Bavarian Nordic - The sky is the limit (Seite 218)
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Zytiga creeps up on Provenge prostate-cancer drug
Fri Oct 7, 2011 3:29pm EDT
* Quicker relief, ease of use help Zytiga pill
* Zytiga's fast ramp-up seen hurting Dendreon
* Bavarian Nordic vaccine moving into Phase III trials
By Ransdell Pierson
NEW YORK, Oct 7 (Reuters) - Interest in Dendreon Corp's Provenge vaccine to treat prostate cancer seems to be waning following recent approval of Johnson & Johnson's more-convenient and faster-acting Zytiga treatment, according to some doctors and industry analysts.
"The bloom is off the rose for Provenge because patients are looking for something that can treat them more quickly," and with greater convenience, said Charles Duncan, a biotechnology analyst for JMP Securities.
Although Provenge extended patient lives by an average of about four months in clinical trials, it does not significantly delay progression of symptoms -- including the bone pain which is a hallmark of advanced prostate cancer.
Even so, hopes for Provenge were sky high when U.S. regulators approved it in April 2010 for patients with prostate cancer who had failed to benefit from standard medicines that work by blocking the body's production of testosterone. Some analysts had expected the vaccine, which spurs the immune system to attack prostate cancer cells, to eventually capture annual sales of more than $4 billion.
But Duncan, whose company helped sponsor the "Cancer Immunology: A Long-Awaited Reality" conference in New York on Thursday, said Provenge is likely to generate peak annual sales of no more than $500 million because of shortcomings that have become evident to patients and doctors.
They include the time and inconvenience of extracting white blood cells from patients and sending them off to Dendreon plants, where they are combined with vaccine components. Patients then receive the final product through infusions.
Dr. Susan Slovin, an oncologist with Memorial Sloan-Kettering Cancer Center, said many patients and doctors are gravitating instead toward J&J's Zytiga -- a pill approved in recent months for advanced prostate cancer patients that have failed to benefit from chemotherapy.
The drug, known by its chemical name abiraterone, also prolonged life by about four months in clinical trials. But patients experience symptom relief far sooner with it than with Provenge, said Slovin, who was interviewed at the conference sponsored by strategy consulting firm MD Becker Partners LLC.
J&J'S PILL COMING ON STRONG
"Abiraterone is taking the market by storm; there is a much faster effect with it" than Provenge, Slovin said. "Patients feel they're getting something beneficial. Pain is markedly improved, along with the ability to eat, drink, go out and do what they normally would do."
"The patient says, 'Look, I really don't see the need to sit here and send my (blood) to wherever. I really don't want to wait. I want to take a pill and go to Florida.' "
Moreover, while Zytiga is expensive -- at about $5,000 a month, usually for eight cycles -- it is far less costly than Provenge.
Dendreon stunned investors in August by withdrawing its own sales forecast for Provenge because it was taking longer than expected for doctors to become comfortable with reimbursement issues for the product, which costs $93,000 for a course of treatment.
"I don't think Provenge will fall out of the arena; I do think it will still be used, but not with the same alacrity as when it first hit our formulary," said Slovin, whose hospital is one of the world's most prestigious cancer centers.
Dr. James Gulley, a director of clinical trials for the National Cancer Institute, said there is a "clear utility" for Provenge.
"Patients love the idea that your immune system is helping you fight cancer," he said. But Gulley said its manufacturing process poses challenges that have no doubt hampered demand for the product. "The vaccine has to be made for each individual patient."
Gulley is leading clinical trials of an experimental vaccine to treat prostate cancer that could be taken out of the freezer and injected into patients -- eliminating the hassles seen with Provenge.
The National Cancer Institute developed the vaccine, called ProstVac, and licensed it to Danish biotechnology company Bavarian Nordic . NCI would be entitled to royalties on sales of the vaccine, which is slated to move into late-stage trials in coming weeks.
Gulley said ProstVac prolonged patient lives by eight months in mid-stage trials -- roughly twice the benefit seen in separate trials of Provenge and Zytiga. But he cautioned that ProstVac's true potential will not be known until its far-larger planned Phase III trials are completed.
