Biomira

[Ca$hmandt]

Biomira Inc. (TSX:BRA) today reported financial results for the six months ended June 30, 2002. Results are reported in Canadian dollars with a June 30, 2002 rate of $1.00 Canadian equaling $0.66 U.S.

Financial results for the six months ended June 30, 2002 reflect a consolidated net loss from operations of $15.4 million or $0.34 per share compared to $22.9 million or $0.45 per share, for the same period in 2001. The decreased loss in 2002 is due to an $8.6 million reduction in gross research and development expenditures offset by $1.1 million in market development costs.

Contract research and development revenues for the six months ended June 30, 2002 totaled $1.9 million compared to $1.7 million for the same period in 2001 and represent research and development funding received from Merck KGaA related to Biomira''s lead programs involving THERATOPE(R) and BLP25 vaccines. Licensing revenues from collaborative arrangements of $0.53 million compared to $0.18 million for the same period in 2001 represent the amortization of upfront payments received from Merck KGaA upon commencement of the Biomira/Merck KGaA collaboration.

Research and development expenditures for the six months ended June 30, 2002 totaled $13.7 million compared to $22.3 million for the same period in 2001. The decrease in research and development expenditures is attributable to the winding down of the THERATOPE(R) vaccine Phase III trial and the suspension of the autologous vaccine and Liposomal Interleukin-2 (L-IL-2) programs. Market and business development expenditures of $1.1 million result from costs associated with both the development of Biomira''s internal marketing capabilities and with pre-launch activities related to the potential world wide commercialization of THERATOPE(R) vaccine.

Biomira''s financial reserves include $60.1 million in cash and short-term investments as at June 30, 2002. During the second quarter, the Company made interest and principal repayments of $4.3 million under the terms of its existing convertible debentures. To date, the convertible debenture repayments have been in cash rather than in common shares. In addition, the Company drew down $1.6 million under its existing equity line agreement in the second quarter in order to partially offset the cash required for the convertible debenture repayments. Approximately 3.3 million shares are still available for issuance under the terms of the equity line agreement.

Biomira announced in May, 2002, that it has put in place a U.S. $150 million shelf registration. The purpose of putting the shelf registration in place was to ensure mechanisms are available to allow the Company to take advantage of favourable financing opportunities, should they arise and to do so in a timely manner.

As Biomira moves towards commercialization of its lead product candidate, it is important to have the appropriate cash available to respond to potential marketing requirements. Biomira also has to ensure adequate funding is available for future pipeline and product candidate development.

The highlight of the second quarter was the Annual General Meeting (AGM) of Shareholders held in Toronto on May 22, 2002. The Company outlined projected milestones for THERATOPE(R) vaccine and other product candidate advancements.

The final analysis for THERATOPE(R) vaccine in metastatic breast cancer is expected to commence in the fourth quarter of 2003 with an interim analysis set to commence in the third quarter of 2002. Both analyses are event driven.

Although the trial was designed to show the strongest data at the final analysis, extensive scenario planning for the interim analysis has occurred. The interim analysis is expected to be initiated in this quarter. The three most conceivable scenarios for the interim analysis are: 1) continue the trial to final analysis; 2) discuss the available interim data with the North American and European regulatory authorities to determine if there is an opportunity for an early marketing application if the data are compelling; and 3) which is unlikely, halt the trial if it is determined that THERATOPE(R) vaccine causes safety concerns or the patients on the vaccine arm are disadvantaged in comparison to the control arm.

"While we certainly hope that the outcome of the interim analysis will lead to discussion with regulatory authorities," said Alex McPherson, MD, PhD, President and CEO of Biomira, "we will not speculate on the results of the interim analysis. That being said, the collaboration team is gearing up to be in a position to meet all currently envisioned scenarios, including the opportunity for an early marketing application."

"We are confident that we have designed a well-controlled and extensive trial, which will yield robust data," added Dr. McPherson. "If the product candidate works in this patient population, we expect that this trial will confirm that."

A Phase II pilot study using THERATOPE(R) vaccine, currently enrolling 20 colorectal cancer patients is ongoing at the Cross Cancer Institute in Edmonton, Alberta, and is expected to complete enrolment by year end.

