Atossa Genetics Announces Intraductal Microcatheter ImmunoOncology Pre-Clinical Program

On July 18, 2018 Atossa Genetics Inc. (ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions, reported that it is advancing its intraductal microcatheter immunotherapy program with pre-clinical studies being conducted by Translational Drug Development, LLC ("TD2") (Press release, Atossa Genetics, JUL 18, 2018, View Source [SID1234527758]). The purpose of the initial study is to develop and validate preclinical methods of using Atossa’s proprietary intraductal microcatheter technology to administer immunotherapy to the site of tumor initiation.

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"While there has been recent success treating blood cancers with chimeric antigen receptor therapy (or, CAR-T), there has not been much success using CAR-T to treat solid tumors like breast cancer," commented Steve Quay, Ph.D., MD, President and CEO of Atossa. "We are, however, encouraged by a recent case study reported June 4, 2018 in Nature Medicine (N. Zacharakis, et al.), in which a patient with metastatic breast cancer who was not responding to chemotherapy had complete tumor regression 22 months after being treated with an intravenous infusion of eighty billion T-cells and interleukin. We believe our proprietary intraductal microcatheter technology may provide a unique and more efficacious and cost-effective treatment method by delivering a significantly smaller number of T-cells directly to the site of the cancer prior to metastasis, rather than through the blood stream, where they are diluted into the entire body. These studies are the first of several steps to develop our intraductal microcatheter technology to treat breast cancer with cell-based immunotherapy, such as CAR-T. These pre-clinical studies will form the basis for the design of human studies, with the ultimate goal of treating breast cancer by administering an immunotherapy with our proprietary microcatheter technology," added Dr. Quay.

The studies are being conducted for Atossa by Translational Drug Development, LLC, which is an oncology development organization that provides innovative services and is uniquely positioned to support improved and accelerated development of medicines for life-threatening oncology diseases.

EUSA Pharma Announces Acquisition of Global Rights to SYLVANT® (siltuximab) from Janssen Sciences Ireland UC for $115 Million

On July 18, 2018 EUSA Pharma (EUSA), a biopharmaceutical company focused on oncology and rare disease, reported that it has entered into a definitive agreement with Janssen Sciences Ireland UC, a subsidiary of Janssen R&D Ireland (Janssen) to acquire the global rights to SYLVANT (siltuximab) for $115 million in cash (Press release, EUSA Pharma, JUL 18, 2018, View Source [SID1234553163]). The transaction is subject to review under the United States Hart–Scott–Rodino Antitrust Improvements Act of 1976, as amended, and the parties expect to close following completion of this regulatory review period and the mutual satisfaction of other remaining closing conditions.

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SYLVANT is approved in more than 40 countries worldwide, including the United States, the European Union, the Republic of Korea and Canada, for the treatment of idiopathic multicentric Castleman’s disease (iMCD), a rare, life threatening and debilitating orphan condition. Idiopathic MCD is an inflammatory lymphoproliferative disorder, which causes the abnormal overgrowth of immune cells and shares many symptomatic and histological features with lymphoma.1 The disease can affect individuals at any age, with iMCD representing one-third to half of all multicentric Castleman’s disease (MCD).2

"iMCD is a devastating disorder with few treatment options for patients, because the underlying mechanisms are so poorly understood," said David Fajgenbaum, MD, MBA, MSc, Assistant Professor of Translational Medicine and Human Genetics, and Associate Director, Patient Impact, Orphan Disease Center, at the Perelman School of Medicine at the University of Pennsylvania.

SYLVANT is the only approved treatment for iMCD in the United States and Europe. It first received approval in the United States in 2014, with subsequent approvals occurring in a number of countries thereafter. Since then, SYLVANT has achieved rapid revenue growth.

The approval of SYLVANT was based on the MCD2001 study (NCT01024036); an international, randomised, double blind, placebo-controlled trial including 79 subjects. More than one-third of subjects in the SYLVANT arm had a durable tumour and symptomatic response to treatment plus best supportive care (BSC), compared to none of the subjects who received placebo plus BSC (34% versus 0% according to stringent criteria; 95% CI: 11.1, 54.8; p=0.0012).3

"The acquisition of SYLVANT represents a significant opportunity for EUSA Pharma. As the only approved treatment for this orphan condition, SYLVANT highlights the importance of ongoing research and development in areas where there are few patients yet high unmet medical needs", said Lee Morley, EUSA Pharma’s Chief Executive Officer. "Following the recent divestment of our critical care portfolio, EUSA Pharma has transformed into a rapidly growing biopharmaceutical company focused solely on oncology and rare disease, backed by leading life science investor EW Healthcare Partners. SYLVANT is a perfect fit with our ambitious plans to roll out innovative biopharmaceutical treatments to serve the oncology and rare disease community worldwide.

