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 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 Varian Medical Systems reported Aarhus University Hospital in Denmark has treated two liver cancer patients with stereotactic body radiotherapy (SBRT) using Calypso ‘GPS for the Body’ transponders from Varian Medical Systems (NYSE: VAR) for real-time monitoring during the treatment (Press release, Varian Medical Systems, JUL 14, 2015, View Source [SID:1234506330]). A 77-year-old man and a woman, aged 76, both with metastases in the liver, were treated in three sessions over six days, making them the first liver cancer patients in Europe, and only the second and third in the world, to be treated in this way.

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!

"Our experience so far is that tracking tumors with Calypso transponders may help make a significant difference in liver SBRT treatments," says Morten Hoyer, professor of clinical oncology at Aarhus. "In the past, we would have to apply a more generous treatment margin around the tumor because of uncertainties regarding the precise tumor position from day to day. Calypso allows us to monitor the treatment real-time and reduce the treatment margin, meaning less healthy tissue is treated."

Per Poulsen, associate professor responsible for motion management tools, adds, "Calypso is a real-time monitoring device that provides additional evidence that the dose is being delivered where it should be, which is even more important in higher dose treatments like radiosurgery. These implanted markers are a very good representation of what is happening real-time."

Medical physicist Esben Worm said the Calypso transponders, three of which are implanted at the edge of the tumors, have enabled the team at Aarhus to deliver respiratory gated stereotactic treatments for the first time. In gated treatments, patients are treated after they have exhaled and the beam is automatically turned off while they inhale, improving precision by adjusting for motion caused by breathing. "The Calypso transponders help ensure the tumor is in the planned treatment position during exhale and provides easy online correction of the patient position to counteract tumor drift," said Esben Worm.

Advanced stereotactic body radiotherapy treatments for lung and liver patients have been delivered at Aarhus for over 15 years. Since 2005, the oncology center has exclusively used Varian equipment and software for its radiotherapy patients.

"As a next step we hope to use Calypso transponders to track tumor motion with the treatment beam, which will allow fast and smooth treatment delivery with real-time adaptation to both respiration and target movement," said Dr. Poulsen. "We also hope to explore their use in proton therapy treatments."

It was recently announced that the National Proton Therapy Center in Denmark will be located at Aarhus University Hospital and Varian has been selected to equip the new facility with its ProBeam proton therapy system.

On July 14, 2015 NewLink Genetics reported shared its strategy for becoming a leading immuno-oncology company at a meeting for analysts and investors in New York (Press release, NewLink Genetics, JUL 14, 2015, View Source [SID:1234506331]). A link to the webcast and the slides can be accessed in the investor relations section of the company’s website, www.newlinkgenetics.com.

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 key pillars of our strategy continue to build on the emerging scientific and clinical consensus that future treatment options for patients with cancer will need to generate a targeted immune response and disrupt checkpoint blockade," said Charles Link, Jr., M.D., Chairman and Chief Executive Officer. "We believe that our HyperAcute Immunotherapy and IDO pathway inhibitor platform products show great promise and could be important advances for patients with cancer."

The NewLink Genetics management team presented on key areas:

Advancing an industry-leading immuno-oncology therapy pipeline across multiple cancer types with seven product candidates in clinical development from Phase 1 to Phase 3. Through the company’s multi-faceted immuno-oncology treatment strategy, NewLink Genetics is engaged in clinical trials for five distinct HyperAcute Immunotherapy candidates and two indoleamine 2, 3-dioxygenase (IDO) pathway inhibitor product candidates. This pipeline of immuno-oncology products is one of the broadest and most advanced of the emerging companies in the immuno-oncology field, addressing multiple cancers including pancreatic, non-small cell lung, breast, melanoma, prostate, renal and glioblastoma multiforme.

Unique HyperAcute Immunotherapy platform. This proprietary technology produces allogeneic whole-cell vaccines engineered to express alpha gal, a carbohydrate that has been shown to produce hyperacute immune responses. HyperAcute Immunotherapy is being studied in the clinic and suggests the inducement of immune responses against pancreatic cancer, non-small-cell lung cancer, melanoma, prostate cancer and renal cancer.

Multiple small molecules targeting the key IDO checkpoint blockade. Indoleamine 2, 3-dioxygenase (IDO) is a naturally occurring enzyme that allows the human body to suppress its immune system, when needed. Some cancers have developed the ability to employ IDO to evade immune attack. Two NewLink Genetics’ products in clinical development —indoximod and GDC-0919 (partnered with Genentech)—inhibit the IDO pathway to counteract this immune suppression.

Founding scientific and business leadership with proven expertise in drug discovery, manufacturing, clinical development and commercialization. The company has built an effective and efficient organization with the capabilities to perform clinical trials on a broad portfolio of product candidates for numerous indications, to prepare the necessary regulatory filings and to manufacture clinical and commercial drug supply.

Algenpantucel-L has the potential to be the first FDA-approved drug for the adjuvant treatment of patients with resected pancreatic cancer. Algenpantucel-L HyperAcute Immunotherapy was developed to address an unmet medical need in resected pancreatic cancer. Algenpantucel-L is in the late stages of a Phase 3 registration clinical trial (IMPRESS) in patients with surgically resected pancreatic cancer. The company also has begun to build out the commercial infrastructure needed to effectively launch algenpantucel-L should it receive FDA approval.

Proven success in substantial strategic collaborations. The quality of the company’s product pipeline has been validated in its ability to form successful collaborations with two leading biopharmaceutical companies—Genentech in immuno-oncology and Merck in infectious disease.

"Over the next 24 months, we expect significant value-creating news flow," commented Nicholas N. Vahanian, M.D., President and Chief Medical Officer. "In addition to pivotal results from our algenpantucel-L program covering two distinct and potential first-mover indications in pancreatic cancer (IMPRESS for patients with resected pancreatic cancer and PILLAR for patients with locally advanced or borderline resectable pancreatic cancer), we expect clinical advancements across our IDO pathway inhibitor program in multiple cancers, clinical milestones with Genentech on the clinical advancement of GDC-0919, the initiation of new combination trials and potential results from the clinical trials assessing our Ebola vaccine candidate through our partnership with Merck."

On July 14, 2015 ProMIS Neurosciences Inc. ("ProMIS Neurosciences" or, the "Company") (formerly, Amorfix Life Sciences Ltd.), reported that it has effected its name change to ProMIS Neurosciences Inc. on July 8, 2015 and shares will begin trading under the new name on July 14, 2015 (Press release, ProMIS Neurosciences, JUL 14, 2015, View Source [SID:1234510740]).
TORONTO, Ontario – July 14, 2015 – the common shares of the Company will commence trading on the Toronto Stock Exchange under the new name "ProMIS Neurosciences Inc." and the new stock symbol "PMN" at the opening of trading on July 14 2015. The new CUSIP number is 74346M109 and the new ISIN number is CA 74346M1095.

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!