Biomira - aussichtsreich? - 500 Beiträge pro Seite

[Grisu 2000]

Entschuldigt wenn ich gleich 2 Treads hintereinander eröffne, aber das sind meine 2 Top-Favoriten für die nächte Zeit.

Auch hier gleich mal ein kurzer Bericht:

05.05.2003
Biomira aussichtsreich
Global Biotech Investing

Weiterhin dabeibleiben lautet der Ratschlag von Experten des Börsenbriefes "Global Biotech Investing" für die Aktie der Biomira Incorporation (ISIN CA09161R1064/ WKN 881836).

Die Ankündigung, dass das Unternehmen die Phase II-Studienergebnisse zu Theratope rechtzeitig zum ASCO-Meeting fertigstellen könne, habe den Kurs stark ansteigen lassen. Eine bessere Bühne für die Präsentation erfolgreicher Testergebnisse hätte der Krebsforscher nicht finden können.

Der Wirkstoff werde bereits in Phase III der klinischen Studien gegen Brustkrebs getestet. Erste Ergebnisse würden hier in der zweiten Jahreshälfte erwartet.

Einige Analysten würden das Kursziel für die Aktien von Biomira bei 5 Kanadischen Dollar sehen. Das Kurspotential betrage somit noch rund 200 Prozent.

Anleger sollten an ihrer spekulativen Position mit Aktien von Biomira festhalten, diesen Ratschlag geben die Experten von "Global Biotech Investing".

Was haltet ihr denn davon?
Hat jemand schon was neues gehört?

Meinungen erbeten!

Viele Grüße

Grisu 2000

[BenicioX]

...das ist eben roulette...
wenn die ergebnisse gut sind und theratope zum verkauf zugelassen wird , dan gehts ab nach oben .....wenn nicht , das ist der laden sofort pleite.schau mal unter biomira.com
die ergebnisse von phase II sprechen für gute chancen , ganz klar , aber sicher ist gar nichts.
du kannst hier 100% verlieren , und bei günstigem verlauf 1000% gewinnnen , so siehts aus-die cahncen überwiegen meiner meinung nach und der trend ist your fiend
ich bleibe noch drin . ,aber wenn ich meine 100% nach oben habe gehe ich raus.
solange keine daten da sind , ist der kurs nach unten halbwegs gesichert , würde ich sagen-aber keiner weiss genau , wann die daten kommen.
es wäre zumndets interessant , ob schlechte daten , die verkündung verzögern oder so....dann wäre einn klanges warten eben gefährlich...naja , man weiss nichts

[Grisu 2000]

Bin ich falsch informiert oder soll im Juni noch ein Medikament bei der FDA hoffentlich zugelassen werden?

Weiß jemand mehr?

[Grisu 2000]

Na bin ich froh, daß ich noch rechtzeitig eingestiegen bin,
jetzt heißt es nur noch abwarten auf den 24. Juni.

Ich hoffe die kommen dann auch mit wirklich guten Nachrichten!

Wenn ja ..... 400 % ???

[BenicioX]

...und wenn nein , dann ist der ofen aus...-denk dran , gute nachrichten sind oft schon vorher eingespeist , und wenn sie dann kommen , fällt der kurs....aber die chancen sind ganz klar gegeben...
so eine rakete wie in den letzen 2 wochen , sowas sieht man selten!

[BenicioX]

wann bist du rein?

[BrauchGeld]

Bin bei 1,20$ rein ,also wann verkaufen ? Heute wäre doch ein günstiger moment da sowieso mit gewinn mitnahmen zurechnen ist.Oder was meint Ihr ?

[Grisu 2000]

bin zu $ 2,1 rein.

Ich glaub nicht, daß man schon verkaufen sollte.

Schaut euch doch mal die anderen Bio`s an. Da sind die meisten die angefangen sind zu laufen noch weiter gestiegen!

