Pain Therapeutics Reports Q3 2016 Financial Results

On October 20, 2016 Pain Therapeutics, Inc. (Nasdaq:PTIE) reported financial results for the third quarter of 2016 (Press release, Pain Therapeutics, OCT 20, 2016, View Source [SID1234515931]). Net loss in Q3 2016 was $3.5 million, or $0.08 per share, compared to a net loss in Q3 2015 of $3.7 million, or $0.08 per share.

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At September 30, 2016, cash and investments were $21.8 million, compared to $24.6 million at June 30, 2016. The Company has no debt.

"We continue to evaluate the comments recently raised by the FDA with regards to REMOXY," said Remi Barbier, President and Chief Executive Officer. "We are encouraged by the preliminary feedback we have received from external experts in the field and look forward to announcing a new strategy after further consultation with external advisors."

Financial Highlights for Q3 2016

Research and development expenses increased to $2.7 million in Q3 2016 from $2.4 million in Q3 2015, primarily due to increased activities related to REMOXY ER (oxycodone capsules CII). Research and development expenses included non-cash stock-related compensation costs of $0.3 million in both Q3 2016 and Q3 2015.
General and administrative expenses decreased to $0.9 million in Q3 2016 from $1.3 million in Q3 2015, primarily due to lower compensation costs. General and administrative expenses included non-cash stock-related compensation costs of $0.5 million in both Q3 2016 and Q3 2015.
Net cash used in Q3 2016 was $2.8 million.

Seattle Genetics Demonstrates Commitment to Improve Hodgkin Lymphoma Treatment Paradigm through Multiple ADCETRIS® (Brentuximab Vedotin) Data Presentations at ISHL 2016

On October 20, 2016 Seattle Genetics, Inc. (Nasdaq: SGEN) today highlighted multiple data presentations at the 10th International Symposium on Hodgkin Lymphoma (ISHL) taking place in Cologne, Germany, October 22-25, 2016, evaluating ADCETRIS (brentuximab vedotin) across a broad range of Hodgkin lymphoma (HL) disease settings (Press release, Seattle Genetics, OCT 20, 2016, View Source;p=RssLanding&cat=news&id=2213330 [SID1234515932]). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL that plays a role in tumor pathogenesis. ADCETRIS is being evaluated globally as the foundation of therapy for HL in more than 45 ongoing corporate- and investigator-sponsored clinical trials.

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"For more than a decade, we have been committed to improving treatment outcomes for classical HL patients. We have made tremendous progress with ADCETRIS, which is now FDA-approved for two HL indications in the U.S. and Europe and is being evaluated broadly across all lines of therapy and in many novel regimens," said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development at Seattle Genetics. "The data presented at ISHL continue to advance our goal of establishing ADCETRIS as the foundation of care for HL. With 21 abstracts accepted for presentation, we, along with our partner Takeda, are pleased to share new and updated data with the scientific community at ISHL to help move the field forward."

Data presented at ISHL include an update of the progression-free survival and safety from the phase 3 AETHERA trial approximately four years since the last patient was enrolled, demonstrating sustained progression-free survival benefit after extended observation. In addition, updates will be presented from trials evaluating ADCETRIS as both mono- and combination therapy in frontline HL patients age 60 and older, and as second-line therapy for relapsed or refractory HL. Lastly, preclinical data will be presented indicating additional potential mechanisms of action for ADCETRIS, including immunogenic cell death, supporting evaluation of combination therapy with immuno-oncology agents.

Multiple corporate and investigator presentations will be featured at ISHL. Abstracts can be found at www.hodgkinsymposium.org and include the following:

