Deciphera’s Highly-Selective Small Molecule CSF1R Immunokinase Inhibitor, DCC-3014, Demonstrates Potent Macrophage Checkpoint Inhibition as a Single Agent and In Combination with an Anti-PD1 Inhibitor

On April 20, 2016 Deciphera Pharmaceuticals, a clinical-stage biotechnology company focused on developing advanced kinase inhibitor treatments targeting the tumor cell and the tumor microenvironment, reported that its highly-selective small molecule CSF1R inhibitor, DCC-3014, has demonstrated highly-specific inhibition of the colony stimulating factor 1 receptor (CSFIR), a key target across many cancer indications (Press release, Deciphera Pharmaceuticals, APR 20, 2016, View Source [SID:1234511141]). In addition, DCC-3014, which was designed as a highly-specific macrophage immunomodulatory agent based on the company’s Switch Control Inhibitor platform, demonstrated significantly enhanced anti-tumor activity when used in combination with an anti-PD-1 checkpoint inhibitor in preclinical cancer models. Based on these data, which were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2016, on April 20, 2016 in New Orleans, Deciphera plans to initiate a Phase 1 clinical trial with DCC-3014 in the second half of 2016.

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"DCC-3014’s robust inhibition of the CSF1R kinase, as demonstrated by these data presented at the AACR (Free AACR Whitepaper) Annual Meeting, provide encouraging evidence of its potential as a immunomodulatory agent through its action on tumor-associated macrophages (TAMs), both as a single agent and in combination with other immune checkpoint inhibitors, across a number of cancer models," said Michael D. Taylor, Ph.D., Deciphera’s President and Chief Executive Officer. "We look forward to initiating the first-in-human Phase 1 trial with DCC-3014 later this year."

In a poster titled, "The highly specific CSF1R inhibitor DCC-3014 exhibits immunomodulatory and anti-invasive activities in cancer models," Deciphera researchers presented preclinical data demonstrating DCC-3014’s robust inhibition of CSF1R kinase, and potential utility as a macrophage immunomodulatory agent in combination with other immune checkpoint inhibitors or chemotherapeutic agents. Highlights of the data include:

DCC-3014 exhibited nanomolar potency for inhibition of CSF1R, sparing highly related kinases such as KIT, PDGFR and FLT3 by greater than 100-fold, and sparing other kinases by more than 1,000-fold.
DCC-3014 showed sustained in vivo inhibition of CSF1R, offering greater than 90% inhibition more than 24 hours after dosing, in a murine PK/PD model.
DCC-3014 demonstrated significant single agent activity and additive effects in combination with a murine anti-PD1 antibody in a murine model of colorectal cancer.
DCC-3014 blocked tumor growth, invasion and bone degradation in a prostate cancer model and exhibited optimized biopharmaceutical properties.
About DCC-3014

DCC-3014, a highly-selective small molecule colony stimulating factor 1 receptor (CSFIR), was designed as a highly-specific macrophage immunomodulatory agent based on the company’s Switch Control Inhibitor platform. In preclinical studies, DCC-3014 has demonstrated highly-specific inhibition of CSF1R, a key target across many cancer indications, as well as significantly enhanced anti-tumor activity when used in combination with an anti-PD-1 checkpoint inhibitors. Based on these data, Deciphera plans to initiate a Phase 1 clinical trial with DCC-3014 in the second half of 2016.

CytRx to Present Updated Aldoxorubicin Clinical Trial Data at the American Society of Clinical Oncology Annual Meeting in June 2016

On April 20, 2016 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported that three aldoxorubicin clinical trials have been accepted for poster presentations during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held at McCormick Place in Chicago, Illinois, from June, 3-7, 2016 (Press release, CytRx, APR 20, 2016, View Source;p=RssLanding&cat=news&id=2158694 [SID:1234511140]). The three clinical trials to be presented are:

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Title: Phase 2 study of aldoxorubicin in relapsed glioblastoma
Date/Time: June 4, 2016 1:00pm-5:00pm
Poster Session: Central Nervous System Tumors; Abstract 2027

