Johnson & Johnson Reports 2017 Fourth-Quarter Results:

On January 23, 2018 Johnson & Johnson (NYSE: JNJ) reported sales of $20.2 billion for the fourth quarter of 2017, an increase of 11.5% as compared to the fourth quarter of 2016 (Press release, Johnson & Johnson, JAN 23, 2018, View Source [SID1234523486]).

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Operational sales results increased 9.4% and the positive impact of currency was 2.1%. Domestic sales increased 9.8% (Press release, Johnson & Johnson, JAN 23, 2018, View Source [SID1234523486]). International sales increased 13.5%, reflecting operational growth of 9.0% and a positive currency impact of 4.5%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales for the fourth quarter of 2017 increased 4.2%, domestic sales increased 4.1% and international sales increased 4.3%.*

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Worldwide sales for the full-year 2017 were $76.5 billion, an increase of 6.3% versus 2016. Operational results increased 6.0% and the positive impact of currency was 0.3%. Domestic sales increased 5.4%. International sales increased 7.4%, reflecting operational growth of 6.6% and a positive currency impact of 0.8%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales for the full-year 2017 increased 2.4%, domestic sales increased 1.6% and international sales increased 3.3%.*

Net loss and diluted loss per share for the fourth quarter of 2017 were $10.7 billion and $3.99, respectively. Fourth-quarter 2017 net loss included after-tax intangible amortization expense of approximately $0.9 billion and a net charge for after-tax special items of approximately $14.6 billion. Included in these special items is a provisional amount of approximately $13.6 billion associated with the recent enactment of tax legislation.** Fourth-quarter 2016 net earnings included after-tax intangible amortization expense of approximately $0.3 billion and a net charge for after-tax special items of approximately $0.3 billion. Excluding after-tax intangible amortization expense and special items, adjusted net earnings for the current quarter were $4.8 billion and adjusted diluted earnings per share were $1.74, representing increases of 9.5% and 10.1%, respectively, as compared to the same period in 2016.* On an operational basis, adjusted diluted earnings per share increased 5.7%.* A reconciliation of non-GAAP financial measures is included as an accompanying schedule.

Net earnings and diluted earnings per share for the full-year 2017 were $1.3 billion and $0.47, respectively. Full-year net earnings included after-tax intangible amortization expense of approximately $2.5 billion and a charge for after-tax special items of approximately $16.2 billion. Included in these special items is a provisional amount of approximately $13.6 billion associated with the recent enactment of tax legislation.** Full-year 2016 net earnings included after-tax intangible amortization expense of approximately $0.9 billion and a charge for after-tax special items of approximately $1.3 billion. Excluding after-tax intangible amortization expense and special items, adjusted net earnings for the full-year of 2017 were $20.0 billion and adjusted diluted earnings per share were $7.30, representing increases of 6.8% and 8.5%, respectively, as compared to the same period in 2016.* On an operational basis, adjusted diluted earnings per share also increased 7.6%.* A reconciliation of non-GAAP financial measures is included as an accompanying schedule.

"Johnson & Johnson delivered strong adjusted earnings per share growth of 8.5% and total shareholder return of greater than 24% in 2017, driven by the robust performance of our Pharmaceutical business, while continuing to make investments in acquisitions, innovation and strategic partnerships to accelerate growth in each of our businesses," said Alex Gorsky, Chairman and Chief Executive Officer. "As we enter 2018 and look beyond, we are experiencing an incredible pace of change in health care. Johnson & Johnson is uniquely positioned to lead during this dynamic era and deliver innovative solutions for patients and consumers that drive sustainable, long-term growth. We are pleased with the passage of recent legislation modernizing the U.S. tax system, which enables Johnson & Johnson to invest in innovation at higher levels to help address the most challenging unmet medical needs facing health care today."

Mr. Gorsky continued, "I want to thank all of our talented colleagues for their commitment, passion and dedication to transforming the lives of patients and consumers worldwide."

