Transgene Announces Poster Presentation at ASCO Annual Meeting on the Phase 3 PHOCUS Clinical Trial with Pexa-Vec Oncolytic Immunotherapy

On May 31, 2016 Transgene (Paris:TNG) (Euronext Paris: TNG), a company focused on designing and developing targeted immunotherapies for the treatment of cancer and infectious diseases, reported that a poster on the ongoing Pexa-Vec Phase 3 trial in first line advanced HCC patients will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Meeting on June 4th, in Chicago, IL, USA (Press release, Transgene, MAY 31, 2016, View Source [SID:1234512908]).

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Date and Time: Saturday, June 4, 2016, 8:00 a.m. – 11:30 a.m. CDT
Abstract Title: PHOCUS: A Phase 3 randomized, open-label study comparing the oncolytic immunotherapy Pexa-Vec followed by Sorafenib (SOR) vs SOR in patients with advanced hepatocellular carcinoma (HCC) without prior systemic therapy.
Abstract Number: TPS4146
Location: Hall A
Poster Board: #130b
Poster Session: Gastrointestinal (Noncolorectal) Cancer
Presenter: Ghassan K. Abou-Alfa, MD – Memorial Sloan Kettering Cancer Center
NCT02562755

The abstract is available via the following link: View Source

PHOCUS trial: study initiated in January 2016 in HCC and actively recruiting

The PHOCUS clinical trial is a multinational, randomized Phase 3 open label study with the oncolytic immunotherapy, Pexa-Vec, in patients with advanced liver cancer, also known as hepatocellular carcinoma (HCC). This trial is being led by Transgene’s partner, SillaJen, Inc. The trial is evaluating the use of Pexa-Vec to treat HCC patients who are eligible for treatment with sorafenib (Nexavar), the only approved drug for advanced HCC.

The study is designed to enroll 600 patients who have not received prior systemic treatment for their cancer. Patients will be randomized 1:1 to one of two treatment groups: one which will receive Pexa-Vec followed by sorafenib and one which will receive sorafenib alone. The study will be conducted at approximately 140 sites worldwide, including in North America, Asia, Australia and Europe. SillaJen, Inc. reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for this global Phase 3 clinical trial. The primary endpoint of the study is overall survival. Secondary objectives include safety, as well as assessments for tumor responses between the two groups as measured by the following endpoints: time to progression, progression-free survival, overall response rate and disease control rate. To learn more about the trial, please visit View Source;rank=15 or www.pexavectrials.com.

About HCC (Hepatocellular carcinoma)

According to recent statistics (GLOBOCAN 2012), there were over 780,000 new cases of liver cancer worldwide in 2012 and over 745,000 deaths due to this disease. In Europe, there were estimated to be over 63,000 new cases and over 62,000 deaths from liver cancer. In the U.S., according to the American Cancer Society, over 35,000 new cases of liver cancer were expected to be diagnosed in 2015 and 24,000 deaths projected from the disease. Hepatocellular carcinoma is estimated to account for over 80% of all liver cancer. Currently there are few treatment options for advanced HCC patients, with only one drug, sorafenib, approved for the treatment of HCC. With a low five-year survival rate, especially for patients diagnosed at later stages of disease, and limited available therapies, new treatments are urgently needed.

About Pexa-Vec

Pexa-Vec (pexastimogene devacirepvec) is an oncolytic immunotherapy armed with a GM-CSF gene that promotes an anti-tumor immune response. Pexa-Vec is designed to selectively target and destroy cancer cells through three different mechanisms of action: the lysis (breakdown) of cancer cells through viral replication, the reduction of the blood supply to tumors through vascular disruption, and the stimulation of the body’s immune response against cancer cells. The lead indication for Pexa-Vec is hepatocellular carcinoma (HCC, liver cancer); trials in other cancer types are underway or planned.

SillaJen, Inc. has partnered with Transgene and Lee’s Pharmaceutical to develop and commercialize Pexa-Vec in major markets outside of the United States. Transgene has exclusive rights to develop and commercialize Pexa-Vec for the treatment of solid tumors in Europe, while Lee’s Pharmaceutical retains exclusive development and commercial rights in Hong Kong and The People’s Republic of China.

