On January 24, 2017 Johnson & Johnson (NYSE: JNJ) reported sales of $18.1 billion for the fourth quarter of 2016, an increase of 1.7% as compared to the fourth quarter of 2015 (Press release, Johnson & Johnson, JAN 24, 2017, View Source [SID1234517545]).

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!

Operational sales results increased 2.3% and the negative impact of currency was 0.6%. Domestic sales increased 2.6%. International sales increased 0.6%, reflecting operational growth of 1.9% and a negative currency impact of 1.3%. As a reminder, there were additional shipping days in the fourth quarter of 2015 that negatively impacted the current quarter by 480 basis points. Excluding the net impact of acquisitions, divestitures, hepatitis C, Venezuela, and the additional shipping days in 2015, on an operational basis, worldwide sales increased 7.6%, domestic sales increased 9.5% and international sales increased 5.6%.*

Worldwide sales for the full-year 2016 were $71.9 billion, an increase of 2.6% versus 2015. Operational results increased 3.9% and the negative impact of currency was 1.3%. Domestic sales increased 6.0%. International sales decreased 0.9%, reflecting operational growth of 1.8% and a negative currency impact of 2.7%. The additional shipping days in 2015 negatively impacted the current year by 130 basis points. Excluding the net impact of acquisitions, divestitures, hepatitis C, Venezuela, and the additional shipping days in 2015, on an operational basis, worldwide sales increased 7.4%, domestic sales increased 8.9% and international sales increased 5.7%.*

Net earnings and diluted earnings per share for the fourth quarter of 2016 were $3.8 billion and $1.38, respectively. 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. Fourth-quarter 2015 net earnings included after-tax intangible amortization expense of approximately $0.2 billion and a net charge for after-tax special items of approximately $0.6 billion. Excluding after-tax intangible amortization expense and special items, adjusted net earnings for the current quarter were $4.4 billion and adjusted diluted earnings per share were $1.58, representing increases of 7.9% and 9.7%, respectively, as compared to the same period in 2015.* On an operational basis, adjusted diluted earnings per share also increased 10.4%.* A reconciliation of non-GAAP financial measures is included as an accompanying schedule.

Net earnings and diluted earnings per share for the full-year 2016 were $16.5 billion and $5.93, respectively. Full-year 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. Full-year 2015 net earnings included after-tax intangible amortization expense of approximately $1.1 billion and a charge for after-tax special items of approximately $0.9 billion. Excluding after-tax intangible amortization expense and special items, adjusted net earnings for the full-year of 2016 were $18.8 billion and adjusted diluted earnings per share were $6.73, representing increases of 7.6% and 8.5%, respectively, as compared to the same period in 2015.* On an operational basis, adjusted diluted earnings per share also increased 9.4%.* A reconciliation of non-GAAP financial measures is included as an accompanying schedule.

"We are pleased to report that we accelerated our adjusted growth for 2016 over the prior year, and delivered a strong total shareholder return of greater than 15 percent. The strong adjusted sales and EPS growth was driven by the impressive performance of our Pharmaceutical business and continued momentum in our Medical Device business and share gains while improving profitability in our Consumer business," said Alex Gorsky, Chairman and Chief Executive Officer. "Looking forward to 2017, we expect to continue driving sustainable, long-term growth through the new products, science and innovation that our talented colleagues and partners of Johnson & Johnson are advancing to positively impact human health."

The Company announced its 2017 full-year guidance for sales of $74.1 billion to $74.8 billion reflecting expected operational growth in the range of 4.0% to 5.0%. Excluding the impact of acquisitions and divestitures, operational sales growth is expected to be in the range of 3.0% to 3.5%.* Additionally, the Company announced adjusted earnings guidance for full-year 2017 of $6.93 to $7.08 per share reflecting expected operational growth in the range of 4.8% to 7.0%.* Adjusted earnings guidance excludes the impact of after-tax intangible amortization expense and special items.

