M6 Métropole Télévision: Déclaration des transactions sur actions propres

NEUILLY SUR SEINE, France–(BUSINESS WIRE)–Regulatory News:

M6 Métropole Télévision (Paris:MMT) :

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  Marché
MÉTROPOLE TÉLÉVISION   96950018NOMJX5XRH047   7/28/2017   FR0000053225   470,000   15.8123   Euronext
 

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MÉTROPOLE TÉLÉVISION   96950018NOMJX5XRH047   7/28/2017   FR0000053225   443,000   N/A   N/A
 
 
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MÉTROPOLE TÉLÉVISION 96950018NOMJX5XRH047 7/28/2017 FR0000053225 15.8123 EUR 470,000 Euronext 2476531758

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(unité)

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MÉTROPOLE TÉLÉVISION 96950018NOMJX5XRH047 7/28/2017 FR0000053225 N/A N/A 443,000 N/A N/A

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Brinker International, Inc. To Host Fourth Quarter Fiscal 2017 Earnings Call

DALLAS, Aug. 3, 2017 /PRNewswire/ -- Brinker International, Inc. (NYSE: EAT) has scheduled its earnings conference call at 10:00 a.m. Eastern Time on Thursday, Aug. 10, 2017 to review fourth quarter fiscal 2017 earnings, which will be announced before the market opens on Aug. 10, 2017.

The live audio webcast can be accessed through the Investor Relations section of Brinker's Web site at http://investors.brinker.com/phoenix.zhtml?c=119205&p=irol-EventDetails&EventId=5260922. A replay of the conference call will also be available on the company's web site for 30 days after the event and via Thomson StreetEvents for their service subscribers.

Brinker International owns, operates, franchises, or is involved in the ownership of restaurants under the names Chili's® Grill & Bar and Maggiano's Little Italy®.

 

View original content:http://www.prnewswire.com/news-releases/brinker-international-inc-to-host-fourth-quarter-fiscal-2017-earnings-call-300498437.html

SOURCE Brinker International, Inc.

Over 19K Certified Diabetes Educators to recognize the best CDEs with launch of America’s Top CDEs

Point of Care Network (POCN) invites close to 20,000 certified diabetes educators to vote for the best CDEs in the country; creating opportunities to recognize and elevate expert CDEs nationally with launch of America's Top CDEs

INDIANAPOLIS, Aug. 3, 2017 /PRNewswire/ -- Point of Care Network (POCN), the largest network of Advanced Clinicians in America, is excited to launch their newest recognition site, America's Top CDEs, while attending the American Association of Diabetes Educators (AADE) National Conference in Indianapolis this week.

To learn more about America's Top CDEs, visit us at

  • www.AmericasTopCDE.com to vote for Top CDEs
  • Booth #1802 at AADE at the Indiana Convention Center in Indianapolis, August 3-7, 2017
  • Or search #AmericasTopCDE on Facebook, Twitter, Instagram, and LinkedIn

Click here to share about America's Top CDE!

In addition to providing Certified Diabetes Educators the opportunity to nominate their peers at www.AmericasTopCDE.com

  • Attendees can also visit the America's Top CDE booth #1802 for a chance to win a copy of Susan Weiner's "The Complete Diabetes Organizer: Your Guide to a Less Stressful and More Manageable Diabetes Life" as well as the grand prize, registration for #AADE18 in Baltimore, MD!

Visitors to the America's Top CDE Website and Booth #1802 can nominate other CDEs based on their clinical skills and ability to promote self-care behaviors, and the sensitivity as well as empathy they possess when working with people with diabetes. Incoming nominations bring the nation's best Diabetes Educators to the forefront. Once nominated, each CDE joins an exclusive network of experts who are acknowledged amongst their personal and professional networks, are better-positioned for peer-reviewed publications, and most importantly, identified by the people with diabetes they see as one of America's Top CDEs.

"America's Top CDEs understands the passion and empathy CDEs bring to their role in promoting self-care and helping people manage diabetes. We're so excited for the opportunity to recognize our peers and promote topics about which we are passionate on a national platform, and beyond," said Susan Weiner, MS, RDN, CDE, CDN, AADE 2015 Diabetes Educator of the Year and POCN Advisory Board Member, who will be at the America's Top CDE booth on Saturday, August 5, from 3:00 pm to 4:00 pm.

About Point of Care Network (POCN):
POCN is an "opportunity destination" comprising the largest network of nurse practitioners and physician assistants in America, specializing in Leadership Marketing while bringing opportunities to EARN, LEARN & PROVIDE.  We are also the administrators of #AmericasTopNP and #AmericasTopPA.

POCN strives to empower NPs, PAs, and CDEs (Advanced Clinicians) to improve outcomes and support their peers locally, regionally, and nationally.  This includes expanding leadership opportunities, access to career development, CE/CME, consulting, advisory boards, patient, disease state and industry education, and much more. Members can register for free at www.PointofCareNetwork.com.