Biomira and Merck KGaA are considering initiating smaller trials for THERATOPE(R) vaccine in other settings in the months to come.

BLP25 Vaccine: Enrolment continues in a 166-patient randomized and controlled study utilizing BLP25 vaccine in patients with metastatic non-small cell lung cancer (NSCLC). Patients are being enrolled in both Canada and the United Kingdom. The trial endpoints are safety, survival and quality of life. The trial is expected to complete enrolment by the end of 2002. A DSMB review of safety data from the first 100 patients was recently announced, with the recommendation to continue the trial without modification.

[Ca$hmandt]

Der Wert ist zwar schon gut gelaufen, aber hier könnte noch einiges gehen, insbesondere wenn man die Termine für diesen Monat beachtet! Richtungsweisend wird hier die KW 26 sein:



BIOMIRA TO PRESENT AT BIO’S 2003 ANNUAL CONFERENCE – JUNE 22-25, 2003 - Annual General Meeting Presentation – June 26, 2003

EDMONTON, ALBERTA, CANADA: June 11, 2003
Biomira Inc. (Nasdaq: BIOM) (TSX: BRA) announced today that Alex McPherson, MD, PhD, President and CEO of Biomira, will present highlights of the Company’s product and corporate advancements at the Biotechnology Industry Organization’s 10th Annual Convention to be held in Washington, D.C., June 22-25. Dr. McPherson’s presentation is scheduled for 8:45-9:00 a.m., EDT, Tuesday, June 24th. This presentation will be web cast and available through a link at www.biomira.com or it may be linked directly through the host URL at http://www.firstcallevents.com/service/ajwz383050061gf12.html.

“Biomira has reached significant milestones within the past year and is expected to announce the results from the Theratope® vaccine Phase III trial this month. This is believed to be the largest trial ever conducted using an immunotherapeutic approach to treating metastatic breast cancer. It is a pivotal juncture for breast cancer patients and all of our stakeholders,” commented Dr. McPherson. “Biomira, in conjunction with our collaborator, Merck KGaA of Darmstadt, Germany, is also expected to have other clinical trial data this year and the BIO meeting will be an excellent opportunity to update the investment community on where we are in our whole clinical development plan.”

Dr. McPherson is a board member of the Biotechnology Industry Organization, which is a Washington, D.C.-based organization that engages in lobbying, advocacy, communications and new business development related to the biotech industry. Established in 1993, the meeting is expected to attract approximately 15,000 attendees.

Annual General Meeting

Biomira will also have the opportunity to update investors at the Company’s Annual General Meeting. The meeting is scheduled to be held at 1:30 p.m. on Thursday, June 26th in Edmonton, Alberta. Those not attending the meeting may access the presentation through a direct link at www.biomira.com or it may be linked directly through the host URL at http://webevents.broadcast.com/cnw/biomira20030626.

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™.


Wie sind eure Meinungen zu diesem Wert?

[Luna]

Wie Du geschrieben hast, sind die Onkologie-Werte gut gelaufen.
Es rotiert ständig im Sektor. Erwarte eine weitere Abkühlung bei BRA. ;)

[Ca$hmandt]

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 /PRNewswire-FirstCall/ - Biomira Inc. (Nasdaq:BIOM - News; TSX:BRA - News) and Merck KGaA of Darmstadt, Germany, announced today that the results from a large pivotal Phase III trial of Theratope® 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.

[Ca$hmandt]

das ganze mal auf deutsch:


Frankfurt, 17. Jun (Reuters) - Der Brustkrebsimpfstoff
Theratope des Parma-und Spezialchemiekonzerns Merck
KGaA [MRK.GER] und des kanadischen Biotech-Unternehmen
Biomira hat die Ziele bei den klinischen Tests verfehlt.
Bei der zulassungsrelevanten Phase III-Studie habe der
Impfstoff bei Frauen mit metastasierendem Brustkrebs die
vordefinierten Endpunkte Gesamtüberlebensdauer und Zeitdauer bis
zum Wiedereinsetzen der Erkrankung nicht erreicht, teilte Merck
am Dienstag mit. Bei Patientinnen unter Hormonbehandlung im
Anschluss an eine Chemotherapie habe sich aber eine positive
Tendenz hin zu einer verbesserten Überlebensrate gezeigt. Diese
Ergebnisse wolle Merck nun mit den Zulassungsbehörden
diskutieren. "Bis zur endgültigen Auswertung der Daten wollen
wir die laufenden klinischen Studien mit Theratorpe fortsetzen,
ehe wir über weitere Schritte entscheiden", hieß es in der
Mitteilung.
Merck war im vergangenen Jahr eine Kooperation mit dem
kanadischen Unternehmen zur Weiterentwicklung und Vermarktung
zweier fortgeschrittener Krebsimpfstoffe, BLP25 und Theratope,
eingegangen. Merck und Biomira hatten beschlossen, die klinische
Prüfung von Theratope fortzusetzen, nachdem ein unabhängiges
Expertengremium in einer Zwischenbilanz zum Ergebnis gekommen
war, dass keinerlei Bedenken bei der Verträglichkeit des Mittels
bestünden. Eigentlich war bei einem erfolgreichen Abschluss der
klinischen Tests nach früheren Angaben von Merck geplant
gewesen, Ende 2003 oder Anfang 2004 den Zulassungsantrag für
Theratope zur Anwendung bei Brustkrebs zu stellen. Ferner hatte
es geheißen, im Falle einer US-Zulassung wollten Merck und
Biomira den Krebsimpfstoff in den USA gemeinsam vermarkten.
Außerhalb Nordamerikas halten die Darmstädter die exklusiven
Marketing- und Entwicklungsrechte, mit Ausnahme von Israel und
Palestina.
Die Investmentbank Lehman Brothers war früheren Angaben
zufolge in einer Studie von einem Spitzenumsatz von rund 500
Millionen Dollar für das Mittel ausgegangen .

[Ca$hmandt]

Das Scheitern des Medikamenten-Kandidaten Theratorpe in der letzten Phase der klinischen Entwicklung wirft ein Schlaglicht auf die Risiken der Branche.

Es hätte ein halber Blockbuster werden können, doch die Hoffnungen auf dreistelligen Millionenumsätze haben sich in Luft aufgelöst. Der Hoffnungsträger Theratope, der von Pharmakonzern Merck KGAA und dem Biotech-Unternehmen Biomira entwickelt worden ist, haben die Tests der abschließenden dritten klinischen Phase das Aus gebracht.

Theratope ist ein Impfstoff, der zur Behandlung von metastasierendem Brustkrebs eingesetzt werden sollte. Die Studie der dritten klinischen Phase hat die angestrebten Endpunkte verfehlt: Die Gesamtüberlebensdauer der Patientinnen und die Zeitspanne bis zum Wiedereinsetzen der Krankheit haben die Erwartungen nicht erfüllen können.

Bei einer kleinen Gruppe der Patientinnen hat sich nach Auskunft des Unternehmens ein positive Tendenz gezeigt: Frauen unter Hormonbehandlung nach einer Chemotherapie. Dieser Gesichtspunkt soll nach der Auswertung der Daten mit den Zulassungsbehörden diskutiert werden. Dahinter dürfte die Hoffnung stehen, möglicherweise für einen eingeschränkten Kreis Theratope zur Anwendung bringen zu können.

Der Fehlschlag ist ein Beweis, dass auch Medikamentenkandidaten in der letzten Phase der klinischen Tests durchfallen können. Statistisch verringert sich zwar die Rate der Ausfälle, doch das immer noch vorhandene Risiko sollte nicht aus den Augen verloren werden. Wie im vorliegenden Fall dürften die negativen Auswirkungen des Misserfolgs auf den kleineren Partner wesentlich größer sein, als für den Pharmakonzern Merck.

Autor: 4investors.de (© 4investors.de),10:05 17.06.2003

[Ca$hmandt]

EDMONTON, Jun 17, 2003 (The Canadian Press via COMTEX) -- Shares of Biomira Inc. plunged nearly 63 per cent Tuesday after the drug developer reported disappointing results from its Theratope vaccine trial for women with metastatic breast cancer.