Immune Systems Engagement Results in Non-Classical Antibody-Drug Conjugate Antitumor Activity of Brentuximab Vedotin (Abstract #P099, poster presentation)
Evaluation of Serum TARC Levels in Patients at Risk of Progression Following Autologous Stem Cell Transplant for Hodgkin Lymphoma: Results from the AETHERA Trial (Abstract #P060, poster presentation)
Brentuximab Vedotin After Autologous Stem Cell Transplant Yields the Strongest Benefit in Hodgkin lymphoma Patients with ≥ 2 Risk Factors: Results of a Multivariate Analysis (Abstract #P089 , poster presentation)
Brentuximab Vedotin Alone and in Combination With Dacarbazine or Bendamustine in Patients Aged ≥60 Years With Newly Diagnosed Hodgkin Lymphoma: Interim Results of a Phase 2 Study (Abstract #P023, poster presentation)
Brentuximab Vedotin Plus Bendamustine as a Salvage Treatment Regimen for Patients with Relapsed or Refractory Hodgkin Lymphoma (Abstract #P082, poster presentation)
PET Adapted Dose Escalation of Brentuximab Vedotin as First Line Salvage Therapy in Relapse/Refractory HL (Abstract #P083, poster presentation)
Post Transplant Outcomes in a Multicenter Phase II Study of Brentuximab Vedotin as First Line Salvage Therapy in Relapsed/Refractory HL Prior to ASCT (Abstract #P086, poster presentation)
Pharmacokinetics, Immunogenicity and Safety of Weekly Dosing of Brentuximab Vedotin in Pediatric Patients with Hodgkin Lymphoma (Abstract #P067, oral presentation)
A Phase I Study with an Expansion Cohort of the Combination of Ipilimumab and Brentuximab Vedotin in Patients with Relapsed/Refractory Hodgkin Lymphoma: A trial of the ECOG-ACRIN Cancer Research Group (Abstract #P080, poster presentation)
The Pharmacokinetic and Pharmacodynamic Properties of Brentuximab Vedotin in a Patient Undergoing Hemodialysis (Abstract #P098, poster presentation)
Single-Arm Study of Brentuximab Vedotin in Patients with Relapsed or Refractory Hodgkin lymphoma who are Ineligible for Stem Cell Transplantation or Multiagent Chemotherapy (Abstract #P104, poster presentation)
Combining Brentuximab Vedotin with DHAP as Salvage Treatment in Relapsed/Refractory Hodgkin lymphoma: a Phase 1 Dose-Escalation study (Abstract #T024, oral presentation)
Preliminary Results of a Phase II Study of Brentuximab Vedotin Using a Response Adapted Design in the First Line Treatment of Patients with Hodgkin lymphoma Unsuitable for Chemotherapy Due to Age, Frailty or Co-morbidity (BREVITY) (Abstract #P002, poster presentation)
Real-World Effectiveness of Brentuximab Vedotin vs. Other Treatments in Patients with Relapsed/Refractory Hodgkin Lymphoma post Autologous Stem-Cell Transplantation (Abstract #P094, poster presentation)
Brentuximab Vedotin in Patients who are Ineligible for Autologous Stem Cell Transplant with Relapsed or Refractory Hodgkin Lymphoma: A UK and Germany Retrospective Study (Abstract #P093, poster presentation)
Risk Factors for Relapse in Patients with Relapsed or Refractory Hodgkin Lymphoma after Autologous Stem Cell Transplant: A Real-World Analysis in Germany and the United Kingdom (Abstract #P095, poster presentation)
Superiority of Modified Progression Free Survival to Evaluate Chemotherapy Effectiveness for Advanced Stage Hodgkin Lymphoma (Abstract #P007, poster presentation)
Sequential Brentuximab Vedotin and Adriamycin, Vinblastine and Darabazine (AVD) for Older Patients with Untreated Hodgkin Lymphoma: Findings from a Phase II Window study (Abstracts #P001, poster presentation)
PET-adapted Therapy with Brentuximab Vedotin and Augmented ICE for Relapsed/Refractory Hodgkin Lymphoma – Lack of Improvement with 3 versus 2 Cycles of Weekly BV (Abstract #P088, poster presentation)
An International Multicenter Phase I/II Study of Brentuximab Vedotin and Bendamustine in Patients with Heavily Treated Relapsed or Refractory Hodgkin Lymphoma and Anaplastic Large T-Cell Lymphoma (Abstract #P085, poster presentation)
HALO Study: a Phase 1/2 Clinical Trial of Brentuximab Vedotin and Bendamustine in Elderly Patients with Previously Untreated Advanced Hodgkin Lymphoma (Abstract #P011, poster presentation)
ADCETRIS is currently not approved for the treatment of frontline or salvage HL in patients eligible for autologous transplant, graft-versus-host disease (GVHD) or as a combination therapy for HL.

About Classical Hodgkin Lymphoma

Lymphoma is a general term for a group of cancers that originate in the lymphatic system and is the most common type of blood cancer. There are two major categories of lymphoma: HL and non-Hodgkin lymphoma. Classical HL is distinguished from other lymphomas by the characteristic presence of CD30-positive Reed-Sternberg cells.

According to the American Cancer Society, approximately 8,500 cases of HL will be diagnosed in the United States during 2016 and more than 1,100 will die from the disease. According to the Lymphoma Coalition, over 62,000 people worldwide are diagnosed with HL each year and approximately 25,000 people die each year from this cancer.

About ADCETRIS

ADCETRIS is being evaluated broadly in more than 70 ongoing clinical trials, including two phase 3 studies, ECHELON-1 in frontline classical HL and ECHELON-2 in frontline mature T-cell lymphomas, as well as trials in many additional types of CD30-expressing malignancies, including B-cell lymphomas.

ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

ADCETRIS for intravenous injection has received approval from the FDA for three indications: (1) regular approval for the treatment of patients with classical Hodgkin lymphoma after failure of autologous hematopoietic stem cell transplantation (auto-HSCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (2) regular approval for the treatment of classical Hodgkin lymphoma patients at high risk of relapse or progression as post-auto-HSCT consolidation, and (3) accelerated approval for the treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen. The sALCL indication is approved under accelerated approval based on overall response rate. Continued approval for the sALCL indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Health Canada granted ADCETRIS approval with conditions for relapsed or refractory Hodgkin lymphoma and sALCL.

ADCETRIS was granted conditional marketing authorization by the European Commission in October 2012 for two indications: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following autologous stem cell transplant (ASCT), or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, and (2) the treatment of adult patients with relapsed or refractory sALCL. ADCETRIS has received marketing authorization by regulatory authorities in 65 countries.

