On October 18, 2016 Johnson & Johnson (NYSE: JNJ) reported sales of $17.8 billion for the third quarter of 2016, an increase of 4.2% as compared to the third quarter of 2015 (Press release, Johnson & Johnson, OCT 18, 2016, View Source [SID1234515896]). Schedule your 30 min Free 1stOncology Demo! Operational sales results increased 4.3% and the negative impact of currency was 0.1%. Domestic sales increased 6.7%. International sales increased 1.5%, reflecting operational growth of 1.7% and a negative currency impact of 0.2%. Excluding the net impact of acquisitions, divestitures and hepatitis C sales, on an operational basis, worldwide sales increased 5.9%, domestic sales increased 7.3% and international sales increased 4.2%.* Operations in Venezuela negatively impacted worldwide operational sales growth by 30 basis points, and international sales growth by 70 basis points.
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Net earnings and diluted earnings per share for the third quarter of 2016 were $4.3 billion and $1.53, respectively. 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. Third quarter 2015 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. Excluding after-tax intangible amortization expense and special items, adjusted net earnings for the current quarter were $4.7 billion and adjusted diluted earnings per share were $1.68, representing increases of 12.2% and 12.8%, respectively, as compared to the same period in 2015. * On an operational basis, adjusted diluted earnings per share also increased 12.8%.* A reconciliation of non-GAAP financial measures is included as an accompanying schedule.
"Our third-quarter results reflect the success of our new product launches and the strength of our core businesses, driven by strong growth in our Pharmaceuticals business. With a number of regulatory approvals, several new drug application submissions and new breakthrough therapy designations from the FDA, we are increasingly confident in our pipeline expectation of filing 10 new pharmaceutical products between 2015 and 2019, each with revenue potential over $1 billion," said Alex Gorsky, Chairman and Chief Executive Officer. "Our broad-based business model, strategic investments and talented colleagues position us well for continued leadership in health care."
The Company maintained its sales guidance for the full-year 2016 of $71.5 billion to $72.2 billion. Additionally, the Company increased its adjusted earnings guidance for full-year 2016 to $6.68 – $6.73 per share.*
Worldwide Consumer sales of $3.3 billion for the third quarter 2016 represented a decrease of 1.6% versus the prior year, consisting of an operational increase of 0.1% and a negative impact from currency of 1.7%. Domestic sales increased 1.1%; international sales decreased 3.3%, which reflected an operational decrease of 0.6% and a negative currency impact of 2.7%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales decreased 0.4%, domestic sales decreased 1.5% and international sales increased 0.3%*. Operations in Venezuela negatively impacted worldwide Consumer operational sales growth by 110 basis points and international sales growth by 180 basis points.
Worldwide operational results, excluding the net impact of acquisitions and divestitures, were negatively impacted by lower trade inventory levels, primarily in the U.S. Positive contributors to Consumer operational sales results included LISTERINE oral care products; AVEENO skin care products and digestive health products and international smoking aids in over-the-counter products.
Worldwide Pharmaceutical sales of $8.4 billion for the third quarter 2016 represented an increase of 9.2% versus the prior year with an operational increase of 9.0% and a positive impact from currency of 0.2%. Domestic sales increased 11.8%; international sales increased 5.4%, which reflected an operational increase of 5.0% and a positive currency impact of 0.4%. Excluding the net impact of acquisitions, divestitures and hepatitis C sales, on an operational basis, worldwide sales increased 10.7%, domestic sales increased 13.0% and international sales increased 7.0%.*
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; and XARELTO (rivaroxaban), an oral anticoagulant.
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; and INVEGA SUSTENNA/XEPLION/TRINZA (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 INVOKAMET XR (canagliflozin/metformin HCl extended-release) for first-line treatment of adults with type 2 diabetes, and STELARA (ustekinumab) for the treatment of adults with moderately to severely active Crohn’s disease. The Committee for Medicinal Products for Human Use issued a positive opinion recommending approval of STELARA for the treatment of adults with moderately to severely active Crohn’s disease.
Additionally, regulatory applications for approval were submitted to the FDA and European Medicines Agency (EMA) for DARZALEX in combination with standard-of-care regimens for patients with multiple myeloma who have received at least one prior therapy. DARZALEX also received Breakthrough Therapy Designation from the FDA for this pending indication. The FDA also granted Breakthrough Therapy Designation to esketamine for major depressive disorder with imminent risk for suicide. Regulatory applications for approval were also submitted to the FDA for sirukumab in rheumatoid arthritis, and to EMA for a darunavir-based single tablet regimen for the treatment of HIV-1.