Shares of Edmonton-based Biomira (TSX:BRA) fell $3.37, or 62.99 per cent cent, to close at $1.98 in heavy trading of more than 5.7 million shares. The stock`s 52-week high is $6.60 and the low is 85 cents. The shares had been rising in recent weeks in anticipation of positive results from the breast cancer trials. In a joint statement Tuesday, Biomira and its German partner, Merck KGaA, said its trial didn`t meet two key targets for significantly slowing the progression of the disease and improving survival rates. Metastatic cancers start in one area and then spread within a patient`s body.

"This is certainly not the best-case scenario by any stretch of the imagination. We had certainly hoped to announce something different from this trial," Alex McPherson, CEO of Biomira, said on a conference call.

The poor trial results are a blow to Biomira, which was hoping to file for regulatory approval for the drug on the basis of the results from this trial. Biomira had cut its workforce to pare costs and also slowed development of other drugs to focus on Theratope.

While this data is being reviewed, Biomira said it plans to continue its two other Theratope trials, which includes one on colorectal cancer.

Biomira`s Theratope is intended to stimulate an immune response to tumours. The current trial with Merck included 1,030 women at 120 sites in 10 countries.

But Biomira focused on a spark of hope from one group of patients - women who used Theratope while on hormonal treatment following chemotherapy - that had improved survival rates. Biomira said it will further analyse the data of that group and the trial overall then discuss the results with regulatory agencies before deciding on its next steps.

"Results showed that Theratope appeared to increase the median survival in a subset of patients," McPherson said, adding that this is preliminary information and hasn`t yet been fully analyzed.

"So I can not say that this subset of patients has hit a level of statistical significance at this point in time," he said. "We are hopeful that our further analysis will confirm that Theratope will be a treatment for women in this subset of the metastatic breast cancer patient population."

The survival rate of those in this select group, which represented about 32 per cent of the patients enrolled in the trial, was a difference of months, McPherson said.

While the results so far can`t be considered statistically significant, McPherson said "the differences that we are seeing here are not trifling."

He added: "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."

Analysts on the call were disappointed with the trial results, and one analyst asked why the company is continuing with its other trials after this one showed few benefits.

"Different products have success in different indications and the same might well be expected to be true" with drugs like Theratope that work on the immune system, McPherson responded, adding that it may work more effectively on different types of cancer.

As at March 31, the company had $25.1 million in cash, and Biomira said Tuesday that at its current rate of cash usage it expects this will last the company until the end of 2004.

Biomira and Merck are also collaborating on the development of BLP25 Liposomal vaccine, which is being evaluated in a 171-patient study for treatment of lung cancer and prostate cancer.

Results from both trials are expected later this year or in early 2004.

[Ca$hmandt]

Biomira Announces Highlights of Today's Annual General Meeting

EDMONTON, June 26 /PRNewswire-FirstCall/ - Biomira Inc. (Nasdaq:BIOM - News; TSX:BRA - News) expects the following highlights to be covered at the Annual General Meeting of its shareholders to be held today at 1:30 p.m. MDT at the Sheraton Grande Hotel, Edmonton, Alberta. The meeting will be chaired by the Board Chairman, Mr. Eric E. Baker, and will be followed by an address by the Company President and CEO, Alex McPherson, MD, PhD. Prior to the meeting there will be a meet and greet with the Board from 1:00 to 1:30 p.m.


Dr. McPherson's comments are expected to focus primarily on the trial results from Biomira's Phase III Theratope® vaccine trial in metastatic breast cancer. The trial enrolled 1,030 women in 10 countries and over 120 clinical sites. The trial was unblinded this month with final results showing that the trial did not meet its two pre-determined statistical endpoints of time to disease progression and survival. However, favourable results were observed in one pre-stratified subset of women in the trial, those on hormonal treatment following chemotherapy. Among this subgroup making up 32 per cent of the total patient population, those on the Theratope arm appeared to show a favourable trend to improvement in survival compared to the control arm. Further analysis of this subset of patients is now underway. Once such analysis is complete, the Company intends to discuss this information with the respective regulatory agencies in the U.S., Canada and Europe as soon as possible, with the first of these discussions expected to take place within the next three to five months.