In June 2016, the European Commission extended the current conditional approval of ADCETRIS and approved ADCETRIS for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT. See important safety information below.

Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.

Abbott Reports Third-Quarter 2016 Results

On October 19, 2016 Abbott (NYSE: ABT) financial results for the third quarter ended Sept. 30, 2016 (Press release, Abbott, OCT 19, 2016, View Source [SID1234515913]).

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Third-quarter worldwide sales of $5.3 billion increased 2.9 percent on a reported basis and 4.0 percent on an operational basis.
Reported diluted EPS from continuing operations under GAAP was a $(0.24) loss in the third quarter, primarily due to an adjustment of $(0.66) per share associated with Abbott’s equity investment in Mylan to reflect Mylan’s share price as of Sept. 30, 2016. Excluding specified items, adjusted diluted EPS from continuing operations was $0.59 in the third quarter, at the high end of the previous guidance range.

Abbott adjusted its full-year 2016 EPS guidance for continuing operations under GAAP to $0.59 to $0.61, and narrowed and raised at the mid-point its full-year 2016 adjusted EPS for continuing operations to $2.19 to $2.21, exceeding its initial guidance for the year.

In the third quarter, Abbott received U.S. FDA approval for its FreeStyle Libre Pro system, a revolutionary continuous glucose monitoring system for healthcare professionals to use with their patients with diabetes; submitted for U.S. regulatory approval a consumer version of FreeStyle Libre, to be used by people with diabetes to self-monitor glucose levels; received U.S. FDA approval for AbsorbTM, the only fully dissolving heart stent; and received U.S. FDA approval for TECNIS Symfony intraocular lenses for the treatment of cataracts, the first and only extended depth of focus lenses for people with cataracts.

On Sept. 16, 2016, Abbott announced the sale of Abbott Medical Optics, its vision care business, to Johnson & Johnson for $4.325 billion. This transaction aligns with Abbott’s shaping of its portfolio, which has recently focused on developing leadership positions in cardiovascular devices and expanding diagnostics. The transaction is expected to close in the first quarter of 2017 and is subject to customary closing conditions, including regulatory approvals.

"Strong performance in Established Pharmaceuticals and Medical Devices led our sales growth this quarter," said Miles D. White, chairman and chief executive officer, Abbott. "We’re on track to deliver the financial commitments we set at the beginning of the year. We also had several key product launches and continued to take strategic actions to shape our business for long-term growth."

THIRD-QUARTER BUSINESS OVERVIEW

Following are sales by business segment and commentary for the third quarter and the first nine months of the year:

Total Company
($ in millions)


% Change vs. 3Q15

Sales 3Q16

Int’l

Total

U.S.

Int’l

Total

U.S.

Reported

Operational

Reported

Operational
Total *
1,645

3,657

5,302

4.5

2.2

3.7

2.9

4.0

Nutrition
755

1,000

1,755

3.5

(5.7)

(4.1)

(2.0)

(1.0)

Diagnostics
362

851

1,213

4.1

5.3

6.0

5.0

5.4

Established Pharmaceuticals
—

1,012

1,012

n/a

5.3

9.0

5.3

9.0

Medical Devices
519

791

1,310

6.0

6.7

6.1

6.4

6.0

* Total Abbott Sales from continuing operations include Other Sales of $12 million.



% Change vs. 9M15

Sales 9M16

Int’l

Total

U.S.

Int’l

Total

U.S.

Reported

Operational

Reported

Operational
Total *
4,831

10,689

15,520

3.5

1.3

5.9

2.0

5.2
Nutrition
2,224

2,942

5,166

3.8

(3.0)

1.6

(0.2)

2.5
Diagnostics
1,062

2,495

3,557

3.6

3.9

7.1

3.8

6.1
Established Pharmaceuticals
—

2,880

2,880

n/a

1.6

9.8

1.6

9.8
Medical Devices
1,520

2,359

3,879

2.8

4.1

5.6

3.6

4.5

* Total Abbott Sales from continuing operations include Other Sales of $38 million.
n/a = Not Applicable.
Note: Operational growth reflects percentage change over the prior year excluding the impact of exchange rates. 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.

Third-quarter 2016 worldwide sales of $5.3 billion increased 2.9 percent on a reported basis, including an unfavorable 1.1 percent effect of foreign exchange, and increased 4.0 percent on an operational basis. Excluding the impact of Venezuelan operations, sales would have increased 4.5 percent on a reported basis and 5.6 percent on an operational basis.

International sales increased 2.2 percent on a reported basis and 3.7 percent on an operational basis in the third quarter. International operational growth was led by strong performance across Established Pharmaceuticals, Diagnostics and Medical Devices.

Nutrition
($ in millions)


% Change vs. 3Q15

Sales 3Q16

Int’l

Total

U.S.

Int’l

Total

U.S.