Contact:   
Richard Zwickel  
(800) 762-6173  
zwickel@pointofcarenetwork.com

View original content with multimedia:http://www.prnewswire.com/news-releases/over-19k-certified-diabetes-educators-to-recognize-the-best-cdes-with-launch-of-americas-top-cdes-300498217.html

SOURCE Point of Care Network

Jazz Pharmaceuticals Announces FDA Approval of Vyxeos(TM) (daunorubicin and cytarabine) Liposome for Injection for the Treatment of Adults with Newly-Diagnosed Therapy-Related Acute Myeloid Leukemia (t-AML) or AML with Myelodysplasia-Related Changes (AML-MRC)

Vyxeos represents the first new chemotherapy advance in more than 40 years for these adults with AMLVyxeos improved overall survival compared to standard of care 7+3 (cytarabine and daunorubicin) regimen (9.6 months vs. 5.9 months, respectively)

DUBLIN, Aug. 3, 2017 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) has approved Vyxeos™ (daunorubicin and cytarabine) liposome for injection for the treatment of adults with two types of Acute Myeloid Leukemia (AML), a rapidly progressing and life-threatening blood cancer.  Vyxeos is indicated for the treatment of adults with newly-diagnosed t-AML or AML-MRC.

"Vyxeos is the first new chemotherapy advance in more than 40 years for adults with newly-diagnosed therapy-related AML or AML with myelodysplasia-related changes," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals.  "The FDA approval of Vyxeos reflects our commitment to addressing unmet needs within the hematology oncology community."

Designed with Jazz's CombiPlex® proprietary technology, Vyxeos is a unique liposomal formulation that delivers a fixed-ratio of daunorubicin and cytarabine to the bone marrow that has been shown to have synergistic effects at killing leukemia cells in vitro and in animal models.  Vyxeos is the first product developed with the company's proprietary CombiPlex platform, which enables the design and rapid evaluation of various combinations of therapies. 

"Vyxeos is the first chemotherapy to demonstrate an overall survival advantage over the standard of care in a Phase 3 randomized study of older adults with newly-diagnosed therapy-related AML or AML with myelodysplasia-related changes," said Jeffrey E. Lancet, MD, Chair of the Department of Malignant Hematology at Moffitt Cancer Center.  "The prognosis for these patients is poor, so the FDA approval of this new drug provides a welcome therapeutic advance."

Vyxeos will be commercially available within a week.  For more information about Vyxeos in the United States, please visit http://www.Vyxeos.com.

Vyxeos has different dosage recommendations from other medications that contain daunorubicin and/or cytarabine.  Do not substitute Vyxeos for other daunorubicin- and/or cytarabine- containing products.

The FDA approval is based on data from a pivotal Phase 3 clinical trial that evaluated the efficacy and safety of Vyxeos compared to cytarabine and daunorubicin (7+3) in 309 patients 60 to 75 years of age with newly diagnosed t-AML or AML-MRC.  In the Vyxeos arm, patients received 44mg/100mg per m2 (daunorubicin and cytarabine) liposome intravenously via a 90 minute infusion on days 1, 3 and 5 of induction (days 1 and 3 if a second induction was needed) and 29mg/65mg per m2 (daunorubicin and cytarabine) liposome on days 1 and 3 for consolidation.  Patients in the 7+3 arm received induction with cytarabine 100mg/m2/day on days 1-7 by continuous infusion and daunorubicin 60mg/m2/day on days 1-3.  For consolidation, cytarabine was dosed on days 1-5 and daunorubicin on days 1-2.  For the primary endpoint of overall survival, Vyxeos demonstrated an improvement that was superior to the 7+3 treatment regimen.  The median overall survival for the Vyxeos treatment group was 9.6 months compared with 5.9 months for the 7+3 treatment group (p = 0.005; HR = 0.69 [0.52, 0.90]).  Vyxeos also demonstrated a statistically significant improvement in complete response rate of 38 percent versus 26 percent; p=0.036.  The overall, all-cause 30-day mortality was 6 percent in the Vyxeos arm and 11 percent in the control arm. Six percent of patients in both the Vyxeos and control arm had a fatal adverse reaction on treatment or within 30 days of therapy that was not in the setting of progressive disease.  During the first 60 days of the study, 14 percent of patients died in the Vyxeos arm versus 21 percent of patients in the 7+3 arm.  In addition, the overall rate of hematopoietic stem cell transplant (HSCT) was 34 percent in the Vyxeos arm and 25 percent in the 7+3 arm.  In the Phase 3 study, the most common adverse reactions (incidence ≥ 25%) were bleeding events, fever, rash, swelling, nausea, sores in the mouth or throat, diarrhea, constipation, muscle pain, tiredness, stomach pain, difficulty breathing, headache, cough, decreased appetite, irregular heartbeat, pneumonia, blood infection, chills, sleep disorders and vomiting.    