Clovis Oncology to Announce Second Quarter 2018 Financial Results and Host Webcast Conference Call on August 1

On July 18, 2018 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that it will announce its second quarter 2018 financial results on Wednesday, August 1, 2018, after the close of the U.S. financial markets (Press release, Clovis Oncology, JUL 18, 2018, View Source [SID1234527759]). Clovis’ senior management will host a conference call and live audio webcast at 4:30 p.m. ET to discuss the company’s results in greater detail.

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The conference call is being webcast and can be accessed from the Clovis Oncology website at www.clovisoncology.com. A replay of the webcast will be available for 30 days.

Conference Call Details

Clovis will hold a conference call to discuss second quarter 2018 results on August 1 at 4:30 p.m. ET. The conference call will be simultaneously webcast on the Company’s website at www.clovisoncology.com, and archived for future review. Dial-in numbers for the conference call are as follows: US participants 866.489.9022, International participants 678.509.7575, conference ID: 9289064.

20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)]

(Filing, Annual, Sellas Life Sciences, 2017, JUL 18, 2018, View Source [SID1234527760])

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Abbott Reports Second-Quarter 2018 Results

On July 18, 2018 Abbott (NYSE: ABT) reported financial results for the second quarter ended June 30, 2018 (Press release, Abbott, JUL 18, 2018, View Source [SID1234527761]).

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Second-quarter worldwide sales of $7.8 billion increased 17.0 percent on a reported basis and 8.0 percent on an organic* basis.
Reported diluted EPS from continuing operations under GAAP was $0.40 in the second quarter.
Adjusted diluted EPS from continuing operations, which excludes specified items, was $0.73, above Abbott’s previous guidance range.
Abbott is raising its full-year 2018 EPS guidance range, which continues to reflect strong double-digit growth. Abbott projects full-year diluted EPS from continuing operations on a GAAP basis of $1.34 to $1.40. Projected full-year adjusted diluted EPS from continuing operations is now $2.85 to $2.91.
In May, Abbott received approval from the U.S. FDA for XIENCE Sierra, the newest generation of its gold-standard coronary stent system, which offers design and technology advances to provide an easier implant and greater ability to treat complex blockages. During the second quarter, XIENCE Sierra also received national reimbursement in Japan to treat people with coronary artery disease.
In May, Abbott announced U.S. FDA clearance of Advisor HD Grid Mapping Catheter, Sensor Enabled, which creates highly detailed maps of the heart and expands Abbott’s leading electrophysiology product portfolio.
In July, Abbott received U.S. FDA approval for a next-generation version of its leading MitraClip heart valve repair device. This new version includes design advancements that simplify the minimally invasive procedure and enable more patients to be treated with MitraClip.
"All four of our businesses exceeded expectations and contributed to strong growth overall," said Miles D. White, chairman and chief executive officer, Abbott. "We forecast continued strong performance and are raising our full-year outlook despite recent currency shifts."

* See note on organic growth below.

SECOND-QUARTER BUSINESS OVERVIEW
Note: Management believes that measuring sales growth rates on an organic basis is an appropriate way for investors to best understand the underlying performance of the business.

Organic sales growth:

Excludes prior year results for the Abbott Medical Optics (AMO) and St. Jude Medical vascular closure businesses, which were divested during the first quarter 2017;
Excludes the current and prior year results for Rapid Diagnostics, which reflect results for Alere Inc., which was acquired on Oct. 3, 2017; and
Excludes the impact of foreign exchange.

Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates.

Second-quarter 2018 worldwide sales of $7.8 billion increased 17.0 percent on a reported basis. On an organic basis, worldwide sales increased 8.0 percent. Refer to tables titled "Non-GAAP Reconciliation of Adjusted Historical Revenue" for a reconciliation of adjusted historical revenue.

Worldwide Nutrition sales increased 7.3 percent on a reported basis in the second quarter, including a favorable 0.9 percent effect of foreign exchange, and increased 6.4 percent on an organic basis.

Worldwide Pediatric Nutrition sales increased 6.4 percent on a reported basis in the second quarter, including a favorable 1.1 percent effect of foreign exchange, and increased 5.3 percent on an organic basis. International sales increased 10.2 percent on a reported basis, including a favorable 2.1 percent effect of foreign exchange, and increased 8.1 percent on an organic basis. Strong performance in the quarter was led by growth in several countries across Asia, including Greater China, and Latin America.

Worldwide Adult Nutrition sales increased 8.5 percent on a reported basis in the second quarter, including a favorable 0.7 percent effect of foreign exchange, and increased 7.8 percent on an organic basis. International sales increased 15.2 percent on a reported basis, including a favorable 1.3 percent effect of foreign exchange, and increased 13.9 percent on an organic basis. Sales performance was led by strong growth of Ensure, Abbott’s market-leading complete and balanced nutrition brand, and Glucerna, Abbott’s market-leading diabetes-specific nutrition brand.