Additionally, as part of the Company’s ongoing portfolio management, the Company is announcing it is engaging in a process to evaluate potential strategic options for the Johnson & Johnson Diabetes Care Companies, specifically LifeScan, Inc., Animas Corporation, and Calibra Medical, Inc. Strategic options may include the formation of operating partnerships, joint ventures or strategic alliances, a sale of the businesses, or other alternatives either separately or together. All options will be evaluated to determine the best opportunity to drive future growth and maximize shareholder value. There can be no assurance that this process will result in any transaction or other strategic alternative of any kind.

Worldwide Consumer sales of $13.3 billion for the full-year 2016 represented a decrease of 1.5% versus the prior year, consisting of an operational increase of 1.5% and a negative impact from currency of 3.0%. Domestic sales increased 3.8%; international sales decreased 4.8%, which reflected an operational increase of 0.1% and a negative currency impact of 4.9%. Excluding the net impact of acquisitions, divestitures, Venezuela, and the additional shipping days in 2015, on an operational basis, worldwide sales increased 4.3%, domestic sales increased 5.6% and international sales increased 3.4%*.

Worldwide operational results, excluding the net impact of acquisitions and divestitures, were driven by over-the-counter products, including TYLENOL analgesics, digestive health products and anti-smoking aids; NEUTROGENA and AVEENO beauty products and LISTERINE oral care products.

Worldwide Pharmaceutical sales of $33.5 billion for the full-year 2016 represented an increase of 6.5% versus the prior year with an operational increase of 7.4% and a negative impact from currency of 0.9%. Domestic sales increased 9.8%; international sales increased 1.8%, which reflected an operational increase of 4.0% and a negative currency impact of 2.2%. Excluding the net impact of acquisitions, divestitures, hepatitis C, Venezuela, and the additional shipping days in 2015, on an operational basis, worldwide sales increased 11.5%, domestic sales increased 13.8% and international sales increased 8.3%.*

Worldwide operational results, excluding the net impact of acquisitions, divestitures and hepatitis C sales, were driven by new products and the strength of core products. Strong growth in new products include IMBRUVICA (ibrutinib), an oral, once-daily therapy approved for use in treating certain B-cell malignancies, a type of blood or lymph node cancer; DARZALEX (daratumumab), for the treatment of patients with multiple myeloma; XARELTO (rivaroxaban), an oral anticoagulant and INVOKANA/INVOKAMET (canagliflozin), for the treatment of adults with type 2 diabetes.

Additional contributors to operational sales growth included STELARA (ustekinumab), REMICADE (infliximab) and SIMPONI/SIMPONI ARIA (golimumab), biologics approved 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 and EDURANT (rilpivirine) for the treatment of HIV.

Sales results were negatively impacted by generic entrants for ORTHO TRI-CYCLEN LO (norgestimate/ethinyl estradiol) oral contraceptive and INVEGA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults.

During the quarter, the U.S. Food and Drug Administration (FDA) approved DARZALEX (daratumumab) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. The European Commission approved STELARA for the treatment of adults with moderately to severely active Crohn’s disease. Subsequent to the quarter, in January, the FDA approved IMBRUVICA (ibrutinib) for the treatment of patients with marginal zone lymphoma who require systemic therapy and have received at least one prior anti-CD20- based therapy.

Additionally, regulatory applications for approval were submitted to the FDA and European Medicines Agency (EMA) for guselkumab for the treatment of adults living with moderate to severe plaque psoriasis. Regulatory applications for approval were also submitted to the FDA for SIMPONI ARIA (golimumab) for the treatment of adults living with active psoriatic arthritis and the treatment of adults living with active ankylosing spondylitis and for STELARA (ustekinumab) for the treatment of adolescents (12 to 17 years of age) with moderate to severe plaque psoriasis.