Reported

Operational

Reported

Operational
Total
755

1,000

1,755

3.5

(5.7)

(4.1)

(2.0)

(1.0)
Pediatric
414

553

967

4.3

(9.4)

(7.5)

(4.0)

(2.8)
Adult
341

447

788

2.6

(0.8)

0.6

0.6

1.4



% Change vs. 9M15

Sales 9M16

Int’l

Total

U.S.

Int’l

Total

U.S.

Reported

Operational

Reported

Operational
Total
2,224

2,942

5,166

3.8

(3.0)

1.6

(0.2)

2.5
Pediatric
1,242

1,664

2,906

5.0

(5.1)

(0.7)

(1.0)

1.6
Adult
982

1,278

2,260

2.3

(0.1)

4.7

0.9

3.7

Worldwide Nutrition sales decreased 2.0 percent on a reported basis in the third quarter, including an unfavorable 1.0 percent effect of foreign exchange, and decreased 1.0 percent on an operational basis.

Worldwide Pediatric Nutrition sales decreased 4.0 percent on a reported basis in the third quarter, including an unfavorable 1.2 percent effect of foreign exchange, and decreased 2.8 percent on an operational basis. During the quarter, Abbott introduced Similac Pro-Advance and Similac Pro-Sensitive, the first infant formulas in the U.S. with a human milk oligosaccharide that offers a unique immune-nourishing prebiotic. International sales declined 9.4 percent on a reported basis and 7.5 percent on an operational basis, driven by challenging market conditions in China, partially offset by continued strong performance in Latin America and Southeast Asia.

Worldwide Adult Nutrition sales increased 0.6 percent on a reported basis in the third quarter, including an unfavorable 0.8 percent effect of foreign exchange, and increased 1.4 percent on an operational basis. Operational sales growth in the quarter was led by growth of Ensure, Abbott’s complete and balanced nutrition brand.

Diagnostics
($ in millions)


% Change vs. 3Q15

Sales 3Q16

Int’l

Total

U.S.

Int’l

Total

U.S.

Reported

Operational

Reported

Operational
Total
362

851

1,213

4.1

5.3

6.0

5.0

5.4
Core Laboratory
220

757

977

7.6

5.0

5.7

5.6

6.1
Molecular
42

70

112

(9.6)

5.4

6.3

(0.8)

(0.3)
Point of Care
100

24

124

3.4

15.6

14.1

5.6

5.3



% Change vs. 9M15

Sales 9M16

Int’l

Total

U.S.

Int’l

Total

U.S.

Reported

Operational

Reported

Operational
Total
1,062

2,495

3,557

3.6

3.9

7.1

3.8

6.1
Core Laboratory
616

2,224

2,840

3.4

3.8

7.1

3.7

6.3
Molecular
140

199

339

(3.4)

1.9

5.2

(0.3)

1.5
Point of Care
306

72

378

7.6

13.3

13.6

8.6

8.7

Worldwide Diagnostics sales increased 5.0 percent on a reported basis in the third quarter, including an unfavorable 0.4 percent effect of foreign exchange, and increased 5.4 percent on an operational basis. During the quarter, Abbott unveiled its new suite of diagnostic instruments, AlinityTM, at the American Association for Clinical Chemistry conference. The Alinity suite includes new instruments for every area of the diagnostics market where Abbott competes and incorporates features deemed important to customers, including increased automation, higher volumes, faster results, smaller size and an improved user interface.

Core Laboratory Diagnostics sales increased 5.6 percent on a reported basis in the third quarter, including an unfavorable 0.5 percent effect of foreign exchange, and increased 6.1 percent on an operational basis. Operational sales growth in the quarter was led by continued share gains in the U.S. and internationally.

Molecular Diagnostics sales decreased 0.8 percent on a reported basis in the third quarter, including an unfavorable 0.5 percent effect of foreign exchange, and decreased 0.3 percent on an operational basis. As expected, continued strong growth in Abbott’s infectious disease testing business was offset primarily by the planned scale down of its genetics business.

Point of Care Diagnostics sales increased 5.6 percent on a reported basis in the third quarter, including a favorable 0.3 percent effect of foreign exchange, and increased 5.3 percent on an operational basis. 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. 3Q15

Sales 3Q16

Int’l

Total

U.S.

Int’l

Total

U.S.

Reported

Operational

Reported

Operational
Total
—

1,012

1,012

n/a

5.3

9.0

5.3

9.0
Key Emerging Markets
—

747

747

n/a

7.0

12.2

7.0

12.2
Other
—

265

265

n/a

0.7

0.6

0.7

0.6



% Change vs. 9M15

Sales 9M16

Int’l

Total

U.S.

Int’l

Total

U.S.

Reported

Operational

Reported

Operational
Total
—

2,880

2,880

n/a

1.6

9.8

1.6

9.8
Key Emerging Markets
—

2,135

2,135

n/a

2.7

13.4

2.7

13.4
Other
—

745

745

n/a

(1.5)

—

(1.5)

—

Established Pharmaceuticals sales increased 5.3 percent on a reported basis in the third quarter, including an unfavorable 3.7 percent effect of foreign exchange, and increased 9.0 percent on an operational basis.

