Glaxosmithkline

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03.06.07 18:29 #1 Glaxosmithkline
Sollte dem Kurs am Montag Auftrieb geben:

Glaxosmithkline Reports Positive New Data on Tykerb(R)(Lapatinib) at the 2007 American Society of Clinical Oncology (Asco) Annual Meeting
Sunday June 3, 10:00 am ET  
KEY TYKERB STUDIES:
- Activity demonstrated for the first time in the treatment of first-line metastatic HER2-(ErbB2) positive breast cancer in combination with paclitaxel (Taxol(R)) one of the most commonly used chemotherapies(1)
- Activity in brain metastases associated with HER2-positive breast cancer, an area of significant unmet medical need(2,3)
- 19% of patients on TYKERB monotherapy had reduction in brain metastases
- In trial extension, reduction in brain metastases found in 40% of patients on TYKERB + capecitabine combination


CHICAGO, June 3 /PRNewswire-FirstCall/ -- GlaxoSmithKline today announced positive data from three key studies on its first-in-class, oral small molecule HER2 kinase inhibitor, TYKERB® (lapatinib). Results of these and other important TYKERB studies are being presented this week at the 2007 American Society of Clinical Oncology (ASCO) annual meeting in Chicago, Illinois. The use of TYKERB in these settings is investigational.
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"The robust clinical data presented for TYKERB at ASCO further demonstrate the great potential of this drug as an essential component of treatment regimens for women with HER2-positive breast cancer," said Paolo Paoletti, M.D., Senior Vice President of the Oncology Medicine Development Center at GSK. "GSK is dedicated to an ongoing TYKERB clinical program to identify additional treatment regimens, as well as patient populations that may respond to TYKERB. The data presented at ASCO this week underscore our unrelenting commitment to improving treatment for these patients."

TYKERB in Combination with Paclitaxel as First-Line Treatment for Patients with Metastatic or Relapsed Advanced Breast Cancer (Abstract #1011, Embargoed until June 3, 9:00 AM, CDT)(1)

Paclitaxel is one of the most commonly used chemotherapies in breast cancer. Therefore, the evaluation of TYKERB in combination with this treatment is of high importance.

This large, randomized, multicenter, prospective trial evaluated a total of 580 patients either negative or untested for HER2 overexpression. While the combination therapy did not demonstrate an incremental benefit for patients with HER2-negative disease, an analysis of 91 patients who were retrospectively identified as having HER2-positive disease showed that TYKERB plus paclitaxel increased progression-free survival in patients with HER2-positive breast cancer not previously treated with trastuzumab. Results as follows represent the combination of TYKERB plus paclitaxel (n=52) versus paclitaxel alone (n=39), respectively, in patients with HER2-positive disease:


   -- Median progression-free survival was 7.9 months versus 5.2 months
      (p=0.007)
   -- Median duration of response was 7.4 months versus 5.5 months
   -- Complete or partial response occurred in 60 percent of patients versus
      36 percent (p = 0.027)
   -- There was a trend towards improvement in overall survival after 39
      deaths had been reported. Data presently available indicate a median
      survival of 24 months versus 19 months (p=0.160), but data are not yet
      fully mature

Data from this trial of TYKERB plus paclitaxel versus paclitaxel alone as first-line treatment in patients with newly diagnosed metastatic breast cancer have provided the first evidence of activity in the HER2-positive subgroup that the combination significantly improves progression-free survival of the disease compared with the chemotherapy alone.

"These results have the potential to directly impact clinical practice and may benefit patients in the first-line treatment setting," said Dr. Angelo Di Leo, Director of the Medical Oncology Unit, Hospital of Prato (Italy) and lead investigator of this trial. "TYKERB in combination with paclitaxel is a step in the right direction as the oncology community explores potential combination therapies to individualize treatment for breast cancer patients."

The most common adverse events (AEs) included rash, diarrhea, nausea, vomiting, neutropenia and mucositis. The addition of TYKERB to paclitaxel resulted in an increase in diarrhea and rash. SAE-related deaths were higher in the combination arm (2.7% vs 0.6%).

Several additional Phase III trials combining TYKERB with taxanes are being conducted in patients with HER2-positive disease.

