On April 18, 2018 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN:ATNM) ("Actinium" or "the Company"), reported that it has expanded its clinical development team with hiring of Vijay Reddy, M.D., Ph.D. as Vice President, Clinical Development, who will focus on Actinium’s clinical programs centered on targeted myeloablation (Press release, Actinium Pharmaceuticals, APR 18, 2018, View Source [SID1234525495]). Actinium is differentiating itself by developing the only multi-disease, multi-target pipeline of drug candidates focused on improving bone marrow transplant access and outcomes through improved myeloablation which includes the Company’s lead program, Iomab-B, that is being studied in the Pivotal Phase 3 SIERRA study and its planned Phase 2 Actimab-MDS trial.

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Dr. Mark Berger, Actinium’s Chief Medical Officer said, "I am incredibly excited to welcome Dr. Reddy, Dr. Safavi and Ms. McNamara to Actinium’s clinical development team. Vijay brings extensive clinical experience in the field of bone marrow transplant along with hematology focused drug development experience. His deep domain expertise and knowledge will allow us to capitalize on the many opportunities in myeloablation, for which our drug candidates and Actinium Warhead Enabling technology are ideally suited. Farnoush has a strong background in clinical trial execution and a proven ability to drive clinical trial enrollment, which will be of great benefit as we work to complete the SIERRA trial and launch new trials such as Actimab-MDS. Kathleen possesses a strong clinical nursing background, drug development experience and significant experience in the administration of complex therapies that will be well received by the SIERRA sites she supports. I am confident that collectively and individually, Dr. Reddy, Dr. Safavi and Ms. McNamara will make invaluable contributions that will allow us to continue to build on Actinium’s leadership position in myeloablation."

Dr. Reddy said, "As a transplant physician I am keenly aware of Iomab-B and its value proposition for patients, so it is incredibly exciting to have the opportunity to help bring this important targeted therapy against acute myeloid leukemia to patients with a clear need that can benefit from a BM. Actinium has done a fantastic job in the execution of the SIERRA trial thus far, as evidenced by participation of many of the leading BMT centers. In addition, expansion of the myeloablation programs with the planned Actimab-MDS trial represents a compelling opportunity. I am incredibly excited by the opportunities that lie ahead for Actinium and look forward to working with Dr. Berger and my new colleagues to build the leading myeloablation company."

Sandesh Seth, Actinium’s Chairman and CEO said, "Actinium is committed to being the leading company focused on myeloablation that improves access to and outcomes from potentially lifesaving bone marrow transplants. What started as a single asset in Iomab-B has evolved into a myeloablation franchise with the only multi-disease multitarget pipeline in myeloablation. The addition of Dr. Reddy, Dr. Safavi and Ms. McNamara will allow us to execute on the critical milestones for our pivotal Phase 3 trial for Iomab-B, efficiently launch our planned Phase 2 Actimab-MDS trial and capitalize on other opportunities in the field. We are incredibly excited for the talent we have assembled within Actinium and are motivated to make great advances with our drug candidates and technologies to better outcomes for patients."

Dr. Reddy has specialized in hematologic oncology with a Ph.D. in cancer immunology who focused his clinical practice in the area of bone marrow transplantation. Dr. Reddy was attending physician at Shands Hospital, University of Florida, and the Medical Director for adult BMT program in Orlando, prior to his starting in industry. He has served as inspector for the Foundation of Accreditation of Cellular Therapies (FACT). He is currently an Editorial Board Member for Biology of Blood and Marrow Transplantation and has authored over 50 publications in hematology/oncology and BMT journals.

Dr. Reddy joins Actinium from Pharmacyclics LLC, an Abbvie company, where he was Senior Medical Director, Oncology Medical Affairs. In this role, Dr. Reddy worked on the Ibrutinib program in CLL, MCL and chronic graft versus host disease (GVHD), along with additional indications. Previously, he worked at Medimmune (AstraZeneca) as Medical Director, Early clinical development, Immuno-Oncology R&D. Prior to Medimmune, Dr. Reddy worked at Janssen, a Johnson & Johnson company as Medical Director, Oncology. Prior to his experience in the pharmaceutical industry, Dr. Reddy was Professor of Medicine at the University of Central Florida. As a practicing clinician, Dr. Reddy participated in several clinical trials for BMT as an investigator, physician advisor or advisory board member.

