Novartis-Medikament erfolgversprechend - 500 Beiträge pro Seite

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Das vom Pharmakonzern Novartis entwickelte Leukämiemedikament Glivec zeigt bei einer Testreihe an 36 britischen Patienten erstaunliche Resultate. Es ist vom Royal-Marsden-Krankenhaus als wirkungsvoll eingestuft worden, wobei aber ein Teil der sonst auftretenden Nebenwirkungen ausgeblieben sind.

Im Mai ist das Produkt bereits in den USA zu Behandlungszwecken zugelassen worden und firmiert dort unter dem Markennamen Gleevec. In Europa steht die Zulassung noch aus, wird aber nicht vor Ende des Jahres erwartet.

[puhvogel]

Die Ergebnisse sind wirklich erstaunlich.

[puhvogel]

Dagegen kann keine Biotechaktie der Welt mithalten:

Early Positive Gleevec(TM) (imatinib mesylate)* Data in Newly Diagnosed Chronic Myeloid Leukemia (CML) Study Prompt Major Protocol Changes

EAST HANOVER, N.J., Jan. 7 /PRNewswire/ -- In an interim analysis of the ongoing Phase III study comparing Gleevec(TM) (imatinib mesylate) to standard therapy (interferon injections plus Ara-C [cytarabine] chemotherapy) for initial treatment in newly diagnosed CML patients, the Gleevec arm was found -- early on -- to demonstrate a substantially higher response. Based on this finding, the Independent Data Monitoring Board (IDMB) has recommended a change in the protocol to enable the patients on standard therapy who have not achieved a major cytogenetic response to switch to Gleevec at this time.
The changes to the study protocol as recommended by the IDMB (comprised of independent hematologists and a clinical statistician) are being communicated to investigators and patients beginning January 3. These changes allow patients on the control arm who have not achieved a major cytogenetic response after one year of treatment with interferon-alpha and cytarabine to switch to Gleevec. A cytogenetic response is the disappearance or reduction in the number of cancerous cells. Patient consent forms will be changed to inform patients of the new data, and to urge them to speak with their physicians.
Called the IRIS study (International Randomized study of Interferon vs. STI571), this large, international multicenter Phase III trial is evaluating Gleevec vs. the combination of standard interferon and cytarabine as first line therapy in patients with CML. Between June 2000 and January 2001, the ongoing study enrolled 1106 patients in 177 centers across 16 countries. The study was designed to help determine the long-term outcome (including survival) of patients with newly diagnosed CML treated with Gleevec in comparison to the combination of interferon-alpha and cytarabine.
The Independent Data Monitoring Board further recommended that a formal, peer-reviewed presentation of the 12-month data results be made to the scientific community at the earliest possible opportunity.
Preliminary results from a different and smaller, single-institution study in newly diagnosed CML patients were presented in December 2001 at the annual meeting of the American Society for Hematology.** The data from this trial on the use of Gleevec in 47 newly diagnosed patients with early chronic phase CML showed that after three months of treatment, 77% (36 patients) had achieved complete or major cytogenetic responses ([Ph<35%] Philadelphia chromosome, hallmark of the disease). The hematologic response rate was 98% (46 patients). In comparison, in previously reported studies of other agents (interferon-alpha alone and interferon-alpha with cytarabine and homoharringtonine [Triple Rx]) 2-24% of patients on other treatments achievedcomplete or major cytogenetic responses after three months of treatment.

Contraindications and Adverse Events
The majority of patients treated with Gleevec experienced adverse events at some time. Most events were of mild to moderate grade, but drug was discontinued for adverse events in 1% of patients in chronic phase, 2% in accelerated phase and 5% in blast crisis. Women of childbearing potential should be advised to avoid becoming pregnant while taking Gleevec. The most common side effects included nausea, fluid retention, vomiting, diarrhea, hemorrhage, muscle cramps, skin rash, fatigue, headache, dyspepsia and dyspnea, as well as neutropenia and thrombocytopenia. Serious and severe side effects, such as hepatoxicity (1.1% to 3.5%), fluid retention syndrome (2% to 10%), neutropenia (8% to 46%) and thrombocytopenia (less than 1% to 31%) have also been reported in some patients. There are no long-term safety data on Gleevec treatment.
In most countries where Gleevec is approved, it is indicated for the treatment of patients with chronic myeloid leukemia (CML) in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. The effectiveness of Gleevec is based on overall hematologic and cytogenetic response rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.

[goreng]

Alle Nachrichten sind SUPER, bis auf den Kurs!

[puhvogel]

Das ist wahr, ich bin auch Aktionär von NVS.
In solche Grösse sind die Firmen aber nur noch geparktes Geld, das je nach Bedarf in spekulativere Anlagen umgeschichtet wird. Versorger und Pharmas laufen aktuell ganz schlecht.
Und ein paar schlechte Nachrichten gab es auch letztes Jahr ja auch. Ein KGV von 20 für ein Pharmawert mit guter Pipeline , dass kann sich sehen lassen.
NVS steht jedenfalls besser da als ELY , BMS oder Schering Plough.

[fettinsky]

hallo puhvogel,

Glivec® ist ein wunderbares Medikament und im Bereich der chronisch myeloischen Leukämie und der sog. GIST-tumoren eine bahnbrechende Neuigkeit. Leider, beide Erkrankungen sind relativ selten (CML etwa 1600 Neuerkrankungen/ Jahr in der BRD, GIST-Tumoren noch seltener). Glivec setzt an einem Wachstumsfaktor für Tumore, dem sog. c-kit, an. Neuerdings hat man diesen Wachstumsfaktor auch bei Lungenkrebs entdeckt. Vielleicht wird er Markt für Novartis doch noch größer.
Eine persönliche Mitteilung findest Du noch in deiner Mailbox.