Title: Phase 1b study of aldoxorubicin + gemcitabine in metastatic solid tumors
Date/Time: June 5, 2016 8:00am-11:30am
Poster Session: Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics; Abstract: 2523

Title: Treatment of HIV-associated Kaposi’s sarcoma with aldoxorubicin
Date/Time: June 6, 2016 8:00am-11:30am
Poster Session: Sarcoma; Abstract: 11038

"Presenting the results from these three clinical trials at the ASCO (Free ASCO Whitepaper) Annual Meeting demonstrates the broad potential for aldoxorubicin and should raise awareness among oncologists," said Daniel Levitt, M.D., Ph.D., CytRx’s EVP and Chief Medical Officer. "Based on its unique ability to selectively bind serum albumin and preferentially release drug at the tumor site, aldoxorubicin has now shown clinical anti-cancer activity in several tumor types including our lead indication of advanced soft tissue sarcomas for which we expect top-line data in June from our pivotal Phase 3 trial."

Aldoxorubicin is CytRx’s lead anti-cancer drug candidate in clinical development utilizing its LADRTM (Linker Activated Drug Release) technology. A global, pivotal Phase 3 trial in patients with relapsed or refractory soft tissue sarcomas has fully enrolled and top-line results for the primary endpoint of progression-free survival are expected in June 2016. The trial is being conducted under a Special Protocol Assessment granted by the FDA. In addition, CytRx is conducting a randomized Phase 2b clinical trial in patients with second-line small cell lung cancer comparing aldoxorubicin topotecan. CytRx has completed enrollment of a Phase 2 trial with aldoxorubicin for patients with relapsed glioblastoma and continues to follow patients for survival. CytRx also conducted a Phase 2 trial with low doses of aldoxorubicin in patients with HIV-related Kaposi’s sarcoma. Aldoxorubicin is currently being tested in two Phase 1b trials in combination with other chemotherapies. The first trial is in combination with gemcitabine for metastatic solid tumors, and the second trial is in combination with ifosfamide as a first-line treatment for patients with soft tissue and bone sarcomas.

About Aldoxorubicin

The widely used chemotherapeutic agent doxorubicin is delivered systemically and is highly toxic, which limits its dose to a level below its maximum therapeutic benefit. Doxorubicin also is associated with many side effects, especially the potential for damage to heart muscle at cumulative doses greater than 450 mg/m2. Aldoxorubicin combines doxorubicin with a novel single-molecule linker that binds directly and specifically to circulating albumin, the most plentiful protein in the bloodstream. Protein-hungry tumors concentrate albumin, thus increasing the delivery of the linker molecule with the attached doxorubicin to tumor sites. In the acidic environment of the tumor, but not the neutral environment of healthy tissues, doxorubicin is released. This allows for greater doses (3 ½ to 4 times) of doxorubicin to be administered while reducing its toxic side effects. In studies thus far there has been no evidence of clinically significant effects of aldoxorubicin on heart muscle, even at cumulative doses of drug well in excess of 2,000 mg/m2.

Curis and Aurigene Present Preclinical Data from Multiple Programs at AACR Annual Meeting

On April 20, 2016 Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development and commercialization of innovative and effective drug candidates for the treatment of human cancers, reported that Curis and its collaborator, Aurigene, presented data from the following programs at the Annual Meeting of American Association of Cancer Research (AACR) (Free AACR Whitepaper) in New Orleans, LA (Press release, Curis, APR 20, 2016, View Source [SID:1234511139]).

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Curis poster presentation on CUDC-907, an oral inhibitor of histone deacetylase (HDAC) and phosphoinositide 3-kinase (PI3K)

Aurigene presentation on CA-170 (previously AUPM-170), a first-in-class oral, small molecule immune checkpoint antagonist targeting programmed death ligand-1 (PD-L1) and V-domain Ig suppressor of T cell activation (VISTA), as well as data from the PD-L1/ T-cell immunoglobulin and mucin-domain containing-3 (TIM-3) antagonist program

Aurigene presentation on CA-4948, the lead compound from the interleukin-1 receptor associated kinase 4 (IRAK4) inhibitor program
"Our data show significant effect of CUDC-907 on MYC levels and the compound’s antitumor activity in multiple preclinical models of MYC-altered malignancies, providing further support to the results of our Phase 1 trial where we observed objective responses in patients with DLBCL, and particularly those with MYC-altered disease," said Ali Fattaey, Ph.D., Curis’ President and CEO. "The presentations by our collaborator, Aurigene not only highlight our progress in immuno-oncology with CA-170, which we look to advance into the clinic in the first half of the year, but also Aurigene’s ability to extend the small molecule discovery capabilities to now target TIM3 in a separate program."

