Evotec 566480, wohin geht die Reise??? (Seite 6607)
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ISIN: DE0005664809 · WKN: 566480 · Symbol: EVT
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| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 4,0920 | +167,10 | |
| 1,2500 | +92,01 | |
| 3,0380 | +75,15 | |
| 0,8905 | +74,51 | |
| 1,7900 | +35,61 |
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 1,2029 | -14,15 | |
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| 13,010 | -19,94 | |
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Antwort auf Beitrag Nr.: 41.852.467 von Marmolata am 27.07.11 14:59:05Wir haben Glück dass der Kurs bei 2,22 gestützt wird. Ansonsten wären wir wahrscheinlich heute wieder 10% gefallen. Der Markt ist zu unsicher! Niemand kauft eine fundamental überbewertete Aktie im Moment!
Zitat von altf4: http://www.kursdiamanten.de/boersenbrief/aktien/auf-was-sollte-man-bei-der-aktie-von-evotec-warten.html
wenn die Recht haben, liegt die Unterstützung jetzt auf 2,20 €. Wenn das nicht hält, kann der Kurs unter 2 € fallen. Hört sich nicht gut an und ist auch unverständlich, da evotec doch gut aufgestellt ist und eigentlich auch trotz dem Studienabbruch längst über 3 € und höher stehen müßte. Ich denke, das ist jetzt alles auch von der Haushalts-Entscheidung der USA abhängig, die jetzt bis Donnerstag vertagt wurde. Die sollen sich mal endlich einigen!
Ok danke ;-)
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Antwort auf Beitrag Nr.: 41.846.469 von altf4 am 26.07.11 15:48:19...ich vermute, der kollege hat bid und ask durcheinander gebracht und als klugsch. wollte ich ihn in luschtiger form darauf hinweisen - ist mir wohl nicht gelungen! ("Sieht heute gar nicht so schlecht aus...Im Ask wird der Kurs mit 40k Stück bei 2,31 gestützt")
Antwort auf Beitrag Nr.: 41.846.022 von dlg am 26.07.11 14:49:04??? Bitte mal erklären ;-)
Antwort auf Beitrag Nr.: 41.838.404 von Marmolata am 25.07.11 10:14:30Sieht heute gar nicht so schlecht aus...
Könnte einen kleines Plus geben. Im Ask wird der Kurs mit 40k Stück bei 2,31 gestützt. Im Bid ist nichts drin
Könnte einen kleines Plus geben. Im Ask wird der Kurs mit 40k Stück bei 2,31 gestützt. Im Bid ist nichts drin
Noch etwas zu den Gründen der Kinaxo Übernahme, mit der man nicht nur die Onkologie Sparte Evotecs stärken wollte, sondern vielleicht vor allem auf dem Biomarker Segment noch einiges vor hat. Das klingt nach guten Wachstums Chancen.
http://www.genengnews.com/keywordsandtools/print/3/23715/
Analysis & Insight : Jul 25, 2011
Companies with Cancer Therapeutic
Candidates Ramp Up Companion
Diagnostic Efforts
As regulatory framework gets fine-tuned, firms realize the importance of
having a biomarker strategy.
Patricia F. Dimond, Ph.D.
Biopharma companies are more focused on developing companion diagnostics for
cancer drugs despite challenges and initial trepidations over this business model.
Indeed, FDA’s recently issued draft guidance on companion tests is testament to the
fact that the field is advancing and more regulatory clarity is needed.
Therapeutic firms are pursuing two strategies in developing diagnostics: through inhouse
work or through external partnerships with diagnostics companies. Depending
on the availability of a clear-cut biomarker, the ideal is to start diagnostic
development early in the clinical development cycle of a drug. The aim is to have a
test ready for use in Phase III drug testing.
Firms are making the investment in companion diagnostics with the belief that it will
ultimately impact the overall cost of drug development. “While there is some up-front
investment, in the ideal scenario co-development of diagnostics will reduce drug
development costs,” David Reese, M.D., Amgen’s vp of medical sciences, told GEN.
“By allowing you to target much earlier in the drug development process patients
that are likely to respond, you can demonstrate the value of the drug early on.”
Developing Dx and Rx Together
Roche’s recent advances with its metastatic melanoma candidate, vemurafenib
developed through its Genentech subsidiary, and its corresponding companion
diagnostic, the Cobas 4800 BRAF V600 Mutation Test developed through Roche
Diagnostics, provides an example of a successful internal collaboration.
