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.

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.

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

On October 20, 2016 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) reported that it has received a milestone payment from Novartis in connection with the initiation of a phase 1 clinical trial with a novel HuCAL antibody. The antibody will be tested in the field of cancer. Financial details were not disclosed (Press release, MorphoSys, OCT 19, 2016, View Source [SID1234515930]).

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"This is the 13th therapeutic antibody based on MorphoSys’s technologies that Novartis is evaluating in clinical trials, thus making our collaboration one of the most successful antibody alliances in our industry" commented Dr. Marlies Sproll, Chief Scientific Officer of MorphoSys AG. "During the course of this year, the MorphoSys pipeline has further matured and currently includes more programs in clinical trials than ever before. This reflects the great value of both MorphoSys’s technology and the resulting products, in our partnered as well as proprietary pipeline."

MorphoSys’s clinical pipeline now comprises 28 clinical programs. Two of them are in phase 3, 15 in phase 2 and 11 in phase 1. Novartis has currently 13 HuCAL antibodies in clinical development, of which six are in phase 2 and seven in phase 1.

On October 18, 2016 Athenex reported that its development partner for KX-02, Xiangxue Pharmaceuticals Company Limited, has publicized that the Guangdong Province Food and Drug Administration (FDA) declared completion of the Investigational New Drug (IND) application for KX-02 active pharmaceutical ingredient and KX-02 Tablet and referred the IND to the Center of Drug Evaluation (CDE) of China FDA for review (Press release, Athenex, OCT 18, 2016, View Source [SID1234525097]). The IND application to the Chinese FDA was submitted jointly by Xiangxue New Drug Development Company Limited, Xiangxue Pharmaceuticals Limited, and Hangzhou Converd Co., Ltd.

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The Guangdong Province FDA has determined, after their inspection of the factory and initial review of the IND submission, that it is complete and was referred to the Center of Drug Evaluation (CDE) of China FDA for review. This IND application has been assigned the application number CXHL1600187.

In 2012, Athenex and Xiangxue Pharmaceuticals announced the execution of a license agreement granting Xiangxue Pharmaceuticals exclusive rights to KX-02, for all oncology indications, in the greater China territory (China, Hong Kong, Taiwan) and Singapore.

KX-02, a novel lipophilic dual Src/pretubulin inhibitor, was discovered and developed by Athenex through their internal research and development efforts. It is a small molecule that has shown potent inhibitory activity against a broad panel of brain tumor cell lines, including cells (T98G) that are resistant to Temodar, the most widely used chemotherapy for the treatment of malignant glioma. In a well-established brain tumor animal model, KX-02 has been shown to consistently clear brain tumors after 4 weeks of therapy in 30-60% of treated animals. Pharmacokinetic studies showed that KX-02 is absorbed orally and has 76% penetration to brain tissue from plasma.

KX-02 is already in Phase 1 study in the US and has been assigned "Orphan Drug" status by the US FDA. Preclinical studies have shown that KX-02 showed excellent brain penetration and promising anti-tumor activities in mouse brain tumor models. A proportion of rodents cleared the tumor after 6 weeks of oral KX-02 treatment.