CUDC-907 presentation:

The Curis poster "Novel dual HDAC & PI3K inhibitor, CUDC-907, for MYC-driven malignancies" provided data on the activity of CUDC-907 in multiple MYC-altered disease models using both in vitro experiments and in vivo animal studies. Cell line and animal model studies using multiple MYC-altered DLBCL models showed that CUDC-907 had significant anti-tumor activity that correlated with the compound’s effect on downregulating MYC levels in a time and dose dependent manner. This effect was independent of disease subtypes classified using other molecular markers. CUDC-907 also showed potent anti-tumor activity in multiple cell lines of NUT midline carcinoma (NMC), a rare genetically defined tumor, which also demonstrates MYC dysregulation. CUDC-907 downregulated MYC levels in NMC cell lines and was more potent than BET inhibitors in in vitro assays of growth inhibition. The anti-tumor effects of CUDC-907 in NMC were further confirmed in a xenograft mouse model and in several MYC-amplified patient-derived xenograft models of solid tumors.

CA-170 (PD-L1/VISTA antagonist) and small molecule PD-L1/TIM-3 antagonist presentation:

The Aurigene presentation "Oral immune antagonist targeting PD-L1/VISTA or PD-L1/Tim3 for cancer therapy" provided data outlining the novel approach of identification and characterization of oral antagonists of immune checkpoint proteins. The lead IND-ready molecule, CA-170, targets PD-L1 and VISTA and has an optimized pharmacologic and safety profile required for human testing. Data from a second, independent program within the collaboration with compounds that target PD-L1 and TIM-3 immune checkpoints were also presented. In vitro studies showed that AUPM-327, a representative molecule from the PD-L1/TIM-3 program, can rescue T cell functions that are inhibited by addition of PD-L1 or TIM-3 checkpoint proteins, but does not affect other checkpoint regulators such as VISTA, CTLA4, and LAG-3, demonstrating its selectivity. Additionally, daily oral administration of the PD-L1/TIM-3 antagonist resulted in anti-tumor activity in multiple syngeneic tumor models including melanoma and colon cancer.

IRAK4 inhibitor presentation:

The Aurigene presentation "Efficacy and safety of highly selective novel IRAK4 inhibitors for treatment of ABC-DLBCL" provided a detailed profile of the pharmacologic and biologic properties of the lead molecule, CA-4948. This compound has favorable drug metabolism as well as pharmacokinetics properties and appears to have a clean in vitro toxicity profile. CA-4948 showed potent anti-tumor activity in vivo in two models of MYD88 mutant- DLBCL disease. CA-4948 also had potent anti-inflammatory effects in a rodent model of inflammation suggesting the potential use of an IRAK4 inhibitor in both cancer and inflammatory diseases.

Curis has exclusive licenses to CA-170 and CA-4948 under a collaboration agreement with Aurigene established in 2015.

Celldex Therapeutics Presents Data Supporting the Clinical Development of Glembatumumab Vedotin and the Preclinical CD40 Program at the AACR Annual Meeting 2016

On April 20, 2016 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported three poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2016 in New Orleans (Press release, Celldex Therapeutics, APR 20, 2016, View Source [SID:1234511138]). The Company previously reported on four poster presentations at AACR (Free AACR Whitepaper), which included Phase 1 safety and immune response data from the ongoing study evaluating varlilumab and nivolumab in patients with advanced cancers. New presentations included data enhancing the understanding of glembatumumab vedotin’s mechanism of action and further validation of the overexpression of its target, gpNMB, in a wide range of tumor types. Additionally, the Company also presented research with lead agonist antibodies targeting the CD40 receptor, a promising target for immunotherapy, in a poster titled "Development and characterization of novel CD40 antibody agonists for cancer immunotherapy."

