Actinium Pharmaceuticals Highlights Successful Investigator Meeting for Pivotal Phase 3 Iomab-B SIERRA Trial

On July 20, 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 the Company conducted a successful investigator meeting on July 15 – 16, 2016 in Dallas, Texas (Press release, Actinium Pharmaceuticals, JUL 20, 2016, View Source [SID:1234513978]). The purpose of the investigator meeting was to bring together bone marrow transplant physicians, care providers and clinical research coordinators from current and prospective clinical trial sites in the pivotal, Phase 3 SIERRA clinical trial for Iomab-B. Members of Actinium’s scientific advisory board, clinical development team and management team presented educational content pertaining to Iomab-B and the SIERRA trial to the meeting attendees. Actinium was joined by members of MedPace, Inc., Actinium’s Clinical Research Organization (CRO) for the SIERRA trial. The meeting drew over 85 attendees including principal investigators, care providers and clinical research coordinators from many of the leading bone marrow transplant centers from across the United States.

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Felix Garzon, M.D., Ph.D., Actinium’s Senior Vice President and Head of Clinical Development said, "The Investigator Meeting furthers our confidence in our ability to successfully execute the pivotal Phase 3 trial for Iomab-B. It was clear from the meeting that there is great enthusiasm from transplant, nuclear medicine and hematology physicians for Iomab-B. Actinium’s clinical development team is excited to work with these physicians to progress the SIERRA trial efficiently and effectively."

The pivotal Phase 3 SIERRA trial is a multi-center, randomized, controlled study that will enroll 150 patients and it is designed to evaluate if treatment with Iomab-B followed by a bone marrow transplant can increase durable Complete Remission (dCR) rates of 6 months compared to physician’s choice of chemotherapy followed by a bone marrow transplant or other treatment modalities with curative intent. There are currently no effective treatments approved by the FDA for AML in this patient population and there is no defined standard of care. The SIERRA trial will include independent Data Monitoring Committee (DMC) reports, which will occur at 25, 50, 75 and 100 percent patient enrollment with the potential for two additional ad-hoc DMC reports. Approximately 150 medical centers provide AML bone marrow transplants, with the top 30 centers performing over 50 percent of the AML BMT procedures. Actinium expects many of the highest volume BMT centers to participate in the SIERRA trial in light of the results of previous studies with Iomab-B conducted in almost 300 patients. Iomab-B has demonstrated the potential to create a new treatment paradigm for bone marrow transplants by: expanding the pool to otherwise ineligible patients who do not have any viable treatment options currently; enabling a shorter and safer preparatory interval for HSCT; reducing post-transplant complications; and demonstrating a clear survival benefit including curative potential.

Sandesh Seth, Actinium’s Executive Chairman stated, "I am delighted by the attendance and enthusiasm that I witnessed at the Investigator Meeting this past weekend. Actinium is fortunate to have such strong support from the leading bone marrow transplant centers, which we can only attribute to the potential for Iomab-b to fulfill a dire unmet medical need as an induction and conditioning agent prior to a bone marrow transplant for patients with relapsed or refractory Acute Myeloid Leukemia who are over the age of 55. We are thankful for the physicians and centers that will be participating in our trial but most importantly we are grateful for the opportunity to be able to provide such a potentially life saving therapy to patients who currently have no viable treatments available."

More information about Iomab-B and the SIERRA trial can be found by visiting www.actiniumpharma.com.

About the SIERRA trial

The SIERRA (Study of Iomab-B in Elderly Relapsed or Refractory AML) trial is a multi-center, randomized, controlled pivotal Phase 3 study of Iomab-B in patients with relapsed or refractory Acute Myeloid Leukemia (AML) who are over the age of 55. The Company established an agreement with the FDA that the path to a Biologics License Application (BLA) submission could include the SIERRA trial, if it is successful. The primary endpoint in the pivotal Phase 3 trial is durable complete remission, defined as a complete remission lasting at least 6 months and the secondary endpoint will be overall survival at one year. There are currently no effective treatments approved by the FDA for AML in this patient population and there is no defined standard of care. Iomab-B has completed several physician sponsored clinical trials examining its potential as a conditioning regimen prior to HSCT in various blood cancers, including the Phase 1/2 study in relapsed and/or refractory AML patients. The results of these studies in almost 300 patients have demonstrated the potential of Iomab-B to create a new treatment paradigm for bone marrow transplants by: expanding the pool to ineligible patients who do not have any viable treatment options currently; enabling a shorter and safer preparatory interval for HSCT; reducing post-transplant complications; and showing a clear survival benefit including curative potential.

