancer patients eligible for targeted therapy. HER2 – human epidermal growth factor receptor 2 – is an important biomarker in breast and gastric cancers, and its detection and inhibition can help manage these aggressive diseases more effectively. This test is designed to be completed within the same day, enabling clinicians to get results back quicker than with the most common methods of confirmatory testing for HER2. Results can be read using light transmission microscopy, eliminating the need for a specialised fluorescence microscope.

The cobas MTB-RIF/INH test to detect resistance to antibiotics within tuberculosis DNA was launched in countries accepting the CE-mark. This assay is part of the mycobacteria test menu that includes the cobas MTB and cobas MAI tests for use on the cobas 6800/8800 Systems. This continues the expansion of the testing menu on the cobas 6800/8800 Systems, supporting true consolidation and efficient testing. Tuberculosis is the leading cause of infectious disease deaths worldwide.5 The rising challenge of drug resistance compounds the global tuberculosis health crisis. The high sensitivity of the cobas MTB test enables the increased detection of tuberculosis in challenging smear-negative samples.