On April 17, 2019 Abbott (NYSE: ABT) reported financial results for the first quarter ended March 31, 2019 (Press release, Abbott, APR 17, 2019, View Source [SID1234535159]).

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First-quarter worldwide sales of $7.5 billion increased 2.0 percent on a reported basis and 7.1 percent on an organic* basis.
Reported diluted EPS from continuing operations under GAAP was $0.38 in the first quarter.
Adjusted diluted EPS from continuing operations, which excludes specified items, was $0.63, above the previous guidance range.
Abbott projects full-year 2019 diluted EPS from continuing operations on a GAAP basis of $1.95 to $2.05. Projected full-year adjusted diluted EPS from continuing operations remains unchanged at $3.15 to $3.25, reflecting double-digit growth at the mid-point.
During the quarter, Abbott received U.S. FDA approval for a new, expanded indication for its market-leading MitraClip device to treat clinically significant secondary mitral regurgitation, a leaky heart valve resulting from advanced heart failure.
In January, Abbott announced U.S. FDA approval of its TactiCath Contact Force Ablation Catheter, Sensor Enabled, which is designed to help physicians accurately and effectively treat atrial fibrillation, a form of irregular heartbeat.
In March, Abbott obtained CE Mark for its Alinity m (molecular) diagnostics system and testing assays, providing market-leading speed and accuracy to help laboratories meet the growing demand for infectious disease testing.
"We’re right on track with our expectations to start the year," said Miles D. White, chairman and chief executive officer, Abbott. "All of our key long-term growth drivers are performing well and we’re targeting another year of strong sales and earnings growth."

* See note on organic growth below.

FIRST-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 the prior year first-quarter results for a non-core business within U.S. Adult Nutrition, which was discontinued during the third quarter 2018; and
Excludes the impact of foreign exchange.
Following are sales by business segment and commentary for the first quarter:

* Total Q1 2019 Abbott sales from continuing operations include Other sales of $15 million.

n/a = Not Applicable.

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.

First-quarter 2019 worldwide sales of $7.5 billion increased 2.0 percent on a reported basis. On an organic basis, worldwide sales increased 7.1 percent. Refer to table titled "Non-GAAP Reconciliation of Adjusted Historical Revenue" for a reconciliation of adjusted historical revenue.

Worldwide Nutrition sales increased 2.0 percent on a reported basis in the first quarter. On an organic basis, sales increased 6.7 percent. Refer to table titled "Non-GAAP Reconciliation of Adjusted Historical Revenue" for a reconciliation of adjusted historical revenue.

Worldwide Pediatric Nutrition sales increased 3.5 percent on a reported basis in the first quarter, including an unfavorable 3.2 percent effect of foreign exchange, and increased 6.7 percent on an organic basis. International Pediatric Nutrition sales increased 5.4 percent on a reported basis and 11.2 percent on an organic basis in the first quarter. Sales performance in the quarter was led by strong growth in Asia and Latin America, including broad-based growth across Abbott’s portfolio of infant and toddler brands.

Worldwide Adult Nutrition sales increased 0.1 percent on a reported basis in the first quarter, and increased 6.8 percent on an organic basis. International Adult Nutrition sales increased 3.9 percent on a reported basis and 11.1 percent on an organic basis in the first quarter. Sales performance in the quarter 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.

Worldwide Diagnostics sales increased 0.2 percent on a reported basis in the first quarter, including an unfavorable 4.2 percent effect of foreign exchange, and increased 4.4 percent on an organic basis.

Core Laboratory Diagnostics sales increased 4.1 percent on a reported basis and 9.9 percent on an organic basis in the first quarter. Sales performance in the quarter was led by above-market growth in the U.S. and internationally, where Abbott is achieving continued strong adoption of its Alinity family of innovative and highly differentiated diagnostic instruments.