About Iomab-B

Iomab-B is a radioimmunotherapy consisting of BC8, a novel murine monoclonal antibody, and iodine-131 radioisotope. BC8 has been developed by the Fred Hutchinson Cancer Research Center to target CD45, a pan-leukocytic antigen widely expressed on white blood cells. This antigen makes BC8 potentially useful in targeting white blood cells in preparation for hematopoietic stem cell transplantation in a number of blood cancer indications, including acute myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), Hodgkin’s disease (HD), Non-Hodgkin lymphomas (NHL) and multiple myeloma (MM). When labeled with radioactive isotopes, BC8 carries radioactivity directly to the site of cancerous growth and bone marrow while avoiding effects of radiation on most healthy tissues. Iomab-B is being studied in the pivotal Phase 3 SIERRA trial and is designed to be used, upon approval, in preparing patients with relapsed or refractory AML over the age of 55 for hematopoietic stem cell transplant (HSCT), commonly referred to as bone marrow transplant (BMT).

Abbott Reports Second-Quarter 2016 Results

On July 20, 2016 Abbott (NYSE: ABT) reported financial results for the second quarter ended June 30, 2016 (Press release, Abbott, JUL 20, 2016, View Source [SID:1234513964]).

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Second-quarter worldwide sales of $5.3 billion increased 3.2 percent on a reported basis and 6.4 percent on an operational basis.
Reported diluted EPS from continuing operations under GAAP was $0.40 in the second quarter. Excluding specified items, adjusted diluted EPS from continuing operations was $0.55 in the second quarter, above the previous guidance range.
Abbott’s full-year 2016 EPS for continuing operations under GAAP is projected to be $1.26 to $1.36. Projected full-year 2016 adjusted EPS for continuing operations remains unchanged at $2.14 to $2.24.
In July, Abbott received U.S. FDA approval for AbsorbTM, the only fully dissolving heart stent, as well as 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.
In the second quarter, Abbott announced the global launch of AlinIQ, the first-of-its-kind informatics solution with enhanced capabilities to help diagnostics laboratories increase productivity and flexibility in managing data throughout hospital networks.
On April 28, 2016, Abbott announced an agreement to acquire St. Jude Medical, Inc. The transaction will create a premier medical device leader with a highly competitive portfolio that will include an industry-leading pipeline across cardiovascular, neuromodulation, diabetes and vision care.
"It was a good quarter," said Miles D. White, chairman and chief executive officer, Abbott. "We’re particularly pleased with the steady cadence of new product approvals and recent launches that are contributing to growth, including FreeStyle Libre, MitraClip, Absorb and Symfony."

SECOND-QUARTER BUSINESS OVERVIEW

Following are sales by business segment and commentary for the second quarter and first half of the year:

Total Company
($ in millions)


% Change vs. 2Q15

Sales 2Q16

Int’l

Total

U.S.

Int’l

Total

U.S.

Reported

Operational

Reported

Operational
Total *

1,655

3,678

5,333

4.0

2.8

7.5

3.2

6.4
Nutrition

750

990

1,740

3.0

0.2

5.3

1.4

4.3
Diagnostics

361

865

1,226

3.0

4.5

7.3

4.1

6.0
Established Pharmaceuticals


980

980

n/a

0.4

9.5

0.4

9.5
Medical Devices

535

837

1,372

6.1

6.6

7.3

6.4

6.8

* Total Abbott Sales from continuing operations include Other Sales of $15 million.


% Change vs. 1H15

Sales 1H16

Int’l

Total

U.S.

Int’l

Total

U.S.

Reported

Operational

Reported

Operational
Total *

3,186

7,032

10,218

3.0

0.8

7.0

1.5

5.8
Nutrition

1,469

1,942

3,411

3.9

(1.5)

4.6

0.8

4.3
Diagnostics

700

1,644

2,344

3.3

3.2

7.7

3.2

6.4
Established Pharmaceuticals


1,868

1,868

n/a

(0.3)

10.2

(0.3)

10.2
Medical Devices

1,001

1,568

2,569

1.2

2.8

5.4

2.1

3.7

* Total Abbott Sales from continuing operations include Other Sales of $26 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.

Second-quarter 2016 worldwide sales of $5.3 billion increased 3.2 percent on a reported basis, including an unfavorable 3.2 percent effect of foreign exchange, and increased 6.4 percent on an operational basis.

International sales increased 2.8 percent on a reported basis and 7.5 percent on an operational basis in the second quarter. International operational growth was led by strong performance across all of Abbott’s business segments.

Emerging market sales increased 1.1 percent on a reported basis and 8.5 percent on an operational basis in the second quarter. Excluding the impact of Venezuelan operations, emerging market sales would have increased 4.8 percent on a reported basis and 12.4 percent on an operational basis.

Nutrition
($ in millions)


% Change vs. 2Q15

Sales 2Q16

Int’l

Total

U.S.

Int’l

Total

U.S.

Reported

Operational

Reported

Operational
Total

750

990

1,740

3.0

0.2

5.3

1.4

4.3
Pediatric

425

547

972

5.8

(3.4)

1.6

0.4

3.4
Adult

325

443

768

(0.6)

5.1

10.3

2.6

5.5




% Change vs. 1H15

Sales 1H16

Int’l

Total

U.S.

Int’l

Total

U.S.