About SillaJen, Inc., Transgene’s Partner for Pexa-Vec

SillaJen, Inc. is a private, South Korean based biotechnology company headquartered in Busan South Korea, with satellite offices in Seoul, South Korea and San Francisco, CA. The company is focused on the development and commercialization of oncolytic immunotherapy products using the SOLVETM platform, including its lead product Pexa-Vec, which is currently in Phase 3 trials for the treatment of advanced primary liver cancer. Additional information about SillaJen is available at www.sillajen.com.

Kite Pharma to Highlight Key Data from Engineered CAR T Cell Therapy Pipeline at the 2016 American Society of Clinical Oncology Annual Meeting

On May 31, 2016 Kite Pharma, Inc., (Nasdaq:KITE) ("Kite") a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT) products for the treatment of cancer, reported four presentations relating to its clinical programs will be delivered at the upcoming 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Kite Pharma, MAY 31, 2016, View Source [SID:1234512909]).

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"Our presence at this year’s ASCO (Free ASCO Whitepaper) reinforces our progress toward delivering a breakthrough personalized cell therapy for patients with refractory hematological malignancies who have limited or no treatment options," said Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer of Kite. "These data represent a key milestone in our trajectory to advance personalized T cell immuno-oncology and ultimately address critical unmet medical needs."

Data to be presented include results from Kite’s SCHOLAR-1 study, the first and largest meta-analysis of outcomes in patients with chemorefractory diffuse large B-cell lymphoma (DLBCL), an aggressive non-Hodgkin lymphoma (NHL). Patients with chemorefractory DLBCL have not responded to prior treatment with chemotherapy or have relapsed within a year after autologous stem cell transplantation.

Data from a Phase 1-2a study evaluating anti-CD19 CAR T cell therapy after low-dose chemotherapy in people with advanced lymphoma will be presented in a Late-Breaking Abstract oral session by James N. Kochenderfer, M.D., an investigator in the Experimental Transplantation and Immunology Branch of the National Cancer Institute (NCI) Center for Cancer Research. This study is being conducted as part of a Cooperative Research and Development Agreement (CRADA) between Kite and the NCI.

Kite will also provide an update on patients with chemorefractory aggressive NHL from the Phase 1 portion of the ZUMA-1 study and present a poster on the study design of ZUMA-4, an ongoing Phase 1/2 study of KTE-C19 in children and young adults with previously treated acute lymphoblastic leukemia.

Presentations at the 2016 ASCO (Free ASCO Whitepaper) Annual Meeting:

Oral Presentation

Anti-CD19 chimeric antigen receptor T cells preceded by low-dose chemotherapy to induce remissions of advanced lymphoma

Date: Monday, June 6, 2016, 4:42-4:54 PM CDT
Location: Hall D2
Abstract Number: LBA3010
Presenter: James Kochenderfer, M.D., Experimental Transplantation and Immunology Branch, National Cancer Institute, Bethesda, MD

Poster Discussion

Outcomes in refractory aggressive diffuse large b-cell lymphoma (DLBCL): results from the international SCHOLAR-1 Study

Date: Monday, June 6, 2016, 1:15-2:45 PM CDT
Location: E354b
Abstract Number: 7516
Presenter: Michael Crump, M.D., FRCPC, Princess Margaret Cancer Centre, Toronto, Ontario, Canada

Poster Presentations

Ongoing complete remissions (CR) in the phase 1 of ZUMA-1: a phase 1-2 multicenter study evaluating the safety and efficacy of KTE-C19 (anti-CD19 CAR T cells) in subjects with refractory aggressive B-cell Non-Hodgkin Lymphoma (NHL)

Date: Monday, June 6, 2016, 8:00-11:30 AM CDT
Location: Poster Board 115, Hall A
Abstract Number: 7559
Presenter: Sattva Swarup Neelapu, M.D., The University of Texas MD Anderson Cancer Center, Houston, TX

ZUMA-4: A phase 1/2 multicenter study evaluating the safety and efficacy of KTE-C19 (anti-CD19 CAR T cells) in pediatric and adolescent subjects with relapsed/refractory B-precursor acute lymphoblastic leukemia (r/r ALL)

Date: Monday, June 6, 2016, 8:00-11:30 AM CDT
Location: Poster Board 65a, Hall A
Abstract Number: TPS7075
Presenter: Alan S. Wayne, M.D., Children’s Hospital Los Angeles, Los Angeles, CA

20-F/A [Amend] – Annual and transition report of foreign private issuers [Sections 13 or 15(d)]

(Filing, Annual, BioLineRx, 2015, MAY 31, 2016, View Source [SID:1234512873])

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Medtronic Reports Fourth Quarter and Fiscal Year 2016 Financial Results

On May 31, 2016 Medtronic plc (NYSE: MDT) reported financial results for its fourth quarter and fiscal year 2016, which ended April 29, 2016 (Press release, Medtronic, MAY 31, 2016, View Source;p=RssLanding&cat=news&id=2173358 [SID:1234512872]).