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Found on antigen presenting cells, such as dendritic cells, macrophages and B cells, CD40 is a key activator of immune responses. The Company has characterized two fully human antibodies that demonstrated potent agonist activity, such as activating human dendritic cells and B cells and indirectly inducing T cell proliferation. Importantly, Fc receptor interaction, which could cause signal amplification and is required for some CD40 agonist antibodies in development, was not required for agonist ability, enabling controlled, sensitive activation of CD40. Additionally, the drug candidates were shown to upregulate CD95/Fas, a receptor involved in apoptosis, on B cell lymphoma cell lines and to mediate potent anti-tumor activity against the lymphomas in vivo.

"The CD40 pathway has a unique and powerful role in bridging the innate and adaptive immune response, and if properly modulated, it could become a very important part of cancer immunotherapy. We have identified some promising and differentiated antibodies, from which we will select a lead clinical candidate to complement our growing immunotherapy pipeline," said Tibor Keler, Ph.D., Executive Vice President and Chief Scientific Officer of Celldex Therapeutics. "In addition, we are enthusiastic about new research demonstrating gpNMB overexpression in a broad set of tumor types, further reinforcing the wide potential clinical applicability of glembatumumab vedotin."

The CD40 poster is available on the "Publications" page of the "Science" section of the Celldex website.

Celldex and its collaborating investigators also presented two additional posters supporting the clinical development of glembatumumab vedotin:

Title: Glycoprotein NMB (gpNMB) overexpression is prevalent in human cancers: pancreatic cancer, non-small cell lung cancer, head and neck cancer, and osteosarcoma

gpNMB is the target of Celldex’s antibody-drug conjugate glembatumumab vedotin. Using a validated immunohistochemistry (IHC) assay to detect the expression of gpNMB, the Company examined tissues from multiple types of solid tumors and normal tissue. Overexpression of gpNMB in samples of tumor tissue versus normal tissue was found in squamous cell carcinoma of the lung (85%), osteosarcoma (62%), pancreatic cancer (55%), lung adenocarcinoma (45%) and squamous cell carcinoma of the head and neck (40%). These results support the potential broad applicability of gpNMB as a therapeutic target across a wide range of tumor types. Celldex is currently investigating glembatumumab vedotin in the pivotal METRIC study in triple-negative breast cancer and in a Phase 2 study in metastatic melanoma. Independent investigators are also studying glembatumumab vedotin in uveal melanoma and osteosarcoma. A Phase 1/2 study in squamous cell carcinoma of the lung is expected to commence in the second quarter of 2016.

The poster is available on the "Publications" page of the "Science" section of the Celldex website.

Title: Targeting gpNMB with 89Zr-CR011 for PET imaging of triple negative breast cancer
Abstract: 4209

Collaborating investigators used a radio-labeled form of the glembatumumab antibody to study uptake by tumor cells in vitro and in vivo. Using positron emission tomography (PET) imaging with xenograft models of triple-negative breast cancer (TNBC), the investigators detected specific localization of glembatumumab in the tumor and plan to perform similar studies with patient derived tumor samples. These studies contribute to understanding the mechanisms of action for glembatumumab vedotin, Celldex’s antibody-drug conjugate targeting gpNMB, and may provide a diagnostic approach for selecting patients with the greatest likelihood of clinical benefit.

About Glembatumumab Vedotin
Glembatumumab vedotin is a fully-human monoclonal antibody-drug conjugate (ADC) that targets glycoprotein NMB (gpNMB). gpNMB is a protein overexpressed by multiple tumor types, including breast cancer, melanoma, lung cancer, uveal melanoma and osteosarcoma. gpNMB has been shown to be associated with the ability of the cancer cell to invade and metastasize and to correlate with reduced time to progression and survival in breast cancer. The gpNMB-targeting antibody, CR011, is linked to a potent cytotoxic, monomethyl auristatin E (MMAE), using Seattle Genetics’ proprietary technology. Glembatumumab vedotin is designed to be stable in the bloodstream but to release MMAE upon internalization into gpNMB-expressing tumor cells, resulting in a targeted cell-killing effect. Glembatumumab vedotin is in development for the treatment of locally advanced or metastatic breast cancer with an initial focus in triple negative disease, stage III and IV melanoma, uveal melanoma and osteosarcoma.