Molecular Diagnostics sales decreased 8.4 percent on a reported basis in the first quarter, including an unfavorable 3.3 percent effect of foreign exchange, and decreased 5.1 percent on an organic basis. International sales growth in Molecular and Rapid Diagnostics was negatively impacted in the quarter by certain non-governmental organization (NGO) purchasing patterns in Africa. During the quarter, Abbott obtained CE Mark for its Alinity m (molecular) diagnostics system and several testing assays, providing market-leading speed and accuracy to help laboratories meet the growing demand for infectious disease testing.

Point of Care Diagnostics sales decreased 4.8 percent on a reported basis in the first quarter, including an unfavorable 0.6 percent effect of foreign exchange, and decreased 4.2 percent on an organic basis.

Rapid Diagnostics sales decreased 4.0 percent on a reported basis in the first quarter, including an unfavorable 2.6 percent effect of foreign exchange, and decreased 1.4 percent on an organic basis. Strong sales growth in several areas of the business, including cardio-metabolic testing and Abbott’s ID-NOW TM infectious disease testing platform, was offset by a difficult comparison versus the first-quarter of 2018 when sales were abnormally high due to a strong flu season.

Established Pharmaceuticals sales decreased 4.9 percent on a reported basis in the first quarter, including an unfavorable 10.3 percent effect of foreign exchange, and increased 5.4 percent on an organic basis.

Key Emerging Markets include India, Brazil, Russia and China along with several additional emerging countries that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these geographies decreased 5.2 percent on a reported basis in the first quarter, including an unfavorable 12.5 percent effect of foreign exchange, and increased 7.3 percent on an organic basis led by growth in several markets.

Other sales decreased 4.2 percent on a reported basis in the first quarter, including an unfavorable 3.3 percent effect of foreign exchange, and decreased 0.9 percent on an organic basis. As expected, Other sales growth was negatively impacted in the quarter by the recent discontinuation of a non-core, low-margin supply agreement.

Includes drug-eluting stents, balloon catheters, guidewires, vascular imaging/diagnostics products, vessel closure, carotid and other coronary and peripheral products.

Worldwide Medical Devices sales increased 5.5 percent on a reported basis in the first quarter and increased 9.5 percent on an organic basis, led by double-digit growth in Electrophysiology, Heart Failure, Structural Heart and Diabetes Care.

In Electrophysiology, in January, Abbott announced U.S. FDA approval of its TactiCath Contact Force Ablation Catheter, Sensor Enabled, which is designed to help physicians accurately and effectively treat atrial fibrillation, a form of irregular heartbeat.

In Heart Failure, growth was driven by rapid U.S. market adoption of Abbott’s HeartMate 3 left ventricular assist device following FDA approval as a destination (long-term use) therapy in late-2018. In March, Abbott announced data from its MOMENTUM 3 clinical study, the largest randomized controlled trial to assess outcomes in patients receiving a heart pump to treat advanced heart failure, which demonstrated HeartMate 3 improved survival and clinical outcomes in this patient population.

Growth in Structural Heart was broad-based across several areas of the business, including MitraClip, Abbott’s market-leading device for the minimally invasive treatment of mitral regurgitation (MR), a leaky heart valve. During the quarter, Abbott received U.S. FDA approval for a new, expanded indication for MitraClip to treat clinically significant secondary MR as a result of underlying heart failure. This new indication significantly expands the number of people with MR that can be treated with the MitraClip device.

In Diabetes Care, sales increased 34.4 percent on a reported basis and 42.0 percent on an organic basis in the first quarter. Sales growth in the quarter was led by FreeStyle Libre, Abbott’s revolutionary continuous glucose monitoring system, with worldwide sales of $379 million, an increase of 70.2 percent on a reported basis and 80.1 percent on an organic basis versus the prior year. During the quarter, Abbott released real-world data from nearly 500,000 users that shows higher rates of scanning with its FreeStyle Libre system improves glucose control for people living with diabetes.