Grüße

[puhvogel]

Neue Studienergebnisse, interessant auch im Hinblick auf Resistenzbildungen
New England Journal of Medicine Data Demonstrate Improved CML Response Rates With Gleevec(TM) (imatinib mesylate)*

An Increasing Number of Patients in Chronic Phase (Earlier Phase) Are Achieving Durable Cytogenetic Responses

EAST HANOVER, N.J., Feb. 27 /PRNewswire-FirstCall/ -- Gleevec(TM)
(imatinib mesylate)* induces higher hematologic and cytogenetic response rates
than previously reported in patients in the chronic phase (first phase) of
chronic myeloid leukemia (CML) who have been unsuccessfully treated with
interferon-alpha, according to updated data from a pivotal Phase II study.
The new data, based on a median follow-up of 18 months, indicate that response
rates to the Novartis drug increased in CML patients taking the drug early in
their disease. These data, an update of the 12-month results presented at the
meeting of the American Society of Hematology (ASH) in December 2001, are
published for the first time in today`s issue of The New England Journal of
Medicine (NEJM).
"The data on Gleevec in chronic phase CML are very exciting because they
are getting continually stronger," said Hagop Kantarjian, MD, Professor of
Medicine, Chairman, Department of Leukemia and Chief, Section of Leukemia
Developmental Therapeutics, M.D. Anderson Cancer Center, Houston, Texas, lead
study investigator. "These results are extremely promising. They suggest that
earlier use of Gleevec could have a major impact in improving patients`
long-term outcome."

Study Details
The Philadelphia chromosome (Ph) is the genetic abnormality that
characterizes CML in most patients. Complete cytogenetic response, the
elimination of the Philadelphia chromosome is regarded as the ultimate goal of
CML treatment.
The NEJM report features 18-month data on 454 evaluable patients with
chronic phase CML who had failed prior therapy with interferon-alpha. The
estimated progression-free survival rate at 18-months was 89%. The data
demonstrated that 41% of patients (188/454) achieved a complete cytogenetic
response (Ph+ cells 0%) and 60% (272/454) achieved a major cytogenetic
response (Ph+ cells < 35%). Of the patients who achieved a major cytogenetic
response, 84% (228/272) were still maintaining that response at the time of
follow-up. The achievement of a cytogenetic response at three months was
associated with an improved progression-free survival rate. In addition, 95%
of patients (430/454) achieved a complete hematologic response (normalization
of blood counts).
The cytogenetic response rates reported, as well as the estimated 18-month
progression-free survival rate, are higher than those historically documented
with other CML therapies, including interferon-alpha (5-7% complete
cytogenetic response) and homoharringtonine (HHT) alone or in combination with
low-dose cytarabine (Ara-C). Although there are no long-term data to provide
clinical results regarding survival rates for CML patients taking Gleevec,
researchers believe that durable complete or major cytogenetic response rates
improve the potential for longer term survival.
"Novartis is very pleased that we continue to see increasing response
rates to Gleevec," said David Parkinson, MD, Vice President, Clinical
Research, Novartis Oncology. "Longer-term follow-up demonstrating higher
cytogenetic response rates to Gleevec provides valuable insight into the
overall efficacy of the drug and how this relates to longer-term survival with
Gleevec."
In most countries where Gleevec is approved, it is indicated for the
treatment of patients with chronic myeloid leukemia (CML) in blast crisis,
accelerated phase, or in chronic phase after failure of interferon-alpha
therapy. The effectiveness of Gleevec is based on overall hematologic and
cytogenetic response rates. There are no controlled trials demonstrating a
clinical benefit, such as improvement in disease-related symptoms or increased
survival.

Contraindications and Adverse Events
In this study, adverse events were similar to those previously reported.
The majority of patients treated with Gleevec experience adverse events at
some time. Most events are of mild to moderate grade, but in clinical trials
the drug was discontinued for adverse events in 1% of patients in chronic
phase, 2% in accelerated phase and 5% in blast crisis. Women of childbearing
potential should be advised to avoid becoming pregnant while taking Gleevec.
The most common side effects included nausea, fluid retention, vomiting,
diarrhea, hemorrhage, muscle cramps, skin rash, fatigue, headache, dyspepsia
and dyspnea, as well as neutropenia and thrombocytopenia. Serious and severe
side effects, such as hepatotoxicity (1.1% to 3.5%), fluid retention syndrome
(2% to 10%), neutropenia (8% to 46%) and thrombocytopenia (less than 1% to
31%) have also been reported in some patients. There are no long-term safety
data on Gleevec treatment available up to now.

The foregoing release contains forward-looking statements that can be
identified by terminology such as "believe that durable complete or major
cytogenetic response rates improve the potential," "continually stronger,"
"induces higher," "could have major impact," "indicate the response rates to
the Novartis drug are being maintained" and "suggest that earlier use," or
similar expressions. Such forward-looking statements involve known and
unknown risks, uncertainties and other factors that may cause actual results
with Gleevec to be materially different from any future results, performance
or achievements expressed or implied by such statements. In particular,
management`s ability to ensure satisfaction of the FDA`s further requirements
is not guaranteed and management`s expectations regarding further
commercialization of Gleevec could be affected by, among other things,
additional analysis of data; new data; unexpected clinical trial results;
unexpected regulatory actions or delays or government regulation generally;
the Company`s ability to obtain or maintain patent or other proprietary
intellectual property protection; competition in general; and other risks and
factors referred to in the Company`s current Form 20-F on file with the
Securities and Exchange Commission of the United States. Should one or more of
these risks or uncertainties materialize, or should underlying assumptions
prove incorrect, actual results may vary materially from those anticipated,
believed, estimated or expected.