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The company reported fourth quarter worldwide revenue of $7.567 billion, compared to the $7.304 billion reported in the fourth quarter of fiscal year 2015, an increase of 4 percent, or 6 percent on a constant currency basis. Foreign currency translation had a negative $179 million impact on fourth quarter revenue. As detailed in the financial schedules included through the link at the end of this release, fourth quarter non-GAAP net income and diluted earnings per share (EPS) were $1.796 billion and $1.27, an increase of 7 percent and 9 percent, respectively. As reported, fourth quarter GAAP net income and diluted EPS were $1.104 billion and $0.78.

Fourth quarter U.S. revenue of $4.217 billion represented 56 percent of company revenue and increased 4 percent. Non-U.S. developed market revenue of $2.393 billion represented 31 percent of company revenue and increased 3 percent, or 6 percent on a constant currency basis. Emerging market revenue of $957 million represented 13 percent of company revenue and increased 4 percent, or 15 percent on a constant currency basis.

Medtronic’s fiscal year 2016 revenue of $28.833 billion increased 42 percent, or 7 percent on a comparable, constant currency basis, which adjusts for the impact of foreign currency translation and includes Covidien plc in the prior year comparison, aligning Covidien’s prior year monthly revenue to Medtronic’s fiscal quarters. 2016 revenue growth rates include the benefit from the extra week in the first quarter. Foreign currency translation had a negative $1.502 billion impact on fiscal year 2016 revenue. As detailed in the link at the end of this release, fiscal year 2016 non-GAAP earnings and diluted EPS were $6.228 billion and $4.37, an increase of 31 percent and 2 percent, respectively. As reported, fiscal year 2016 net earnings were $3.538 billion or $2.48 per diluted share, an increase of 32 percent and 3 percent, respectively.

"Our organization once again successfully delivered strong, balanced revenue growth across our groups and geographic regions – growing above the market and exceeding our revenue growth projections," said Omar Ishrak, Medtronic chairman and chief executive officer. "This quarter caps a transformative year for Medtronic, our first full year after closing the largest ever MedTech acquisition. I am pleased with the execution and focus of our teams around the world who delivered sustained revenue growth and exceeded our Covidien cost synergy commitments."

Cardiac and Vascular Group
The Cardiac and Vascular Group (CVG) includes the Cardiac Rhythm & Heart Failure (CRHF), Coronary & Structural Heart (CSH), and Aortic & Peripheral Vascular (APV) divisions. CVG worldwide fourth quarter revenue of $2.736 billion increased 5 percent, or 8 percent on a constant currency basis. CVG revenue performance was driven by strong, balanced growth across all three divisions.
CRHF fourth quarter revenue of $1.492 billion grew 7 percent, or 9 percent on a constant currency basis, significantly outperforming the market on the strength of the Amplia MRI(TM) and Compia MRI(TM) Quad CRT-D launches and ongoing Evera MRI ICD launch in the U.S., adoption of the Micra TPS pacemaker in Europe, continued global adoption of the Reveal LINQ insertable cardiac monitor, and mid-thirties growth in AF Solutions on a constant currency basis.

CSH fourth quarter revenue of $816 million increased 3 percent, or 7 percent on a constant currency basis, led by high-twenties growth on a constant currency basis in transcatheter valves as a result of strong customer adoption of the CoreValve Evolut R. Coronary grew in the low-single digits on a constant currency basis driven by Resolute Onyx(TM) in Europe and emerging markets.
APV fourth quarter revenue of $428 million increased 5 percent, or 8 percent on a constant currency basis, driven by mid-single digit growth on a constant currency basis in Aortic, led by the continued strength of the Endurant IIs aortic stent graft and solid adoption of the Heli-FX EndoAnchor System, as well as strong above-market growth of the clinically differentiated IN.PACT Admiral drug-coated balloon, which holds the leading market position in the U.S. and globally.