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 7.0 percent on a reported basis and 12.2 percent on an operational basis. Operational sales growth was led by continued strong growth in India, which comprises more than 20 percent of Abbott’s Established Pharmaceuticals sales, as well as above-market growth in several countries throughout Latin America driven by commercial initiatives and locally relevant portfolio expansion.

Medical Devices
($ in millions)


% Change vs. 3Q15

Sales 3Q16

Int’l

Total

U.S.

Int’l

Total

U.S.

Reported

Operational

Reported

Operational
Total
519

791

1,310

6.0

6.7

6.1

6.4

6.0
Vascular
305

403

708

9.8

2.0

1.4

5.2

4.9
Diabetes Care
96

210

306

(2.2)

19.1

20.7

11.5

12.5
Medical Optics
118

178

296

3.7

4.8

1.7

4.4

2.5

Vascular Product Lines:

Coronary Devicesa)
201

336

537

4.8

—

(0.8)

1.8

1.2
Endovascularb)
76

66

142

4.6

13.7

14.3

8.6

8.9

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.



% Change vs. 9M15


Sales 9M16

Int’l

Total

U.S.

Int’l

Total

U.S.

Reported

Operational

Reported

Operational
Total
1,520

2,359

3,879

2.8

4.1

5.6

3.6

4.5
Vascular
940

1,235

2,175

9.5

0.1

1.8

3.9

4.9
Diabetes Care
238

594

832

(18.6)

12.6

15.7

1.5

3.5
Medical Optics
342

530

872

4.2

4.9

4.6

4.6

4.4

Vascular Product Lines:

Coronary Devicesa)
597

1,039

1,636

4.5

(1.5)

—

0.6

1.6
Endovascularb)
226

194

420

7.5

9.0

11.7

8.2

9.4

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 6.4 percent on a reported basis in the third quarter, including a favorable 0.4 percent effect of foreign exchange, and increased 6.0 percent on an operational basis.

Worldwide sales of Vascular products increased 5.2 percent on a reported basis in the third quarter, including a favorable 0.3 percent effect of foreign exchange, and increased 4.9 percent on an operational basis. Sales growth in Vascular products was led by double-digit growth of MitraClip, Abbott’s device for the treatment of mitral regurgitation, as Abbott continues to build the market for this first-in-class device. Strong sales growth in Abbott’s Endovascular business was driven by vessel closure products and Supera, Abbott’s unique stent for the treatment of blockages in the leg. In the quarter, Abbott received U.S. FDA approval for Absorb, the only fully dissolving heart stent.

Worldwide Diabetes Care sales increased 11.5 percent on a reported basis in the third quarter, including an unfavorable 1.0 percent effect of foreign exchange, and increased 12.5 percent on an operational basis. International sales growth was driven by continued consumer uptake of FreeStyle Libre, Abbott’s revolutionary continuous glucose monitoring system that eliminates the need for finger-sticks. In September, Abbott received U.S. FDA approval for the FreeStyle Libre Pro system, which is designed to help healthcare professionals make better, customized treatment decisions for their patients – and at a significantly lower cost than other professional continuous glucose monitoring systems. During the quarter, Abbott submitted the consumer version of the FreeStyle Libre system for review by the U.S. FDA. The consumer version of the FreeStyle Libre system is designed to eliminate the need for routine finger-sticks and provides glucose data in a simple format that allows people with diabetes to better self-monitor their glucose levels.

Worldwide Medical Optics sales increased 4.4 percent on a reported basis in the third quarter, including a favorable 1.9 percent effect of foreign exchange, and increased 2.5 percent on an operational basis. Operational sales growth was driven by continued market uptake of cataract products in the premium intraocular lens segment. In the quarter, Abbott received U.S. FDA approval and launched its TECNIS Symfony intraocular lenses, the first and only lenses in the U.S. that provide a full range of continuous high-quality vision following cataract surgery.

ABBOTT NARROWS ITS FULL-YEAR EARNINGS-PER-SHARE GUIDANCE

Abbott is adjusting its projected earnings per share from continuing operations under Generally Accepted Accounting Principles (GAAP) to $0.59 to $0.61 for the full year 2016.

Abbott forecasts net specified items for the full year 2016 of approximately $1.60 per share. Specified items include intangible amortization expense, the impact of the Venezuelan currency devaluation in the first quarter and an adjustment to the equity investment in Mylan in the third quarter, expenses associated with acquisitions, including bridge facility fees, charges related to cost reduction initiatives and other expenses and the recognition of deferred taxes associated with the pending sale of the Abbott Medical Optics business (AMO), partially offset by the favorable resolution of various tax positions from prior years.

Excluding specified items, Abbott is raising the mid-point and narrowing its full-year 2016 guidance range for earnings per share from continuing operations to $2.19 to $2.21, exceeding its initial guidance for the year.

ABBOTT DECLARES 371ST QUARTERLY DIVIDEND

On Sept. 15, 2016, the board of directors of Abbott declared the company’s quarterly dividend of $0.26 per share. Abbott’s cash dividend is payable Nov. 15, 2016, to shareholders of record at the close of business on Oct. 14, 2016.