He said the vaccine, which coaxes immune system T-cells to attack a protein called Prostate-Specific Antigen (PSA) -- could prove to be a bigger drug than Provenge.
"Here's why: because it is off the shelf. There are no logistical constraints."
Currently, the world's top selling prostate cancer drugs are Taxotere (docetaxel), a chemotherapy sold by Sanofi , and drugs that reduce testosterone, the male hormone that fuels the growth of prostate cancer. They include AstraZeneca Plc's Zoladex and Casodex, and widely-used Lupron.
Prostate cancer kills about 250,000 men a year globally and is the second most common cause of cancer death in men in the United States, after lung cancer.
http://www.reuters.com/article/2011/10/07/dendreon-zytiga-id…
Fri Oct 7, 2011 3:29pm EDT
* Quicker relief, ease of use help Zytiga pill
* Zytiga's fast ramp-up seen hurting Dendreon
* Bavarian Nordic vaccine moving into Phase III trials
By Ransdell Pierson
NEW YORK, Oct 7 (Reuters) - Interest in Dendreon Corp's Provenge vaccine to treat prostate cancer seems to be waning following recent approval of Johnson & Johnson's more-convenient and faster-acting Zytiga treatment, according to some doctors and industry analysts.
"The bloom is off the rose for Provenge because patients are looking for something that can treat them more quickly," and with greater convenience, said Charles Duncan, a biotechnology analyst for JMP Securities.
Although Provenge extended patient lives by an average of about four months in clinical trials, it does not significantly delay progression of symptoms -- including the bone pain which is a hallmark of advanced prostate cancer.
Even so, hopes for Provenge were sky high when U.S. regulators approved it in April 2010 for patients with prostate cancer who had failed to benefit from standard medicines that work by blocking the body's production of testosterone. Some analysts had expected the vaccine, which spurs the immune system to attack prostate cancer cells, to eventually capture annual sales of more than $4 billion.
But Duncan, whose company helped sponsor the "Cancer Immunology: A Long-Awaited Reality" conference in New York on Thursday, said Provenge is likely to generate peak annual sales of no more than $500 million because of shortcomings that have become evident to patients and doctors.
They include the time and inconvenience of extracting white blood cells from patients and sending them off to Dendreon plants, where they are combined with vaccine components. Patients then receive the final product through infusions.
Dr. Susan Slovin, an oncologist with Memorial Sloan-Kettering Cancer Center, said many patients and doctors are gravitating instead toward J&J's Zytiga -- a pill approved in recent months for advanced prostate cancer patients that have failed to benefit from chemotherapy.
The drug, known by its chemical name abiraterone, also prolonged life by about four months in clinical trials. But patients experience symptom relief far sooner with it than with Provenge, said Slovin, who was interviewed at the conference sponsored by strategy consulting firm MD Becker Partners LLC.
J&J'S PILL COMING ON STRONG
"Abiraterone is taking the market by storm; there is a much faster effect with it" than Provenge, Slovin said. "Patients feel they're getting something beneficial. Pain is markedly improved, along with the ability to eat, drink, go out and do what they normally would do."
"The patient says, 'Look, I really don't see the need to sit here and send my (blood) to wherever. I really don't want to wait. I want to take a pill and go to Florida.' "
Moreover, while Zytiga is expensive -- at about $5,000 a month, usually for eight cycles -- it is far less costly than Provenge.
Dendreon stunned investors in August by withdrawing its own sales forecast for Provenge because it was taking longer than expected for doctors to become comfortable with reimbursement issues for the product, which costs $93,000 for a course of treatment.
"I don't think Provenge will fall out of the arena; I do think it will still be used, but not with the same alacrity as when it first hit our formulary," said Slovin, whose hospital is one of the world's most prestigious cancer centers.
Dr. James Gulley, a director of clinical trials for the National Cancer Institute, said there is a "clear utility" for Provenge.
"Patients love the idea that your immune system is helping you fight cancer," he said. But Gulley said its manufacturing process poses challenges that have no doubt hampered demand for the product. "The vaccine has to be made for each individual patient."