Worldwide Medical Devices sales of $6.2 billion for the third quarter 2016 represented an increase of 1.1% versus the prior year consisting of an operational increase of 0.7% and a positive currency impact of 0.4%. Domestic sales increased 1.4%; international sales increased 0.7%, which reflected an operational decline of 0.2% and a positive currency impact of 0.9%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 3.1%, domestic sales increased 2.3% and international sales increased 3.9%.*
Worldwide operational results, excluding the net impact of acquisitions and divestitures, were driven by electrophysiology products in the Cardiovascular business; endocutters and energy 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, a definitive agreement was announced to acquire Abbott Medical Optics, a wholly-owned subsidiary of Abbott Laboratories, for $4.325 billion in cash. Acclarent announced the U.S. launch of ACCLARENT AERA, the first balloon dilation intervention approved by the FDA for Eustachian Tube Dysfunction.
Author: [email protected]
Spherix Provides Update on Patent Infringement Litigation
On October 17, 2016 Spherix Incorporated (Nasdaq: SPEX) an intellectual property development company committed to the fostering of technology and monetization of intellectual property, reported an update on its active patent infringement lawsuits, new lawsuits filed, and spending reduction initiatives (Press release, Spherix, OCT 17, 2016, View Source [SID1234538994]).
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Anthony Hayes, Chief Executive Officer of Spherix, stated, "Spherix is now in the best position to deliver shareholder value from its patent portfolio than at any time in the past. In the last six months, we’ve effectuated ten new patent infringement lawsuits against defendants with a combined market capitalization of approximately $48 billion. There are more suits on file now than at any time in the last four years. And while most of these suits are recently filed, we are working with our partner Equitable IP to reach fair and equitable settlements with any licensee. Copies of all ten complaints can be viewed on our website, (www.spherix.com). We anticipate additional suits will be filed before year end. I am increasingly encouraged with our strategic position and confident in our ability to create sustainable shareholder value, even as our stock continues to be valued at less than the Company’s net tangible book value."
The following is a list of our key initiatives:
Through our relationship with Equitable IP, we have commenced litigation against:
ATN International, Inc. Commnet Wireless, LLC Choice Communications LLC, and Choice Communications, LLC ("Choice Wireless"), case number: 1:16-cv-00718-RGA, in the U.S. District Court for the District of Delaware, related to alleged infringement of the ‘999 patent.
Cincinnati Bell, Inc., case number 1:16-cv-00715-RGA, in the U.S. District Court for the District of Delaware, related to alleged infringement of the ‘999 patent, ‘461 patent, and the ‘167 patent.
Echostar Corporation, case number 1:16-cv-00716-RGA, in the U.S. District Court for the District of Delaware, related to alleged infringement of the ‘999 patent.
Frontier Communications Corporation, case number 1:16-cv-00714-RGA, in the U.S. District Court for the District of Delaware, related to alleged infringement of the ‘999 patent.
Sprint Corporation and Clearwire Corporation case number 1:16-cv-00719-RGA, in the U.S. District Court for the District of Delaware, related to alleged infringement of the ‘999 patent.
Fortinet Inc., case number 1:16-cv-00795-RGA, in the U.S. District Court for the District of Delaware, related to alleged infringement of the ‘999 patent.
ViaSat, Inc., case number 1:16-cv-00720-RGA, in the U.S. District Court for the District of Delaware, related to alleged infringement of the ‘999 patent.
DragonWave Inc. and DragonWave Corp, case number 1:16-cv-00797-RGA, in the U.S. District Court for the District of Delaware, related to alleged infringement of the ‘999 patent.
Fortinet, Inc, case number 1:16-cv-00795-RGA, in the U.S. District Court for the District of Delaware, related to alleged infringement of the ‘999 patent.
GTT Communications, Inc., case number 1:16-cv-00796-RGA, in the U.S. District Court for the District of Delaware, related to alleged infringement of the ‘999 patent.
The Company’s Federal Circuit appeal against Uniden continues to proceed. The Uniden case has now been fully briefed and oral argument is expected to be calendared in the next several weeks. Oral argument in such appeals is usually calendared within two months of the submission of the Joint Appendix of the record, which was completed on October 5, 2016. The oral argument hearing usually occurs within five to six months of the submission of the Joint Appendix.
Spherix management is confident in its position that the Patent Trial and Appeals Board erred and that the Board’s Decision invalidating Spherix’s patent-in-suit should be reversed. As stated in the briefing, the Board failed to comply with the Administrative Procedure Act and its conclusion is not supported by the evidence. The Board also applied the wrong patent claim construction, requiring a reversal of its obviousness finding. Management looks forward to discussing its position with the Court during the upcoming oral argument and setting the record straight so that this case can move forward.