Dr. Reddy received his M.B., B.S. (M.D. equivalent) from the Madras Medical College in India and his Ph.D. in cancer immunology from Memorial University of Newfoundland in Canada. He completed fellowships in hematology at The Princess Margaret Hospital and in Blood and Marrow Transplantation at the University of Toronto. He also was a Research Associate at the Dana Farber Cancer Institute.

Dr. Safavi joined Actinium from Progenics Pharmaceuticals, Inc., where she focused on oncology clinical studies. Prior to Progenics, Dr. Safavi had clinical roles of increasing responsibility at Stealth Bio Therapeutics, Verastem Inc. and New England Research Institute, Inc. Before her work in industry, Dr. Safavi supported academic clinical research at Massachusetts General Hospital, Emory University, Memorial Sloan Kettering Cancer Center, Montefiore Medical Center – Albert Einstein School of Medicine and MD Anderson Cancer Center.

Dr. Safavi received her M.D. from Xavier University School of Medicine, West Indies, Master of Health Services Administration from St. Joseph’s College of Maine and her Bachelor of Science degree in Biology from the University of Houston.

Kathleen McNamara is a Registered Nurse and Oncology Certified Nurse with significant clinical experience in the care of oncology patients. Most recently, Ms. McNamara was the Nurse Manager at a large infusion center where she oversaw patient care and trained the nursing staff in oncology therapy administration. Kathleen gained valuable experience in drug developing where she worked at Celgene Corporation as a Clinical Research Scientist on leukemia focused clinical trials and at Quintiles as an Oncology Nurse Educator. The majority of Kathleen’s career has been focused on the clinical care of oncology patients where she gained valuable experience in the administration of complex oncology therapies including biologics, bone marrow transplants and clinical trials. In addition, Kathleen has successfully managed, led and helped educate nursing staffs in a number of hospitals and infusion centers.

Kathleen earned her Bachelor of Science degree in Nursing from Niagara University and her Master of Arts degree in Education from Long Island University. She is a Registered Nurse with a certificate in Pediatric Nurse Practitioner in Ambulatory Pediatrics from the State University of New York.

On April 18, 2018 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, reported that it will participate in the Deutsche Bank’s 43rd Annual Health Care Conference on Wednesday, May 9, 2018 (Press release, AbbVie, APR 18, 2018, View Source [SID1234525494]). Bill Chase, executive vice president and chief financial officer, will present at 7 a.m. Central time.

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A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.

On April 18, 2018 Abbott (NYSE: ABT) reported financial results for the first quarter ended March 31, 2018 (Press release, Abbott, APR 18, 2018, View Source [SID1234525493]).

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First-quarter worldwide sales of $7.4 billion increased 16.7 percent on a reported basis and 6.9 percent on an organic* basis.
Reported diluted EPS from continuing operations under GAAP was $0.23 in the first quarter.
Adjusted diluted EPS from continuing operations, which excludes specified items, was $0.59, at the upper end of Abbott’s previous guidance range.
Abbott projects full-year 2018 diluted EPS from continuing operations of $1.23 to $1.33 on a GAAP basis1. Projected full-year adjusted diluted EPS from continuing operations remains $2.80 to $2.90, reflecting 14.0 percent growth at the midpoint.
In January, Abbott announced U.S. FDA approval for magnetic resonance (MR)-conditional labeling for its Quadra AssuraTM and Quadra Assura MPTM cardiac resynchronization therapy defibrillator (CRT-D) devices and its Fortify AssuraTM implantable cardioverter defibrillator (ICD). With these approvals, Abbott has MR-conditional labeling for its suite of pacemaker, ICD and CRT-D devices.
In January, Abbott announced that FreeStyle Libre, Abbott’s revolutionary sensor-based continuous glucose monitoring system, is now available and approved for coverage by the U.S. Center for Medicare and Medicaid Services.
In March, Abbott announced clinical trial data from the MOMENTUM 3 study, which demonstrated that its HeartMate 3TM left ventricular assist device (LVAD) improved survival and clinical outcomes at two years for patients with advanced heart failure. The trial data will be submitted to the U.S. FDA to support consideration to expand the current HeartMate 3 indication to include long-term use.
"We’re off to a strong start to the year as we forecasted," said Miles D. White, chairman and chief executive officer, Abbott. "We’re particularly pleased with the continued strong growth in Medical Devices and improving performance in our Nutrition business."