The Company announced its 2018 full-year guidance for sales of $80.6 billion to $81.4 billion reflecting expected operational growth in the range of 3.5% to 4.5%. The Company also announced adjusted earnings guidance for full-year 2018 of $8.00 to $8.20 per share reflecting expected operational growth in the range of 6.8% to 9.6%.* Adjusted earnings guidance excludes the impact of after-tax intangible amortization expense and special items.

Segment Sales Performance
Worldwide Consumer sales of $13.6 billion for the full-year 2017 represented an increase of 2.2% versus the prior year, consisting of an operational increase of 1.3% and a positive impact from currency of 0.9%. Domestic sales increased 2.7%; international sales increased 1.9%, which reflected an operational increase of 0.4% and a positive currency impact of 1.5%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales decreased 0.5%, domestic sales decreased 0.7% and international sales decreased 0.3%*.

Worldwide operational results, excluding the net impact of acquisitions and divestitures, were negatively impacted by declines in the Baby Care and Oral Care businesses, mostly offset by growth in over-the-counter products, including TYLENOL analgesics and upper respiratory products, and NEUTROGENA beauty products.

Worldwide Pharmaceutical sales of $36.3 billion for the full-year 2017 represented an increase of 8.3% versus the prior year with an operational increase of 8.0% and a positive impact from currency of 0.3%. Domestic sales increased 6.7%; international sales increased 10.8%, which reflected an operational increase of 10.1% and a positive currency impact of 0.7%. Sales included the impact of the acquisition of Actelion Ltd. which was completed in June 2017 and contributed 4.2% to worldwide operational sales growth. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 4.2%, domestic sales increased 3.1% and international sales increased 5.8%.* Worldwide operational sales growth was negatively impacted by approximately 1.8 points due to a positive adjustment of U.S. rebate accruals in the first half of 2016, which did not repeat in the first half of 2017.

Worldwide operational results, excluding the net impact of acquisitions and divestitures, were driven by new products and the strength of core products. Strong growth in new products include DARZALEX (daratumumab), for the treatment of patients with multiple myeloma, IMBRUVICA (ibrutinib), an oral, once-daily therapy approved for use in treating certain B-cell malignancies, a type of blood or lymph node cancer and TREMFYA (guselkumab), for the treatment of adults living with moderate to severe plaque psoriasis.

Additional contributors to operational sales growth included STELARA (ustekinumab), a biologic for the treatment of a number of immune-mediated inflammatory diseases, INVEGA SUSTENNA/XEPLION/TRINZA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults, ZYTIGA (abiraterone acetate), an oral, once-daily medication for use in combination with prednisone for the treatment of metastatic, castration-resistant prostate cancer, and XARELTO (rivaroxaban), an oral anticoagulant, partially offset by declines in REMICADE (infliximab), a biologic approved for the treatment of a number of immune-mediated inflammatory diseases, due to biosimilar entrants.

During the quarter, the U.S. Food and Drug Administration (FDA) approved JULUCA (rilpivirine and dolutegravir), the first, complete, single-pill, two-drug regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection; a 10 mg once-daily dose of XARELTO (rivaroxaban) for reducing the continued risk for recurrent venous thromboembolism after completing at least six months of initial anticoagulation therapy; and SIMPONI ARIA (golimumab) for the treatment of adults with active psoriatic arthritis or active ankylosing spondylitis. The European Commission approved TREMFYA (guselkumab) for the treatment of adults with moderate to severe plaque psoriasis and granted approval to broaden the existing marketing authorization for ZYTIGA (abiraterone acetate) plus prednisone / prednisolone to include the treatment of newly-diagnosed high-risk metastatic hormone-sensitive prostate cancer.