Mr. Hayes continued, "In addition to the strong progress we have made towards generating revenue, we have taken meaningful steps to reduce overhead and decrease our monthly cash burn. We have delivered sequential reductions in our overhead expenses in each of our last two quarters and expect this trend to continue as we work to refine our cost structure to an appropriate level consistent with providing the company with ample runway to achieving success. With costs on the decline and more than $7 million in unencumbered cash, we have the staying power to drive shareholder value."
"We understand that each of our cases may widely vary with respect to its size, scope and complexity," concluded Mr. Hayes. "However, there is one feature that tends to remain consistent. The patent enforcement process is often long and requires tremendous patience. To that end we want to thank our committed shareholders for their patience and long term focus. Our multimillion dollar settlement with RPX this past May is emblematic of the rewards that we can enjoy from our hard work and dedication simply by staying the course. As we move forward, we are constantly looking for ways to further creating value."
Accurexa and StemImmune Collaborate to Develop Stem Cell-mediated Immunotherapy for Cancer
On October 17, 2016 Accurexa Inc. ("Accurexa") (ACXA), a biotechnology company focused on the development of novel neurological therapies to be directly delivered into the brain reported a collaboration with StemImmune Inc. ("StemImmune") to develop its stem cell-mediated immunotherapy for the treatment of cancer, such as brain cancer (Press release, Accurexa, OCT 17, 2016, View Source [SID1234516525]). StemImmune’s immunotherapy uses the stealth anti-cancer payload carrying and tumor seeking capacities of a patient’s own readily available (adult) stem cells to target cancer. The patient’s immune system cannot recognize and react to the "Trojan Horse" stem cells, because they are the patient’s own. To date, StemImmune has treated 25 cancer patients with its proprietary technology in a Phase 1 clinical trial that showed that its stem cell-mediated immunotherapy was safe and well-tolerated with no adverse events reported, and demonstrated potential anti-tumor activity which supports further investigation in clinical trials. All patients received treatment through a minimally invasive outpatient procedure.
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"We are excited to collaborate with StemImmune and to use stem cells for the delivery of immunotherapies. Stem cells have the capacity to home to tumors, and efficiently carry proprietary anti-cancer payloads directly to cancer cells, while mobilizing the patient’s immune system to recognize and fight the cancer. This approach is in line with the mission of Accurexa to directly deliver therapies to targeted areas in the treatment of cancer and other disorders, and adds a clinical-stage oncology program to our pipeline," said George Yu, MD, President & CEO of Accurexa.
"Eradicating cancer and giving patients the ability to undergo lifesaving treatment with no debilitating side effects is what drives our research. Combining our patented technology with Accurexa’s proprietary methods of delivering targeted therapies to specific areas of the brain makes Accurexa a valuable partner for us as we pursue the eradication of cancer," said Aladar Szalay, PhD, Founder, CEO and Chairman of StemImmune. "We look forward to a long and productive relationship with Accurexa."
Review Of Delcath’s CHEMOSAT Accepted For Publication In Advances In Therapy
On October 17, 2016 Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology Company focused on the treatment of primary and metastatic liver cancers, reported that a review of research conducted with the Delcath Hepatic CHEMOSAT Delivery System (CHEMOSAT) has been accepted for publication by the prestigious medical journal, Advances in Therapy (Press release, Delcath Systems, OCT 17, 2016, View Source;p=RssLanding&cat=news&id=2212191 [SID1234515872]). The retrospective study, "Chemosaturation Percutaneous Hepatic Perfusion: A Systemic Review," was conducted by a team led by Dr. Arndt Vogel of the University of Hanover in Germany, and resulted from a CHEMOSAT Experts Forum convened by Delcath in February 2015.
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"This retrospective study originated as a white paper produced by our Experts Panel in 2015 as a means of sharing information, recent research results, and clinical experiences using CHEMOSAT to treat primary and metastatic liver cancers," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and Chief Executive Officer of Delcath. "We are pleased that Dr. Vogel and his teams’ work has been accepted for publication in such a prestigious journal as Advances in Therapy, and that the potential for CHEMOSAT to treat primary and metastatic liver cancers as identified by our experts will reach a wider audience."
DelMar Pharmaceuticals Presents Overview of VAL-083’s Unique Anticancer Mechanism at the European Association of Neuro-Oncology (EANO) Annual Meeting
On October 17, 2016 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported that the Company presented additional data regarding VAL-083’s unique anti-cancer mechanism on Saturday October 15, 2016 at the 12th Meeting of the European Association of Neuro-Oncology (EANO) in Mannheim, Germany (Press release, DelMar Pharmaceuticals, OCT 17, 2016, View Source [SID1234515856]).