ABBOTT’S EARNINGS-PER-SHARE GUIDANCE

Abbott projects 2019 diluted earnings per share from continuing operations under Generally Accepted Accounting Principles (GAAP) of $1.95 to $2.05. Abbott forecasts net specified items for the full year 2019 of $1.20 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 $3.15 to $3.25 for the full year 2019.

Abbott is issuing second-quarter 2019 guidance for diluted earnings per share from continuing operations under GAAP of $0.47 to $0.49. Abbott forecasts specified items for the second quarter 2019 of $0.32 per share 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 $0.79 to $0.81 for the second quarter.

ABBOTT DECLARES 381ST CONSECUTIVE QUARTERLY DIVIDEND

On Feb. 22, 2019, the board of directors of Abbott declared the company’s quarterly dividend of $0.32 per share. Abbott’s cash dividend is payable May 15, 2019, to shareholders of record at the close of business on April 15, 2019.

Abbott has increased its dividend payout for 47 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.

On April 17, 2019 PureTech Health plc (LSE: PRTC) ("PureTech Health"), an advanced biopharmaceutical company developing novel medicines for dysfunctions of the Brain-Immune-Gut (BIG) axis, reported that it has entered into a research collaboration with Boehringer Ingelheim to develop novel product candidates for an undisclosed number of targets by leveraging PureTech’s proprietary lymphatic targeting technology for immune modulation (Press release, PureTech Health, APR 17, 2019, View Source [SID1234535154]). Under terms of the agreement, PureTech Health will receive up to $26 million, including upfront payments, research support, and preclinical milestones, and is eligible to receive more than $200 million in development and sales milestones, in addition to royalties on product sales. The collaboration will initially focus on applying PureTech’s lymphatic targeting technology to an immuno-oncology product candidate designated by Boehringer Ingelheim.

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"We see great promise in leveraging PureTech’s platform to target the lymphatic system and deliver therapeutic candidates directly to the lymph nodes responsible for priming, educating and proliferating immune cells," said Clive Wood, PhD, global head of discovery research at Boehringer Ingelheim. "The approach is a potentially powerful tool for modulating the immune system and may allow us to improve efficacy and reduce systematic toxicities through precise targeting."

The partnership leverages the potential of the proprietary lymphatic targeting platform that PureTech Health is developing through its internal R&D division. The approach harnesses the gut’s lipid transport mechanisms to enable oral administration and transport of drug candidates directly through the gut-draining lymphatic vasculature, also bypassing first pass metabolism in the liver. More specifically, the therapeutic candidates are directed to the mesenteric lymph nodes, which program as many as 70 percent of circulating adaptive immune cells. By targeting the lymphatic system directly, the technology has the potential to achieve more effective and precise immunomodulation of local tissues, while sparing the patient from the risks of extensive systemic exposure to the drug. PureTech’s lymphatic targeting approach, which is based on the research of Chris Porter, PhD, Director of the Monash Institute of Pharmaceutical Sciences (MIPS) at Monash University, can potentially be applied to therapeutic molecules across a range of physiochemical properties and holds promise for the development of novel therapeutics for gastrointestinal, central nervous system, and autoimmune diseases as well as cancer.

"This collaboration signals the exciting potential of another proprietary platform from our internal R&D to enable novel immunotherapy approaches by harnessing the lymphatic system’s capacity for immune cell trafficking and immunomodulation," said Daphne Zohar, co-founder and chief executive officer of PureTech Health. "We look forward to working with the excellent scientific teams at Boehringer Ingelheim to advance this important program, which has the potential to greatly expand therapeutic options for patients with cancer."

The research collaboration with Boehringer Ingelheim will focus first on using this approach to administer an immuno-oncology candidate for gastrointestinal (GI) cancers directly to the gut lymphatics. About 70 percent of immune cells reside in lymphatic tissues associated with the GI tract, so targeting immunomodulatory agents with this approach could potentially tune both systemic and local immunity. Once the product candidates enter the development stage, Boehringer Ingelheim will assume full responsibility for development and PureTech Health will be eligible for various developmental and sales milestones in addition to royalties on product sales.