TYKERB Activity in Brain Metastases Associated with Breast Cancer (Abstract #1012, Embargoed until June 3, 9:00 AM, CDT), (Abstract #1035, Embargoed until June 2, 8:00 AM, CDT) One-third of women with HER2-positive metastatic breast cancer currently develop central nervous system (CNS) or brain metastases.(4) Limited treatment options clearly demonstrate that brain metastases is an area of significant unmet medical need. Once the disease advances to this stage, overall disease prognosis is poor with the average one-year survival from diagnosis estimated at about 20 percent.(5)

Results from an ongoing, multicenter Phase II study suggest that TYKERB has clinical activity in heavily pretreated patients with CNS metastases from HER2-positive breast cancer. Patients (n=241) enrolled in this study had radiographically documented progressive brain lesions following prior therapy with trastuzumab and cranial radiotherapy. Results from an independent radiology review show that 19 patients (7%) treated with TYKERB monotherapy experienced a partial response, defined by a greater than or equal to 50% volumetric reduction in brain lesions with no progression of tumor outside the brain, no increase in steroid requirements or worsening of neurological symptoms. Forty-six patients (19%) experienced a greater than or equal to 20% volumetric reduction in brain lesions.

An additional 102 patients (42%) achieved stable disease for at least eight weeks based on a protocol defined composite response criteria. Twenty- two percent of all patients had no disease progression within the first six months on TYKERB monotherapy.(2)

An exploratory analysis in a previous, Phase III study found that numerically fewer patients on TYKERB plus capecitabine developed brain metastases as compared to capecitabine alone. As a result, this Phase II study was amended to allow patients whose disease progressed in the brain and/or non-CNS on monotherapy TYKERB to then receive the combination of TYKERB and capecitabine. In patients (n=40) treated with TYKERB in combination with capecitabine, 8 (20%) experienced a greater than or equal to 50% volume reduction in brain metastases, and 16 (40%) experienced greater than or equal to 20% volume reduction.(2)

"There is a significant need for effective alternatives to prevent and treat brain metastases arising from breast cancer as there are no currently approved systemic treatments for these patients. These data suggest that TYKERB may cross a compromised blood brain barrier and suggest the CNS activity of TYKERB," said Nancy U. Lin, M.D., Harvard Medical School (Boston,

Massachusetts) and principal investigator for this trial. "TYKERB has promise in the treatment of brain metastases."

The most common AEs included diarrhea (13% Grades 3 and 4), skin rash (3% Grades 3 and 4), nausea (3% Grade 3), vomiting (4% Grade 3), fatigue (3% Grade 3) and anorexia (1% Grade 3).(2)

In addition, updated brain metastases data (abstract #1035) from an unplanned, retrospective subset analysis of the pivotal trial of TYKERB plus capecitabine versus capecitabine alone in patients with HER2-positive, trastuzumab-exposed advanced breast cancer showed a reduction in the number of patients developing CNS metastases as a first site of relapse (4 versus 13 patients, p=0.0445).(3) Original data were presented at ASCO 2006.

Ongoing Trials

GSK has a comprehensive clinical trial program that is actively studying TYKERB in other breast cancer settings and other cancers to better identify patient populations that may respond to therapy. The landmark Phase III study TEACH (Tykerb® Evaluation After CHemotherapy), trial has reached a key milestone, enrolling more than 1,000 patients. TEACH is designed to investigate whether adjuvant treatment with TYKERB will improve disease-free survival in women with early-stage HER2-positive breast cancer, including those with positive and negative node involvement.(6)

About TYKERB/TYVERB

TYKERB/TYVERB (lapatinib) is a first-in-class oral small-molecule inhibitor of the HER2 tyrosine kinase receptor. Stimulation of HER2 is associated with cell proliferation and with multiple processes involved in tumor progression and metastases. Overexpression of this receptor has been reported in a variety of human tumors and is associated with poor prognosis and reduced overall survival. On March 13, 2007, the United States Food and Drug Administration (FDA) approved TYKERB, in combination with capecitabine, for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab.

TYVERB was approved in Switzerland in May 2007. Marketing applications for TYKERB/TYVERB have been filed around the world, including the European Union, Canada, Brazil, Australia and South Korea.

xpfuture
 

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265 Postings ausgeblendet.
09.02.22 11:06 #267 Zum Glück bin ich gestern raus
eigentlich war Pfizer ja der Auslöser, aber auch hier wurde der Ausblick gesenkt und bis zur nächsten Dividende dauert es ja noch. Überlege bei Takeda einzusteigen.  