[BenicioX]

hier von der IR-

Biomira and Merck KGaA Announce Phase III Theratope(R) Vaccine Trial Does Not Meet Primary Endpoints



Trend to Improvement in Survival Seen in Subset of Patients

EDMONTON, AB and DARMSTADT, GERMANY, June 17 /CNW/ - Biomira Inc.
(Nasdaq:BIOM) (TSX:BRA) and Merck KGaA of Darmstadt, Germany, announced today
that the results from a large pivotal Phase III trial of Theratope(R) vaccine
for women with metastatic breast cancer did not meet the two pre-determined
statistical endpoints of time to disease progression and overall survival.
However, one pre-stratified subset of patients in the treatment group, women
on hormonal treatment following chemotherapy, appeared to show a favourable
trend to improvement in survival. Further analysis of this subset of patients
is underway, as is additional analyses of the complete trial data.
Following this further analysis of the subset data, the Companies plan to
discuss the results with regulatory agencies. Based on these conversations and
a full evaluation of the data, the Companies will then determine how to
proceed and the information will be communicated to stakeholders at that time.
"Metastatic breast cancer is a serious, life-threatening disease. This
study has resulted in a wealth of information about metastatic breast cancer,
and it is important that we conduct a complete review of the data so that we
can determine our best course of action," said Alex McPherson, MD, PhD,
President and CEO of Biomira. "After analysis of the subset data, we intend to
discuss this information with the respective regulatory agencies in the U.S.,
Canada and Europe as soon as possible. We hope to have the first of these
discussions within the next three to five months."
"We have additional clinical trials underway and plan to continue those
Theratope trials while we fully evaluate the data from the Phase III
metastatic breast cancer study and determine our next steps," said Nancy
Wysenski, President of EMD Pharmaceuticals Inc., Merck KGaA`s wholly-owned
U.S. subsidiary.
Dr. Will Steward, Chairman of the Data Safety Monitoring Board (DSMB)
complimented the Companies saying, "This study was conducted to the highest
possible standards, with no safety concerns, excellent compliance and high
quality data. From the DSMB`s perspective, it is a good example of how to run
a trial."
The working hypothesis for Theratope is that it stimulates an immune
response to the tumour associated STn marker; this in turn may lead to a
therapeutic effect. The Phase III randomized, double-blind trial was designed
and powered primarily as a survival study. Enrolment in the trial totaled
1,030 women at more than 120 sites in 10 countries and, to date, is believed
to be the largest trial of a therapeutic vaccine conducted in women with
metastatic breast cancer. Overall, Theratope was well tolerated by patients,
with the most common side effects being flu-like symptoms and local injection
site reactions.
"I would like to thank the patients and clinicians who participated in
this study," said David W. Miles, MD, BSc, FRCP, Senior Lecturer and Honourary
Consultant in Medical Oncology at Guy`s Hospital in London, England and lead
clinical investigator. "It has yielded important information that warrants
further investigation."
In addition to the Phase III trial for women with metastatic breast
cancer, Theratope is also being studied in a Phase II study of women with
metastatic breast cancer being treated with hormone therapy and a Phase II
study in men and women for the treatment of colorectal cancer. The Phase II
colorectal cancer study results, presented in a poster at the American Society
of Clinical Oncology Meeting in May 2003, showed that patients are capable of
mounting an immune response to the investigational vaccine while receiving
concurrent chemotherapy. The study also showed a current median of 8.4 months
for progression of their disease.
Biomira and Merck KGaA are also collaborating on the development of BLP25
Liposomal vaccine. BLP25 is being evaluated in a 171-patient Phase IIb
controlled study for non-small cell lung cancer and in a Phase II pilot study
for prostate cancer patients. Results from both of these trials are expected
later this year or in early 2004.
"We appreciate the continued support of our investors in our
collaborative effort to develop innovative approaches for cancer control,"
said Alex McPherson.
Biomira is a biotechnology company specializing in the development of
innovative therapeutic approaches to cancer management. Biomira`s commitment
to the treatment of cancer currently focuses on the development of synthetic
vaccines and novel strategies for cancer immunotherapy. We are The Cancer
Vaccine People(TM).
With more than 34,500 employees in 53 countries, the Merck Group
generated sales of EUR 7.5 billion in 2002. Founded in 1668 in Darmstadt,
Germany, the Company aims to be a world leader in its core businesses of
pharmaceuticals and chemicals. Merck groups its operating activities under
Merck KGaA, in which the Merck family holds 74 percent and the remaining
26 percent is publicly traded. The former U.S. subsidiary, Merck & Co., has
been a completely independent company since 1917. Merck KGaA has built a
strategic oncology portfolio by developing and in-licensing product candidates
in four areas -- monoclonal antibodies, therapeutic vaccines, immunocytokines
and angiogenesis inhibitors.
EMD Pharmaceuticals Inc., the U.S. affiliate of Merck KGaA, is a new,
fully integrated pharmaceutical company with an initial emphasis on launching
new products in oncology. Located in Durham, N.C., EMD focuses on meeting
patient and physician needs with pioneering pharmaceutical products and
services.
As information becomes available relevant to patients, it will be
conveyed to the applicable clinical investigator. Therefore, patients with
questions currently involved in trials involving Theratope should contact
their physicians. For all other persons desiring additional information about
clinical trials involving Theratope, please call the following numbers for
assistance: Residents of North America should call the Theratope Hotline
toll-free at 866-518-8811. Residents outside of the United States and Canada
should call 919-768-9741. In addition, information about clinical trials can
be found on the companies` Web sites: http://www.biomira.com and
http://www.emdpharmaceuticals.com.