Reported

Operational

Reported

Operational
Total

1,469

1,942

3,411

3.9

(1.5)

4.6

0.8

4.3
Pediatric

828

1,111

1,939

5.3

(2.8)

2.9

0.5

3.9
Adult

641

831

1,472

2.2

0.3

7.0

1.1

4.9

Worldwide Nutrition sales increased 1.4 percent on a reported basis in the second quarter, including an unfavorable 2.9 percent effect of foreign exchange, and increased 4.3 percent on an operational basis. Excluding the impact of Venezuelan operations, worldwide Nutrition sales would have increased 3.3 percent on a reported basis and 6.2 percent on an operational basis.

Worldwide Pediatric Nutrition sales increased 0.4 percent on a reported basis in the second quarter, including an unfavorable 3.0 percent effect of foreign exchange, and increased 3.4 percent on an operational basis. Sales growth in the quarter was led by above-market growth in the U.S. with continued uptake of recently launched products, including infant and toddler non-GMO products, as well as strong performance across several countries in Latin America and Asia.

Worldwide Adult Nutrition sales increased 2.6 percent on a reported basis in the second quarter, including an unfavorable 2.9 percent effect of foreign exchange, and increased 5.5 percent on an operational basis. Operational sales growth in the quarter was led by strong growth of Abbott’s complete and balanced nutrition brand, Ensure, and double-digit growth internationally.

Diagnostics
($ in millions)


% Change vs. 2Q15

Sales 2Q16

Int’l

Total

U.S.

Int’l

Total

U.S.

Reported

Operational

Reported

Operational
Total

361

865

1,226

3.0

4.5

7.3

4.1

6.0
Core Laboratory

206

772

978

0.1

4.3

7.1

3.4

5.6
Molecular

51

68

119

1.1

3.6

5.9

2.5

3.8
Point of Care

104

25

129

10.2

17.2

17.4

11.5

11.5




% Change vs. 1H15

Sales 1H16

Int’l

Total

U.S.

Int’l

Total

U.S.

Reported

Operational

Reported

Operational
Total

700

1,644

2,344

3.3

3.2

7.7

3.2

6.4
Core Laboratory

396

1,467

1,863

1.2

3.2

7.8

2.8

6.4
Molecular

98

129

227

(0.5)

0.2

4.6

(0.1)

2.4
Point of Care

206

48

254

9.7

12.1

13.4

10.1

10.4

Worldwide Diagnostics sales increased 4.1 percent on a reported basis in the second quarter, including an unfavorable 1.9 percent effect of foreign exchange, and increased 6.0 percent on an operational basis.

Core Laboratory Diagnostics sales increased 3.4 percent on a reported basis in the second quarter, including an unfavorable 2.2 percent effect of foreign exchange, and increased 5.6 percent on an operational basis. Operational sales growth in the quarter was led by double-digit growth in emerging markets. During the quarter, Abbott launched AlinIQ, a first-of-its-kind professional services and informatics solution that enhances diagnostic laboratory productivity and flexibility in managing data throughout hospital networks.

Molecular Diagnostics sales increased 2.5 percent on a reported basis in the second quarter, including an unfavorable 1.3 percent effect of foreign exchange, and increased 3.8 percent on an operational basis. As expected, continued strong growth in Abbott’s infectious disease testing business was partially offset by the planned scale down of its genetics business.

Point of Care Diagnostics sales increased 11.5 percent on a reported and operational basis. Double-digit 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. 2Q15

Sales 2Q16

Int’l

Total

U.S.

Int’l

Total

U.S.

Reported

Operational

Reported

Operational
Total



980

980

n/a

0.4

9.5

0.4

9.5
Key Emerging Markets



754

754

n/a

3.9

15.9

3.9

15.9
Other



226

226

n/a

(9.9)

(9.1)

(9.9)

(9.1)




% Change vs. 1H15

Sales 1H16

Int’l

Total

U.S.

Int’l

Total

U.S.

Reported

Operational

Reported

Operational
Total



1,868

1,868

n/a

(0.3)

10.2

(0.3)

10.2
Key Emerging Markets



1,388

1,388

n/a

0.5

14.0

0.5

14.0
Other



480

480

n/a

(2.6)

(0.4)

(2.6)

(0.4)

Established Pharmaceuticals sales increased 0.4 percent on a reported basis in the second quarter, including an unfavorable 9.1 percent effect of foreign exchange, and increased 9.5 percent on an operational basis. Excluding the impact of Venezuelan operations, Established Pharmaceuticals sales would have increased 4.6 percent on a reported basis and 14.1 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 3.9 percent on a reported basis and 15.9 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 Russia, China and several countries throughout Latin America.

Medical Devices
($ in millions)


% Change vs. 2Q15

Sales 2Q16

Int’l

Total

U.S.

Int’l

Total

U.S.