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.

Actinium Announces Acceptance of Actimab-A Data for Poster Presentation at American Society of Hematology Annual Meeting

On October 19, 2016 Actinium Pharmaceuticals, Inc. (NYSE MKT:ATNM) ("Actinium" or "the Company"), a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, reported that data from the Company’s Actimab-A program, Actinium’s most advanced alpha particle immunotherapy program intended for newly diagnosed AML patients over the age of 60, has been selected by the American Society of Hematology (ASH) (Free ASH Whitepaper) Program Committee for poster presentation at the 58th Annual Meeting in San Diego, California on December 5, 2016 (Press release, Actinium Pharmaceuticals, OCT 19, 2016, View Source [SID1234515918]).

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Title: Phase I Trial of Targeted Alpha-Particle Therapy with Actinium-225 (225Ac)-Lintuzumab and Low-Dose Cytarabine (LDAC) in Patients Age 60 or Older with Untreated Acute Myeloid Leukemia (AML)

Abstract: #4050

Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster III

Location: San Diego Convention Center, Hall GH

Presentation: December 5, 6:00 PM – 8:00 PM

Abstracts are expected to be available at www.hematology.org on November 3, 2016 at 9:00 am Eastern time. In addition, the abstracts will be published online in the December 3, 2015 supplemental volume of Blood.

About Actimab-A

Actimab-A, Actinium’s most advanced alpha particle immunotherapy (APIT) program, is in a Phase 2 clinical trial for patients newly diagnosed with AML over the age of 60. Actimab-A is being developed as a first-line therapy and it has attracted support from some of the leading experts at the most prestigious cancer treatment hospitals due to the potential of its safety and efficacy profile. Actimab-A consists of the monoclonal antibody, HuM195, and the radioisotope, actinium-225. Actinium-225 decays by giving off high-energy alpha particles, which kill cancer cells. When actinium decays, it produces a series of daughter atoms, each of which gives off its own alpha particle, increasing the chances that the cancer cell will be destroyed. HuM195 is the humanized version of M195 and is a monoclonal antibody that targets CD33, which is abundantly found on myeloid leukemia cells. Both the alpha particle technology and HuM195 were initially developed at Memorial Sloan Kettering Cancer Center. Actimab-A is a second-generation therapy from the Company’s HuM195-Alpha program, which has now been studied in almost 90 patients in four clinical trials.

FDA Approves Lilly’s LARTRUVO™ (olaratumab) in Combination with Doxorubicin for Soft Tissue Sarcoma

On October 19, 2016 Eli Lilly and Company (NYSE: LLY) reported that the U.S. Food and Drug Administration (FDA) has granted approval of LARTRUVO (olaratumab injection, 10 mg/mL), in combination with doxorubicin, for the treatment of adults with soft tissue sarcoma (STS) with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery (Press release, Eli Lilly, OCT 19, 2016, View Source [SID1234515929]). LARTRUVO’s indication is approved under Accelerated Approval, and is based on data from the Phase 2 portion of the pivotal JGDG trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. LARTRUVO, in combination with doxorubicin, is the first FDA-approved front-line therapy for STS in four decades. The confirmatory Phase 3 trial, ANNOUNCE, is fully enrolled.

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"LARTRUVO represents an important step forward in soft tissue sarcoma treatment," said William D. Tap, M.D., chief of the sarcoma medical oncology services at Memorial Sloan Kettering Cancer Center in New York and the principal investigator of the JGDG registration trial. "We are pleased with this approval, which will provide patients with a treatment option that offers new hope in their battle against this difficult disease."

Soft tissue sarcoma is a complex disease with multiple subtypes, making it hard to diagnose and difficult to treat. For decades, there have been no first-line therapeutic advancements for STS that have improved overall survival (OS). According to the American Cancer Society, in 2015, there were an estimated 12,000 new STS cases diagnosed and nearly 5,000 deaths in the U.S. alone, representing an unmet medical need.

LARTRUVO is the first monoclonal antibody approved to treat STS. It also received Fast Track, Orphan Drug and Breakthrough Therapy designations from the FDA for this indication, and was reviewed and approved under the FDA’s Accelerated Approval program. This program allows for earlier approval of drugs that treat serious conditions and that fill an unmet medical need.

"The approval of LARTRUVO is based on an encouraging and positive study for patients, and represents progress in soft tissue sarcoma treatment. For the first time in four decades, we now have a combination regimen – LARTRUVO and doxorubicin – that offers progress over doxorubicin alone in the front-line setting, by improving overall survival for people with soft tissue sarcoma," said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology. "This continues our commitment to discovering new ways to treat cancer, including for people who have rare types of cancer."

"The entire sarcoma patient community is excited to have an innovative medicine approved for the treatment of advanced soft tissue sarcoma," said Bert E. Thomas IV, PhD, MBA, CEO of the Sarcoma Foundation of America. "We are confident that the approval of LARTRUVO may help these patients live longer."