About VyxeosTM

Vyxeos™ (daunorubicin and cytarabine) liposome for injection 44mg/100mg is a liposome formulation of a fixed combination of daunorubicin and cytarabine for intravenous infusion.1  Vyxeos is indicated for the treatment of adults with newly-diagnosed t-AML or AML-MRC.  The FDA granted the Vyxeos application Priority Review status, designated Vyxeos as a Breakthrough Therapy and also granted Fast Track Designation.  Vyxeos received Orphan Drug Designation by the FDA and the European Commission for the treatment of AML. 

Important Safety Information

Vyxeos has different dosage recommendations from other medications that contain daunorubicin and/or cytarabine.  Do not substitute Vyxeos for other daunorubicin- and/or cytarabine- containing products.

Vyxeos should not be given to patients who have a history of serious allergic reaction to daunorubicin, cytarabine or any of its ingredients.

Vyxeos can cause a severe decrease in blood cells (red and white blood cells and cells that prevent bleeding, called platelets) which can result in serious infection or bleeding and possibly lead to death. Your doctor will monitor your blood counts during treatment with Vyxeos.  Patients should tell the doctor about new onset fever or symptoms of infection or if they notice signs of bruising or bleeding.

Vyxeos can cause heart-related side effects. Tell your doctor about any history of heart disease, radiation to the chest, or previous chemotherapy. Inform your doctor if you develop symptoms of heart failure such as:

  • shortness of breath or trouble breathing
  • swelling or fluid retention, especially in the feet, ankles or legs
  • unusual tiredness

Vyxeos may cause allergic reactions including anaphylaxis. Seek immediate medical attention if you develop signs and symptoms of anaphylaxis such as:

  • trouble breathing
  • severe itching
  • skin rash or hives
  • swelling of the face, lips, mouth, or tongue

Vyxeos contains copper and may cause copper overload in patients with Wilson's disease or other copper-processing disorders. 

Vyxeos can damage the skin if it leaks out of the vein. Tell your doctor right away if you experience symptoms of burning, stinging, or blisters and skin sores at the injection site. 

Vyxeos can harm your unborn baby. Inform your doctor if you are pregnant, planning to become pregnant, or nursing.  Do not breastfeed while receiving Vyxeos.  Females and males of reproductive potential should use effective contraception during treatment and for 6 months following the last dose of Vyxeos.

The most common side effects were bleeding events, fever, rash, swelling, nausea, sores in the mouth or throat, diarrhea, constipation, muscle pain, tiredness, stomach pain, difficulty breathing, headache, cough, decreased appetite, irregular heartbeat, pneumonia, blood infection, chills, sleep disorders, and vomiting.

Please see full Prescribing Information for Vyxeos before prescribing: http://pp.jazzpharma.com/pi/vyxeos.en.USPI.pdf

About AML

Acute myeloid leukemia (AML) is a blood cancer that begins in the bone marrow, which produces most of the body's new blood cells.2  AML cells crowd out healthy cells and move aggressively into the bloodstream to spread cancer to other parts of the body.3  AML is a relatively rare disease representing 1.3 percent of all new cancer cases.4  It is estimated that more than 21,000 people will be diagnosed with AML in the United States this year with the potential for nearly 11,000 people to die from the disease.5  The median age at diagnosis is 68 years old,4 with rising age associated with a progressively worsening prognosis.6  There is also a reduced tolerance for intensive chemotherapy as patients age.7  AML has the lowest survival rate of any other form of leukemia.4  Patients with newly diagnosed t-AML or AML-MRC may have a particularly poor prognosis.8-10   A hematopoietic stem cell transplant (HSCT) may be a curative treatment option for patients.11 

About Jazz Pharmaceuticals plc

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs.  The company has a diverse portfolio of products and product candidates with a focus in the areas of sleep and hematology/oncology.  In these areas, Jazz Pharmaceuticals markets Xyrem® (sodium oxybate) oral solution, Erwinaze® (asparaginase Erwinia chrysanthemi), Defitelio® (defibrotide sodium) and Vyxeos™ (daunorubicin and cytarabine) liposome for injection in the U.S. and markets Erwinaze® and Defitelio® (defibrotide) in countries outside the U.S.  For more information, please visit www.jazzpharmaceuticals.com.

About CombiPlex®

The CombiPlex proprietary technology enables the design and rapid evaluation of various combinations of therapies to deliver enhanced anti-cancer activity.  The CombiPlex technology seeks to identify the most synergistic ratio of drugs in vitro and fix this ratio in a nano-scale delivery complex that maintains the synergistic combination after administration.  CombiPlex utilizes two proprietary nano-scale delivery platforms: liposomes to control the release and distribution of water-soluble drugs and drugs that are both water- and fat-soluble (amphipathic), and nanoparticles to control the release and distribution of non-water-soluble (hydrophobic) drugs.