Reported

Operational

Reported

Operational
Total

535

837

1,372

6.1

6.6

7.3

6.4

6.8
Vascular

346

436

782

16.4

2.7

3.6

8.3

8.9
Diabetes Care

73

210

283

(21.6)

13.4

15.2

1.7

2.8
Medical Optics

116

191

307

1.9

9.1

7.7

6.2

5.4

Vascular Product Lines:

Coronary Devicesa)

202

367

569

3.9

1.2

2.0

2.1

2.6
Endovascularb)

77

68

145

8.5

10.5

12.3

9.4

10.2

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. 1H15

Sales 1H16

Int’l

Total

U.S.

Int’l

Total

U.S.

Reported

Operational

Reported

Operational
Total

1,001

1,568

2,569

1.2

2.8

5.4

2.1

3.7
Vascular

635

832

1,467

9.3

(0.8)

1.9

3.3

5.0
Diabetes Care

142

384

526

(26.8)

9.3

13.2

(3.6)

(1.1)
Medical Optics

224

352

576

4.5

5.0

6.0

4.8

5.4

Vascular Product Lines:

Coronary Devicesa)

396

703

1,099

4.4

(2.2)

0.4

0.1

1.8
Endovascularb)

150

128

278

9.0

6.8

10.5

7.9

9.7

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 second quarter, including an unfavorable 0.4 percent effect of foreign exchange, and increased 6.8 percent on an operational basis.

Worldwide sales of Vascular products increased 8.3 percent on a reported basis in the second quarter, including an unfavorable 0.6 percent effect of foreign exchange, and increased 8.9 percent on an operational basis. Sales were favorably impacted by the resolution of previously disputed third-party royalty revenue related to the prior year. Excluding this impact, worldwide sales of Vascular products would have increased 4.1 percent on a reported basis and 4.7 percent on an operational basis, and U.S. sales would have increased 6.2 percent on a reported and 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. Double-digit operational sales growth in Abbott’s Endovascular business was driven by vessel closure products and Supera, Abbott’s unique peripheral stent for the treatment of blockages in the leg. In July, the U.S. FDA approved Abbott’s Absorb bioresorbable stent, the only fully dissolving heart stent. Absorb offers a unique benefit to patients, as it is designed to treat coronary artery disease like a metallic stent, but then disappears after the artery is healed, leaving no metal behind to restrict natural vessel motion.

Worldwide Diabetes Care sales increased 1.7 percent on a reported basis in the second quarter, including an unfavorable 1.1 percent effect of foreign exchange, and increased 2.8 percent on an operational basis. 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. In the U.S., sales were impacted by competitive and market dynamics.

Worldwide Medical Optics sales increased 6.2 percent on a reported basis in the second quarter, including a favorable 0.8 percent effect of foreign exchange, and increased 5.4 percent on an operational basis. Operational sales growth was driven by continued market uptake of cataract products in the premium intraocular lens segment. In July, Abbott received U.S. FDA approval for the 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’S FULL-YEAR EARNINGS-PER-SHARE GUIDANCE

Abbott projects earnings per share from continuing operations under Generally Accepted Accounting Principles (GAAP) of $1.26 to $1.36 for the full year 2016.

Abbott forecasts net specified items for the full year 2016 of approximately $0.88 per share. Specified items include intangible amortization expense, the impact of the Venezuelan currency devaluation in the first quarter, expenses associated with acquisitions, including bridge facility fees, and charges related to cost reduction initiatives and other expenses, partially offset by the favorable resolution of various tax positions from prior years.

Excluding specified items, projected earnings per share from continuing operations remains unchanged at $2.14 to $2.24 for the full year 2016.

ABBOTT DECLARES 370TH QUARTERLY DIVIDEND

On June 10, 2016, the board of directors of Abbott declared the company’s quarterly dividend of $0.26 per share. Abbott’s cash dividend is payable Aug. 15, 2016, to shareholders of record at the close of business on July 15, 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.

Roche delivers strong performance in the first half of 2016

On July 21, 2016 Roche reported continued growth in the first half of 2016 (Press release, Hoffmann-La Roche , JUL 20, 2016, View Source [SID:1234513980]).

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Group sales increased by 5%1 at constant exchange rates, 6% in Swiss francs

Pharmaceuticals Division sales up 4%, driven by oncology and immunology medicines

Diagnostics Division sales grew 6%, driven primarily by immunodiagnostic products; challenging market conditions in Diabetes Care

Core earnings per share grew slightly faster than sales at 5% at constant exchange rates, 7% in Swiss francs

OCREVUS filed in US and EU for relapsing and primary progressive forms of multiple sclerosis; FDA granted priority review

Cancer immunotherapy medicine Tecentriq received accelerated FDA approval in bladder cancer in the US

cobas e801 immunodiagnostic module launched for high-volume testing

Outlook for 2016 confirmed

Key figures January – June
In millions of CHF % change
2016
2015
CER1
CHF

Group sales
25,022
23,585
+5
+6

Pharmaceuticals Division
19,460
18,350
+4
+6

Diagnostics Division
5,562
5,235
+6
+6

Core operating profit
9,854
9,236
+5
+7

Core EPS-diluted (CHF)
7.74
7.22
+5
+7

IFRS net income
5,467
5,249
+3
+4

Commenting on the Group’s results, Roche CEO Severin Schwan said: “In the first half of the year, both our Pharmaceuticals and Diagnostics Divisions showed good growth across all regions. The launch of our first cancer immunotherapy medicine Tecentriq is off to a strong start. We also completed the US and EU filings of OCREVUS, which brings us an important step closer toward launching this promising multiple sclerosis medicine. Based on our half year performance, I am confident that we will meet our full-year targets for 2016.”