Rapid Diagnostics reflects sales from Alere Inc., which was acquired on Oct. 3, 2017. Organic growth rates above exclude results from the Rapid Diagnostics business.

n/m = Percent change is not meaningful.

Worldwide Diagnostics sales increased 47.2 percent on a reported basis in the second quarter. On an organic basis, sales increased 6.6 percent. Refer to tables titled "Non-GAAP Reconciliation of Adjusted Historical Revenue" for a reconciliation of adjusted historical revenue.

Core Laboratory Diagnostics sales increased 10.6 percent on a reported basis in the second quarter, including a favorable 2.9 percent effect of foreign exchange, and increased 7.7 percent on an organic basis. Growth in the quarter was driven by continued share gains globally.

Molecular Diagnostics sales increased 7.9 percent on a reported basis in the second quarter, including a favorable 1.9 percent effect of foreign exchange, and increased 6.0 percent on an organic basis. Worldwide sales were led by strong growth in infectious disease testing, Abbott’s core area of focus in the molecular diagnostics market, which was partially offset by a planned scale down in other testing areas, primarily in the U.S.

Point of Care Diagnostics sales decreased 0.8 percent on a reported basis in the second quarter, including a favorable 0.5 percent effect of foreign exchange, and decreased 1.3 percent on an organic basis.

Rapid Diagnostics worldwide sales of $484 million were led by infectious disease and cardiometabolic testing.

Established Pharmaceuticals sales increased 10.5 percent on a reported basis in the second quarter, including an unfavorable 1.8 percent effect of foreign exchange, and increased 12.3 percent on an organic basis.

Key Emerging Markets comprise several countries that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these geographies increased 8.4 percent on a reported basis in the second quarter, including an unfavorable 3.6 percent effect of foreign exchange, and increased 12.0 percent on an organic basis. Sales growth was led by double-digit growth across several geographies, including India and China.

Worldwide Medical Devices sales increased 11.3 percent on a reported basis in the second quarter. On an organic basis, sales increased 8.2 percent. Refer to tables titled "Non-GAAP Reconciliation of Adjusted Historical Revenue" for a reconciliation of adjusted historical revenue.

Cardiovascular and Neuromodulation sales growth in the quarter was led by double-digit growth in Electrophysiology and Structural Heart.

In Electrophysiology, growth was led by strong performance in cardiac mapping and ablation as well as share gains from the recent U.S. launch of Abbott’s Confirm Rx Insertable Cardiac Monitor (ICM), the world’s first and only smartphone-compatible ICM designed to help physicians remotely identify cardiac arrhythmias. In May, Abbott announced U.S. FDA clearance of Advisor HD Grid Mapping Catheter, Sensor Enabled, which creates highly detailed maps of the heart and expands Abbott’s leading electrophysiology product portfolio.

In Vascular, during the second quarter, Abbott received approval from the U.S. FDA for XIENCE Sierra, the newest generation of its gold-standard coronary stent system, which offers design and technology advances to provide an easier implant and greater ability to treat complex blockages. During the quarter, XIENCE Sierra also received national reimbursement in Japan to treat people with coronary artery disease.

Growth in Structural Heart was driven by several product areas across Abbott’s broad portfolio, including AMPLATZER PFO Occluder and MitraClip, Abbott’s market-leading device for the minimally invasive treatment of mitral regurgitation. In July, Abbott announced U.S. FDA approval for a next-generation version of MitraClip, with an enhanced design that provides even greater precision and accuracy.

In Diabetes Care, where sales increased 39.8 percent on a reported basis and 33.6 percent on an organic basis, growth was led by continued rapid market uptake of FreeStyle Libre, Abbott’s revolutionary sensor-based continuous glucose monitoring (CGM) system, which removes the need for routine fingersticks1 for people with diabetes.

ABBOTT’S FULL-YEAR EARNINGS-PER-SHARE GUIDANCE

Abbott projects 2018 diluted earnings per share from continuing operations under Generally Accepted Accounting Principles (GAAP) of $1.34 to $1.40.

Abbott forecasts net specified items for the full year 2018 of approximately $1.51 per share. Specified items include intangible amortization expense, acquisition-related expenses, charges associated with cost reduction initiatives and other expenses.

Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be $2.85 to $2.91 for the full year 2018.

Abbott is issuing third-quarter 2018 guidance for diluted earnings per share from continuing operations under GAAP of $0.32 to $0.34. Abbott forecasts specified items for the third quarter 2018 of $0.41 primarily related to intangible amortization, acquisition-related expenses, cost reduction initiatives and other expenses. Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be $0.73 to $0.75 for the third quarter.

ABBOTT DECLARES 378TH CONSECUTIVE QUARTERLY DIVIDEND

On June 8, 2018, the board of directors of Abbott declared the company’s quarterly dividend of $0.28 per share. Abbott’s cash dividend is payable Aug. 15, 2018, to shareholders of record at the close of business on July 13, 2018.

Abbott has increased its dividend payout for 46 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.