Abbott Reports First-Quarter 2016 Results

On April 20, 2016 Abbott (NYSE: ABT) reported financial results for the first quarter ended March 31, 2016 (Press release, Abbott, APR 20, 2016, View Source [SID:1234511137]).

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Abbott 2016 Q1 Performance at-a glance

Adjusted diluted EPS from continuing operations, which excludes specified items, was $0.41 in the first quarter, above Abbott’s previous guidance range. Reported diluted EPS from continuing operations under GAAP was $0.04 in the first quarter.
First-quarter worldwide sales of $4.9 billion increased 5.1 percent on an operational basis and decreased 0.2 percent on a reported basis.
Abbott is raising its full-year 2016 adjusted EPS guidance range for continuing operations to $2.14 to $2.24 from $2.10 to $2.20. Projected full-year 2016 EPS for continuing operations under GAAP is $1.36 to $1.46.
Abbott’s recent innovations and product launches contributed to sales growth in the first quarter. Select recently launched products include ElevaTM in the premium segment of the Chinese infant formula market; Abbott’s portfolio of infant and toddler non-GMO nutrition products in the U.S.; MitraClip, Abbott’s structural heart product for the treatment of mitral regurgitation; Freestyle Libre in Europe; Supera peripheral stent in the U.S. for treatment of blockages in the superficial femoral artery; and Abbott’s portfolio of TECNIS intraocular lenses for the treatment of cataracts.
In the first quarter, Abbott received European approval for use in children and teens of its revolutionary FreeStyle Libre Flash Glucose Monitoring System that eliminates routine finger sticks and finger-stick calibration. In Abbott Vascular, AbsorbTM, Abbott’s fully dissolving vascular stent, earned a positive review from an independent U.S. Food and Drug Administration advisory committee.
"We’re off to a good start to the year and are raising our full-year adjusted EPS guidance range," said Miles D. White, chairman and chief executive officer, Abbott. "All four of our businesses met or exceeded our growth expectations and underlying demand remains strong."

FIRST-QUARTER BUSINESS OVERVIEW

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

Total Company
($ in millions)


% Change vs. 1Q15

Sales 1Q16

Int’l

Total

U.S.

Int’l

Total

U.S.

Operational

Reported

Operational

Reported
Total *

1,531

3,354

4,885

1.9

6.6

(1.2)

5.1

(0.2)
Nutrition

719

952

1,671

4.9

3.9

(3.2)

4.3

0.1
Diagnostics

339

779

1,118

3.7

8.2

1.8

6.9

2.3
Established Pharmaceuticals


888

888

n/a

11.0

(1.0)

11.0

(1.0)
Medical Devices

466

731

1,197

(3.9)

3.5

(1.3)

0.5

(2.4)

Note: Operational growth reflects percentage change over the prior year excluding the impact of exchange rates.
* Total Abbott Sales from continuing operations include Other Sales of $11 million.
n/a = Not Applicable.

First-quarter 2016 worldwide sales of $4.9 billion increased 5.1 percent on an operational basis and decreased 0.2 percent on a reported basis, including an unfavorable 5.3 percent effect of foreign exchange.

U.S. sales increased 1.9 percent, led by 9.2 percent growth in Point of Care Diagnostics, 7.5 percent growth in Medical Optics, and 4.9 percent growth in Nutrition.

International sales increased 6.6 percent on an operational basis and decreased 1.2 percent on a reported basis in the first quarter. International operational sales growth was led by 11.0 percent growth in Established Pharmaceuticals, 11.0 percent growth in Diabetes Care and 8.2 percent growth in Diagnostics.

Nutrition
($ in millions)


% Change vs. 1Q15

Sales 1Q16

Int’l

Total

U.S.

Int’l

Total

U.S.