Group
Strong performance in both divisions
In the first half of 2016, Group sales rose 4.8% at constant exchange rates to CHF 25.0 billion. Core EPS grew 5.2% at constant exchange rates, slightly faster than sales. Core EPS growth reflects the good underlying business performance, investments into the launch of new products and the product pipeline, the one-off accounting impact of changes to the Group’s Swiss pension plans, as well as an early bond redemption.

IFRS net income was up 3% at constant exchange rates and 4% in Swiss francs. The positive currency effect was driven by the weakening of the Swiss franc against the US dollar, the yen and the euro, partly offset by a strengthening of Latin American currencies.

Sales in the Pharmaceuticals Division were up 4% to CHF 19.5 billion, driven by demand for oncology and immunology medicines. Sales in the US increased 4%, led by immunology treatments Xolair and Esbriet, as well as Herceptin and Perjeta against HER2-positive breast cancer. There was high demand for Alecensa, which was recently launched in the US for a specific type of lung cancer. Sales of Lucentis and Tarceva declined due to the continued impact of competition. In Europe (+5%), Perjeta, MabThera/Rituxan and Actemra/RoActemra recorded strong sales growth, especially in Germany and France. In the International region (+4%), growth was driven by HER2 medicines, Avastin and MabThera/Rituxan. This growth was partly offset by lower Pegasys sales due to competition from a new generation of hepatitis C treatments. In Japan, sales rose 2% driven by HER2 medicines, Alecensa and Actemra/RoActemra.

Sales in the Diagnostics Division grew 6% to CHF 5.6 billion. All regions contributed to this growth, particularly Asia-Pacific (+17%). Professional and Tissue Diagnostics grew strongly. Diabetes Care sales were impacted by continued challenging market conditions, especially in North America.

Regulatory approvals
In the second quarter, Roche achieved several key regulatory milestones. In April, Venclexta (venetoclax) received accelerated approval in the US for a specific form of leukemia. This medicine was jointly developed with AbbVie. In May, the FDA granted cancer immunotherapy Tecentriq (atezolizumab) accelerated approval in the US for a specific type of bladder cancer. Also in May, the subcutaneous formulation of MabThera/Rituxan received approval in the EU for people with chronic lymphocytic leukaemia. In June, the European Commission approved Gazyva/Gazyvaro plus bendamustine for the second-line treatment of follicular lymphoma. The EU authorities also approved the combination of Avastin and Tarceva for the treatment of people with a specific type of lung cancer.

Strong Pharma pipeline
Roche made significant progress in late-stage development. In June, the European Medicines Agency (EMA) and the FDA confirmed that the data submission for OCREVUS (ocrelizumab) is complete, and the marketing applications for both relapsing and progressive multiple sclerosis are being reviewed. In addition, the FDA granted priority review for the US application with an action date of 28 December 2016.

In the same month, the largest clinical trial ever conducted in giant cell arteritis (GCA), a serious inflammatory disease of blood vessels, showed positive results. Initially combined with a six-month steroid regimen, Actemra/RoActemra more effectively sustained remission through one year compared to a 6- or 12-month steroid-only regimen in people with newly diagnosed and relapsing GCA.

At the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in June, Roche presented an updated clinical analysis for Tecentriq in previously treated lung cancer. Overall survival benefit was seen regardless of Programmed Death-Ligand 1 (PD-L1) expression compared to chemotherapy. In addition, Roche shared encouraging results from clinical trials with Tecentriq in combination with chemotherapy, targeted anti-cancer medicines and other cancer immunotherapy agents in several tumour types.
In May, a phase III study (J-ALEX) by Chugai found that Alecensa significantly reduced the risk of disease worsening or death compared to crizotinib. This trial in a Japanese patient population with advanced or recurrent ALK-positive non-small cell lung cancer was stopped early after a pre-planned interim analysis.

Roche recently provided an update on the phase III study of Gazyva/Gazyvaro in previously untreated diffuse large B-cell lymphoma (GOYA). The study did not meet its primary goal of extending the time patients live without their disease advancing. In May, another phase III study of Gazyva/Gazyvaro (GALLIUM) was stopped early after a pre-planned interim analysis showed positive results in the first-line treatment of follicular lymphoma. In both studies, Gazyva/Gazyvaro plus chemotherapy was tested head-to-head with MabThera/Rituxan combined with chemotherapy. The GALLIUM data will be submitted to health authorities for approval consideration. Gazyva/Gazyvaro is already approved for previously treated follicular lymphoma.