* 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 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.
Following are sales by business segment and commentary for the first quarter:

Total Company

($ in millions)

% Change vs. 1Q17

Sales 1Q18

Reported

Organic

U.S.

Int’l

Total

U.S.

Int’l

Total

U.S.

Int’l

Total

Total *

2,675

4,715

7,390

15.1

17.6

16.7

5.0

8.0

6.9

Nutrition

758

998

1,756

3.8

9.5

7.0

3.8

5.5

4.7

Diagnostics

700

1,137

1,837

89.2

44.3

58.7

1.8

7.3

5.5

Established Pharmaceuticals

—

1,044

1,044

n/a

9.9

9.9

n/a

6.8

6.8

Medical Devices

1,209

1,535

2,744

6.4

22.0

14.6

6.9

11.7

9.4

* Total 2018 Abbott sales from continuing operations include Other Sales of $9 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 2018 worldwide sales of $7.4 billion increased 16.7 percent on a reported basis. On an organic basis, worldwide sales increased 6.9 percent. Refer to tables titled "Non-GAAP Reconciliation of Adjusted Historical Revenue" for a reconciliation of adjusted historical revenue.

Nutrition

($ in millions)

% Change vs. 1Q17

Sales 1Q18

Reported

Organic

U.S.

Int’l

Total

U.S.

Int’l

Total

U.S.

Int’l

Total

Total

758

998

1,756

3.8

9.5

7.0

3.8

5.5

4.7

Pediatric

448

546

994

3.7

10.5

7.3

3.7

6.3

5.1

Adult

310

452

762

4.0

8.4

6.6

4.0

4.4

4.3

Worldwide Nutrition sales increased 7.0 percent on a reported basis in the first quarter, including a favorable 2.3 percent effect of foreign exchange, and increased 4.7 percent on an organic basis.

Worldwide Pediatric Nutrition sales increased 7.3 percent on a reported basis in the first quarter, including a favorable 2.2 percent effect of foreign exchange, and increased 5.1 percent on an organic basis. International sales increased 10.5 percent on a reported basis, including a favorable 4.2 percent effect of foreign exchange, and increased 6.3 percent on an organic basis, which was led by strong growth across several countries in Asia, including Greater China. In the U.S., continued above-market growth was led by market share gains in the infant nutrition category.

Worldwide Adult Nutrition sales increased 6.6 percent on a reported basis in the first quarter, including a favorable 2.3 percent effect of foreign exchange, and increased 4.3 percent on an organic basis. Worldwide sales growth was led by Ensure, Abbott’s market-leading complete and balanced nutrition brand, and Glucerna, Abbott’s market-leading diabetes-specific nutrition brand.

Diagnostics

($ in millions)

% Change vs. 1Q17

Sales 1Q18

Reported

Organic

U.S.

Int’l

Total

U.S.

Int’l

Total

U.S.

Int’l

Total

Total *

700

1,137

1,837

89.2

44.3

58.7

1.8

7.3

5.5

Core Laboratory

228

791

1,019

5.6

13.8

11.9

5.6

6.5

6.3

Molecular

39

79

118

(13.8)

17.5

5.0

(13.8)

11.4

1.3

Point of Care

110

31

141

0.6

23.0

4.8

0.6

18.6

4.0

Rapid Diagnostics *

323

236

559

n/m

n/m

n/m

n/m

n/m

n/m

* 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 58.7 percent on a reported basis in the first quarter. On an organic basis, sales increased 5.5 percent. Refer to tables titled "Non-GAAP Reconciliation of Adjusted Historical Revenue" for a reconciliation of adjusted historical revenue.

