On July 14, 2015 OncoSec Medical reported that Robert H. Pierce, MD, Chief Scientific Officer, will participate in a BioPharma Dealmakers webcast featuring four companies developing cancer immunotherapies (Press release, OncoSec Medical, JUL 14, 2015, View Source [SID:1234506329]). The webcast is scheduled for 11:00 am ET on July 21, 2015. To register for the webcast, please click here.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The webcast will explore some of the challenges and opportunities of technologies at the cutting edge of cancer immunotherapy. Participants will learn about new approaches that have been developed to:

Harness the full potential of our immune system
Screen for novel target and antibody combinations
Enlist our own immune system to attack cancer cells
Improve the delivery of cancer-specific therapeutics to tumors

The webcast will include a round table discussion and a Q&A session to enable participants to contribute their own thoughts on this highly innovative area of cancer research. The webcast is sponsored in part by OncoSec. In addition to Dr. Pierce, other webcast participants include:

Jeremy Graff, PhD, Senior Vice President, Pharmaceutical Research for Biothera. Dr. Graff joined Biothera from Eli Lilly and Company where he was Research Fellow and Group Leader, Oncology Patient Tailoring.

Björn Frendéus, PhD, Chief Scientific Officer, BioInvent. Dr. Frendéus is an immunologist and graduate of the Swedish Foundation for Strategic Research.

Harlan Robins, PhD, Adaptive Biotechnologies. Dr. Robins is the Chief Scientific Officer and Co-Founder of Adaptive Biotechnologies.

Moderator: Gaspar Taroncher-Oldenburg, PhD. Dr. Taroncher-Oldenburg is an independent consultant and former managing editor of SciBX: Science-Business eXchange for Nature Publishing Group and the former scientific editor at Nature Biotechnology.

On July 14, 2015 Johnson & Johnson reported sales of $17.8 billion for the second quarter of 2015, a decrease of 8.8% as compared to the second quarter of 2014 (Press release, Johnson & Johnson, JUL 14, 2015, View Source [SID:1234506328]). Operational results decreased 0.9% and the negative impact of currency was 7.9%. Domestic sales decreased 2.4%. International sales decreased 14.3%, reflecting operational growth of 0.5% and a negative currency impact of 14.8%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 1.7%, domestic sales increased 0.6% and international sales increased 2.7%.* Additionally excluding hepatitis C sales, underlying operational growth worldwide was 5%.*

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Net earnings and diluted earnings per share for the second quarter of 2015 were $4.5 billion and $1.61, respectively. Second quarter 2015 net earnings included after-tax intangible amortization expense of approximately $0.2 billion and a charge for after-tax special items of approximately $0.1 billion. Second quarter 2014 net earnings included after-tax intangible amortization expense of approximately $0.4 billion and a charge for after-tax special items of approximately $0.4 billion. A reconciliation of non-GAAP financial measures is included as an accompanying schedule. 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 $1.71, representing decreases of 6.3% and 3.9%, respectively, as compared to the same period in 2014.* On an operational basis, adjusted diluted earnings per share increased 6.7%.*

"Our solid sales and earnings results in the quarter reflect the strong underlying growth we’re seeing across the enterprise," said Alex Gorsky, Chairman and Chief Executive Officer. "Our diverse portfolio and scale are enabling this performance, and we’ve continued to invest in building a robust enterprise pipeline that will drive our growth over the long term. Our passion to deliver transformational new medicines and products reflects the ongoing commitment of our dedicated employees to improve health and well-being."

The Company increased its adjusted earnings guidance for full-year 2015 to $6.10 – $6.20 per share. The Company’s guidance excludes the impact of after-tax intangible amortization expense and special items.

Worldwide Consumer sales of $3.5 billion for the second quarter represented a decrease of 7.0% versus the prior year, consisting of an operational increase of 2.3% and a negative impact from currency of 9.3%. Domestic sales increased 2.7%; international sales decreased 12.2%, which reflected an operational increase of 2.1% and a negative currency impact of 14.3%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 3.1%, domestic sales increased 2.9% and international sales increased 3.2%.*

Positive contributors to Consumer operational results were sales of over-the-counter products including ZYRTEC allergy medications and TYLENOL analgesics; international feminine protection products; and LISTERINE oral care products.

Worldwide Pharmaceutical sales of $7.9 billion for the second quarter represented a decrease of 6.6% versus the prior year with operational growth of 1.0% and a negative impact from currency of 7.6%. Domestic sales decreased 1.5%; international sales decreased 12.7%, which reflected an operational increase of 3.8% and a negative currency impact of 16.5%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 1.5%, domestic sales decreased 0.6% and international sales increased 3.9%.* Additionally excluding hepatitis C sales, underlying operational growth worldwide was 9.7%.*

Worldwide operational sales growth was driven by new products and the strength of core products. New product sales growth was negatively impacted by lower sales of OLYSIO (simeprevir) in the U.S and lower sales of SOVRIAD (simeprevir) in Japan due to competitive entrants. Strong growth in new products include INVOKANA/INVOKAMET (canagliflozin), for the treatment of adults with type 2 diabetes; international sales of OLYSIO (simeprevir), for combination treatment of chronic hepatitis C in adult patients; IMBRUVICA (ibrutinib), an oral, once-daily therapy approved for use in treating certain B-cell malignancies, or blood cancers; XARELTO (rivaroxaban), an oral anticoagulant; and ZYTIGA (abiraterone acetate), an oral, once-daily medication for use in combination with prednisone for the treatment of metastatic, castration-resistant prostate cancer.