Portfolio progress in Diagnostics
In May, Roche launched the CoaguChek INRange, the first Bluetooth enabled home device, allowing patients and their healthcare providers greater control over their coagulation status. In June, Roche launched the cobas e801 module in countries accepting the CE Mark. As part of the cobas 8000 analyzer, this module provides increased immunochemistry testing capacity and an extensive test menu to laboratories with high testing volumes. Also in June, the cobas liquid biopsy test for the detection of specific mutations of the epidermal growth factor receptor (EGFR) gene became the first FDA approved liquid biopsy test. It can support therapy guidance in non-small cell lung cancer (NSCLC) via the analysis of a simple blood sample; and it complements the existing tissue-based EGFR test.

Roche delivers strong performance in the first half of 2016

On July 21, 2016 Roche reported continued growth in the first half of 2016 (Press release, Hoffmann-La Roche , JUL 20, 2016, View Source [SID:1234513980]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Group sales increased by 5%1 at constant exchange rates, 6% in Swiss francs

Pharmaceuticals Division sales up 4%, driven by oncology and immunology medicines

Diagnostics Division sales grew 6%, driven primarily by immunodiagnostic products; challenging market conditions in Diabetes Care

Core earnings per share grew slightly faster than sales at 5% at constant exchange rates, 7% in Swiss francs

OCREVUS filed in US and EU for relapsing and primary progressive forms of multiple sclerosis; FDA granted priority review

Cancer immunotherapy medicine Tecentriq received accelerated FDA approval in bladder cancer in the US

cobas e801 immunodiagnostic module launched for high-volume testing

Outlook for 2016 confirmed

Key figures January – June
In millions of CHF % change
2016
2015
CER1
CHF

Group sales
25,022
23,585
+5
+6

Pharmaceuticals Division
19,460
18,350
+4
+6

Diagnostics Division
5,562
5,235
+6
+6

Core operating profit
9,854
9,236
+5
+7

Core EPS-diluted (CHF)
7.74
7.22
+5
+7

IFRS net income
5,467
5,249
+3
+4

Commenting on the Group’s results, Roche CEO Severin Schwan said: “In the first half of the year, both our Pharmaceuticals and Diagnostics Divisions showed good growth across all regions. The launch of our first cancer immunotherapy medicine Tecentriq is off to a strong start. We also completed the US and EU filings of OCREVUS, which brings us an important step closer toward launching this promising multiple sclerosis medicine. Based on our half year performance, I am confident that we will meet our full-year targets for 2016.”

Group
Strong performance in both divisions
In the first half of 2016, Group sales rose 4.8% at constant exchange rates to CHF 25.0 billion. Core EPS grew 5.2% at constant exchange rates, slightly faster than sales. Core EPS growth reflects the good underlying business performance, investments into the launch of new products and the product pipeline, the one-off accounting impact of changes to the Group’s Swiss pension plans, as well as an early bond redemption.

IFRS net income was up 3% at constant exchange rates and 4% in Swiss francs. The positive currency effect was driven by the weakening of the Swiss franc against the US dollar, the yen and the euro, partly offset by a strengthening of Latin American currencies.

Sales in the Pharmaceuticals Division were up 4% to CHF 19.5 billion, driven by demand for oncology and immunology medicines. Sales in the US increased 4%, led by immunology treatments Xolair and Esbriet, as well as Herceptin and Perjeta against HER2-positive breast cancer. There was high demand for Alecensa, which was recently launched in the US for a specific type of lung cancer. Sales of Lucentis and Tarceva declined due to the continued impact of competition. In Europe (+5%), Perjeta, MabThera/Rituxan and Actemra/RoActemra recorded strong sales growth, especially in Germany and France. In the International region (+4%), growth was driven by HER2 medicines, Avastin and MabThera/Rituxan. This growth was partly offset by lower Pegasys sales due to competition from a new generation of hepatitis C treatments. In Japan, sales rose 2% driven by HER2 medicines, Alecensa and Actemra/RoActemra.

Sales in the Diagnostics Division grew 6% to CHF 5.6 billion. All regions contributed to this growth, particularly Asia-Pacific (+17%). Professional and Tissue Diagnostics grew strongly. Diabetes Care sales were impacted by continued challenging market conditions, especially in North America.

Regulatory approvals
In the second quarter, Roche achieved several key regulatory milestones. In April, Venclexta (venetoclax) received accelerated approval in the US for a specific form of leukemia. This medicine was jointly developed with AbbVie. In May, the FDA granted cancer immunotherapy Tecentriq (atezolizumab) accelerated approval in the US for a specific type of bladder cancer. Also in May, the subcutaneous formulation of MabThera/Rituxan received approval in the EU for people with chronic lymphocytic leukaemia. In June, the European Commission approved Gazyva/Gazyvaro plus bendamustine for the second-line treatment of follicular lymphoma. The EU authorities also approved the combination of Avastin and Tarceva for the treatment of people with a specific type of lung cancer.