Gulley is leading clinical trials of an experimental vaccine to treat prostate cancer that could be taken out of the freezer and injected into patients -- eliminating the hassles seen with Provenge.
The National Cancer Institute developed the vaccine, called ProstVac, and licensed it to Danish biotechnology company Bavarian Nordic . NCI would be entitled to royalties on sales of the vaccine, which is slated to move into late-stage trials in coming weeks.
Gulley said ProstVac prolonged patient lives by eight months in mid-stage trials -- roughly twice the benefit seen in separate trials of Provenge and Zytiga. But he cautioned that ProstVac's true potential will not be known until its far-larger planned Phase III trials are completed.
He said the vaccine, which coaxes immune system T-cells to attack a protein called Prostate-Specific Antigen (PSA) -- could prove to be a bigger drug than Provenge.
"Here's why: because it is off the shelf. There are no logistical constraints."
Currently, the world's top selling prostate cancer drugs are Taxotere (docetaxel), a chemotherapy sold by Sanofi , and drugs that reduce testosterone, the male hormone that fuels the growth of prostate cancer. They include AstraZeneca Plc's Zoladex and Casodex, and widely-used Lupron.
Prostate cancer kills about 250,000 men a year globally and is the second most common cause of cancer death in men in the United States, after lung cancer.
http://www.reuters.com/article/2011/10/07/dendreon-zytiga-id…
Gute Idee jetzt bei BAVA einzusteigen.
Hier die aktuellen Facts zu BAVA:
Marketcap: 230 Mio Dollar
Umsatz 2011e: 96 Mio Dollar
Verlust 2011e: 67 Mio Dollar
Cash Ende 2011e: 101 Mio Dollar
Vergleich mit SIGA:
Marketcap: 297 Mio Dollar
Umsatz 2011e: 28,3 Mio Dollar
Verlust H1 2011: 17,6 Mio Dollar (operativ)
Cash H1 2011: 15 Mio Dollar
Hier die aktuellen Facts zu BAVA:
Marketcap: 230 Mio Dollar
Umsatz 2011e: 96 Mio Dollar
Verlust 2011e: 67 Mio Dollar
Cash Ende 2011e: 101 Mio Dollar
Vergleich mit SIGA:
Marketcap: 297 Mio Dollar
Umsatz 2011e: 28,3 Mio Dollar
Verlust H1 2011: 17,6 Mio Dollar (operativ)
Cash H1 2011: 15 Mio Dollar
Hallo,
Hab die Tage Positionen in Morphosys und Bavarian Nordic aufgebaut.
Alle beide Long auf min. 2 Jahre.
Gruß
C.
Hab die Tage Positionen in Morphosys und Bavarian Nordic aufgebaut.
Alle beide Long auf min. 2 Jahre.
Gruß
C.
Endlich löst sich BAVA von den Tiefstständen. Diese Unterbewertung ist schon sonderbar. Mit PROSTVAC und IMVAMUNE hat BAVA gleich zwei potenzielle Blockbuster kurz vor der Phase 3. Im Laufe des 2. Halbjahres wird sich diese Unterbewertung auflösen. Zu viele gute Nachrichten warten:
- Start Phase 3 PROSTVAC
- Erreichung der Profitabilität der Infektions-Sparte
Das 2. Halbjahr gehört Bavarian Nordic!
- Start Phase 3 PROSTVAC
- Erreichung der Profitabilität der Infektions-Sparte
Das 2. Halbjahr gehört Bavarian Nordic!
Bavarian Nordic macht es genau richtig:
http://seekingalpha.com/article/257526-to-partner-or-not-to-…
http://seekingalpha.com/article/257526-to-partner-or-not-to-…
Trading Spotlight
Auf der Homepage sehe ich gerade, dass BB Biotech mit über 5% an BAVA beteiligt ist.
http://www.bavarian-nordic.com/investor/share-information.as…
http://www.bavarian-nordic.com/investor/share-information.as…
Bewertungsrelationen:
SIGA
Ohne gültigen BARDA-Vertrag beträgt die Marktkapitalisierung derzeit etwa 400 Mio Euro.