"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995

This press release contains forward-looking statements, including, but not limited to, statements related to the potential benefits and commercial availability of Vyxeos in the U.S., the company's commitment to addressing unmet needs within the hematology oncology community, and other statements that are not historical facts.  These forward-looking statements are based on the company's current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties.  Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with: the company's ability to effectively commercialize Vyxeos in the U.S.; delays or problems in the supply or manufacture of Vyxeos; obtaining and maintaining appropriate pricing and reimbursement for Vyxeos; complying with applicable U.S. regulatory requirements; achieving and maintaining commercial success of Vyxeos; pharmaceutical product development and clinical success thereof; the regulatory approval process; and effectively commercializing the company's other products and product candidates; and other risks and uncertainties affecting the company and its development programs, including those described from time to time under the caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals plc's Securities and Exchange Commission filings and reports (Commission File No. 001-33500), including the company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2017 and future filings and reports by the company.  Other risks and uncertainties of which the company is not currently aware may also affect the company's forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated.  The forward-looking statements herein are made only as of the date hereof or as of the dates indicated in the forward-looking statements, even if they are subsequently made available by the company on its website or otherwise.  The company undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made.

References:

1.    Vyxeos [package insert]. Palo Alto, CA: Jazz Pharmaceuticals; 2017.

2.    National Cancer Institute. General Information About Adult Acute Myeloid Leukemia https://www.cancer.gov/types/leukemia/patient/adult-aml-treatment-pdq Accessed June 7, 2017.

3.    American Cancer Society. What is Acute Myeloid Leukemia? https://www.cancer.org/cancer/acute-myeloid-leukemia/about/what-is-aml.html Accessed March 20, 2017.

4.    SEER Stat Facts: AML. 2017.

5.    American Cancer Society. Key Statistics About Acute Myeloid Leukemia. https://www.cancer.org/cancer/acute-myeloid-leukemia/about/key-statistics.html Accessed March 20, 2017. 

6.    Baer MR, et al., Leukemia, 2011 May; 25(5):10.1038/eu.2011.9.

7.    Klepin HD. Hematology Am Soc Hematol Educ Program. 2014;2014(1):8-13.

8.    Goldstone AH, Burnett AK, Avivi I et al. Secondary acute myeloid leukemia has a worse outcome than de novo AML, even taking into account cytogenetics and age. AML 10, 11, 12 MRC Trials. Blood 2002; 100 (88a): (Abstr 322).

9.    Schiller GJ, Hematol Educ Program, 2013:201-208.

10.  Kern W, Haferlach T, Schnittger S, Hiddemann W, Schoch C. Prognosis in therapy-related acute myeloid leukemia and impact of karyotype. J Clin Oncol. 2004 Jun 15;22(12):2510-1.

11.  Peccatori, J and Ciceri, F. Haematologica. 2010 Jun; 95(6): 857–859. doi: 10.3324/haematol.2010.023184.

 

 

 

View original content with multimedia:http://www.prnewswire.com/news-releases/jazz-pharmaceuticals-announces-fda-approval-of-vyxeos-daunorubicin-and-cytarabine-liposome-for-injection-for-the-treatment-of-adults-with-newly-diagnosed-therapy-related-acute-myeloid-leukemia-t-aml-or-aml-with-myelodysplasia-300499129.html

SOURCE Jazz Pharmaceuticals plc

SHAREHOLDER ALERT: Bronstein, Gewirtz & Grossman, LLC Notifies Shareholders of Class Action Against Foundation Medicine, Inc. (FMI) & Lead Plaintiff Deadline: September 26, 2017

NEW YORK, Aug. 3, 2017 /PRNewswire/ -- Attorney Advertising -- Bronstein, Gewirtz & Grossman, LLC notifies investors that a class action lawsuit has been filed against Foundation Medicine, Inc. ("Foundation" or the "Company") (NASDAQ: FMI) and certain of its officers, on behalf of shareholders who purchased Foundation securities between February 26, 2014 and November 3, 2015, both dates inclusive (the "Class Period"). Such investors are encouraged to join this case by visiting the firm's site: http://www.bgandg.com/fmi.

This class action seeks to recover damages against Defendants for alleged violations of the federal securities laws under the Securities Exchange Act of 1934.  

The Complaint alleges that throughout the Class Period, Defendants made false and/or misleading statements, regarding: (1) the reimbursement process and likelihood of coverage for Foundation's tumor tests by Medicare; and (2) Foundation's financial guidance. As a result of these false statements, Foundation stock traded at artificially inflated prices throughout the Class Period. Once the true details were made public, the complaint alleges that investors suffered damages.

A class action lawsuit has already been filed. If you wish to review a copy of the Complaint you can visit the firm's site: http://www.bgandg.com/fmi or you may contact Peretz Bronstein, Esq. or his Investor Relations Analyst, Yael Hurwitz of Bronstein, Gewirtz & Grossman, LLC at 212-697-6484. If you suffered a loss in Foundation you have until September 26, 2017 to request that the Court appoint you as lead plaintiff.  Your ability to share in any recovery doesn't require that you serve as a lead plaintiff.