Strong Pharma pipeline
Roche made significant progress in late-stage development. In June, the European Medicines Agency (EMA) and the FDA confirmed that the data submission for OCREVUS (ocrelizumab) is complete, and the marketing applications for both relapsing and progressive multiple sclerosis are being reviewed. In addition, the FDA granted priority review for the US application with an action date of 28 December 2016.

In the same month, the largest clinical trial ever conducted in giant cell arteritis (GCA), a serious inflammatory disease of blood vessels, showed positive results. Initially combined with a six-month steroid regimen, Actemra/RoActemra more effectively sustained remission through one year compared to a 6- or 12-month steroid-only regimen in people with newly diagnosed and relapsing GCA.

At the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in June, Roche presented an updated clinical analysis for Tecentriq in previously treated lung cancer. Overall survival benefit was seen regardless of Programmed Death-Ligand 1 (PD-L1) expression compared to chemotherapy. In addition, Roche shared encouraging results from clinical trials with Tecentriq in combination with chemotherapy, targeted anti-cancer medicines and other cancer immunotherapy agents in several tumour types.
In May, a phase III study (J-ALEX) by Chugai found that Alecensa significantly reduced the risk of disease worsening or death compared to crizotinib. This trial in a Japanese patient population with advanced or recurrent ALK-positive non-small cell lung cancer was stopped early after a pre-planned interim analysis.

Roche recently provided an update on the phase III study of Gazyva/Gazyvaro in previously untreated diffuse large B-cell lymphoma (GOYA). The study did not meet its primary goal of extending the time patients live without their disease advancing. In May, another phase III study of Gazyva/Gazyvaro (GALLIUM) was stopped early after a pre-planned interim analysis showed positive results in the first-line treatment of follicular lymphoma. In both studies, Gazyva/Gazyvaro plus chemotherapy was tested head-to-head with MabThera/Rituxan combined with chemotherapy. The GALLIUM data will be submitted to health authorities for approval consideration. Gazyva/Gazyvaro is already approved for previously treated follicular lymphoma.

Portfolio progress in Diagnostics
In May, Roche launched the CoaguChek INRange, the first Bluetooth enabled home device, allowing patients and their healthcare providers greater control over their coagulation status. In June, Roche launched the cobas e801 module in countries accepting the CE Mark. As part of the cobas 8000 analyzer, this module provides increased immunochemistry testing capacity and an extensive test menu to laboratories with high testing volumes. Also in June, the cobas liquid biopsy test for the detection of specific mutations of the epidermal growth factor receptor (EGFR) gene became the first FDA approved liquid biopsy test. It can support therapy guidance in non-small cell lung cancer (NSCLC) via the analysis of a simple blood sample; and it complements the existing tissue-based EGFR test.

Roche delivers strong performance in the first half of 2016

On July 21, 2016 Roche reported continued growth in the first half of 2016 (Press release, Hoffmann-La Roche , JUL 20, 2016, View Source [SID:1234513980]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Group sales increased by 5%1 at constant exchange rates, 6% in Swiss francs

Pharmaceuticals Division sales up 4%, driven by oncology and immunology medicines

Diagnostics Division sales grew 6%, driven primarily by immunodiagnostic products; challenging market conditions in Diabetes Care

Core earnings per share grew slightly faster than sales at 5% at constant exchange rates, 7% in Swiss francs

OCREVUS filed in US and EU for relapsing and primary progressive forms of multiple sclerosis; FDA granted priority review

Cancer immunotherapy medicine Tecentriq received accelerated FDA approval in bladder cancer in the US

cobas e801 immunodiagnostic module launched for high-volume testing

Outlook for 2016 confirmed

Key figures January – June
In millions of CHF % change
2016
2015
CER1
CHF

Group sales
25,022
23,585
+5
+6

Pharmaceuticals Division
19,460
18,350
+4
+6

Diagnostics Division
5,562
5,235
+6
+6

Core operating profit
9,854
9,236
+5
+7

Core EPS-diluted (CHF)
7.74
7.22
+5
+7

IFRS net income
5,467
5,249
+3
+4

Commenting on the Group’s results, Roche CEO Severin Schwan said: “In the first half of the year, both our Pharmaceuticals and Diagnostics Divisions showed good growth across all regions. The launch of our first cancer immunotherapy medicine Tecentriq is off to a strong start. We also completed the US and EU filings of OCREVUS, which brings us an important step closer toward launching this promising multiple sclerosis medicine. Based on our half year performance, I am confident that we will meet our full-year targets for 2016.”

Group
Strong performance in both divisions
In the first half of 2016, Group sales rose 4.8% at constant exchange rates to CHF 25.0 billion. Core EPS grew 5.2% at constant exchange rates, slightly faster than sales. Core EPS growth reflects the good underlying business performance, investments into the launch of new products and the product pipeline, the one-off accounting impact of changes to the Group’s Swiss pension plans, as well as an early bond redemption.