Worldwide Medical Devices sales of $25.1 billion for the full-year 2016 represented a decrease of 0.1% versus the prior year consisting of an operational increase of 0.9% and a negative currency impact of 1.0%. Domestic sales increased 1.1%; international sales decreased 1.2%, which reflected an operational increase of 0.7% and a negative currency impact of 1.9%. Excluding the net impact of acquisitions, divestitures, Venezuela and the additional shipping days in 2015, on an operational basis, worldwide sales increased 3.8%, domestic sales increased 2.9% and international sales increased 4.7%.*

Worldwide operational results, excluding the net impact of acquisitions and divestitures, were driven by electrophysiology products in the Cardiovascular business; endocutters, energy and biosurgicals in the Advanced Surgery business; ACUVUE contact lenses in the Vision Care business; and joint reconstruction and trauma products in the Orthopaedics business.

During the quarter, the FDA approved OneTouch Vibe Plus Insulin Pump and Continuous Glucose Monitoring System for the treatment of patients age two and older living with diabetes.

Also during the quarter, the purchase of expandable cage technologies for spinal fusion was completed, and a development agreement was entered into, with Interventional Spine, Inc.

On January 24, 2017 TapImmune, Inc. (NASDAQ: TPIV), a clinical-stage immuno-oncology company specializing in the development of innovative peptide and gene-based immunotherapeutics for the treatment of cancer and metastatic disease, reported that Memorial Sloan Kettering Cancer Center (MSKCC) successfully completed the first safety cohort in its Phase 2 ovarian cancer study (Press release, TapImmune, JAN 24, 2017, View Source [SID1234517564]). The study is designed to examine the efficacy of the TapImmune lead investigational product candidate, TPIV 200, in combination with AstraZeneca’s investigational checkpoint inhibitor, durvalumab.

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 Phase 2 ovarian cancer study is sponsored by MKSCC under the leadership of Dr. Jason Konner. This clinical milestone allows MSKCC to increase the number of patients that can be enrolled and will subsequently increase the study’s enrollment rate. Patients in this study are resistant to platinum chemotherapy and have few treatment options. Since TPIV 200 and durvalumab have not been used before in combination, the protocol required the start of the study to proceed cautiously for the first four patients. There have been no safety issues to date, and the enrollment is now allowed to proceed at a faster rate.

"This study and the TapImmune-sponsored Phase 2 study in triple negative breast cancer study represent the company’s progress in clinical development of its lead product, TPIV 200," said Glynn Wilson, Chairman and CEO of TapImmune, Inc. "We also recently announced the opening of our second ovarian cancer study with FDA Fast Track designation in platinum-sensitive patients. As we have previously stated, TapImmune has Fast Track designation for TPIV 200 as maintenance therapy in subjects with platinum-sensitive advanced ovarian cancer who achieved stable disease or partial response following completion of standard of care chemotherapy."

On January 24, 2017 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), a biopharmaceutical company specializing in the development of innovative drugs for the treatment of orphan diseases, in particular in oncology, reported the completion of enrollment in ReLive, the international Phase III clinical trial evaluating Livatag for the treatment of advanced hepatocellular carcinoma (HCC) (Press release, Onxeo, JAN 24, 2017, View Source [SID1234517561]).

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!

"Advanced HCC is a particularly severe form of liver cancer with a high mortality and very few treatment options", commented Pr. Philippe Merle, Professor in Hepatology (La Croix Rousse Hospital, Lyon, France) and Principal Investigator of the ReLive study. "All patients have now been enrolled in the Phase III trial of Livatag and the DSMB recommendations point towards an adequte safety profile. We hope this treatment will become a new option for patients with advanced HCC for whom there is a strong unmet therapeutic need and we are now looking forward to the preliminary efficacy data expected within a few months."

The ReLive trial is evaluating the efficacy of intravenous (IV) administration of Livatag (doxorubicin transdrug) in patients with advanced HCC after failure or intolerance to sorafenib compared to the best standard of care chosen by the physician. In line with Onxeo’s international development plan, the company has conducted this Phase III trial in 11 countries (Europe, USA, MENA*).