Vemurafenib is being co-developed under a 2006 license and collaboration
agreement between Roche/Genentech and Plexxikon, the original drug developer.
The NDA and MAA for the drug, submitted last May, covers the treatment of
individuals with BRAF V600 mutation-positive metastatic melanoma.
The Cobas 4800 BRAF V600 Mutation Test, a PCR-based companion diagnostic, is
designed to identify people whose tumors carry the BRAF V600 mutation. About
60% of melanomas have this mutation; melanoma cells lacking it are not inhibited by
the drug, which stimulates normal BRAF and can promote tumor growth.
Commenting on the Phase III trial (BRIM3) evaluating the drug, Paul Brown, head of
Roche Molecular Systems, said, “In BRIM3 our investigational test enabled rapid
and accurate identification of eligible patients with metastatic melanoma.” The study
met its co-primary endpoints of overall survival and progression-free survival. Risk of
death was reduced by 63% and risk of disease progression by 74%.
One of the key factors in the successful, side-by-side development of vemurafenib
and its companion diagnostic was that Plexxikon was in the Bay area, Walter Koch,
Ph.D., vp, head of global research at Roche Molecular Diagnostics, told GEN. “Peter
Hirth of Plexxikon had reached out to us in 2005, told us what Plexxikon was
working on, and asked if we could develop a test.
“Our diagnostics agreement predated that of Roche Pharma, and having that
diagnostic relationship in place played a key role in our pharmaceutical colleagues
getting involved in it. Once Roche had decided to in-license and develop the drug, a
lot of planning had started in 2006 to coordinate the development of the drug and
the test and to have the test available for the clinical trials.”
Expected Challenges
Commenting on hurdles with companion diagnostic development for vemurafenib,
Dr. Koch said the first challenge was a “generic one. Drug development and
diagnostic development are fundamentally different, and aligning the processes so
that both the therapeutic and the test can be filed with the FDA simultaneously works
better if you have both teams at the same table together.
“This was greatly facilitated in our case because we were all the same company.”
While he believes it can be done with external partners, Dr. Koch noted that it would
be more complicated.
The second challenge he mentioned was linking hardware, software, and test
reagents. “We were working with a different generation platform in 2005, then had to
change the platform during the development process. We moved to a newer
generation instrument, and so had to revalidate, re-tune, and re-optimize the
reagents so they worked with the new instrument and software.”
Despite inherent challenges, Dr. Koch said that “in Roche and in most pharma
companies, personalized healthcare is the way we are moving forward. We believe
we will greatly improve the efficacy of therapeutics when we can identify appropriate
patients. We are seeing early success rates that suggest that companion diagnostics
are a far better way to improve therapeutics and success rates of clinical trials.”
Having Biomarker Data Early
Vemurafenib stands apart from other cancer drugs with companion tests because
knowledge of specific mutations affecting drug response was available early in the
drug’s development cycle. Dr. Koch explained that while there are multiple examples
of cancer drugs with specific biomarker tests that characterize the diseases,
knowledge of specific mutations affecting drug response became available after the
drugs were developed. “This substantially changes the market,” Dr. Koch said.
Drugs approved along with a companion diagnostic include Eli Lilly’s Erbitux and
Amgen’s Vectibix, both anti-epidermal growth factor receptor (EGFR) antibodies.
The original companion diagnostic, EGFR pharmDx, which detected EGRF status in
patients, was developed by partnering with DAKO.
Evidence that KRAS mutation status would affect how subjects responded to anti-
EGFR treatments became apparent only after clinical trials that formed the basis of
NDA and MAA submissions were completed. Amgen and Imclone analyzed the
existing information and found that about 43% of patients, those with KRAS
mutations, did not respond to the EGRF inhibitors.
“Therefore, if you had a diagnostic test for the KRAS mutations, you would have
40% of patients who wouldn’t get the therapy but who would have been treated prior
to that knowledge.”
But, Dr. Koch said, many drugs are evolving along the lines of BRAF, “where an
activating mutation in an oncogene makes sense to target specifically or knowledge
of a pathway downstream portends failure for the drug and suggests other
development strategies.”
Amgen has bolstered work on identifying biomarkers that will allow the company to
predict which patients will or won’t respond to a given drug. Generally the company
identifies a diagnostic company with appropriate expertise to partner with depending
on the type of test needed.
“We believe it’s an essential part of the drug development process,” Dr. Reese told
GEN. “Every product we put into humans has a biomarker team formed typically one
to two years before the first patient is dosed with a drug.” He explained that the
teams have two mandates. “One is to potentially develop pharmacodynamic
biomarkers that tell you whether the drug is doing what you think it should be doing.