Minimally Invasive Therapies Group
The Minimally Invasive Therapies Group (MITG) includes the Surgical Solutions and the Patient Monitoring & Recovery (PMR) divisions. MITG worldwide fourth quarter revenue of $2.460 billion increased 3 percent, or 6 percent on a constant currency basis. MITG had a strong quarter of above-market growth in Surgical Solutions and low-single digit growth on a constant currency basis in PMR.

Surgical Solutions fourth quarter revenue of $1.358 billion increased 5 percent, or 9 percent on a constant currency basis, driven by double-digit growth on a constant currency basis in Advanced Energy and upper-single digit growth on a constant currency basis in Advanced Stapling. Early Technologies grew double-digits on a constant currency basis, led by strong growth in GI Solutions.

PMR fourth quarter revenue of $1.102 billion increased 1 percent, or 3 percent on a constant currency basis, driven by growth in Renal Care Solutions from the recent acquisition of Bellco, which offset negative revenue impacts resulting from the product hold of the Puritan Bennett(TM) 980 ventilator and recall of the battery pack in the Capnostream(TM) 20 capnography monitor.

Restorative Therapies Group
The Restorative Therapies Group (RTG) includes the Spine, Neuromodulation, Surgical Technologies, and Neurovascular divisions. RTG worldwide fourth quarter revenue of $1.875 billion increased 1 percent, or 3 percent on a constant currency basis. Group results were driven by strong growth in Neurovascular and Surgical Technologies and improved results in Spine, which offset low-single digit declines on a constant currency basis in Neuromodulation.

Spine fourth quarter revenue of $737 million declined 1 percent, or was flat on a constant currency basis. Core Spine and Interventional Spine both delivered improved growth. BMP declined in the low-single digits on a constant currency basis, as mid-single digit growth in the U.S. only partially offset the continued loss of BMP sales in Europe as a result of a product hold.

Neuromodulation fourth quarter revenue of $494 million declined 5 percent, or declined 3 percent on a constant currency basis. In Drug Pumps, the business was negatively affected by challenges related to its April 2015 U.S. FDA consent decree as well as by a recent divestiture of its intrathecal baclofen drug. In addition, Pain Stim and Deep Brain Stimulation (DBS) declined, driven by competitive challenges.

Surgical Technologies fourth quarter revenue of $485 million increased 5 percent, or increased 7 percent on a constant currency basis, with high-teens growth on a constant currency basis in Advanced Energy and high-single digit growth on a constant currency basis in Neurosurgery, offsetting low-single digit declines on a constant currency basis in ENT.

Neurovascular fourth quarter revenue of $159 million increased 20 percent, or 23 percent on a constant currency basis, driven by continued strong growth in stents and flow diversion as a result of customer adoption of the company’s Solitaire(TM) FR revascularization device for the treatment of ischemic stroke, as well as the Pipeline(TM) Flex device in the U.S. and Japan and Pipeline(TM) Shield in Europe for the treatment of intracranial aneurysms.

Diabetes Group
The Diabetes Group includes the Intensive Insulin Management (IIM), Diabetes Service & Solutions (DSS), and Non-Intensive Diabetes Therapies (NDT) divisions. Diabetes Group worldwide fourth quarter revenue of $496 million increased 6 percent, or 10 percent on a constant currency basis. The group had strong, broad-based performance across all three divisions.

IIM grew in the high-single digits on a constant currency basis, driven by continued strong sales in Europe and Asia Pacific of the MiniMed 640G System with the enhanced Enlite sensor and SmartGuard(TM) technology.

NDT grew over 230 percent on a constant currency basis, led by strong U.S. sales of the iPro2 Professional Continuous Glucose Monitor (CGM) technology with Pattern Snapshot.

DSS grew in the high-single digits on a constant currency basis as a result of solid growth of consumables, revenue from the company’s acquisition of Diabeter in Europe, and continued strong growth of the MiniMed Connect, where now over 16,000 people with diabetes are using the product to view their insulin pump and CGM information on a smartphone.

Revenue Outlook and EPS Guidance
The company today provided its initial 2017 revenue outlook and EPS guidance. The company’s baseline goal is to consistently grow revenue in the mid-single digits on a constant currency basis. In fiscal year 2017, given current trends, the company expects constant currency revenue growth to be in the upper-half of the mid-single digit range, which is in the range of 5 to 6 percent and excludes the estimated negative 150 basis point impact from the extra selling week the company had in the first quarter of fiscal year 2016. The company expects a negative impact from foreign currency in fiscal year 2017 of approximately $25 to $75 million based on current exchange rates.