To date, 390 patients have been randomized, with about 260 patients in the Livatag treatment group and 130 in the the comparative group (best standard of care). The completion of patient randomization is an important milestone that confirms the expected timeline of issuing the preliminary efficacy outcomes of the study mid-2017.

"Completion of enrollment in ReLive marks a significant milestone for the HCC community. This is a major step forward in the development of Livatag as a new therapeutic option in a pathology for which there is a strong need for new treatment. It is also a major achievement for Onxeo, which demonstrates its ability to complete a large international Phase III trial and marks a major value creation catalyst, in line with the expected publication of preliminary results in mid-2017," concludes Judith Greciet, Chief Executive Officer of Onxeo. "On behalf of Onxeo, we would like to extend our warmest thanks to the investigators and coordinators of the clinical sites for their active participation that enabled us to carry out this trial".

From a safety standpoint, nine DSMB** reviews of the ReLive study have already been conducted over the course of the study. During these reviews, the experts did not identify unexpected adverse effects or signals and unanimously recommended each time the continuation of the trial without modification. These repeated positive recommendations – based on data from the administration of almost 1,000 Livatag infusions – seem to indicate an adequate safety profile of the drug to date. These findings are important because they reflect the likelihood that this profile will be acceptable to both physicians and regulators.


Livatag, an innovative therapeutic approach to hepatocellular carcinoma
Livatag is a nanoparticle formulation of doxorubicin, developed using Onxeo’s proprietary Transdrug technology designed to facilitate the penetration of the drug into the tumor cell and increase the target DNA exposure to the drug, thereby bypassing the mechanisms of multi-drug resistance developed by tumor cells. By specifically accumulating in the liver cells and overcoming resistance to doxorubicin, Livatag represents a potentially significant breakthrough in the treatment of hepatocellular carcinoma.

Hepatocellular Carcinoma, an aggressive form of primary liver cancer
Hepatocellular carcinoma (HCC) or hepatocarcinoma is the most common of the primary liver cancers (85% to 90%). According to Globocan (2012 data), liver cancer is the 6th most common cancer in terms of incidence (782,000 new cases worldwide each year, 5.6% of all new cancer cases) with the 2nd highest mortality rate (95% lethality) after lung cancer. The major risk factors are infection by hepatitis viruses (B and C), overconsumption of alcohol and metabolic diseases, especiallynon-alcoholic steato-hepatitis, a growing cause of cirrhosis and HCC.

On January 24, 2017 TG Therapeutics, Inc. (NASDAQ:TGTX) reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation covering the combination of TG-1101 (ublituximab), the Company’s novel, glycoengineered anti-CD20 monoclonal antibody, and TGR-1202 the Company’s oral, next generation PI3K delta inhibitor, for the treatment of patients with diffuse large B-cell lymphoma (DLBCL) (Press release, TG Therapeutics, JAN 24, 2017, View Source [SID1234517546]).

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 combination of TG-1101 and TGR-1202 is currently being evaluated in the UNITY-DLBCL Phase 2b Trial for patients with relapsed or refractory DLBCL as well as the UNITY-CLL Phase 3 Trial for patients with both frontline and previously treated chronic lymphocytic leukemia (CLL).

"We are pleased to receive orphan drug designation for our proprietary combination of TG-1101 and TGR-1202 in diffuse large B-cell lymphoma. This status complements our already strong proprietary protection portfolio which includes composition of matter patents issued for both TG-1101 and TGR-1202, as well as orphan drug designation already granted for the combination in CLL," stated Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics. Mr. Weiss continued, "DLBCL is an area of significant unmet medical need and we are highly encouraged by the early clinical data we have seen in DLBCL patients treated with 1101 plus 1202 and look forward to evaluating this further in our ongoing Phase 2b registration directed trial."

ABOUT ORPHAN DRUG DESIGNATION

Orphan drug designation is granted by the FDA to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. Orphan drug designation provides certain incentives which may include tax credits towards the cost of clinical trials and prescription drug user fee waivers. If a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan product exclusivity.

