Xcovery to Present at the ASCO Annual Meeting 2016

On June 1, 2016 Xcovery, a developer of targeted therapeutics for cancer, reported that data on the plasma genotyping of patients enrolled in its expansion Phase I/II trial of ensartinib (X-396), the Company’s lead ALK inhibitor drug candidate, in patients with anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC) will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2016, which is being held from June 3 – 7, 2016 in Chicago, Illinois (Press release, Xcovery, JUN 1, 2016, View Source [SID:1234512947]). The presentation details are as follows:

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Poster Title: Plasma genotyping of patients enrolled on the expansion phase I/II trial of X-396 in patients (pts) with ALK+ non-small cell lung cancer (NSCLC)
Poster Session: Lung Cancer – Non-Small Cell Metastatic
Poster Time: Sunday, June 5, 2016 from 8:00am – 11:30am CDT
Session Location: McCormick Place, Hall A
Poster Board Number: 379
Abstract Number: 9056
Presented by: Leora Horn, MD, MSc, Vanderbilt University Medical Center
Additional abstract details can be found at abstracts.asco.org.

About Ensartinib (X-396)

Xcovery’s lead asset is Ensartinib (X-396), a small molecule, anaplastic lymphoma kinase (ALK) inhibitor. It is being studied in the eXalt2 Study, a Phase II trial for the treatment of ALK-positive non-small cell lung cancer (NSCLC). The eXalt2 Study is currently enrolling patients. To learn more, visit: www.xalt2study.com or ClinicalTrials.gov under trial identifier NCT01625234.

About NSCLC and ALK

Lung cancer is the second most common type of cancer identified in the United States with an estimated 221,000 new diagnoses expected in 2015. Non‐small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for an estimated 85‐90% of the lung cancer cases. The anaplastic lymphoma kinase (ALK) gene is located on chromosome 2 and rearrangement of the ALK gene can lead to its activation or expression, therefore increasing a person’s chance of developing certain types of cancer, including NSCLC. Between three and seven percent of patients with NSCLC have the ALK rearrangement, making this a molecular target warranting investigation for NSCLC patients.

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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Baxalta and Award-winning Photographer Debut Unique Exhibition Showcasing Perspectives of Those Impacted by Rare Cancers

On May 31, 2016 Baxalta Incorporated, a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, reported the unveiling of an initiative that illustrates the perspectives of those impacted by rare cancers, created in partnership with photographer Rick Guidotti of Positive Exposure (Press release, Baxalta, MAY 31, 2016, View Source [SID:1234512924]). The photo exhibit, Rare Cancer Illuminated: a View From Within, debuts on June 2 in Chicago as part of The Atlantic’s "The Search for Answers: Fighting Rare Cancers," which Baxalta is underwriting.

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"The Search for Answers: Fighting Rare Cancers"
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This press release has an accompanying Smart Marketing Page providing further details about the organization, products and services introduced below. You can access the Smart Marketing Page via the following link: View Source

People living with rare and underserved cancers often experience difficulty with disease recognition, late or inaccurate diagnosis,1 limited treatment options, and scarcity of clinical trial availability or registries.2 Through photography, Guidotti and Baxalta aim to raise awareness and understanding of the unique challenges that rare cancer communities face and encourage greater collaboration to achieve more efficient diagnoses, treatment, access, and support.

The exhibit gathers individuals connected by various types of rare adult, pediatric, and adolescent cancers, such as pancreatic cancer, myelodysplastic syndromes (MDS), and acute lymphoblastic leukemia (ALL), and aims to illuminate the passion that drives them daily. While there is no international consensus on the definition of rare cancer, it is defined as fewer than 15 per 100,000 cases per year in the U.S.3 In Europe, rare disease is defined as those with a prevalence of fewer than 50 per 100,000 cases.3 Underserved cancers are typically referred to as those receiving inadequate physical or emotional resources.

"At Baxalta, our mission is to improve the lives of individuals affected by rare cancers through the use of innovative technologies and approaches, such as harnessing the body’s immune system," said David Meek, Executive Vice President and President, Oncology, Baxalta. "Our collaboration with Positive Exposure aims to raise awareness of rare cancers and to unite the community to drive action."

Guidotti founded the not-for-profit organization, Positive Exposure, in 1998, to celebrate and understand human diversity. Using photography, Guidotti aims to change public perception by helping people to see beyond standard definitions of beauty and arrive at their own interpretation. Rare Cancer Illuminated: a View From Within features photographs by Guidotti of rare cancer community members including those who have been diagnosed with cancer, their family and friends, advocacy organizations, and healthcare professionals. The exhibit will travel to Europe later this year.

"Baxalta’s commitment to serving rare cancer communities aligns with my vision to see beyond disease or diagnosis and celebrate our shared humanity," said Guidoitti, Founder, Positive Exposure. "We hope that people who experience this exhibit are able to take away a greater sense of understanding and compassion for communities that are up against these challenges, and feel empowered to learn more and become part of the effort to bring solutions."

The exhibit includes representation from leading advocacy organizations including: American Cancer Society Cancer Action Network; Austrian Childhood Cancer Organization; the Myelodysplastic Syndromes (MDS) Foundation, Inc.; PAN-Austria (Patient Advocacy for Adolescents and Young Adults with Neoplasia); Pancreatic Cancer Action; Stupid Cancer, Inc.; and TEB e.V. Germany (translated to Tumors and Diseases of the Pancreas). Together, their stories focus on the need for improved delivery and access to critical resources and support worldwide.

The Atlantic’s "The Search for Answers: Fighting Rare Cancers," underwritten by Baxalta, will take place on June 2 from 2:00-5:00 p.m. CDT in Chicago ahead of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. The event will focus on topics such as the fight against rare cancer, the role of advocacy organizations, the White House’s Moonshot Initiative, patient access, and support networks. Confirmed speakers include: Richard Schilsky, American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Chief Medical Officer and co-author of Value Framework; American Cancer Society Deputy Chief Medical Officer J. Leonard Lichtenfeld; and Kim Thiboldeaux, President and Chief Executive Officer of the Cancer Support Community.

This event is open to media; please RSVP directly to The Atlantic’s Sydney Simon ([email protected]; 202-266-7338) to attend. A live stream of the afternoon’s conversations will be available beginning at 2:30 p.m. CDT on June 2 on AtlanticLIVE’s website where it will be archived for later viewing.