* 2017 Third-Quarter Sales of $19.7 Billion Increased 10.3% versus 2016 .
* 2017 Third-Quarter EPS was $1.37 .
* 2017 Adjusted Third-Quarter EPS of $1.90 increased 13.1%* .
* Accelerated Sales and Adjusted EPS Growth .
*Increased Full-Year Sales and Adjusted EPS Guidance .
New Brunswick, N.J. (October 17, 2017) –
Johnson & Johnson (NYSE: JNJ) today announced sales of $19.7 billion for the third quarter of 2017, an increase of 10.3% as compared to the third quarter of 2016. Operational sales results increased 9.5% and the positive impact of currency was 0.8%. Domestic sales increased 9.7%. International sales increased 10.9%, reflecting operational growth of 9.3% and a positive currency impact of 1.6%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide, domestic and international sales each increased 3.8%.*
Net earnings and diluted earnings per share for the third quarter of 2017 were $3.8 billion and $1.37, respectively. Third-quarter 2017 net earnings included after-tax intangible amortization expense of approximately $0.9 billion and a charge for after-tax special items of approximately $0.5 billion. Third-quarter 2016 net earnings included after-tax intangible amortization expense of approximately $0.2 billion and a charge for after-tax special items of approximately $0.2 billion. Excluding after-tax intangible amortization expense and special items, adjusted net earnings for the current quarter were $5.2 billion and adjusted diluted earnings per share were $1.90, representing increases of 11.2% and 13.1%, respectively, as compared to the same period in 2016.* On an operational basis, adjusted diluted earnings per share also increased 10.1%.* A reconciliation of non-GAAP financial measures is included as an accompanying schedule.
“Johnson & Johnson accelerated growth in the third quarter. This is driven by the strong performance of our Pharmaceutical business, and augmented by Actelion and other recent acquisitions across the enterprise that will continue to fuel growth,” said Alex Gorsky, Chairman and Chief Executive Officer. “Our dedicated colleagues continue to focus on advancing our pipelines to bring innovative solutions to patients and consumers around the globe.”
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P.J. : Por recordar que Janssen ( J&J ) esta ya Comercializando Yondelis en EEUU y Paises NO U.E. ... en la indicación de Sarcomas .
Y que esta llevando a cabo la Fase III para la indicación de Ovario tambien para ser comercializado en EEUU .
IASLC 2017 .
ATLANTIS: Phase III Study of PM01183 with Doxorubicin vs. CAV or Topotecan in Small-Cell Lung Cancer After Platinum Therapy (ID 9326) .
Presenting Author(s): Jose Antonio Lopez-Vilariño | Author(s): A. Farago, Luis Paz-Ares, A. Fülop, A. Chiappori, K. Syrigos, C. Kahatt, G. Kos, A. Soto-Matos .
Abstract
Background:
Lurbinectedin (PM01183) is a new compound that blocks active transcription, produces DNA breaks and apoptosis, and affects the inflammatory microenvironment. First signs of synergism with doxorubicin (DOX) and responses, especially in relapsed small cell lung cancer (SCLC) (overall response rate [ORR] ~67%, including about 10% of complete responses [CR]), were reported in a phase I expansion cohort in 21 second-line SCLC patients (ASCO 2015, abstract 7509). Main toxicity was hematological. A lower dose was used to improve safety, and activity was confirmed in an expansion cohort of 27 patients with relapsed SCLC (~37%, with 4% of CR)
Method:
Multinational (20 countries), multicenter (154 sites), open-label, randomized phase III study of PM01183/DOX vs. a control arm with investigator choice of either standard cyclophosphamide, DOX and vincristine (CAV) or topotecan (T). A total of 600 patients will be randomized (1:1) and stratified according to ECOG performance status (PS), central nervous system (CNS) involvement, previous treatment with antiPD1/antiPD-L1, chemotherapy-free interval and investigator´s choice of control arm. Patients with clinical benefit after 10 cycles of the combination could continue with single-agent PM01183 or CAV, until progressive disease or unacceptable toxicity. An interim safety analysis by an independent data monitoring committee (IDMC) is planned when the first 150 patients have been randomized. Most relevant inclusion criteria includes: age 18 years and confirmed diagnosis of SCLC (if primary site is unknown, the patient will be eligible if Ki-67 expression 50%), mandatory previous platinum-containing line (additional immunotherapy is allowed), ECOG PS 0-2, and adequate major organ function (including LVEF 50%). Patients are excluded if chemotherapy-free interval is 30 days, pre-treated with PM01183, DOX or T, symptomatic or steroids-requiring CNS involvement, or any medical condition that might preclude safe compliance with study treatment. Primary objective is to determine a difference in progression-free survival (RECIST v.1.1) by independent review committee. Secondary endpoints include overall survival, survival rates at 12/18/24 months, antitumor response (RECIST v.1.1), duration of response, quality of life, safety, subgroup analyses and pharmacokinetics of PM01183/DOX.
Result:
The first patient was included in August 2016. An interim safety analysis, requested by the IDMC, was conducted on the first 50 patients randomized and treated with 2 cycles, and resulted in a recommendation to continue the trial unmodified.
Conclusion:
The ATLANTIS randomized phase III study is currently ongoing. Trial recruitment is expected to be completed at Q1 2018.
P.J. : Por recordar que Janssen ( J&J ) esta ya Comercializando Yondelis en EEUU y Paises NO U.E. ... en la indicación de Sarcomas . 