Regulatory applications for approval were submitted to the FDA and European Medicines Agency to expand the current indication of DARZALEX (daratumumab) for use in combination with bortezomib, melphalan and prednisone, as a treatment for newly diagnosed patients with multiple myeloma ineligible for autologous stem cell transplantation. In addition, a supplemental New Drug Application was submitted to the FDA for two new XARELTO (rivaroxaban) vascular indications: reducing the risk of major cardiovascular (CV) events such as CV death, heart attack or stroke in patients with chronic coronary and/or peripheral artery disease (CAD/PAD), and for reducing the risk of acute limb ischemia in patients with PAD.

Also in the quarter, a worldwide collaboration and license agreement was executed with Legend Biotech, a subsidiary of GenScript Biotech Corporation, to develop, manufacture and commercialize a chimeric antigen receptor (CAR) T-cell therapy, LCAR-B38M, targeting BCMA for the treatment of multiple myeloma.

Worldwide Medical Devices sales of $26.6 billion for the full-year 2017 represented an increase of 5.9% versus the prior year consisting of an operational increase of 5.7% and a positive currency impact of 0.2%. Domestic sales increased 4.5%; international sales increased 7.1%, which reflected an operational increase of 6.7% and a positive currency impact of 0.4%. Sales included the impact of the acquisition of Abbott Medical Optics which contributed 4.5%, to worldwide operational sales growth. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 1.5%, domestic sales were flat and international sales increased 3.0%.*

Worldwide operational results, excluding the net impact of acquisitions and divestitures, were driven by electrophysiology products in the Cardiovascular business; endocutters and biosurgicals in the Advanced Surgery business; ACUVUE contact lenses in the Vision Care business; and wound closure products in the General Surgery business, partially offset by declines in the Diabetes Care business and spine products in the Orthopaedics business.

BioTime to Present at the Noble Capital Markets 14th Annual Institutional Investor Conference in Fort Lauderdale, January 29, 2018

On January 23, 2018 BioTime, Inc. (NYSE American: BTX), a late-stage, clinical biotechnology company developing and commercializing products addressing degenerative diseases, reported that Russell Skibsted, Chief Financial Officer, will be presenting at the Noble Capital Markets 14th Annual Investor Conference on Monday, January 29, 2018 at 4:00pm ET, at the W Hotel Fort Lauderdale (Press release, BioTime, JAN 23, 2018, View Source;p=RssLanding&cat=news&id=2327855 [SID1234523484]).

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A webcast of Mr. Skibsted’s presentation at this conference will be available at noble.mediasite.com. A replay of the presentation will also be available at the Events and Presentations section of the BioTime website.

BioLineRx Reports Data at ASCO-SITC Conference Showing Complete Tumor Regression by AGI-134 in Pre-Clinical Studies

On January 23, 2018 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX) (TASE: BLRX.TA), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported that AGI-134, an immunotherapy compound in development for the treatment of multiple solid tumors, demonstrated successful results in two pre-clinical melanoma studies (Press release, BioLineRx, JAN 23, 2018, View Source;p=RssLanding&cat=news&id=2327860 [SID1234523483]). Results of these studies will be presented as a poster titled "Intratumoral Administration of the Alpha-Gal Glycolipid AGI-134 to Induce Tumor Regression in a Mouse Model of Melanoma" (Abstract 68) on January 25, 2018 at the ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium, being held January 25-27, 2018, in San Francisco, CA.

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The ability of intratumorally injected AGI-134 to induce regression of established primary tumors was assessed in two murine melanoma models. In the two models, there was complete tumor regression in 50% and 67%, respectively, of mice treated with AGI-134. Moreover, treatment with AGI-134 showed a beneficial effect on survival, compared to the control group. In addition, the results show that injection of AGI-134 into the tumors induces activation of the complement system, an important component of the innate immune system. Activation of the complement system within tumors by AGI-134 is predicted to destroy tumor cells and create a pro-inflammatory tumor microenvironment that attracts and activates other immune cells, ultimately resulting in adaptive anti-tumor immunity. Previous studies with intratumoral administration of AGI-134 to primary tumors had shown that AGI-134 protects mice from the development of distant, untreated tumors.