ABOUT DIFFUSE LARGE B-CELL LYMPHOMA

According to the American Cancer Society, diffuse large B-cell lymphoma (DLBCL) is an aggressive (fast growing) type of non-Hodgkin lymphoma (NHL), a cancer that starts in cells called lymphocytes, which are part of the body’s immune system. Diffuse large B-cell lymphoma is the most common type of NHL in the United States, accounting for about 30% of newly diagnosed cases of NHL. DLBCL occurs in both men and women and can affect any age group, although its prevalence increases with age, with the average age of diagnosis being in the mid-60s.

On January 24, 2017 Cellectar Biosciences, Inc. (Nasdaq: CLRB), an oncology-focused clinical stage biotechnology company, reported that the United States Patent and Trademark Office ("USPTO") has granted patent number 9,550,002, which covers method of use for the company’s lead compound, CLR 131, as well as CLR 125, for the treatment of cancer (Press release, Cellectar Biosciences, JAN 24, 2017, View Source [SID1234517543]). The granting of this patent follows the company’s previous announcement of patent allowances for the use of the company’s phospholipid drug conjugate (PDC) delivery platform in these tumor types.

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!

"This patent strengthens our radiotherapeutic intellectual property portfolio and further demonstrates Cellectar’s commitment to optimizing our PDC technology platform," said Jim Caruso, president and CEO of Cellectar. "While we are currently focused on developing CLR 131 for hematologic malignancies such as multiple myeloma, the claims granted provide additional development optionality for Cellectar or a potential partner."

The granted patent covers the use of CLR 131 for the potential treatment of a broad range of malignant solid tumors, which include adrenal, lung, ovarian or cervical, prostate, liver, breast and colon, as well as melanoma or subcutaneous cancers.

About CLR 131
CLR 131 is an investigational compound under development for a range of hematologic malignancies. It is currently being evaluated in a Phase I clinical trial in patients with relapsed or refractory multiple myeloma. The company plans to initiate a Phase II clinical study to assess efficacy in a range of B-cell malignancies in the first quarter of 2017. Based upon pre-clinical and interim Phase I study data, treatment with CLR 131 provides a novel approach to treating hematological diseases and may provide patients with therapeutic benefits, including overall response rate (ORR), an improvement in progression-free survival (PFS) and overall quality of life. CLR 131 utilizes the company’s patented PDC tumor targeting delivery platform to deliver a cytotoxic radioisotope, iodine-131 directly to tumor cells. The FDA has granted Cellectar an orphan drug designation for CLR 131 in the treatment of multiple myeloma.

About CLR 125
CLR 125 is a broad-spectrum, cancer-targeting, radiotherapeutic, which may be uniquely suited to treat micro-metastatic disease. CLR 125 uses the radioisotope iodine-125 conjugated to the company’s proprietary phospholipid drug conjugate (PDC) delivery platform. Similar to CLR 131, the selective uptake and retention of CLR 125 has been observed in malignant tissues during pre-clinical studies. Funded by a recent NCI SBIR award, the company evaluated the feasibility and safety of CLR 125 for the treatment of triple-negative breast cancer (TNBC) in the (neo) adjuvant setting. This program was successfully completed and demonstrated appropriate biodistribution, tolerability, and dose response.

About Phospholipid Drug Conjugates (PDCs)
Cellectar’s product candidates are built upon its patented cancer cell-targeting delivery and retention platform of optimized phospholipid ether-drug conjugates (PDCs). The company deliberately designed its phospholipid ether (PLE) carrier platform to be coupled with a variety of payloads to facilitate both therapeutic and diagnostic applications. The basis for selective tumor targeting of our PDC compounds lies in the differences between the plasma membranes of cancer cells compared to those of normal cells. Cancer cell membranes are highly enriched in lipid rafts, which are glycolipoprotein microdomains of the plasma membrane of cells that contain high concentrations of cholesterol and sphingolipids, and serve to organize cell surface and intracellular signaling molecules. PDCs have been tested in more than 80 different xenograft models of cancer.