IFRS net income was up 3% at constant exchange rates and 4% in Swiss francs. The positive currency effect was driven by the weakening of the Swiss franc against the US dollar, the yen and the euro, partly offset by a strengthening of Latin American currencies.

Sales in the Pharmaceuticals Division were up 4% to CHF 19.5 billion, driven by demand for oncology and immunology medicines. Sales in the US increased 4%, led by immunology treatments Xolair and Esbriet, as well as Herceptin and Perjeta against HER2-positive breast cancer. There was high demand for Alecensa, which was recently launched in the US for a specific type of lung cancer. Sales of Lucentis and Tarceva declined due to the continued impact of competition. In Europe (+5%), Perjeta, MabThera/Rituxan and Actemra/RoActemra recorded strong sales growth, especially in Germany and France. In the International region (+4%), growth was driven by HER2 medicines, Avastin and MabThera/Rituxan. This growth was partly offset by lower Pegasys sales due to competition from a new generation of hepatitis C treatments. In Japan, sales rose 2% driven by HER2 medicines, Alecensa and Actemra/RoActemra.

Sales in the Diagnostics Division grew 6% to CHF 5.6 billion. All regions contributed to this growth, particularly Asia-Pacific (+17%). Professional and Tissue Diagnostics grew strongly. Diabetes Care sales were impacted by continued challenging market conditions, especially in North America.

Regulatory approvals
In the second quarter, Roche achieved several key regulatory milestones. In April, Venclexta (venetoclax) received accelerated approval in the US for a specific form of leukemia. This medicine was jointly developed with AbbVie. In May, the FDA granted cancer immunotherapy Tecentriq (atezolizumab) accelerated approval in the US for a specific type of bladder cancer. Also in May, the subcutaneous formulation of MabThera/Rituxan received approval in the EU for people with chronic lymphocytic leukaemia. In June, the European Commission approved Gazyva/Gazyvaro plus bendamustine for the second-line treatment of follicular lymphoma. The EU authorities also approved the combination of Avastin and Tarceva for the treatment of people with a specific type of lung cancer.

Strong Pharma pipeline
Roche made significant progress in late-stage development. In June, the European Medicines Agency (EMA) and the FDA confirmed that the data submission for OCREVUS (ocrelizumab) is complete, and the marketing applications for both relapsing and progressive multiple sclerosis are being reviewed. In addition, the FDA granted priority review for the US application with an action date of 28 December 2016.

In the same month, the largest clinical trial ever conducted in giant cell arteritis (GCA), a serious inflammatory disease of blood vessels, showed positive results. Initially combined with a six-month steroid regimen, Actemra/RoActemra more effectively sustained remission through one year compared to a 6- or 12-month steroid-only regimen in people with newly diagnosed and relapsing GCA.

At the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in June, Roche presented an updated clinical analysis for Tecentriq in previously treated lung cancer. Overall survival benefit was seen regardless of Programmed Death-Ligand 1 (PD-L1) expression compared to chemotherapy. In addition, Roche shared encouraging results from clinical trials with Tecentriq in combination with chemotherapy, targeted anti-cancer medicines and other cancer immunotherapy agents in several tumour types.
In May, a phase III study (J-ALEX) by Chugai found that Alecensa significantly reduced the risk of disease worsening or death compared to crizotinib. This trial in a Japanese patient population with advanced or recurrent ALK-positive non-small cell lung cancer was stopped early after a pre-planned interim analysis.

Roche recently provided an update on the phase III study of Gazyva/Gazyvaro in previously untreated diffuse large B-cell lymphoma (GOYA). The study did not meet its primary goal of extending the time patients live without their disease advancing. In May, another phase III study of Gazyva/Gazyvaro (GALLIUM) was stopped early after a pre-planned interim analysis showed positive results in the first-line treatment of follicular lymphoma. In both studies, Gazyva/Gazyvaro plus chemotherapy was tested head-to-head with MabThera/Rituxan combined with chemotherapy. The GALLIUM data will be submitted to health authorities for approval consideration. Gazyva/Gazyvaro is already approved for previously treated follicular lymphoma.

Portfolio progress in Diagnostics
In May, Roche launched the CoaguChek INRange, the first Bluetooth enabled home device, allowing patients and their healthcare providers greater control over their coagulation status. In June, Roche launched the cobas e801 module in countries accepting the CE Mark. As part of the cobas 8000 analyzer, this module provides increased immunochemistry testing capacity and an extensive test menu to laboratories with high testing volumes. Also in June, the cobas liquid biopsy test for the detection of specific mutations of the epidermal growth factor receptor (EGFR) gene became the first FDA approved liquid biopsy test. It can support therapy guidance in non-small cell lung cancer (NSCLC) via the analysis of a simple blood sample; and it complements the existing tissue-based EGFR test.