Dendreon
DNDN wurde während der Phase 3 zu Provenge zwischen 350 und 700 Mio Euro bewertet.
Bavarian Nordic
Es besteht ein Liefervertrag mit dem US-Ministerium über 505 Mio Dollar für das Pocken-Vakzin. Der Hauptanteil
wird 2012 und 2013 ausgeliefert. UND die Immuntherapie PROSTVAC geht noch in diesem Jahr
in die 3. Phase der klinischen Studien.
Die Bewertung von BAVA beträgt allerdings 225 Mio Euro...
Das Potenzial ist greifbar!
SIGA
Ohne gültigen BARDA-Vertrag beträgt die Marktkapitalisierung derzeit etwa 400 Mio Euro.
Dendreon
DNDN wurde während der Phase 3 zu Provenge zwischen 350 und 700 Mio Euro bewertet.
Bavarian Nordic
Es besteht ein Liefervertrag mit dem US-Ministerium über 505 Mio Dollar für das Pocken-Vakzin. Der Hauptanteil
wird 2012 und 2013 ausgeliefert. UND die Immuntherapie PROSTVAC geht noch in diesem Jahr
in die 3. Phase der klinischen Studien.
Die Bewertung von BAVA beträgt allerdings 225 Mio Euro...
Das Potenzial ist greifbar!
Weitere Verträge über Lieferungen von IMVAMUNE (obwohl noch nicht zugelassen...)
Bavarian Nordic Has Signed Contract with Denmark and another European NATO Country for the Delivery of IMVAMUNE® Smallpox Vaccine
Kvistgård, Denmark, June 15, 2011 - Bavarian Nordic A/S (NASDAQ OMX: BAVA) today announced that it has signed a contract with the Danish Defence for the delivery of the company's third generation smallpox vaccine, IMVAMUNE®. Furthermore, Bavarian Nordic has signed a contract with another European NATO country for the delivery of IMVAMUNE®.
The vaccines will be delivered in 2011. The size and value of the contracts are undisclosed.
Like the U.S. government, which has so far ordered 20 million doses of the vaccine, IMVAMUNE® will form part of these countries' bio-preparedness in the event of a smallpox outbreak due to e.g. an act of terrorism. Although IMVAMUNE® is an unlicensed vaccine, it has been made available for government purchase. Data from more than 10 years of research indicate that IMVAMUNE® has a favorable safety profile and is well tolerated, including in people who are not recommended to receive the traditional smallpox vaccines, such as people with weakened immune systems (e.g. people infected with HIV) or diagnosed with atopic dermatitis (skin allergies).
The contracts do not affect the company's expectations for the 2011 full year results.
Anders Hedegaard, President & CEO comments: "Although these are smaller orders, we believe they can be the launch pad for a long-term cooperation on building up a modern bio-preparedness in these countries. Just like the U.S., Canada and the other countries which have purchased our vaccine, these countries now recognize the excellent features of IMVAMUNE®, which not only appears to be safer, but studies have also shown it has faster onset of protection than the old vaccines. We are continuously working to position IMVAMUNE® towards governments and national defences in other countries that have shown their interest in the vaccine."
http://www.bavarian-nordic.com/investor/announcements/2011-2…
Bavarian Nordic Has Signed Contract with Denmark and another European NATO Country for the Delivery of IMVAMUNE® Smallpox Vaccine
Kvistgård, Denmark, June 15, 2011 - Bavarian Nordic A/S (NASDAQ OMX: BAVA) today announced that it has signed a contract with the Danish Defence for the delivery of the company's third generation smallpox vaccine, IMVAMUNE®. Furthermore, Bavarian Nordic has signed a contract with another European NATO country for the delivery of IMVAMUNE®.
The vaccines will be delivered in 2011. The size and value of the contracts are undisclosed.