Bronstein, Gewirtz & Grossman, LLC is a corporate litigation boutique.  Our primary expertise is the aggressive pursuit of litigation claims on behalf of our clients.  In addition to representing institutions and other investor plaintiffs in class action security litigation, the firm's expertise includes general corporate and commercial litigation, as well as securities arbitration.   Attorney advertising. Prior results do not guarantee similar outcomes.

Contact:
Bronstein, Gewirtz & Grossman, LLC
Peretz Bronstein or Yael Hurwitz 
212-697-6484 | info@bgandg.com

 

View original content with multimedia:http://www.prnewswire.com/news-releases/shareholder-alert-bronstein-gewirtz--grossman-llc-notifies-shareholders-of-class-action-against-foundation-medicine-inc-fmi--lead-plaintiff-deadline-september-26-2017-300497823.html

SOURCE Bronstein, Gewirtz & Grossman, LLC

Jazz Pharmaceuticals Announces FDA Approval of Vyxeos™ (daunorubicin and cytarabine) Liposome for Injection for the Treatment of Adults with Newly-Diagnosed Therapy-Related Acute Myeloid Leukemia (t-AML) or AML with Myelodysplasia-Related Changes (AML-MRC)

Vyxeos represents the first new chemotherapy advance in more than 40 years for these adults with AML

Vyxeos improved overall survival compared to standard of care 7+3 (cytarabine and daunorubicin) regimen (9.6 months vs. 5.9 months, respectively)

DUBLIN, Aug. 3, 2017 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) has approved Vyxeos™ (daunorubicin and cytarabine) liposome for injection for the treatment of adults with two types of Acute Myeloid Leukemia (AML), a rapidly progressing and life-threatening blood cancer.  Vyxeos is indicated for the treatment of adults with newly-diagnosed t-AML or AML-MRC.

"Vyxeos is the first new chemotherapy advance in more than 40 years for adults with newly-diagnosed therapy-related AML or AML with myelodysplasia-related changes," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals.  "The FDA approval of Vyxeos reflects our commitment to addressing unmet needs within the hematology oncology community."

Designed with Jazz's CombiPlex® proprietary technology, Vyxeos is a unique liposomal formulation that delivers a fixed-ratio of daunorubicin and cytarabine to the bone marrow that has been shown to have synergistic effects at killing leukemia cells in vitro and in animal models.  Vyxeos is the first product developed with the company's proprietary CombiPlex platform, which enables the design and rapid evaluation of various combinations of therapies. 

"Vyxeos is the first chemotherapy to demonstrate an overall survival advantage over the standard of care in a Phase 3 randomized study of older adults with newly-diagnosed therapy-related AML or AML with myelodysplasia-related changes," said Jeffrey E. Lancet, MD, Chair of the Department of Malignant Hematology at Moffitt Cancer Center.  "The prognosis for these patients is poor, so the FDA approval of this new drug provides a welcome therapeutic advance."

Vyxeos will be commercially available within a week.  For more information about Vyxeos in the United States, please visit http://www.Vyxeos.com.

Vyxeos has different dosage recommendations from other medications that contain daunorubicin and/or cytarabine.  Do not substitute Vyxeos for other daunorubicin- and/or cytarabine- containing products.

The FDA approval is based on data from a pivotal Phase 3 clinical trial that evaluated the efficacy and safety of Vyxeos compared to cytarabine and daunorubicin (7+3) in 309 patients 60 to 75 years of age with newly diagnosed t-AML or AML-MRC.  In the Vyxeos arm, patients received 44mg/100mg per m2 (daunorubicin and cytarabine) liposome intravenously via a 90 minute infusion on days 1, 3 and 5 of induction (days 1 and 3 if a second induction was needed) and 29mg/65mg per m2 (daunorubicin and cytarabine) liposome on days 1 and 3 for consolidation.  Patients in the 7+3 arm received induction with cytarabine 100mg/m2/day on days 1-7 by continuous infusion and daunorubicin 60mg/m2/day on days 1-3.  For consolidation, cytarabine was dosed on days 1-5 and daunorubicin on days 1-2.  For the primary endpoint of overall survival, Vyxeos demonstrated an improvement that was superior to the 7+3 treatment regimen.  The median overall survival for the Vyxeos treatment group was 9.6 months compared with 5.9 months for the 7+3 treatment group (p = 0.005; HR = 0.69 [0.52, 0.90]).  Vyxeos also demonstrated a statistically significant improvement in complete response rate of 38 percent versus 26 percent; p=0.036.  The overall, all-cause 30-day mortality was 6 percent in the Vyxeos arm and 11 percent in the control arm. Six percent of patients in both the Vyxeos and control arm had a fatal adverse reaction on treatment or within 30 days of therapy that was not in the setting of progressive disease.  During the first 60 days of the study, 14 percent of patients died in the Vyxeos arm versus 21 percent of patients in the 7+3 arm.  In addition, the overall rate of hematopoietic stem cell transplant (HSCT) was 34 percent in the Vyxeos arm and 25 percent in the 7+3 arm.  In the Phase 3 study, the most common adverse reactions (incidence ≥ 25%) were bleeding events, fever, rash, swelling, nausea, sores in the mouth or throat, diarrhea, constipation, muscle pain, tiredness, stomach pain, difficulty breathing, headache, cough, decreased appetite, irregular heartbeat, pneumonia, blood infection, chills, sleep disorders and vomiting.    