"Cancer vaccines hold the promise of meeting the vast unmet medical need facing patients with cancer today," said Dr. McPherson. "We are still hopeful that Theratope will one day be used to control cancer, complementing traditional therapies in extending survival by stimulating the patient's immune system to recognize the metastatic and micrometastatic disease. We intend to continue to fight the good fight until we have a product on the market."

[Ca$hmandt]

The Company's strategy is to fully understand the data and present a comprehensive package of data to the regulatory authorities in order to optimize the eventual outcome.

Biomira is also conducting four other clinical trials at this time:

1. Biomira and its collaborator, Merck KGaA of Darmstadt, Germany, are enrolling 95 metastatic breast cancer patients in a Phase II study of women being treated with aromatase inhibitors or Faslodex(R). The trial is being run by Merck KGaA's wholly owned U.S. subsidiary, EMD Pharmaceuticals, Inc., and is enrolling the patients in the U.S. As patients are being treated with a form of hormonal therapy, the trial results could prove complementary to the Theratope Phase III study. Enrolment is expected to be completed in 2004.

2. Biomira recently announced the results of its Phase II study of
Theratope in patients with metastatic colorectal cancer. Results were presented in a poster at the American Society of Clinical Oncology Meeting in Chicago, IL in May. The trial met its expected outcomes showing the vaccine was safe and that patients could mount an immune response while receiving concurrent chemotherapy. The trial also showed a current median time to disease progression in 17 of the 20 patients of 8.4 months. Final analysis is expected towards the end of 2003.

3. In November 2002, Biomira completed enrolment of 171 men and women with Non-Small Cell Lung Cancer in trial sites in both Canada and the United Kingdom. Patients were randomized to receive Biomira's BLP25 Liposomal vaccine plus best standard care, or best standard care alone. While results had originally been forecast to be available in the third quarter of 2003, the trial is event driven. Fortunately, patients are not progressing at the rate originally forecast and results are now expected towards the end of 2003 or early 2004.

4. Biomira also completed a second pilot study with BLP25 in patients with prostate cancer. The purpose of this small study in 16 men was to determine if BLP25 could affect rising Prostate Specific Antigen (PSA) levels. Results in this small patient population did not conclusively show this to be the case and no further tests in this area are expected at this time, although the patients currently on trial will be followed to trial completion.

[Ca$hmandt]

Finance

At the end of the first quarter 2003, Biomira had U.S. $17.1 million or $25.1 million Canadian in available funds. During the current quarter the Company raised $10.4 million U.S. or $14.5 million Canadian. The Company believes that it has funds to sustain it until the end of 2004. There are currently 63.2 million common shares of the Company outstanding.

"Our finances are in place. Our corporate relationships have never been stronger. Our team has fire in its belly like never before. The control of cancer is critical -- and we are no less committed to this cause than we were when we began," concluded Dr. McPherson.

The Companies

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.

[Ca$hmandt]

up! :)

[sterntaler]

Schon zur Eröffnung sprang der Wert an (mom. immer noch > 10%) wegen dieser News. (http://www.nasdaq.com//asp/quotes_news.asp?pageName=Company%20News&selected=BIOM&consumer=NDQ&StoryTargetFrame=_top&market=Nasdaq-NM&coname=Biomira%20Inc.&symbol=BIOM`&cpath=20031208\ACQPRN200312080730PR_NEWS_B_GBL_HS_ TO020.htm)
Wenn ich's richtig verstehe, dann wurden auf einem jährlich stattfindenden Brustkrebs-Symposium in San Antonio die positiven Ergebnisse einer Reihe klinischer Versuche von Biomira in Zusammenarbeit mit Merck KGaA zu dem Krebsmittel "Theratope(R)" veröffentlicht.