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09.02.22 12:59 #268 GlaxoSmithKline
Die neuen Zahlen sind da, wie schätzt Ihr die Aussichten für das Jahr 2022 ein?
https://www.gsk.com/en-gb/investors/quarterly-results/  
09.02.22 18:34 #269 Dividende
Wann ist denn Ex-Datum der kommenden Quartalsdividende? Müsste doch demnächst sein...  
09.02.22 19:54 #270 Siehe hier
https://www.gsk.com/en-gb/investors/...information/dividend-calendar/

24.02.2022 ist Ex-Tag

Denke, dass 2022 ganz ok ist wenn man die Ziele erreicht, Verschuldung ist leider relativ hoch aber als Value Titel sollte man sich halten. Bin kein Fan der Abspaltung aber das ist ein anderes Thema...

Man muss auch bedenken, der Wert hat letztes Jahr 30 % plus gemacht + die 5-6 % Dividende  
09.02.22 19:55 #271 Wenn Link nicht funktioniert
einfach bei GSK selber schauen, da sind auch die voraussichtlichen Termine für 2022  
09.02.22 20:44 #272 Wollen wir
mal schauen was bei der Abspaltung für die Aktionäre rausspringt,es soll ja ein eigenes Börsennotiertes Unternehmen werden. Aber so sag ich mal kann man mit den Zahlen leben, bei anderen Unternehmen in der Pharmazie schaut's a bisschen schlechter aus.  

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18.02.22 14:25 #273 Glaxosmithkline
GlaxoSmithKline (GSK) hat eine Phase-3-Impfstudie an schwangeren Frauen wegen Sicherheitsbedenken unterbrochen
https://www.gsk.com/en-gb/media/press-releases/gsk-provides-…  
13.04.22 09:05 #274 Übernahme
13.04.22, 08:37 | Von Dow Jones News
Glaxosmithkline übernimmt Sierra Oncology für 1,9 Milliarden Dollar
Von Ian Walker

LONDON (Dow Jones) - Der Pharmakonzern Glaxosmithkline übernimmt für 1,9 Milliarden US-Dollar das kanadische Biopharma-Unternehmen Sierra Oncology. Je Aktie zahlt Glaxosmithkline nach eigenen Angaben 55 Dollar in bar. Das entspricht einem Aufschlag von 39 Prozent auf den Schlusskurs der Sierra-Oncology-Aktie vom Dienstag. Die Übernahme wird laut Glaxosmithkline sowohl vom Board der Sierra Oncology Inc unterstützt als auch von Aktionären, die 28 Prozent der Anteile halten. Mit dem Abschluss der Transaktion rechnet die Glaxosmithkline plc im dritten Quartal.

Kontakt zum Autor: unternehmen.de@dowjones.com


Anscheinend forschen die an seltenen Formen von Krebs, fast Milliarden USD ist schon ein Brett

DJG/DJN/brb/sha

Copyright (c) 2022 Dow Jones & Company, Inc. / Quelle: Guidants News https://news.guidants.com  
13.04.22 11:04 #275 Glaxosmithkline
Milliarden-Deal! Dividenden-Garant GlaxoSmithKline will Sierra Oncology - Übernahmekarussell ...
https://www.finanznachrichten.de/...ology-uebernahmekarussell-124.htm  
19.05.22 13:56 #276 Warum hat...
GSK eigentlich die Dividende gekürzt? Irgendwie ging die Meldung an mir vorbei.  

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19.05.22 21:59 #277 Die Gründe
der Dividende Kürzung interessieren mich auch.  

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20.05.22 09:41 #278 Wo bitte
wurde die Dividende gekürzt. Ich war etwas überrascht, aber nach einigem Forschen …..laut letztem report —>

Dividend policies and expected pay-out ratios are unchanged for new GSK and new Consumer Healthcare (subject to new Consumer Healthcare board approval).  

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20.05.22 09:47 #279 Und etwas genauer hier
Returns to shareholders



Quarterly dividends

The Board has declared a first interim dividend for 2022 of 14 pence per share (Q1 2021: 19 pence per share).



As set out at the new GSK Investor Update in June 2021, from 2022 GSK will adopt a progressive dividend policy targeting a dividend pay-out ratio equivalent to 40 to 60% over the investment cycle. The dividend policy, the total expected cash distribution, and the respective dividend pay-out ratios for new GSK and new Consumer Healthcare remain unchanged.