For example, if you are targeting a receptor in cancer, is your drug getting in at an
appropriate level and shutting the receptor off?
“The second mandate of that team is to identify those patients likely to respond or
not respond to the therapy. Our goal is to get the right drug to the right patient as
early in the process as possible, starting that effort even with preclinical work.”
Dr. Reese explained that what potentially differentiates Amgen from companies
developing companion diagnostics for their drug candidates is “the scale of the effort
and the formation of cross-functional teams with the sole mandate of biomarker
development.”
Integrating Companion Dx Development
“Patient selection can take many forms, depending on the clinical scenario and
really has to be customized to each setting,” Dr. Reese remarked. “There is no one
size fits all development process. We have the philosophy that the science and the
biology drive what we do and shape what we do in the clinic.”
Companion diagnostics offer the perfect means of fulfilling the promise of
personalized medicine. They have, however, been viewed as disruptors of the
biopharmaceutical market, as the tests could restrict the size of treatable
populations.
Increasingly, however, pharma and biotech companies are realizing that they cannot
ignore companion diagnostics. With FDA’s draft guidance on this sector suggesting
that drugs and their corresponding tests must be approved simultaneously,
investment in either internal strategies or external partnerships are ramping up.
Grüße
http://www.genengnews.com/keywordsandtools/print/3/23715/
Analysis & Insight : Jul 25, 2011
Companies with Cancer Therapeutic
Candidates Ramp Up Companion
Diagnostic Efforts
As regulatory framework gets fine-tuned, firms realize the importance of
having a biomarker strategy.
Patricia F. Dimond, Ph.D.
Biopharma companies are more focused on developing companion diagnostics for
cancer drugs despite challenges and initial trepidations over this business model.
Indeed, FDA’s recently issued draft guidance on companion tests is testament to the
fact that the field is advancing and more regulatory clarity is needed.
Therapeutic firms are pursuing two strategies in developing diagnostics: through inhouse
work or through external partnerships with diagnostics companies. Depending
on the availability of a clear-cut biomarker, the ideal is to start diagnostic
development early in the clinical development cycle of a drug. The aim is to have a
test ready for use in Phase III drug testing.
Firms are making the investment in companion diagnostics with the belief that it will
ultimately impact the overall cost of drug development. “While there is some up-front
investment, in the ideal scenario co-development of diagnostics will reduce drug
development costs,” David Reese, M.D., Amgen’s vp of medical sciences, told GEN.
“By allowing you to target much earlier in the drug development process patients
that are likely to respond, you can demonstrate the value of the drug early on.”
Developing Dx and Rx Together
Roche’s recent advances with its metastatic melanoma candidate, vemurafenib
developed through its Genentech subsidiary, and its corresponding companion
diagnostic, the Cobas 4800 BRAF V600 Mutation Test developed through Roche
Diagnostics, provides an example of a successful internal collaboration.
Vemurafenib is being co-developed under a 2006 license and collaboration
agreement between Roche/Genentech and Plexxikon, the original drug developer.
The NDA and MAA for the drug, submitted last May, covers the treatment of
individuals with BRAF V600 mutation-positive metastatic melanoma.
The Cobas 4800 BRAF V600 Mutation Test, a PCR-based companion diagnostic, is
designed to identify people whose tumors carry the BRAF V600 mutation. About
60% of melanomas have this mutation; melanoma cells lacking it are not inhibited by
the drug, which stimulates normal BRAF and can promote tumor growth.
Commenting on the Phase III trial (BRIM3) evaluating the drug, Paul Brown, head of
Roche Molecular Systems, said, “In BRIM3 our investigational test enabled rapid
and accurate identification of eligible patients with metastatic melanoma.” The study
met its co-primary endpoints of overall survival and progression-free survival. Risk of
death was reduced by 63% and risk of disease progression by 74%.
One of the key factors in the successful, side-by-side development of vemurafenib
and its companion diagnostic was that Plexxikon was in the Bay area, Walter Koch,
Ph.D., vp, head of global research at Roche Molecular Diagnostics, told GEN. “Peter
Hirth of Plexxikon had reached out to us in 2005, told us what Plexxikon was
working on, and asked if we could develop a test.