Core Laboratory Diagnostics sales increased 11.9 percent on a reported basis in the first quarter, including a favorable 5.6 percent effect of foreign exchange, and increased 6.3 percent on an organic basis, reflecting continued above-market growth driven by share gains in the U.S. and internationally.

Molecular Diagnostics sales increased 5.0 percent on a reported basis in the first quarter, including a favorable 3.7 percent effect of foreign exchange, and increased 1.3 percent on an organic basis. As expected, strong growth in infectious disease testing, Abbott’s core area of focus in the molecular diagnostics market, was partially offset by a planned scale down in other testing areas, primarily in the U.S.

Point of Care Diagnostics sales increased 4.8 percent on a reported basis in the first quarter, including a favorable 0.8 percent effect of foreign exchange, and increased 4.0 percent on an organic basis, led by strong international growth of Abbott’s i-STAT handheld system.

Rapid Diagnostics worldwide sales of $559 million were led by infectious disease testing, including strong flu and strep testing volumes in the U.S.

Established Pharmaceuticals

($ in millions)

% Change vs. 1Q17

Sales 1Q18

Reported

Organic

U.S.

Int’l

Total

U.S.

Int’l

Total

U.S.

Int’l

Total

Total

—

1,044

1,044

n/a

9.9

9.9

n/a

6.8

6.8

Key Emerging Markets

—

793

793

n/a

8.7

8.7

n/a

6.8

6.8

Other

—

251

251

n/a

13.9

13.9

n/a

6.6

6.6

Established Pharmaceuticals sales increased 9.9 percent on a reported basis in the first quarter, including a favorable 3.1 percent effect of foreign exchange, and increased 6.8 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 8.7 percent on a reported basis in the first quarter, including a favorable 1.9 percent effect of foreign exchange, and increased 6.8 percent on an organic basis. Sales growth was led by double-digit growth across several geographies, including India, China and Brazil.

Medical Device
Worldwide Medical Devices sales increased 14.6 percent on a reported basis in the first quarter. On an organic basis, sales increased 9.4 percent. Refer to tables titled "Non-GAAP Reconciliation of Adjusted Historical Revenue" for a reconciliation of adjusted historical revenue.

In Cardiovascular and Neuromodulation, worldwide sales growth in the first quarter was led by double-digit growth in Electrophysiology and Neuromodulation. Growth in Electrophysiology includes share gains from the recent U.S. launch of Abbott’s Confirm RxTM Insertable Cardiac Monitor (ICM), the world’s first and only smartphone-compatible ICM designed to help physicians remotely identify cardiac arrhythmias. In Heart Failure, sales growth was led by market uptake of Abbott’s HeartMate 3 system. In the quarter, Abbott announced clinical trial data from the MOMENTUM 3 study demonstrating that its HeartMate 3 LVAD improved survival and clinical outcomes at 2 years for patients with advanced heart failure. The trial data will be submitted to the U.S. FDA to support consideration to expand the current HeartMate 3 indication to include long-term use. Growth in Structural Heart was driven by MitraClip, Abbott’s market-leading device for the minimally-invasive treatment of mitral regurgitation. In March, Abbott announced MitraClip was granted national reimbursement in Japan, which enables greater access for patients to this life-altering therapy. In Neuromodulation, strong double-digit growth was led by a portfolio of recently launched products for the treatment of chronic pain and movement disorders.

In Diabetes Care, worldwide sales increased 44.2 percent on a reported basis in the first quarter, including a favorable 11.3 percent effect of foreign exchange, and increased 32.9 percent on an organic basis. Strong double-digit growth was led by FreeStyle Libre, Abbott’s revolutionary sensor-based continuous glucose monitoring (CGM) system, which removes the need for routine fingersticks2 for people with diabetes. During the quarter, Abbott announced that the FreeStyle LibreLink3,4 app is available in Europe for use with compatible smartphones, which allows people to access glucose data directly from their phones and eliminates the need to carry a separate scanning device.

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 $1.23 to $1.33.

Abbott forecasts net specified items for the full year 2018 of approximately $1.57 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 $2.80 to $2.90 for the full year 2018.