Like the U.S. government, which has so far ordered 20 million doses of the vaccine, IMVAMUNE® will form part of these countries' bio-preparedness in the event of a smallpox outbreak due to e.g. an act of terrorism. Although IMVAMUNE® is an unlicensed vaccine, it has been made available for government purchase. Data from more than 10 years of research indicate that IMVAMUNE® has a favorable safety profile and is well tolerated, including in people who are not recommended to receive the traditional smallpox vaccines, such as people with weakened immune systems (e.g. people infected with HIV) or diagnosed with atopic dermatitis (skin allergies).
The contracts do not affect the company's expectations for the 2011 full year results.
Anders Hedegaard, President & CEO comments: "Although these are smaller orders, we believe they can be the launch pad for a long-term cooperation on building up a modern bio-preparedness in these countries. Just like the U.S., Canada and the other countries which have purchased our vaccine, these countries now recognize the excellent features of IMVAMUNE®, which not only appears to be safer, but studies have also shown it has faster onset of protection than the old vaccines. We are continuously working to position IMVAMUNE® towards governments and national defences in other countries that have shown their interest in the vaccine."
http://www.bavarian-nordic.com/investor/announcements/2011-2…
Hört sich, für einen Biotech-Ahnungslosen, interessant an. 
Gruß
P.
Gruß
P.
Bavarian Nordic A/S - Interim Report for the period 1 January to 31 March 2011
Kvistgaard, Denmark, May 31, 2011 - Bavarian Nordic A/S (OMX: BAVA) today publishes its first quarter 2011 results. Bavarian Nordic generated revenue of DKK 29 million and recorded a loss before tax of DKK 135 million. As of 31 March 2011 the cash preparedness was DKK 326 million, including credit lines of DKK 112 million. After the successful completion of a rights issue in May 2011, the cash preparedness has been significantly strengthened and amounts to approximately DKK 825 million by end of May. The company maintains its full-year expectations with revenues in the level of DKK 500 million, and a pre-tax loss in the level of DKK 350 million. The cash preparedness at year-end is expected to be in the level of DKK 525 million.
Anders Hedegaard, President & CEO commented on the interim report: "Since we announced our new development strategy for PROSTVAC® there has been much focus on Bavarian Nordic and we are therefore delighted that the successful rights issue last week has enabled us to pursue the independent development of PROSTVAC® and thus initiate the Phase 3 trial in the second half of 2011 as planned. At the same time we have secured both the progress of the project, as well as a strong position in the further discussions with potential partners by maintaining the value of the project in the company. We have also witnessed important events in our Infectious Disease division, especially with the expansion of the contract for freeze-dried IMVAMUNE®, which further strengthens the ties with the U.S. Government, leading to potential new, future contracts."
Highlights from the period
Marketing authorization application for IMVAMUNE® submitted in Canada
In March, Bavarian Nordic submitted a marketing authorization application in Canada for IMVAMUNE®. If found acceptable by Health Canada following a standard NDS review time of approximately one year, IMVAMUNE® will be indicated for active immunization against smallpox in the general population of 18 years and older.
New Phase 2 study comparing PROSTVAC® and chemotherapy versus chemotherapy
A new multicenter, randomized Phase 2 study of 144 patients with metastatic castration-resistant prostate cancer (mCRPC) was initiated in February 2011. The study will compare PROSTVAC® followed by docetaxel (chemotherapy) versus docetaxel alone. Currently, PROSTVAC® is being investigated alone or as combination therapy in six ongoing clinical Phase 1 and Phase 2 studies in a total of more than 370 patients in different disease settings.
Important events after the period
DKK 653 million net raised in successful rights issue
In May, Bavarian Nordic successfully completed an offering, generating net proceeds of DKK 653 million. The rights issue attracted positive attention from both domestic and international blue chip and healthcare specialist investors. The proceeds from the rights issue will be used to pursue the independent development of PROSTVAC® which is expected to start the pivotal Phase 3 trial in the second half of 2011.
Patent position on MVA-BN® yet again successfully defended
In April, the ICC International Court of Arbitration rendered its decision in favour of Bavarian Nordic in the arbitration that had been pending against Helmholtz Zentrum München since 2009. Helmholtz Zentrum München`s claims of rights to royalties on Bavarian Nordic`s MVA-BN® based vaccines, including IMVAMUNE®, were found to be baseless on all grounds.