Additional contributors to operational sales growth were STELARA (ustekinumab), a biologic approved for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis; INVEGA SUSTENNA/XEPLION (paliperidone palmitate), a once-monthly, long-acting, injectable atypical antipsychotic for the treatment of schizophrenia in adults; domestic sales of CONCERTA (methylphenidate HCI), for the treatment of attention deficit hyperactivity disorder; and SIMPONI/SIMPONI ARIA (golimumab), biologics approved for the treatment of a number of immune-mediated inflammatory diseases.

During the quarter, the U.S. Food and Drug Administration (FDA) granted approval of INVEGA TRINZA (paliperidone palmitate), an atypical antipsychotic injection administered four times a year for the treatment of schizophrenia. In July, a rolling submission was completed with the FDA for the Biologic License Application for daratumumab for the treatment of multiple myeloma. The European Commission approved STELARA (ustekinumab) for the treatment of adolescents with moderate-to-severe psoriasis, SIMPONI (golimumab) for treatment of non-radiographic axial spondyloarthritis and IMBRUVICA (ibrutinib) for the treatment of Waldenström’s Macroglobulinemia.

Also in the quarter, an exclusive worldwide license and collaboration arrangement was entered into with Achillion Pharmaceuticals, Inc. to develop and commercialize one or more of Achillion’s lead hepatitis C virus assets.

Worldwide Medical Devices sales of $6.4 billion for the second quarter represented a decrease of 12.2% versus the prior year consisting of an operational decrease of 4.7% and a negative currency impact of 7.5%. Domestic sales decreased 5.8%; international sales decreased 17.3%, which reflected an operational decrease of 3.9% and a negative currency impact of 13.4%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 1.4%, domestic sales increased 1.6% and international sales increased 1.4%.*

Primary contributors to operational growth were sales of endocutters in the Surgical Care business; electrophysiology products in the Cardiovascular Care business; joint reconstruction products in the Orthopaedics business; international sales of contact lenses in the Vision Care business; and sales of biosurgicals and energy products in the Specialty Surgery business.

During the quarter, the Company announced the acceptance of the March 1, 2015 binding offer from Cardinal Health to acquire its Cordis business for an approximate value of $2 billion.

On July 14, 2015 Celator Pharmaceuticals reported that patients have been enrolled in an investigator-initiated Phase 2 clinical study evaluating CPX-351 (cyatarabine:daunorubicin) Liposome Injection as a treatment for patients with newly diagnosed Acute Myeloid Leukemia (AML) at high risk for induction treatment mortality (Press release, Celator Pharmaceuticals, JUL 14, 2015, View Source [SID:1234506326]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Patients with newly diagnosed AML at increased risk of early death urgently need safer and more effective treatment," said Jorge Cortes, M.D., Deputy Department Chair, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center. "Our earlier experiences with CPX-351 in newly diagnosed and first relapse AML patients make us optimistic about this trial."

Phase 2 studies with CPX-351 observed improved efficacy and reduced early mortality in the majority of patients studied directly supporting evaluating CPX-351 in this population of newly diagnosed AML patients at high risk for induction treatment mortality.

The Phase 2 study will enroll up to 55 patients, with the primary objective to assess the preliminary efficacy and safety of multiple dose levels of CPX-351 in patients with newly diagnosed AML at high risk for induction treatment mortality. High risk for induction treatment mortality is defined as 30%-50% predicted risk of expiring by day 60. Estimation of risk for induction treatment mortality will be based on factors associated with lower likelihood of AML response with or without factors that reduce tolerance to treatment-associated adverse events. Every patient must have at least one AML-related factor (adverse cytogenetics, secondary AML, MDR phenotype, etc.) that contributes to elevated risk of induction treatment mortality. Patients may or may not have patient-related factors (poor performance status, co-morbidities, poor organ function, etc.) that also contribute to elevated risk of induction treatment mortality.

"We are pleased that Dr. Cortes and MD Anderson Cancer Center chose to study CPX-351 in this patient population," said Arthur Louie, Chief Medical Officer of Celator Pharmaceuticals. "As we await overall survival data from our CPX-351 Phase 3 trial in patients with high-risk AML, we believe there is significant potential for CPX-351 in other AML populations as well as other blood cancers, and we believe it important to evaluate these opportunities."