Abbott is issuing second-quarter 2018 guidance for diluted earnings per share from continuing operations under GAAP of $0.33 to $0.35. Abbott forecasts specified items for the second quarter 2018 of $0.37 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 $0.70 to $0.72 for the second quarter.

ABBOTT DECLARES 377TH CONSECUTIVE QUARTERLY DIVIDEND

On Feb. 16, 2018, the board of directors of Abbott declared the company’s quarterly dividend of $0.28 per share. Abbott’s cash dividend is payable May 15, 2018, to shareholders of record at the close of business on April 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.

On April 18, 2018 Tusk Therapeutics, an immuno-oncology company focused on developing immune-modulating therapeutics by targeting immune cells in cancer, presented pre-clinical proof-of-concept data generated in collaboration with Cancer Research UK and University College London (UCL), relating to its anti-CD25 programme at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper).

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Tusk Therapeutics presented data on its first-in-class anti-CD25 programme that has entered pre-clinical development. The antibody depletes regulatory T cells (Tregs) while preserving IL-2 binding and signalling on effector T cells (Teffs). Tusk, together with the University College London research group led by Dr. Sergio Quezada, has shown that targeting Tregs with non-IL-2 blocking anti-CD25 antibodies creates highly potent anti-tumour responses in monotherapy and combination therapy. Proof-of-concept has been established in multiple pre-clinical models.

Tregs, a subpopulation of T cells, are key players in the suppressive tumour microenvironment (TME). Tregs in the TME hinder the body’s ability to control the growth of cancerous cells and their presence is correlated with a worse prognosis in multiple cancers. Effective Treg targeting has been a topic in the cancer field for several years and Tusk’s approach demonstrates it is possible to deplete Tregs in solid tumour which leads to tumour control. Tusk’s antibody is specifically selected to preserve signalling of the IL-2 cytokine on effector cells which is a key regulator of immune-activation.

Commenting on the data, Luc Dochez, Chief Executive Officer of Tusk Therapeutics, said: "The data presented at AACR (Free AACR Whitepaper) demonstrate the unique mechanism of action of our anti-CD25 antibody. Unlike existing aCD25 antibodies our antibody has the ability to deplete Tregs without inhibiting effector cell responses. Based on the promising pre-clinical data, we believe that our anti-CD25 candidates will be an ideal combination partner for existing standard of care and immuno-oncology treatments."

​The data was presented as an oral presentation by Dr. Sergio Quezada, Group Leader and Cancer Research UK Senior Research Fellow at The UCL Cancer Institute, and Chairman of Tusk Therapeutics’ Scientific Advisory Board and in two posters, presented by the Tusk and UCL teams. Tusk Therapeutics’ first-in-class anti-CD25 antibody programme was built on novel biology discovered by Tusk Therapeutics in collaboration with Dr. Quezada and his team at UCL. Tusk Therapeutics, Cancer Research UK (via its Commercial Partnerships Team) and UCL announced in 2017, an exclusive licensing and collaboration deal to develop and commercialise antibody-based therapeutics against CD25.

On April 18, 2018 Transgene (Paris:TNG), a biotech company that designs and develops virus-based immunotherapies, presents a poster with promising preclinical data on a novel viral vector (pseudocowpox, PCPV) at the AACR (Free AACR Whitepaper) (American Association for Cancer Research) Annual Meeting 2018, Chicago, IL, USA, April 14 – 18 (Press release, Transgene, APR 18, 2018, View Source [SID1234525490]).

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PCPV was found to be the most promising therapeutic candidate amongst the poxviridae evaluated by Transgene:

It displayed the strongest immunogenicity, and the best ability to reduce tumor size and increase survival in immunocompetent mice carrying fast-growing tumors.
It induced a very strong cellular response and showed an attractive cytokine/chemokine profile.
It also induced a strong local secretion of IFN-α and impressive changes in the tumor micro-environment, including decreased frequency of immunosuppressive cells in the tumor.
The abstract is available on the AACR (Free AACR Whitepaper) 2018 website (#LB-287) and will be published in Cancer Research in June 2018.

Poster title: Pseudocowpox: A next generation viral vector for cancer immunotherapy. A poxviral vector selected for its remarkable ability to induce IFN-alpha.