U.S. Government expands development contract for freeze-dried IMVAMUNE®
In April, the U.S. Government through the Biomedical Advanced Research and Development Authority (BARDA) increased the value of the existing contract to develop a freeze-dried version of IMVAMUNE® smallpox vaccine from USD 40 million to USD 94 million, thus underscoring the continued commitment to support the IMVAMUNE® development programme.
http://finance.yahoo.com/news/Bavarian-Nordic-A-S-Interim-th…
Kvistgaard, Denmark, May 31, 2011 - Bavarian Nordic A/S (OMX: BAVA) today publishes its first quarter 2011 results. Bavarian Nordic generated revenue of DKK 29 million and recorded a loss before tax of DKK 135 million. As of 31 March 2011 the cash preparedness was DKK 326 million, including credit lines of DKK 112 million. After the successful completion of a rights issue in May 2011, the cash preparedness has been significantly strengthened and amounts to approximately DKK 825 million by end of May. The company maintains its full-year expectations with revenues in the level of DKK 500 million, and a pre-tax loss in the level of DKK 350 million. The cash preparedness at year-end is expected to be in the level of DKK 525 million.
Anders Hedegaard, President & CEO commented on the interim report: "Since we announced our new development strategy for PROSTVAC® there has been much focus on Bavarian Nordic and we are therefore delighted that the successful rights issue last week has enabled us to pursue the independent development of PROSTVAC® and thus initiate the Phase 3 trial in the second half of 2011 as planned. At the same time we have secured both the progress of the project, as well as a strong position in the further discussions with potential partners by maintaining the value of the project in the company. We have also witnessed important events in our Infectious Disease division, especially with the expansion of the contract for freeze-dried IMVAMUNE®, which further strengthens the ties with the U.S. Government, leading to potential new, future contracts."
Highlights from the period
Marketing authorization application for IMVAMUNE® submitted in Canada
In March, Bavarian Nordic submitted a marketing authorization application in Canada for IMVAMUNE®. If found acceptable by Health Canada following a standard NDS review time of approximately one year, IMVAMUNE® will be indicated for active immunization against smallpox in the general population of 18 years and older.
New Phase 2 study comparing PROSTVAC® and chemotherapy versus chemotherapy
A new multicenter, randomized Phase 2 study of 144 patients with metastatic castration-resistant prostate cancer (mCRPC) was initiated in February 2011. The study will compare PROSTVAC® followed by docetaxel (chemotherapy) versus docetaxel alone. Currently, PROSTVAC® is being investigated alone or as combination therapy in six ongoing clinical Phase 1 and Phase 2 studies in a total of more than 370 patients in different disease settings.
Important events after the period
DKK 653 million net raised in successful rights issue
In May, Bavarian Nordic successfully completed an offering, generating net proceeds of DKK 653 million. The rights issue attracted positive attention from both domestic and international blue chip and healthcare specialist investors. The proceeds from the rights issue will be used to pursue the independent development of PROSTVAC® which is expected to start the pivotal Phase 3 trial in the second half of 2011.
Patent position on MVA-BN® yet again successfully defended
In April, the ICC International Court of Arbitration rendered its decision in favour of Bavarian Nordic in the arbitration that had been pending against Helmholtz Zentrum München since 2009. Helmholtz Zentrum München`s claims of rights to royalties on Bavarian Nordic`s MVA-BN® based vaccines, including IMVAMUNE®, were found to be baseless on all grounds.
U.S. Government expands development contract for freeze-dried IMVAMUNE®
In April, the U.S. Government through the Biomedical Advanced Research and Development Authority (BARDA) increased the value of the existing contract to develop a freeze-dried version of IMVAMUNE® smallpox vaccine from USD 40 million to USD 94 million, thus underscoring the continued commitment to support the IMVAMUNE® development programme.
http://finance.yahoo.com/news/Bavarian-Nordic-A-S-Interim-th…
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