[sterntaler]

"Sell on good news" hatte es da wohl vor knapp einem Monat geheißen.
That's trading ...
Momentan jedoch streckt der Wert seine Nase ganz vorsichtig über alle GDs hinweg.
Eine Beobachtung mag Biomira Inc. sicher wert sein im Hinblick auf eine erwartete Bestätigung des Ausbruchs aus dem Konsolidierungsdreieck.
Die Kursspitzen (von Sept. + Anf. Dez.) mitgerechnet dürfte diese wohl schon erfolgt sein ... :unsure:
aber ich lasse die KursSPITZEN oft weg, so scheinen mir Charts aussagekräftiger.

http://chart.bigcharts.com/bc3/quickchart/chart.asp?symb=biom&compidx=aaaaa%3A0&ma=1&maval=20%2C50%2C200&uf=0&lf=1&lf2=0&lf3=0&type=4&size=2&state=11&sid=553&style=340&time=7&freq=1&nosettings=1&rand=7478&mocktick=1&rand=8933

[Gruenfeld]

sterntaler hallo.

aber ich lasse die KursSPITZEN oft weg, so scheinen mir Charts aussagekräftiger.

das kannst du ruhig normal gross schreiben, die schatten lasse ich gewöhnlich auch aussen vor. und wundere mich, dass viele ihre trendlinien tatsächlich penetrant von tageshoch zu tageshoch ziehn. klar setze ich auch schon mal am high oder low an. aber habe auch keine probleme selbst mitten durch einen kerzenkörper zu zeichnen, wenn es sinn macht! :bang: :eek: :lol

na ja, also..... mit welcher wahrscheinlichkeit der bruch einer linie tatsächlich die erwünschte wirkung zeigt, wäre die nächste frage.

[Luna]

Schöner Hüpfer. Über 100%. :eek:
Wie seinerzeit Imclone. Neu zum leben erwacht. Wird weiter anziehen.

Das mit Merck KGaA entwickelte Medikament L-BLP25 lieferte nun erfreuliche Ergebnisse bei klinischen Tests. So wurde das Präparat zur Immuntherapie von nicht-kleinzelligem Bronchialkarzinom (NSCLC) eingesetzt und konnte so das Leben mancher Patienten verlängern.
Die Biomira-Aktie legt aktuell in Toronto 137 Prozent auf 4,39 C-Dollar zu. Die Merck-Aktie legte im XETRA-Handel knapp 3 Prozent auf 45,19 Euro zu.

[Reinhard]

sterntaler hallo.

aber ich lasse die KursSPITZEN oft weg, so scheinen mir Charts aussagekräftiger.

das kannst du ruhig normal gross schreiben, die schatten lasse ich gewöhnlich auch aussen vor. und wundere mich, dass viele ihre trendlinien tatsächlich penetrant von tageshoch zu tageshoch ziehn. klar setze ich auch schon mal am high oder low an. aber habe auch keine probleme selbst mitten durch einen kerzenkörper zu zeichnen, wenn es sinn macht! :bang: :eek: :lol

na ja, also..... mit welcher wahrscheinlichkeit der bruch einer linie tatsächlich die erwünschte wirkung zeigt, wäre die nächste frage.
:tup:

[Steff23]

26.01.2006 14:08
Biomira Inc. announces amendment to licensing agreement for BLP25 Liposome Vaccine

EDMONTON, Jan. 26 /PRNewswire-FirstCall/ -- Biomira Inc. (Nachrichten) (TSX: BRA) today announced the signing of a letter of intent to amend the licensing agreement between Biomira B.V. and Merck KGaA of Darmstadt, Germany for BLP25 Liposome Vaccine (L-BLP25), currently in development for the treatment of non-small cell lung cancer (NSCLC).

Under the letter of intent, approved by the Boards of both Companies, Merck KGaA will take over administrative and financial responsibility for the development and commercialization of L-BLP25, including the planned phase 3 trial in NSCLC, which remains on schedule with the enrolment of the first patient expected in mid 2006. Merck also plans to investigate the use of L-BLP25 to treat other types of cancer. All future development, regulatory, commercialization and marketing costs for L-BLP25 (including the planned phase 3 trial, but excluding the Canadian territory) will be borne exclusively by Merck KGaA effective March 1, 2006.

In return, Biomira's co-promotion interest in U.S. sales will be converted to a specified royalty rate, which will be higher than what Merck has agreed to pay on its sales of L-BLP25 in all markets outside of North America or the Rest of World (ROW). The royalty and other arrangements with respect to the ROW will remain generally unchanged (Merck KGaA to assume a specified third party royalty obligation on behalf of Biomira). Similarly, the milestone payments to be made by Merck KGaA pursuant to the collaboration will remain essentially the same. The agreed upon royalty rate for the U.S. territory reflects the stage and promise of L-BLP25.