About VyxeosTM

Vyxeos™ (daunorubicin and cytarabine) liposome for injection 44mg/100mg is a liposome formulation of a fixed combination of daunorubicin and cytarabine for intravenous infusion.1  Vyxeos is indicated for the treatment of adults with newly-diagnosed t-AML or AML-MRC.  The FDA granted the Vyxeos application Priority Review status, designated Vyxeos as a Breakthrough Therapy and also granted Fast Track Designation.  Vyxeos received Orphan Drug Designation by the FDA and the European Commission for the treatment of AML. 

Important Safety Information

Vyxeos has different dosage recommendations from other medications that contain daunorubicin and/or cytarabine.  Do not substitute Vyxeos for other daunorubicin- and/or cytarabine- containing products.

Vyxeos should not be given to patients who have a history of serious allergic reaction to daunorubicin, cytarabine or any of its ingredients.

Vyxeos can cause a severe decrease in blood cells (red and white blood cells and cells that prevent bleeding, called platelets) which can result in serious infection or bleeding and possibly lead to death. Your doctor will monitor your blood counts during treatment with Vyxeos.  Patients should tell the doctor about new onset fever or symptoms of infection or if they notice signs of bruising or bleeding.

Vyxeos can cause heart-related side effects. Tell your doctor about any history of heart disease, radiation to the chest, or previous chemotherapy. Inform your doctor if you develop symptoms of heart failure such as:

  • shortness of breath or trouble breathing
  • swelling or fluid retention, especially in the feet, ankles or legs
  • unusual tiredness

Vyxeos may cause allergic reactions including anaphylaxis. Seek immediate medical attention if you develop signs and symptoms of anaphylaxis such as:

  • trouble breathing
  • severe itching
  • skin rash or hives
  • swelling of the face, lips, mouth, or tongue

Vyxeos contains copper and may cause copper overload in patients with Wilson's disease or other copper-processing disorders. 

Vyxeos can damage the skin if it leaks out of the vein. Tell your doctor right away if you experience symptoms of burning, stinging, or blisters and skin sores at the injection site. 

Vyxeos can harm your unborn baby. Inform your doctor if you are pregnant, planning to become pregnant, or nursing.  Do not breastfeed while receiving Vyxeos.  Females and males of reproductive potential should use effective contraception during treatment and for 6 months following the last dose of Vyxeos.

The most common side effects were bleeding events, fever, rash, swelling, nausea, sores in the mouth or throat, diarrhea, constipation, muscle pain, tiredness, stomach pain, difficulty breathing, headache, cough, decreased appetite, irregular heartbeat, pneumonia, blood infection, chills, sleep disorders, and vomiting.

Please see full Prescribing Information for Vyxeos before prescribing: http://pp.jazzpharma.com/pi/vyxeos.en.USPI.pdf

About AML

Acute myeloid leukemia (AML) is a blood cancer that begins in the bone marrow, which produces most of the body's new blood cells.2  AML cells crowd out healthy cells and move aggressively into the bloodstream to spread cancer to other parts of the body.3  AML is a relatively rare disease representing 1.3 percent of all new cancer cases.4  It is estimated that more than 21,000 people will be diagnosed with AML in the United States this year with the potential for nearly 11,000 people to die from the disease.5  The median age at diagnosis is 68 years old,4 with rising age associated with a progressively worsening prognosis.6  There is also a reduced tolerance for intensive chemotherapy as patients age.7  AML has the lowest survival rate of any other form of leukemia.4  Patients with newly diagnosed t-AML or AML-MRC may have a particularly poor prognosis.8-10   A hematopoietic stem cell transplant (HSCT) may be a curative treatment option for patients.11 

About Jazz Pharmaceuticals plc

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs.  The company has a diverse portfolio of products and product candidates with a focus in the areas of sleep and hematology/oncology.  In these areas, Jazz Pharmaceuticals markets Xyrem® (sodium oxybate) oral solution, Erwinaze® (asparaginase Erwinia chrysanthemi), Defitelio® (defibrotide sodium) and Vyxeos™ (daunorubicin and cytarabine) liposome for injection in the U.S. and markets Erwinaze® and Defitelio® (defibrotide) in countries outside the U.S.  For more information, please visit www.jazzpharmaceuticals.com.

About CombiPlex®

The CombiPlex proprietary technology enables the design and rapid evaluation of various combinations of therapies to deliver enhanced anti-cancer activity.  The CombiPlex technology seeks to identify the most synergistic ratio of drugs in vitro and fix this ratio in a nano-scale delivery complex that maintains the synergistic combination after administration.  CombiPlex utilizes two proprietary nano-scale delivery platforms: liposomes to control the release and distribution of water-soluble drugs and drugs that are both water- and fat-soluble (amphipathic), and nanoparticles to control the release and distribution of non-water-soluble (hydrophobic) drugs.