"We are pleased to report these encouraging results for our second lead oncology project at the upcoming ASCO (Free ASCO Whitepaper)-SITC conference," said Philip Serlin, Chief Executive Officer of BioLineRx. "Previous studies have demonstrated that intratumoral administration of AGI-134 induces a systemic anti-tumor response that protects mice from the development of distant tumors. These new studies now show direct regression of established primary tumors after injection with AGI-134, and that this regression is associated with activation of the innate immune system. These compelling pre-clinical data support investigating this approach in a Phase 1/2a study, and we are excited and on track to commence a first-in-man study with this promising novel oncology asset in patients with solid tumors in the first half of 2018."

About AGI-134

AGI-134 is a synthetic alpha-Gal immunotherapy in development for solid tumors. AGI-134 harnesses the body’s pre-existing, highly abundant anti-alpha-Gal antibodies to induce a systemic, specific anti-tumor response to the patient’s own tumor neo-antigens. This response not only kills the tumor cells at the site of injection, but also brings about a durable, follow-on, anti-metastatic immune response. AGI-134 has completed numerous pre-clinical studies, demonstrating robust protection against the development of secondary tumors in a model of melanoma with a single dose only. Synergy has also been demonstrated in additional pre-clinical studies when combined with a PD-1 immune checkpoint inhibitor, offering the potential to broaden the utility of such immunotherapies, and improve the rate and duration of responses in multiple cancer types. AGI-134 was obtained by BioLineRx through the acquisition of Agalimmune Ltd.

BioLineRx Presents Preclinical Data at ASCO-SITC Showing BL-8040 Prolongs Survival by Mediating Tumor Infiltration of Antigen-Specific T-cells

On January 23, 2018 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX) (TASE: BLRX.TA) a clinical-stage biopharmaceutical company focused on oncology and immunology, reported the publication of data showing that BL-8040, its lead oncology platform, augments the ability of the immune system to fight cancer by increasing the infiltration of anti-tumor-specific T-cells into the tumor microenvironment (TME), resulting in decreased tumor growth and prolonged survival in a murine model of cancer (Press release, BioLineRx, JAN 23, 2018, View Source;p=RssLanding&cat=news&id=2327885 [SID1234523482]). Results of the study will be presented as a poster titled "CXCR4 Antagonist (BL-8040) Enhances Antitumor Effects by Increasing Tumor Infiltration of Antigen-specific Effector T-cells" (Abstract 73) on January 25, 2018 at the ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium, being held January 25-27, 2018, in San Francisco, CA.

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In the preclinical study, a murine model of cancer was used to assess the effects of BL-8040 in combination with a cancer vaccine that primes the immune system against the tumor. The results of the study show that combining BL-8040 with the cancer vaccine leads to a significantly enhanced anti-tumor immune response, which attenuates tumor growth and prolongs mouse survival better than either agent administered alone. The results go on to demonstrate that BL-8040 significantly increases the abundance of tumor-specific T-cells in the TME, suggesting an explanation for the enhanced efficacy of the combination over either agent when administered alone.

"I am highly encouraged by the data generated in this preclinical study, which further demonstrates the therapeutic potential of BL-8040," commented Dr. Samir Khleif, Professor of Oncology and Director of the Loop Immunology-Oncology Laboratory at Georgetown Lombardi Comprehensive Cancer Center. "The results provide further evidence that BL-8040 promotes the infiltration of cytotoxic T-cells into tumors, which is seen as a key objective to improve responsiveness to checkpoint therapy. I look forward to seeing the results from the clinical studies in which BL-8040 is being combined with checkpoint blockade."

"We have shown in numerous preclinical and clinical studies that BL-8040 has various anti-tumor effects, including direct and indirect effects, influencing T-cell location and activity as well as tumor cell survival," commented Philip Serlin, Chief Executive Officer of BioLineRx. "The results of the current study suggest that BL-8040 enhances anti-tumor immune response by increasing the number of anti-tumor T-cells in the TME. These results also suggest that BL-8040, a CXCR4 antagonist, is a promising immune-modulatory agent with potent anti-tumor effects, and we remain on track with our eight ongoing clinical trials for this product in various indications, both in blood cancers as well as in solid tumors."