The approval of LARTRUVO is based on the results of JGDG, an open-label, randomized, active-controlled study of 133 patients, which compared LARTRUVO, in combination with doxorubicin chemotherapy, to doxorubicin alone in patients with STS with a histologic subtype for which an anthracycline-containing regimen was appropriate and which is not amenable to curative treatment with surgery or radiotherapy. The efficacy outcome measures were OS, progression-free survival (PFS), and objective response rate (ORR).

Median OS was improved by 11.8 months in patients randomized to receive LARTRUVO plus doxorubicin compared to patients randomized to doxorubicin alone, and was statistically significant. Median OS was 26.5 months (95% CI: 20.9, 31.7) on the LARTRUVO-doxorubicin arm compared to 14.7 months (95% CI: 9.2, 17.1) on the doxorubicin-only arm (stratified hazard ratio [HR], 0.52; 95% CI: 0.34, 0.79, < 0.05). The study met its prespecified protocol-defined endpoint for PFS. Patients treated on the LARTRUVO and doxorubicin arm achieved 8.2 months (95% CI: 5.5, 9.8) of median PFS compared to 4.4 months (95% CI: 3.1, 7.4) on the doxorubicin-only arm (stratified hazard ratio [HR], 0.74; 95% CI: 0.46, 1.19), based on independent review. The number of events at the time of analysis was 37 (56%) on the LARTRUVO-doxorubicin arm and 34 (51%) on the doxorubicin-only arm. The number of deaths at the time of analysis was 39 (59%) on the LARTRUVO-doxorubicin arm and 52 (78%) on the doxorubicin-only arm. Objective response rate (ORR), based on independent review and defined as complete response (CR) plus partial response (PR), was also assessed with an ORR of 18.2 percent (95% CI: 9.8, 29.6) (CR, 4.5%; PR, 13.6%) on the LARTRUVO-doxorubicin arm and 7.5 percent (95% CI: 2.5, 16.6) (CR, 1.5%; PR, 6%) on the doxorubicin-only arm.

The labeling for LARTRUVO contains Warnings and Precautions for infusion-related reactions and embryo-fetal toxicity. The most commonly reported adverse reactions (all grades) occurring in ≥20 percent of patients receiving LARTRUVO plus doxorubicin versus doxorubicin alone were nausea (73% vs 52%), fatigue (69% vs 69%), musculoskeletal pain (64% vs 25%), mucositis (53% vs 35%), vomiting (45% vs 19%), diarrhea (34% vs 23%) and headache (20% vs 9%). The most common laboratory abnormalities (all grades) occurring in ≥20% of patients receiving LARTRUVO plus doxorubicin versus doxorubicin alone were lymphopenia (77% vs 73%), neutropenia (65% vs 63%), thrombocytopenia (63% vs 44%), hyperglycemia (52% vs 28%), elevated aPTT (33% vs 13%), hypokalemia (21% vs 15%) and hypophosphatemia (21% vs 7%). Febrile neutropenia was reported in 13% of LARTRUVO plus doxorubicin-treated patients versus 12% of doxorubicin-treated patients.

Adverse reactions resulting in permanent discontinuation of LARTRUVO occurred in 8% (5/64) of patients. The most common adverse reaction leading to LARTRUVO discontinuation was infusion-related reaction (3%). Dose reductions of LARTRUVO for adverse reactions occurred in 25% (16/64) of patients; the most common adverse reaction leading to dose reduction was Grade 3 or 4 neutropenia (20%). Dose delays of LARTRUVO for adverse reactions occurred in 52% (33/64) of patients; the most common adverse reactions resulting in dose delays were neutropenia (33%), thrombocytopenia (8%) and anemia (5%). See the full Important Safety Information at the end of this press release and the Prescribing Information.

Lilly is committed to helping patients access LARTRUVO and offers support programs for qualified uninsured, underinsured and insured patients who receive LARTRUVO for its FDA-approved indication and who may need assistance with their out-of-pocket prescription medication costs, including a co-pay program where qualified patients pay no more than $25 per infusion. Patients and healthcare professionals with questions about LARTRUVO should contact The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979) or visit www.lilly.com.

About LARTRUVO (olaratumab)

LARTRUVO is a platelet-derived growth factor receptor alpha (PDGFR-α) blocking antibody that specifically binds PDGFR-α and prevents receptor activation. LARTRUVO exhibits in vitro and in vivo anti-tumor activity against selected sarcoma cell lines and disrupted the PDGFR-α signaling pathway in in vivo tumor implant models. Information about additional clinical trials for LARTRUVO in sarcoma can be found at ClinicalTrials.gov (in the search box on the home page, type in "olaratumab").

A Phase 3 trial of LARTRUVO and doxorubicin in advanced STS is fully enrolled (ClinicalTrials.gov Identifier: NCT02451943).

About the JGDG Trial

JGDG was an open-label, randomized, active-controlled study that compared LARTRUVO, in combination with doxorubicin chemotherapy, to doxorubicin alone in patients with unresectable, soft tissue sarcoma (STS).