"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995

This press release contains forward-looking statements, including, but not limited to, statements related to the potential benefits and commercial availability of Vyxeos in the U.S., the company's commitment to addressing unmet needs within the hematology oncology community, and other statements that are not historical facts.  These forward-looking statements are based on the company's current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties.  Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with: the company's ability to effectively commercialize Vyxeos in the U.S.; delays or problems in the supply or manufacture of Vyxeos; obtaining and maintaining appropriate pricing and reimbursement for Vyxeos; complying with applicable U.S. regulatory requirements; achieving and maintaining commercial success of Vyxeos; pharmaceutical product development and clinical success thereof; the regulatory approval process; and effectively commercializing the company's other products and product candidates; and other risks and uncertainties affecting the company and its development programs, including those described from time to time under the caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals plc's Securities and Exchange Commission filings and reports (Commission File No. 001-33500), including the company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2017 and future filings and reports by the company.  Other risks and uncertainties of which the company is not currently aware may also affect the company's forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated.  The forward-looking statements herein are made only as of the date hereof or as of the dates indicated in the forward-looking statements, even if they are subsequently made available by the company on its website or otherwise.  The company undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made.

References:

1.    Vyxeos [package insert]. Palo Alto, CA: Jazz Pharmaceuticals; 2017.

2.    National Cancer Institute. General Information About Adult Acute Myeloid Leukemia https://www.cancer.gov/types/leukemia/patient/adult-aml-treatment-pdq Accessed June 7, 2017.

3.    American Cancer Society. What is Acute Myeloid Leukemia? https://www.cancer.org/cancer/acute-myeloid-leukemia/about/what-is-aml.html Accessed March 20, 2017.

4.    SEER Stat Facts: AML. 2017.

5.    American Cancer Society. Key Statistics About Acute Myeloid Leukemia. https://www.cancer.org/cancer/acute-myeloid-leukemia/about/key-statistics.html Accessed March 20, 2017. 

6.    Baer MR, et al., Leukemia, 2011 May; 25(5):10.1038/eu.2011.9.

7.    Klepin HD. Hematology Am Soc Hematol Educ Program. 2014;2014(1):8-13.

8.    Goldstone AH, Burnett AK, Avivi I et al. Secondary acute myeloid leukemia has a worse outcome than de novo AML, even taking into account cytogenetics and age. AML 10, 11, 12 MRC Trials. Blood 2002; 100 (88a): (Abstr 322).

9.    Schiller GJ, Hematol Educ Program, 2013:201-208.

10.  Kern W, Haferlach T, Schnittger S, Hiddemann W, Schoch C. Prognosis in therapy-related acute myeloid leukemia and impact of karyotype. J Clin Oncol. 2004 Jun 15;22(12):2510-1.

11.  Peccatori, J and Ciceri, F. Haematologica. 2010 Jun; 95(6): 857–859. doi: 10.3324/haematol.2010.023184.

Logo - https://mma.prnewswire.com/media/272253/Jazz_Pharmaceuticals_Logo.jpg

 

Entoro Capital Announces Appointment of Ian Fay as Partner

HOUSTON, Aug. 3, 2017 /PRNewswire/ -- Entoro Capital, LLC, a leading middle-market Energy & Infrastructure-focused investment bank, is pleased to announce the appointment of Ian H. Fay as Partner.  Ian will lead the firm's efforts in M&A, Private and Institutional Equity, and will be based in New York City.

Prior to joining Entoro, Ian led the Upstream Oil & Gas effort at Headwaters MB.  Prior to his role at Headwaters, Ian served in the role of Chief Financial Officer for ZaZa Energy Corporation, where he oversaw all finance and accounting functions, business development, investor relations, and public relations.  Ian was a Founding Partner of Odin Advisors LLC, a full-service energy and natural resources mergers and acquisitions advisory boutique. Additional positions Mr. Fay has held over his extensive career in investment banking include Managing Director and Head of the Energy & Natural Resources Group - Americas for BNP Paribas, and Managing Director of Mergers & Acquisitions for RBC Capital Markets, concentrating on Energy (E&P, MLP and Oil Field Services) companies.

"Ian brings an excellent set of investment banking experiences and relationships to Entoro and to OfferBoard, our recently launched private securities syndication platform, that will be instrumental as the team continues its rapid growth and expansion plans," said James Row, Entoro's Managing Partner.

"I am thrilled to expand the dynamic team at Entoro and lead the firm alongside Jim as we continue to enhance the firm's capabilities.  Our extensive experience in our core focus areas, along with the fundraising efficiency and breadth of the OfferBoard platform, will further Entoro's dedication to providing un-paralleled service to our clients," said Ian Fay.