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DelMar’s poster presentation can be viewed at View Source
"These data further differentiate VAL-083’s mechanism of action against cancer from the current standard of care in the treatment of glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer," said Dr. Dennis Brown, DelMar’s Chief Scientific Officer.
Temozolomide, the current front-line therapy generates its anti-tumor activity by methylation of the O6-position of guanine, resulting in a base-pair mismatch which can be lethal to the tumor cell if not repaired. The majority of patients exhibit a high expression of the DNA repair enzyme "MGMT", which readily repairs temozolomide-derived DNA damage leading to tumor resistance and treatment failure. GBM patients failing temozolomide have a very poor prognosis with median survival of 6 – 9 months.
VAL-083 attacks the tumor’s DNA at a different location and in a different way, rapidly forming durable cross links at the N7-position of guanine. These cross-links are not repaired by MGMT.
"These cross-links result in double-strand breaks during DNA replication which are more potent and more difficult for the cell to repair in comparison to the DNA damage conferred by temozolomide. In particular, MGMT does not act against the type of DNA damage resulting from VAL-083 treatment," added Dr. Brown.
"The EANO meeting provided an opportunity to introduce our VAL-083 to European neuro-oncology thought-leaders," said Jeffrey Bacha chairman & CEO of DelMar. Expanding our relationships with key opinion leaders on a global basis will provide opportunities for collaboration as we expand the development of VAL-083 beyond our current focus in the refractory, Avastin-failed population.
"Importantly, poor patient outcomes due to MGMT-mediated chemo-resistance were a consistent theme throughout the conference. Based on our research, we believe VAL-083’s unique mechanism and ability to circumvent the tumor’s MGMT resistance mechanism may provide a foundational opportunity as a new treatment paradigm," stated Mr. Bacha.
About VAL-083
VAL-083 is a "first-in-class," small-molecule chemotherapeutic. In more than 40 Phase I and II clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 demonstrated clinical activity against a range of cancers including lung, brain, cervical, ovarian tumors and leukemia both as a single-agent and in combination with other treatments.
VAL-083 has received an orphan drug designation in Europe for the treatment of malignant gliomas and the U.S. FDA Office of Orphan Products has granted an orphan designation to VAL-083 for the treatment of glioma, medulloblastoma and ovarian cancer.
The Company has completed a successful end of Phase II meeting with the US FDA and plans to advance VAL-083 into a pivotal clinical trial for GBM patients following bevacizumab failure. DelMar presented data from its Phase I/II clinical trial in refractory GBM at the 2016 American Association of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual meeting demonstrating that the median survival of 22 patients receiving an assumed therapeutic dose of VAL-083 (≥20mg/m2) was 8.35 months following bevacizumab (Avastin) failure compared to published literature where survival of approximately two to five months has been reported.
DelMar’s advanced development program will feature a single multi-center randomized Phase III study measuring survival outcomes compared to a "physicians’ choice" control, which, if successful, would serve as the basis for a New Drug Application (NDA) submission for VAL-083. The control arm will consist of a limited number of salvage chemotherapies currently utilized in the treatment of Avastin-failed GBM. The final pivotal trial design will be confirmed with the FDA following further discussions with the Company’s clinical advisors.
In addition to the pivotal trial, DelMar also plans to initiate two separate Phase II clinical trials in earlier-stage GBM patients.
In collaboration with the University of Texas MD Anderson Cancer Center: A non-comparative, biomarker-driven, Phase II study to determine if treatment of MGMT-unmethylated recurrent GBM with VAL-083 or CCNU improves overall survival at 9 months, compared to historical control in bevacizumab naïve patients. (clinicaltrials.gov identifier: NCT02717962)
In collaboration with Sun-Yat Sen University and Guangxi Wuzhou Pharmaceutical (Group) Co.: A single arm Phase II clinical trial to confirm the tolerability of DelMar’s dosing regimen in combination with radiotherapy (XRT) and to explore the activity of VAL-083 in newly diagnosed MGMT-unmethylated GBM patients whose tumors are known to express high levels of MGMT.
DelMar believes that data from these clinical trials, if successful, will form the basis of a new paradigm in the treatment for all GBM patients who fail, or whose tumors exhibit features that make them unlikely to respond to, currently available chemotherapy.
In addition to its clinical research in GBM, DelMar believes that its research supports a unique mechanism of action for VAL-083 and that these data support the potential of VAL-083 as a new chemotherapy that may offer improved outcomes in the treatment of GBM and other solid tumors in patients whose tumors have failed or exhibit features that make them resistant to or unlikely to respond to current standard-of-care chemotherapy.