In fiscal year 2017, the company expects non-GAAP diluted EPS in the range of $4.60 to $4.70, which includes an expected $0.20 to $0.25 negative foreign currency impact based on current exchange rates. The company indicated this guidance would imply diluted EPS growth in the range of 12 to 16 percent, after adjusting for the estimated impact of foreign currency translation and the extra selling week in the company’s first quarter of fiscal year 2016.

"As we enter our new fiscal year, we look forward to delivering on our robust pipeline of products and services, expanding our global reach to serve more patients, and partnering with others around the world to develop new value-based business models," said Ishrak. "We believe that Medtronic can play a meaningful leadership role with others in healthcare that can lead to better outcomes for patients, while improving overall healthcare system performance."

8-K – Current report

On May 31, 2016 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) and Celator Pharmaceuticals, Inc. (Nasdaq: CPXX) reported that they have entered into a definitive agreement for Jazz Pharmaceuticals to acquire Celator for $30.25 per share in cash, or approximately $1.5 billion (Filing, 8-K, Celator Pharmaceuticals, MAY 31, 2016, View Source [SID:1234512874]).

The transaction with Celator is well-suited to advance Jazz Pharmaceuticals’ growth strategy.

· VYXEOS is the first product candidate to demonstrate a statistically significant improvement in Overall Survival in patients with high-risk (secondary) AML1
· U.S. FDA Breakthrough Therapy designation granted for VYXEOS2
· U.S. FDA and European Commission Orphan Drug designation for VYXEOS for the treatment of AML
· VYXEOS is an innovative product candidate based on the Celator CombiPlex platform
· Anticipated long-lived exclusivity for VYXEOS
· Broadens Jazz Pharmaceuticals’ hematology/oncology portfolio
· Worldwide development and commercialization rights to VYXEOS
· Synergies with Jazz Pharmaceuticals’ commercial expertise and infrastructure
· Transaction expected to close in the third quarter of 2016
· Transaction expected to be accretive to Non-GAAP adjusted EPS beginning in 2018 and beyond

1 Included secondary AML and de novo AML with a karyotype characteristic of myelodysplastic syndrome (MDS)
2 U.S. FDA Breakthrough Therapy designation granted for VYXEOS for the treatment of adults with therapy-related AML or AML with myelodysplasia-related changes

"Celator Pharmaceuticals is a strong strategic fit with Jazz Pharmaceuticals. VYXEOS will further diversify our product portfolio and is complementary to our clinical and commercial expertise in hematology/oncology," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals plc. "As Celator is currently preparing a regulatory submission in the U.S. for VYXEOS, this acquisition would add a new orphan product with the potential for short- and long-term revenue generation and expansion of our international commercial platform."

"The planned combination of Jazz and Celator is highly complementary, as both companies are dedicated to bringing differentiated therapies to patients who have high unmet medical needs," said Scott Jackson, chief executive officer of Celator Pharmaceuticals. "We believe that Jazz Pharmaceuticals’ clinical and commercial expertise in hematology/oncology and existing international infrastructure will help realize the value of VYXEOS as a treatment to patients with AML. After thoroughly evaluating our strategic options, our board of directors has unanimously determined that this all-cash transaction is in the best interest of our stockholders."

Transaction Closing
The transaction is structured as a tender offer and second step merger. The closing of the tender offer is conditioned upon customary conditions, including the tender of a majority of the outstanding shares of Celator common stock and expiration or termination of the Hart Scott Rodino waiting period. The transaction is expected to close in the third quarter of 2016.

Certain stockholders of Celator holding approximately 18.4 percent of Celator’s outstanding shares of common stock, including executive officers, members of the Celator board of directors and certain investment funds affiliated with the members of the board of directors, have agreed to tender their shares in the tender offer.

Financing
Jazz Pharmaceuticals expects to finance the transaction with a combination of cash on hand and borrowings under its senior secured credit facility.

Advisors
Jazz Pharmaceuticals’ financial advisor for the transaction is RBC Capital Markets, and its primary legal advisor is Cooley LLP.

Celator Pharmaceuticals’ financial advisor for the transaction is MTS Health Partners, and its primary legal advisor is Kirkland and Ellis LLP.

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