Operational

Reported

Operational

Reported
Total

719

952

1,671

4.9

3.9

(3.2)

4.3

0.1
Pediatric

403

564

967

4.7

4.1

(2.3)

4.4

0.5
Adult

316

388

704

5.2

3.6

(4.6)

4.3

(0.5)

Worldwide Nutrition sales increased 4.3 percent in the first quarter on an operational basis and 0.1 percent on a reported basis, including an unfavorable 4.2 percent effect of foreign exchange.

Worldwide Pediatric Nutrition sales increased 4.4 percent on an operational basis and 0.5 percent on a reported basis in the quarter, including an unfavorable 3.9 percent effect of foreign exchange. In the U.S., above-market sales growth was led by recently launched infant and toddler non-GMO products, including Similac Advance Non-GMO and Go & Grow by Similac Non-GMO. International growth was led by market share expansion of Eleva in the premium segment of the Chinese infant formula market, as well as continued strong performance in Russia and across several countries in Latin America.

Worldwide Adult Nutrition sales increased 4.3 percent on an operational basis and decreased 0.5 percent on a reported basis in the quarter, including an unfavorable 4.8 percent effect of foreign exchange. International Adult Nutrition growth was led by continued strong growth of Ensure and Glucerna in Latin America and other priority geographies. U.S. Adult Nutrition sales growth of 5.2 percent was led by growth of Ensure in the retail and institutional market segments. During the quarter, Abbott launched Ensure Enlive, a nutrition drink that helps adults rebuild lost muscle and regain strength and energy.

Diagnostics
($ in millions)


% Change vs. 1Q15

Sales 1Q16

Int’l

Total

U.S.

Int’l

Total

U.S.

Operational

Reported

Operational

Reported
Total

339

779

1,118

3.7

8.2

1.8

6.9

2.3

Core Laboratory

190

695

885

2.4

8.6

2.1

7.3

2.1

Molecular

47

61

108

(2.1)

3.2

(3.4)

1.0

(2.8)

Point of Care

102

23

125

9.2

9.6

7.2

9.3

8.8

Worldwide Diagnostics sales increased 6.9 percent in the first quarter on an operational basis, driven by continued above-market growth globally, including strong growth in both emerging and developed markets. Sales increased 2.3 percent on a reported basis, including an unfavorable 4.6 percent effect of foreign exchange.

Core Laboratory Diagnostics sales increased 7.3 percent in the quarter on an operational basis and 2.1 percent on a reported basis, including an unfavorable 5.2 percent effect of foreign exchange. Operational sales growth in the quarter was driven by double-digit growth in emerging markets.

Molecular Diagnostics sales increased 1.0 percent in the quarter on an operational basis and decreased 2.8 percent on a reported basis, including an unfavorable 3.8 percent effect of foreign exchange. Strong operational sales growth in Abbott’s infectious disease testing business was offset, as expected, by the planned scale down of its genetics business.

Point of Care Diagnostics sales increased 9.3 percent in the quarter on an operational basis and 8.8 percent on a reported basis, including an unfavorable 0.5 percent effect of foreign exchange. Sales growth was led by continued adoption of Abbott’s i-STAT handheld system in the U.S. and international markets.

Established Pharmaceuticals
($ in millions)


% Change vs. 1Q15

Sales 1Q16

Int’l

Total

U.S.

Int’l

Total

U.S.

Operational

Reported

Operational

Reported
Total



888

888

n/a

11.0

(1.0)

11.0

(1.0)
Key Emerging Markets



634

634

n/a

11.9

(3.2)

11.9

(3.2)
Other



254

254

n/a

8.6

4.9

8.6

4.9

Established Pharmaceuticals sales increased 11.0 percent in the first quarter on an operational basis and decreased 1.0 percent on a reported basis, including an unfavorable 12.0 percent effect of foreign exchange.

Key Emerging Markets include India, Russia, Brazil and China, along with several additional emerging markets that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these key geographies increased 11.9 percent on an operational basis and decreased 3.2 percent on a reported basis, including an unfavorable 15.1 percent effect of foreign exchange.