The study enrolled 133 doxorubicin-naïve patients with STS with a histologic subtype for which an anthracycline-containing regimen was appropriate and which is not amenable to curative treatment with surgery or radiotherapy. Sixty-six patients with an ECOG performance status of 0 – 2 were randomized to the LARTRUVO-doxorubicin arm and 67 to the doxorubicin-only arm.

Patients were randomized to receive LARTRUVO at 15 mg/kg as an intravenous infusion on day one of each 21-day cycle in combination with 75 mg/m2 doxorubicin, and LARTRUVO only on day eight. Doxorubicin was administered following LARTRUVO infusion on day one of each 21-day cycle for up to eight cycles. After doxorubicin was discontinued, patients on the LARTRUVO plus doxorubicin arm without evidence of disease progression or unacceptable toxicity could continue to receive LARTRUVO monotherapy until disease progression. All patients received the cardioprotectant dexrazoxane prior to doxorubicin in cycles five to eight.

About Sarcomas

Sarcomas are a diverse and relatively rare type of cancer that usually develop in the connective tissue of the body, which include fat, blood vessels, nerves, bones, muscles, deep skin tissues and cartilage. Soft tissue sarcoma is a complex disease with multiple subtypes, making it very hard to diagnose and difficult to treat. For decades, there have been no front-line therapeutic advancements for STS that have improved overall survival. According to the American Cancer Society, in 2015, there were an estimated 12,000 new STS cases diagnosed and nearly 5,000 deaths in the U.S. alone.

INDICATION

LARTRUVO is indicated, in combination with doxorubicin, for the treatment of adult patients with soft tissue sarcoma (STS) with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery.

This indication is approved under Accelerated Approval. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.

IMPORTANT SAFETY INFORMATION FOR LARTRUVO

Warnings and Precautions

Infusion-Related Reactions

Infusion-related reactions (IRR) occurred in 70 (14%) of 485 patients who received at least one dose of LARTRUVO across clinical trials. For 68 of these 70 patients (97%), the first occurrence of IRR was in the first or second cycle. Grade ≥3 IRR occurred in 11 (2.3%) of 485 patients, with one (0.2%) fatality. Symptoms of IRR included flushing, shortness of breath, bronchospasm, or fever/chills, and in severe cases symptoms manifested as severe hypotension, anaphylactic shock, or cardiac arrest. Infusion-related reactions required permanent discontinuation in 2.3% of patients and interruption of infusion in 10% of patients. All 59 patients with Grade 1 or 2 IRR resumed LARTRUVO; 12 (20%) of these patients had a Grade 1 or 2 IRR with rechallenge. The incidence of IRR in the overall safety database (N = 485) was similar (18% versus 12%) between those who did (56%) and those who did not (44%) receive premedication. Monitor patients during and following LARTRUVO infusion for signs and symptoms of IRR in a setting with available resuscitation equipment. Immediately and permanently discontinue LARTRUVO for Grade 3 or 4 IRR.
Embryo-Fetal Toxicity

Based on animal data and its mechanism of action, LARTRUVO can cause fetal harm when administered to a pregnant woman. Animal knockout models link disruption of platelet-derived growth factor receptor alpha (PDGFR-α) signaling to adverse effects on embryo-fetal development. Administration of an anti-murine PDGFR-α antibody to pregnant mice during organogenesis caused malformations and skeletal variations. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with LARTRUVO and for 3 months after the last dose.
Most Common Adverse Reactions/Lab Abnormalities

The most commonly reported adverse reactions (all grades; grade 3-4) occurring in ≥20% of patients receiving LARTRUVO plus doxorubicin versus doxorubicin alone were nausea (73% vs 52%; 2% vs 3%), fatigue (69% vs 69%; 9% vs 3%), musculoskeletal pain (64% vs 25%; 8% vs 2%), mucositis (53% vs 35%; 3% vs 5%), alopecia (52% vs 40%; 0% vs 0%), vomiting (45% vs 19%; 0% vs 0%), diarrhea (34% vs 23%; 3% vs 0%) decreased appetite (31% vs 20%; 2% vs 0%), abdominal pain (23% vs 14%; 3% vs 0%), neuropathy (22% vs 11%; 0% vs 0%), and headache (20% vs 9%; 0% vs 0%).
The most common laboratory abnormalities (all grades; grade 3-4) occurring in ≥20% of patients receiving LARTRUVO plus doxorubicin versus doxorubicin alone were lymphopenia (77% vs 73%; 44% vs 37%), neutropenia (65% vs 63%; 48% vs 38%) and thrombocytopenia (63% vs 44%; 6% vs 11%), hyperglycemia (52% vs 28%; 2% vs 3%), elevated aPTT (33% vs 13%; 5% vs 0%), hypokalemia (21% vs 15%; 8% vs 3%), and hypophosphatemia (21% vs 7%; 5% vs 3%).
Use in Specific Populations

Lactation: Because of the potential risk for serious adverse reactions in breastfeeding infants, advise women not to breastfeed during treatment with LARTRUVO and for at least 3 months following the last dose.
For more information about LARTRUVO, please see full Prescribing Information at View Source

OR HCP ISI 19OCT2016