About Entoro Group
The Entoro Group is a global, strategic advisory and investment banking group that focuses on mid-market Energy & Infrastructure investment banking. The Entoro Group of companies includes Entoro Capital (Energy & Infrastructure Investment Banking), Entoro Securities (FINRA licensed Broker/Dealer – formerly The Oil & Gas Asset Clearinghouse II), Entoro International (Advisory & Merchant Banking) and OfferBoard (online transaction syndication portal). Together, the Entoro Group's professionals provide the Energy industry with global financial and strategic solutions.  Entoro's team is comprised of proven executives with over $100 Billion in transactional experience. www.entoro.com

Contact
Michael L. Grant
+1.713.823.2900, ext. 404
mgrant@entoro.com

© 2017 Entoro Capital, LLC.  Entoro Capital, LLC is the parent company of OfferBoard, LLC and Entoro Securities, LLC.

 

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SOURCE Entoro Capital

Billabong Announces Second Limited Collection Of Warhol Surf

WARHOL SURF APPAREL + ACCESSORY LINE AVAILABLE GLOBALLY

IRVINE, Calif., Aug. 3, 2017 /PRNewswire/ -- Billabong is proud to announce today a second limited collection of Warhol Surf.

This collaboration comes through Billabong LAB, a division of the company that supports artists, musicians, designers, photographers and surf icons, and The Andy Warhol Foundation for the Visual Arts, a non-profit organization recognized as one of the leading funders of contemporary art in the United States.

The original iconic collection has been revamped using the Warhol archives as inspiration. Polaroids, black and white photography, slides, sound recordings, silkscreen paintings and screen-prints showed the deep connection that Warhol had with the surf community.

"The second collection of Warhol x Billabong continues to disrupt and keep it fresh with insider references from his groundbreaking Exploding Plastic Inevitable Show to his beachside getaway in Montauk, NY," said Michael Dayton Hermann, Director of Licensing, The Andy Warhol Foundation for the Visual Arts, Inc. "Warhol passionately embraced surf culture and the Foundation is pleased to know that the love is mutual."

"As we searched the archives and discovered more of Andy's unique and unsighted work, it illustrated the connection between his work and surf culture," says Billabong's Global Creative Director Brad Lancaster. "With this second drop of Warhol x Billabong we have brought these narratives and concepts to life again, colliding them with Billabong's iconic take on boardshorts, bikinis and complimentary products."

Warhol Surf is designed to tell those still relevant, but untold stories that the collaboration uncovered. By refreshing Warhol's iconography of the early surf era, Billabong has taken another step in furthering the relationship between Warhol and the surfing community to create a collection that reflects the surfing and lifestyle we love.

For more information on Billabong, Billabong LAB, The Andy Warhol Foundation for the Visual Arts, Inc., and Andy, visit warholsurf.billabong.com and warholfoundation.org or on Instagram at @Billabong and @Billabongwomens.

 

View original content with multimedia:http://www.prnewswire.com/news-releases/billabong-announces-second-limited-collection-of-warhol-surf-300498730.html

SOURCE Billabong

Samenvatting: euNetworks geeft prestatie-update voor tweede kwartaal van 2017

LONDON–(BUSINESS WIRE)–euNetworks is een horizontale geïntegreerde brandbreedte-infrastructuuraanbieder in Europa die focusproducten verkoopt met als doel om klanten te verwerven. Onze drijvende krachten achter de groei van bandbreedte zijn datacentra en cloud-connectiviteit.

In het tweede kwartaal gaf euNetworks een vervolg aan zijn sterke groeitraject. De totale omzet groeide met 5% ten opzichte van het tweede kwartaal van 2016 en bereikte de €33.8 miljoen, met terugkerende omzet van focusproducten van Fibre, Wavelenghts en Ethernet naar 11% ten opzichte van het tweede kwartaal van 2016, ondanks een negatief valuta-effect. De bijgestelde EBITDA groeide met 17% ten opzichte van het tweede kwartaal van 2016.

Deze bekendmaking is officieel geldend in de originele brontaal. Vertalingen zijn slechts als leeshulp bedoeld en moeten worden vergeleken met de tekst in de brontaal, die als enige rechtsgeldig is.

Resumen: Datos actualizados sobre los resultados económicos de euNetworks en el segundo trimestre de 2017

LONDRES–(BUSINESS WIRE)–euNetworks es un proveedor europeo de servicios de infraestructura de banda ancha integrada horizontalmente basada en instalaciones que vende productos especiales a clientes objetivo. Nuestros principales factores de impulso del crecimiento son la conectividad en la nube y los centros de datos.

En el segundo trimestre, euNetworks ha continuado con su sólida trayectoria de crecimiento. Los ingresos brutos totales crecieron un 5% con respecto al segundo trimestre de 2016, alcanzando los 33,8 millones de euros.

El comunicado en el idioma original, es la versión oficial y autorizada del mismo. La traducción es solamente un medio de ayuda y deberá ser comparada con el texto en idioma original, que es la única versión del texto que tendrá validez legal.