GSK expects to declare a 27p per share dividend payable by the current group for the first half. This comprises 22p per share for new GSK and 5p per share representing Consumer Healthcare during the first half whilst part of the group. For the second half of 2022, new GSK continues to expect to declare a 22p per share dividend. As previously communicated, new GSK would expect to declare a dividend of 45p per share for 2023.



Following separation, the dividend policy for the new Consumer Healthcare company will be the responsibility of its Board of Directors and is expected to be guided by a 30 to 50 per cent pay-out ratio. We expect a second-half dividend from the new Consumer Healthcare company equivalent to a pay-out of around 3p per share, subject to its Board's decisions on the intra-year phasing of dividend payments.



In aggregate, this would represent on the full year 2022 basis the equivalent of a Group dividend of around 52p per share. Dividends payable by Consumer Healthcare will only be receivable by shareholders who remain invested in Consumer Healthcare post-separation and at the appropriate record dates.



Payment of dividends

The equivalent interim dividend receivable by ADR holders will be calculated based on the exchange rate on 29 June 2022. An annual fee of $0.03 per ADS (or $0.0075 per ADS per quarter) is charged by the Depositary.



The ex-dividend date will be 19 May 2022, with a record date of 20 May 2022 and a payment date of 1 July 2022.


Wer sich die Mühe machen möchte, kann das im Q1 Bericht finden inklusive einer Zeittabelle der zukünftigen Zahlungen
 

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20.05.22 10:08 #280 Also mal wieder eine Abspaltung
Das bedeutet für mich persönlich die Aktie nach über 12 Jahren Haltedauer zu verkaufen, denn dieses deutsche Steuergefummel bei Abspaltungen mache ich nicht mit. Wenn man Pech hat wird es als Ausschüttung versteuert und du bist ohne Grund Geld los. Hatte ich in der Vergangenheit schon ein paar mal. Sehr Schade. Hätte sie gerne weiter gehalten. War immer ein zuverlässiger Dividendenzahler.  

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20.05.22 13:19 #281 Abspaltung
gibt es schon einen konkretes Datum (Stichtag) für die Abspaltung? Ich meine irgendwas von Juli gelesen zu haben.  

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20.05.22 16:43 #282 @carben
Laut Internetseite gsk wird jeder im Juni angeschrieben wie es bei der Abspaltung weitergeht und wieviel Aktien von der Firma bei jeden eingebucht wird.  

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31.05.22 13:19 #283 GSK
GlaxoSmithKline übernimmt US-Impfspezialisten Affinivax
https://www.ariva.de/news/...t-us-impfspezialisten-affinivax-10171232

Was haltet ihr von der Übernahme?  
31.05.22 13:22 #284 GlaxoSmithKline
03.06.22 10:47 #285 GSK
Spin-Off steht vor der Tür: GSK will künftig im Impfstoff-Geschäft angreifen
https://www.wallstreet-online.de/nachricht/...off-geschaeft-angreifen  
06.06.22 17:47 #286 Steuergefummel bei Abspaltung

Hallo, akzeptiere deine Meinung mit der Bemerkung, dass bei Abspaltung von Daimler Truck von Daimler AG und neu Mercedes Benz alles ohne Steuergefummel oder Gewinnversteuerung ablief.

 

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07.06.22 20:53 #287 1:1

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15.06.22 08:26 #288 Comdirect
Guten Morgen,

ist jemand von euch bei der comdirect und hat heute ebenfalls das Umtauschangebot erhalten? Muss man darauf irgendwie reagieren oder werden die Aktien automatisch 1:1 eingebucht?

Vielen Dank im Voraus!  

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17.06.22 07:43 #289 Comdirect
Die Aktien werden am 1 zu 1, d.h. eine Haleon für jede GSK-Aktie am 18.07.2022.
GSK beginnt dann Handel ohne Consumer, so dass Kurs fallen wird.Nach Handelsschluss vom 1.Tag erfolgt Konsolidierung bei GSK und Kurs kehrt zurück zu gleichen Stand wie vor Spaltung, somit Vergleichbarkeit mit Vorperioden. D.h. die Konsolidierung wird die Gesamtzahl der ausgegebenen GSK-Aktien bei gleichzeitiger Steigerung des Individuellen Wertes verringern. Also ein komplizierter Prozess.  

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1


01.07.22 19:21 #290 DIVI
Gab es eine Dividendenkürzung? Hätte mehr erwartet...  
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