Operational sales growth in Key Emerging Markets was led by continued double-digit growth in India, which comprises more than 20 percent of Abbott’s Established Pharmaceuticals sales. Sales growth in India was led by double-digit growth across several core therapeutic areas, including women’s health, gastroenterology, and cardio-metabolics. During the quarter, Abbott also achieved above-market growth in China and several countries in Latin America as it continues to expand its presence and portfolio in these key geographies.

Medical Devices
($ in millions)


% Change vs. 1Q15

Sales 1Q16

Int’l

Total

U.S.

Int’l

Total

U.S.

Operational

Reported

Operational

Reported

Total

466

731

1,197

(3.9)

3.5

(1.3)

0.5

(2.4)

Vascular

289

396

685

1.9

0.2

(4.5)

0.9

(1.9)

Diabetes Care

69

174

243

(31.6)

11.0

4.8

(5.2)

(9.1)

Medical Optics

108

161

269

7.5

4.2

0.5

5.4

3.2

Vascular Product Lines:

Coronary Devicesa)

194

336

530

4.9

(1.1)

(5.6)

0.9

(2.0)

Endovascularb)

73

60

133

9.5

8.6

2.9

9.0

6.4

a) Includes DES / BVS product portfolio, structural heart, guidewires, balloon catheters, and other coronary products.
b) Includes vessel closure, carotid stents and other peripheral products.

Worldwide Medical Devices sales increased 0.5 percent in the first quarter on an operational basis and decreased 2.4 percent on a reported basis, including an unfavorable 2.9 percent effect of foreign exchange.

Worldwide sales of Vascular products increased 0.9 percent in the quarter on an operational basis and decreased 1.9 percent on a reported basis, including an unfavorable 2.8 percent effect of foreign exchange. Sales of MitraClip, Abbott’s device for the treatment of mitral regurgitation, increased double-digits globally, as Abbott continues to build the market for this first-in-class device. Growth in Abbott’s Endovascular business was driven by vessel closure products and Supera, Abbott’s peripheral stent for the treatment of blockages in the superficial femoral artery and proximal popliteal artery in the upper leg. In March, Absorb, Abbott’s fully dissolving vascular stent, received a positive review from an independent U.S. FDA advisory committee.

Worldwide Diabetes Care sales decreased 5.2 percent in the quarter on an operational basis and 9.1 percent on a reported basis, including an unfavorable 3.9 percent effect of foreign exchange. Strong international sales growth was driven by continued consumer uptake of FreeStyle Libre, Abbott’s revolutionary Flash Glucose Monitoring System that eliminates routine finger sticks and finger-stick calibration. During the quarter, Abbott received European approval for use of FreeStyle Libre in children and teens. In the U.S., sales were impacted by competitive and market dynamics.

Worldwide Medical Optics sales increased 5.4 percent in the quarter on an operational basis and 3.2 percent on a reported basis, including an unfavorable 2.2 percent effect of foreign exchange. Operational sales growth was driven by continued market uptake of cataract products in the premium intraocular lens segment, including TECNIS Symfony and TECNIS Toric lenses.

ABBOTT RAISES FULL-YEAR ADJUSTED EARNINGS-PER-SHARE GUIDANCE RANGE

Abbott is raising its full-year 2016 guidance range for earnings per share from continuing operations, excluding specified items, to $2.14 to $2.24 from $2.10 to $2.20.

Abbott forecasts net specified items for the full year 2016 of approximately $0.78 per share. Specified items include intangible amortization expense, the impact of the Venezuelan currency devaluation, and charges associated with cost reduction initiatives and deal and other expenses, partially offset by the favorable resolution of various tax positions from prior years.

Including net specified items, projected earnings per share from continuing operations under Generally Accepted Accounting Principles (GAAP) would be $1.36 to $1.46 for the full year 2016.

ABBOTT DECLARES 369TH QUARTERLY DIVIDEND

On Feb. 19, 2016, the board of directors of Abbott declared the company’s quarterly dividend of $0.26 per share. Abbott’s cash dividend is payable May 16, 2016, to shareholders of record at the close of business on April 15, 2016. This marks the 369th consecutive quarterly dividend paid by Abbott.

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