About PureTech’s Lymphatic Targeting Platform
PureTech’s proprietary lymphatic targeting platform is designed to the body’s natural lipid transport mechanisms to enable the transport of drug molecules directly into the lymphatic system when administered orally. This pathway facilitates entry into the mesenteric lymph nodes, which are crucial centers for immune cell priming, education and proliferation in the GI tract. Targeting the lymphatic vasculature enables rational design of therapeutics to modulate immunity in a tissue-specific manner and minimize systemic toxicity due to global immunosuppression. Preclinical data suggest PureTech’s lymphatic targeting platform could potentially enable more efficacious and less toxic therapeutics addressing cancer and inflammatory and autoimmune diseases. This technology is based on the pioneering research of Professor Chris Porter and his team at the Monash Institute of Pharmaceutical Sciences, Monash University, who continue to collaborate with PureTech Health on the program. All the relevant intellectual property associated with his work on this technology is exclusively licensed to PureTech and is supported by additional PureTech Health patents.

On April 16, 2019 BioAtla , LLC, a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) protein therapeutics for the oncology market, reported that Himalaya Therapeutics SEZC, a Cayman Island corporation and majority owned subsidiary of BioAtla, has the exclusive license from BioAtla to develop and commercialize several specific, differentiated product candidates for the Greater China market of the PRC, Hong Kong, Macau and Taiwan (Press release, BioAtla, APR 16, 2019, View Source [SID1234621324]). The Himalaya Therapeutics portfolio includes two CAB candidates, CAB-AXL-ADC and CAB-ROR2-ADC, each currently in Phase 1/2 clinical trials conducted by BioAtla at sites in the United States. In addition, Himalaya Therapeutics will participate in BioAtla’s potential Greater China derived returns from the recently announced BioAtla and BeiGene, Ltd. global co-development and collaboration agreement for the development, manufacture and commercialization of CAB-CTLA-4 (BA3071). Himalaya will also support BioAtla’s global clinical trials effort in Greater China.

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"We believe that Himalaya’s product development and business related activities directly addressing Greater China will maximize the strategic opportunities for both BioAtla and Himalaya in the world’s second largest pharmaceutical market," stated Carolyn Short, General Manager of Himalaya Therapeutics. "The access to clinical development capabilities in China can accelerate the global development and potential commercialization of the BioAtla product portfolio and effectively address markets with strong growth potential and high unmet medical need," added Scott Smith, President of BioAtla.

Recent sweeping changes to the China regulatory processes for the development of pharmaceutical products now closely align them with those in the United States and broadens the use of clinical data for regulatory purposes between the two nations. Consequently, close coordination of clinical development in the U.S. and China of a pharmaceutical candidate is highly desireable and more efficient. Furthermore, the access to capital markets for early-stage biotechnology companies in China has recently been greatly enhanced especially with the revision to the stock listing requirements on the Hong Kong Stock Exchange. Himalaya Therapeutics is expected to fund its operations independent from BioAtla. These were primary motivating factors for Beijing Sinobioway Group Company and its related investor groups to contribute all of their rights to certain and any future CAB candidates that were part of their 2015 collaboration agreement with BioAtla in exchange for a minority equity position in Himalaya Therapeutics.

About Conditionally Active Biologics (CABs)

Conditionally Active Biologics are proteins generated using BioAtla’s proprietary protein discovery, evolution and expression technologies. These proteins can be monoclonal antibodies, enzymes and other proteins designed with functions dependent on changes in micro physiological conditions (e.g., pH level, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof) both outside and inside cells.

Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These cancerous microenvironments are primarily a result of the well understood unique glycolytic metabolism associated with cancer cells, referred to as the Warburg Effect in aerobic cancer cells. CAB proteins are designed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body and to be active only in the presence of a particular cellular microenvironment. In addition, the activation is designed to be reversible to repeatedly switch ‘on and off’ should the CAB move from a diseased to a normal cellular microenvironment and vice versa. CABs can be developed in a variety of formats, including antibodies, antibody drug conjugates (ADCs), bispecifics, chimeric antigen receptor T-cells (CAR-Ts) and combination therapies.

On April 16, 2019 Nordic Nanovector ASA (OSE: NANO) reported that the Safety Review Committee (SRC) for the ongoing LYMRIT 37-05 clinical trial of single-administration Betalutin (177Lu-satetraxetan-lilotomab) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) not eligible for stem cell transplantation (SCT) has now reviewed safety data from the first three cohorts of patients (Press release, Nordic Nanovector, APR 16, 2019, View Source [SID1234553452]). Based on the data, the SRC approved advancing the trial to the next and final cohort with the dose regimen 20 MBq/kg Betalutin and a lilotomab pre-dose of 100 mg/m2.

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The LYMRIT 37-05 study is a Phase 1 open-label, single-arm, dose-escalation study designed to assess the safety, tolerability, pharmacokinetic profile and preliminary anti-tumour activity of Betalutin. Up to 24 patients are planned to be enrolled in the US and Europe in total. More information on this study can be found at www.clinicaltrials.gov (NCT02658968). Preliminary results are expected in the second half of 2019.

Lisa Rojkjaer, Chief Medical Officer of Nordic Nanovector, commented: "We are pleased to be moving ahead with the final cohort of patients in the study, which will enable the selection of a recommended dose for further evaluation of safety and preliminary efficacy in additional patients."

DLBCL is an aggressive form of non-Hodgkin’s Lymphoma (NHL) that accounts for up to 43% of all NHL cases, making it the most common form of the disease. Approximately 40% of DLBCL patients relapse after first-line combination treatment with rituximab and chemotherapy and only 30-40% of relapsed patients respond with subsequent high-dose chemotherapy followed by SCT (ref. 1). There are currently very few therapeutic options for patients not eligible for SCT, which makes relapsed DLBCL a serious unmet medical need. The number of diagnosed cases of DLBCL in the US and Europe in 2016 was 26,500 and 17,200, respectively. These numbers are expected to reach 31,500 (US) and 19,000 (Europe) by 2024 (ref. 2).

On April 16 2019 Orion Biotechnology Canada Ltd., a developer of novel medical treatments, reported that its European subsidiary Orion Biotechnology Polska Sp. z.o.o. was awarded a grant of just under two million U.S. dollars by the Polish National Centre for Research and Development (NCBR) (Press release, Orion Biotechnology, APR 16, 2019, View Source [SID1234535183]). The grant will help co-fund a project to advance development of the company’s innovative oncological drug candidate (OB-002O). Pre-clinical evaluation and a Phase 1 clinical trial are planned as part of the project.

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OB-002O is a first-in-class chemokine analog drug candidate being testing by Orion Biotechnology for use in the treatment of solid tumors including colorectal cancer (CRC). The active agent in OB-002O is 5P12-RANTES, a CCR5 receptor antagonist, or chemokine analog, being developed by Orion Biotechnology for a range of clinical indications including cancer, neuroinflammation and HIV prevention.

"Our goal for OB-002O is to block the CCL5/CCR5 pathway which plays a critical role in cancer biology in order to inhibit tumor growth and metastasis," explained Ian McGowan, chief medical officer for Orion Biotechnology. "NCBR’s financial support will help us to investigate the potential for OB-002O to treat late-stage cancers, including CRC, for which there is no effective treatment available today."

"OB-002O represents an exciting new class of drugs – chemokine analogues – that falls under the broad and promising category of immunotherapy," said Mark Groper, CEO of Orion Biotechnology. "We are very pleased that the National Centre for Research and Development has demonstrated confidence in our technology and company by providing this sizable investment."