Biomira will retain responsibility for manufacturing L-BLP25, both for clinical trials and following any marketing approval. The existing arrangements for Canada remain in place with Biomira responsible for the Canadian territory.

Dr. Alex McPherson, President and CEO of Biomira Inc., commented, "This is an excellent agreement and will ensure the fastest possible initiation of the phase 3 program in NSCLC as well as the possibility of exploring L-BLP25's potential in other forms of cancer. We are delighted by the strong and continued commitment that Merck has shown to this innovative and promising product. Merck's decision to take over the full cost of the trials will enable Biomira to focus our efforts and resources on our follow-on cancer vaccine, BGLP40, and on building our pipeline by acquiring new products."

"Merck is pleased that it has the opportunity to develop what appears to be a very promising treatment for NSCLC, which is one of the most prevalent and deadly of all cancers," said Elmar Schnee, Merck Deputy Executive Board Member with responsibility for Pharmaceuticals. "We believe this new agreement is not only beneficial for both companies but also for patients."

About L-BLP25

L-BLP25 is a synthetic MUC1 peptide vaccine and is a biological response modifier with a chemically synthesized peptide of a cancer-associated protein antigen widely expressed on common cancers. It is designed to induce an immune response to both the synthetic antigen and the natural corresponding antigen as expressed on the cancer. In October 2005 Biomira announced that median survival for patients with Stage IIIB locoregional NSCLC who received L-BLP25 in a phase 2b study had been determined. These results demonstrated an average survival of 30.6 months in the vaccinated group compared with 13.3 months for the unvaccinated group. A more comprehensive analysis of these data is expected in the first quarter of this year. In November 2005 Biomira announced the interim results of a phase 2 NSCLC single-arm, multi-centre, open label study of L-BLP25. The results showed that the new formulation of the vaccine to be used in the phase 3 clinical trial program is not different from the previous formulation from a safety perspective.

The reformulated vaccine incorporated manufacturing changes intended to secure the future commercial supply of the vaccine. Thus far, ongoing testing has demonstrated that the steps taken to address the manufacturing issue discovered in late 2005 have been successful. Pending completion of this testing, it is expected that manufacturing for the phase 3 trial will resume in the first quarter of this year.

Analyst Conference Call Details:

Today at 10:00 a.m. EST, Biomira Inc. will Web cast an analyst conference call hosted by Alex McPherson, M.D., Ph.D., President and CEO of Biomira. Analysts may participate in the conference call by dialing 1-210-234-0075 (Pass code: BIOM) approximately 10 minutes before the start of the call.

Investors and the general public are invited to listen to the live conference call on the Web, by accessing the following site: https://e-meetings.mci.com/ and entering the conference number: PA1499468 and the participant pass code: BIOM. The archive of the analyst conference call will be available for approximately 30 days following the live call.

About Lung Cancer

In 2005, approximately 172,000 new cases of lung cancer were diagnosed in the U.S. Approximately 163,000 people are estimated to have died of this disease in the U.S. alone in 2005. NSCLC accounts for approximately 75 to 80 per cent of all primary lung cancers. At the time of diagnosis, only 25 per cent of patients are potentially curable by surgery.

About Biomira Inc.

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.

This release may contain forward-looking statements. Various factors could cause actual results to differ materially from those projected in forward-looking statements, including those predicting the timing, duration and results of clinical trials, particularly the phase 3 clinical trial of L-BLP25 and the possible additional phase 2 trials for its use in other indications, trial reviews and analyses and regulatory reviews, the safety and efficacy of the product, the ability to secure and manufacture vaccine supplies and the resolution of a recent manufacturing problem by an outside vendor of the vaccine, and the ability of Biomira to acquire new pipeline product candidates. Although the Company believes that the forward-looking statements contained herein are reasonable, it can give no assurance that the Company's expectations are correct or that the Company will have sufficient resources to fund clinical trials and in-license new product candidates. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

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