About BL-8040

BL-8040 is a short peptide for the treatment of acute myeloid leukemia, solid tumors, and stem cell mobilization. It functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis, metastasis and cell survival. CXCR4 is over-expressed in more than 70% of human cancers and its expression often correlates with disease severity. In a number of clinical and preclinical studies, BL-8040 has shown robust mobilization of cancer cells and immune-cells from the bone marrow, thereby sensitizing cancer cells to chemo- and bio-based anti-cancer therapy, as well as a direct anti-cancer effect by inducing cell death (apoptosis) and mobilizing immune-cells. In addition, BL-8040 has also demonstrated robust stem-cell mobilization, including the mobilization of colony-forming cells, T, B and NK cells. BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.

ABL Europe and SillaJen Expand Strategic Manufacturing Collaboration for Oncolytic Virus Therapies

On January 22, 2018 SillaJen, Inc., (KOSDAQ:215600), a clinical-stage, biotherapeutics company focused on the development of oncolytic immunotherapy products for cancer, and ABL Europe, an ABL, Inc. company providing dedicated viral vector GMP services for gene therapy, oncolytic products and vaccines for all stages of clinical supply, reported that thay have expanded their strategic manufacturing collaboration (Press release, Advanced BioScience Laboratories, JAN 22, 2018, View Source [SID1234565002]). Under the current agreement, ABL is currently manufacturing Pexa-Vec (formerly JX-594) for SillaJen’s multinational, randomized Phase 3, open-label study of Pexa-Vec in patients with advanced liver cancer. Under the expanded agreement, ABL will also provide development, manufacturing & QC release testing services for SillaJen’s pipeline product, JX-970.

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"Based on SillaJen’s established partnership with ABL, we are pleased to further expand our agreement to include another exciting product in our pipeline," stated Georg Roth, Ph.D, Senior Vice President, Technical Operations at SillaJen. "ABL has significant experience in virus manufacturing, and we are glad to be able to utilize their expertise in order to continue to expedite the development of these important oncolytic virus therapies."

"We are excited about the significant potential of SillaJen’s oncolytic immunotherapy products and are pleased to further expand our agreement with an additional product," stated Patrick Mahieux, Ph.D., General Manager of ABL Europe. "Our primary focus is ultimately to safely help patients in need, and so we look forward to applying our twenty-plus years of experience in virus manufacturing to these exciting oncolytic products."

Pexa-Vec Clinical Development Program and SOLVE Platform
Pexa-Vec is the most advanced product candidate from SillaJen’s proprietary SOLVE (Selective Oncolytic Vaccinia Engineering) platform. The vaccinia strain backbone of Pexa-Vec has been used safely in millions of people as part of a worldwide vaccination program. This strain naturally targets cancer cells due to common genetic defects in cancer cells; Pexa-Vec was engineered to enhance this by deleting its thymidine kinase (TK) gene, thus making it dependent on the cellular TK expressed at persistently high levels in cancer cells. Pexa-Vec is also engineered to express the immunogenic GM-CSF protein. GM-CSF complements the cancer cell lysis of the product candidate, leading to a cascade of events resulting in tumor necrosis, tumor vasculature shutdown and sustained anti-tumoral immune attack.

The ongoing Phase 3 study, named the PHOCUS trial, is designed to enroll 600 patients who have not received prior systemic treatment for their cancer. To learn more about the trial, please visit: View Source

About JX-970
JX-970 is an oncolytic virus that is derived from a Western Reserve strain vaccinia virus, and its tumor selectivity has been optimized through deletion of thymidine kinase (TK) and vaccinia growth factor (VGF). In addition, it expresses GM-CSF to stimulate immune responses. In nonclinical studies, the JX-970 backbone exerted a tumor debulking effect and at the same time demonstrated a selective preference for tumor tissues.