“Our diagnostics agreement predated that of Roche Pharma, and having that
diagnostic relationship in place played a key role in our pharmaceutical colleagues
getting involved in it. Once Roche had decided to in-license and develop the drug, a
lot of planning had started in 2006 to coordinate the development of the drug and
the test and to have the test available for the clinical trials.”
Expected Challenges
Commenting on hurdles with companion diagnostic development for vemurafenib,
Dr. Koch said the first challenge was a “generic one. Drug development and
diagnostic development are fundamentally different, and aligning the processes so
that both the therapeutic and the test can be filed with the FDA simultaneously works
better if you have both teams at the same table together.
“This was greatly facilitated in our case because we were all the same company.”
While he believes it can be done with external partners, Dr. Koch noted that it would
be more complicated.
The second challenge he mentioned was linking hardware, software, and test
reagents. “We were working with a different generation platform in 2005, then had to
change the platform during the development process. We moved to a newer
generation instrument, and so had to revalidate, re-tune, and re-optimize the
reagents so they worked with the new instrument and software.”
Despite inherent challenges, Dr. Koch said that “in Roche and in most pharma
companies, personalized healthcare is the way we are moving forward. We believe
we will greatly improve the efficacy of therapeutics when we can identify appropriate
patients. We are seeing early success rates that suggest that companion diagnostics
are a far better way to improve therapeutics and success rates of clinical trials.”
Having Biomarker Data Early
Vemurafenib stands apart from other cancer drugs with companion tests because
knowledge of specific mutations affecting drug response was available early in the
drug’s development cycle. Dr. Koch explained that while there are multiple examples
of cancer drugs with specific biomarker tests that characterize the diseases,
knowledge of specific mutations affecting drug response became available after the
drugs were developed. “This substantially changes the market,” Dr. Koch said.
Drugs approved along with a companion diagnostic include Eli Lilly’s Erbitux and
Amgen’s Vectibix, both anti-epidermal growth factor receptor (EGFR) antibodies.
The original companion diagnostic, EGFR pharmDx, which detected EGRF status in
patients, was developed by partnering with DAKO.
Evidence that KRAS mutation status would affect how subjects responded to anti-
EGFR treatments became apparent only after clinical trials that formed the basis of
NDA and MAA submissions were completed. Amgen and Imclone analyzed the
existing information and found that about 43% of patients, those with KRAS
mutations, did not respond to the EGRF inhibitors.
“Therefore, if you had a diagnostic test for the KRAS mutations, you would have
40% of patients who wouldn’t get the therapy but who would have been treated prior
to that knowledge.”
But, Dr. Koch said, many drugs are evolving along the lines of BRAF, “where an
activating mutation in an oncogene makes sense to target specifically or knowledge
of a pathway downstream portends failure for the drug and suggests other
development strategies.”
Amgen has bolstered work on identifying biomarkers that will allow the company to
predict which patients will or won’t respond to a given drug. Generally the company
identifies a diagnostic company with appropriate expertise to partner with depending
on the type of test needed.
“We believe it’s an essential part of the drug development process,” Dr. Reese told
GEN. “Every product we put into humans has a biomarker team formed typically one
to two years before the first patient is dosed with a drug.” He explained that the
teams have two mandates. “One is to potentially develop pharmacodynamic
biomarkers that tell you whether the drug is doing what you think it should be doing.
For example, if you are targeting a receptor in cancer, is your drug getting in at an
appropriate level and shutting the receptor off?
“The second mandate of that team is to identify those patients likely to respond or
not respond to the therapy. Our goal is to get the right drug to the right patient as
early in the process as possible, starting that effort even with preclinical work.”
Dr. Reese explained that what potentially differentiates Amgen from companies
developing companion diagnostics for their drug candidates is “the scale of the effort
and the formation of cross-functional teams with the sole mandate of biomarker
development.”
Integrating Companion Dx Development
“Patient selection can take many forms, depending on the clinical scenario and
really has to be customized to each setting,” Dr. Reese remarked. “There is no one
size fits all development process. We have the philosophy that the science and the
biology drive what we do and shape what we do in the clinic.”
Companion diagnostics offer the perfect means of fulfilling the promise of
personalized medicine. They have, however, been viewed as disruptors of the
biopharmaceutical market, as the tests could restrict the size of treatable
populations.
Increasingly, however, pharma and biotech companies are realizing that they cannot
ignore companion diagnostics. With FDA’s draft guidance on this sector suggesting
that drugs and their corresponding tests must be approved simultaneously,
investment in either internal strategies or external partnerships are ramping up.
Grüße
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Evotec 566480, wohin geht die Reise???