Conference Call Details:

Today at 08:45 a.m. EDT, Biomira Inc. and Merck KGaA will webcast an
analyst conference call co-hosted by Alex McPherson, MD, PhD, President and
CEO of Biomira, and Nancy J. Wysenski, President of EMD Pharmaceuticals Inc.
Investors and the general public are invited to listen to the live conference
call on the Web, by accessing the following site:
www.viavid.com/detailpage.asp?sid=2053 or the archive following the
call at www.biomira.com. The archive of the analyst conference call will be
available on the Biomira Web site for approximately 30 days following the live
call. Analysts may participate in the conference call at 1-888-295-1311 (North
America toll-free), 0-800-91-748-60 (United Kingdom), 0-800-181-5287
(Germany), approximately 10 minutes before the start of the call.

Except for historical information contained herein, this release contains
forward-looking statements that are subject to risks and uncertainties that
may cause actual results to differ materially from the results discussed in
the forward-looking statements, particularly those risks and uncertainties
surrounding the efficacy of Theratope(R) vaccine to treat women with
metastatic breast cancer, risks and uncertainties surrounding the presentation
of data to the regulatory authorities and approval of marketing applications
by the regulatory authorities and risks and uncertainties inherent in the
process of discovering, developing and commercializing drugs that are safe and
effective for use as human therapeutics. Factors that may cause such a
difference include risks related to the fact that our analyses of the clinical
results from our Phase III clinical trial involving Theratope vaccine to treat
women with metastatic breast cancer is ongoing, the risk that the regulatory
authorities may not be satisfied with our analyses of such data, the risk that
further analyses of the data from our clinical trials may not support the
results observed to date or a marketing application, the risk that additional
trials may not demonstrate the safety and efficacy required to satisfy the
regulatory authorities, the risk that the Company may lack the financial
resources and access to capital to fund the required clinical trials, or that
it will elect to conduct such additional trials, and other matters required to
bring products to market, the uncertainties as to when, if at all, the
regulatory authorities will agree to discuss the trial results with the
Company, the need to establish and scale-up manufacturing processes,
dependence on the efforts of third parties, including suppliers and
collaborators, dependence on intellectual property rights and the
effectiveness thereof, difficulties or delays in manufacturing products, and
regulatory developments involving products and manufacturing facilities. For
more detailed information on the risks and uncertainties associated with the
Company`s product candidates and other activities see the Company`s periodic
reports filed with the applicable securities regulatory authorities in Canada
and the United States Securities and Exchange Commission. The Company assumes
no obligation to update any forward-looking statements.




-30-


For further information: Biomira Company Contacts: Bill Wickson,
Manager, Public Relations, [phone], After hours contact:
[e-mail]; Jane Tulloch, Director, Investor Relations,
[phone]; Merck KGaA Contacts: Hartmut Vennen, Head of Ext.
Communications, 011-49-6151-72-2386; EMD Pharmaceuticals Media Contact: David
Reeder, Director, Corporate Communications, [phone]; Patient
Information Call Centre: 1-866-518-8811 (within North America), 1-919-768-9741
(outside North America);
To request a free copy of this organization`s annual report, please go to
http://www.newswire.ca and click on reports@cnw.

[puhvogel]

Das wars dann wohl:

06:47 ET Biomira breast cancer trial fails to meet endpoints (BIOM) 4.00: German drugmaker Merck KGaA and Canada`s Biomira announce that a Phase III trial on breast cancer vaccine Theratope failed to meet key targets for disease progression and overall survival. [Briefing.com note: Theratope vaccine was considered the lead candidate for BIOM with a sales potential of up to $1 bln. Of note the ENHANZYN adjuvant used in Theratope is licenced from Corixa (CRXA) which uses it in its marketed Melacine melanoma vaccine.]