AVEO Pharmaceuticals (Seite 50)
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Aveo’s kidney cancer drug submitted for approval in Europe
An application for approval in the world’s second-largest drug market has been submitted for a kidney cancer drug developed in Cambridge by Aveo Oncology — marking a potential second act for a drug that was rejected by U.S. regulators almost three years ago.
In December, Aveo (Nasdaq: AVEO) sold an exclusive marketing license for its drug, called tivozanib, to a recently-launched U.K.-based drug company called EUSA Pharma for $2.5 million up front and up to $394 million in potential milestone payments. The license would allow EUSA to market the drug in all of Europe plus South America and South Africa, and also to treat other types of cancer, assuming it can get approval to do so. Besides the milestone payments, Aveo would be eligible for tiered royalties “ranging from a low double-digit up to mid-20 percent” on sales of the drug.
Early this morning, EUSA and Aveo announced the application has been submitted seeking just such an approval from the European Medicines Agency. The application is based heavily on the results of a 517 patient trial completed in 2012 that found tivozanib stopped the growth of cancer in patients by an average of three months longer than other drugs, namely Nexavar by Bayer.
The FDA rejected the drug in 2013, however, because the trial results seemed to show patients died sooner who received the drug, although the company has argued that’s only because patients in that trial who were first given Nexavar were allowed to switch to Aveao' tivozanib after their cancer relapsed.
EUSA is applying for approval as a first-line treatment — that is, for newly diagnosed patients — and not just those who have already tried at least one other drug, as Aveo’s original application was for.
Results of an extension of the same trial announced last year suggest tivozanib may provide an even greater benefit to patients than the original study showed. Among the 167 patients who received tivozanib from the start, the average length of so-called progression-free survival was 11 months, versus the 8.4 months shown in the trial as of the FDA application.
An application for approval in the world’s second-largest drug market has been submitted for a kidney cancer drug developed in Cambridge by Aveo Oncology — marking a potential second act for a drug that was rejected by U.S. regulators almost three years ago.
In December, Aveo (Nasdaq: AVEO) sold an exclusive marketing license for its drug, called tivozanib, to a recently-launched U.K.-based drug company called EUSA Pharma for $2.5 million up front and up to $394 million in potential milestone payments. The license would allow EUSA to market the drug in all of Europe plus South America and South Africa, and also to treat other types of cancer, assuming it can get approval to do so. Besides the milestone payments, Aveo would be eligible for tiered royalties “ranging from a low double-digit up to mid-20 percent” on sales of the drug.
Early this morning, EUSA and Aveo announced the application has been submitted seeking just such an approval from the European Medicines Agency. The application is based heavily on the results of a 517 patient trial completed in 2012 that found tivozanib stopped the growth of cancer in patients by an average of three months longer than other drugs, namely Nexavar by Bayer.
The FDA rejected the drug in 2013, however, because the trial results seemed to show patients died sooner who received the drug, although the company has argued that’s only because patients in that trial who were first given Nexavar were allowed to switch to Aveao' tivozanib after their cancer relapsed.
EUSA is applying for approval as a first-line treatment — that is, for newly diagnosed patients — and not just those who have already tried at least one other drug, as Aveo’s original application was for.
Results of an extension of the same trial announced last year suggest tivozanib may provide an even greater benefit to patients than the original study showed. Among the 167 patients who received tivozanib from the start, the average length of so-called progression-free survival was 11 months, versus the 8.4 months shown in the trial as of the FDA application.
News! hilft es diesmal den kurs??
EUSA Pharma and AVEO Announce Submission of Marketing Authorization Application for Tivozanib in Advanced Renal Cell Carcinoma
HEMEL HEMPSTEAD, England & CAMBRIDGE, Mass.--(BUSINESS WIRE)--
EUSA Pharma, a newly-established specialty pharmaceutical business, and AVEO Oncology (AVEO) today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency for tivozanib for the first-line treatment of advanced renal cell carcinoma (RCC). The filing is based on tivozanib’s existing dataset and follows positive interactions with the Rapporteur and Co-Rapporteur during 2015 which indicated support for a filing using the phase III TIVO-1 trial as the pivotal study. EUSA Pharma submitted the application under the European Union’s centralized procedure, which permits the agency to issue a single marketing authorization that is valid across all EU countries.
Under the companies’ license agreement announced in December 2015, EUSA holds exclusive commercialization rights to tivozanib in RCC in Europe and in a number of other territories outside North America, including South America and South Africa, in addition to a range of further indications. Under the terms of the agreement, EUSA Pharma will undertake and fund the commercialization of the product in its territories, assuming approval.
“Survival rates in advanced renal cancer remain low and current therapies can be associated with treatment-limiting toxicities, resulting in significant unmet need where tivozanib has the potential to become an important new first-line therapy,” said Lee Morley, Chief Executive Officer of EUSA Pharma. “We are delighted to have achieved the submission of our Marketing Authorization Application to the European Medicines Agency so soon after licensing this exciting product, and we look forward to the outcome of the regulators’ review. In our short history, we have made great strides in building a strong portfolio of specialist medicines, and our filing of tivozanib in Europe is another milestone in EUSA’s journey to become a leading specialty pharmaceutical business.”
“Filing of an MAA by our partner EUSA Pharma is an important step toward the potential commercialization of tivozanib in territories around the world,” said Michael Bailey, President and Chief Executive Officer of AVEO. “We continue to leverage strong partnerships to advance our pipeline, including tivozanib in areas outside of North America and oncology, while we focus on the development and regulatory path forward for tivozanib in North America. We look forward to making progress on this path in the near-term, including the potential initiation of a Phase 3 trial of tivozanib in third line RCC to potentially enable registration in the first- and third-lines in the U.S.”
EUSA Pharma and AVEO Announce Submission of Marketing Authorization Application for Tivozanib in Advanced Renal Cell Carcinoma
HEMEL HEMPSTEAD, England & CAMBRIDGE, Mass.--(BUSINESS WIRE)--
EUSA Pharma, a newly-established specialty pharmaceutical business, and AVEO Oncology (AVEO) today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency for tivozanib for the first-line treatment of advanced renal cell carcinoma (RCC). The filing is based on tivozanib’s existing dataset and follows positive interactions with the Rapporteur and Co-Rapporteur during 2015 which indicated support for a filing using the phase III TIVO-1 trial as the pivotal study. EUSA Pharma submitted the application under the European Union’s centralized procedure, which permits the agency to issue a single marketing authorization that is valid across all EU countries.
Under the companies’ license agreement announced in December 2015, EUSA holds exclusive commercialization rights to tivozanib in RCC in Europe and in a number of other territories outside North America, including South America and South Africa, in addition to a range of further indications. Under the terms of the agreement, EUSA Pharma will undertake and fund the commercialization of the product in its territories, assuming approval.
“Survival rates in advanced renal cancer remain low and current therapies can be associated with treatment-limiting toxicities, resulting in significant unmet need where tivozanib has the potential to become an important new first-line therapy,” said Lee Morley, Chief Executive Officer of EUSA Pharma. “We are delighted to have achieved the submission of our Marketing Authorization Application to the European Medicines Agency so soon after licensing this exciting product, and we look forward to the outcome of the regulators’ review. In our short history, we have made great strides in building a strong portfolio of specialist medicines, and our filing of tivozanib in Europe is another milestone in EUSA’s journey to become a leading specialty pharmaceutical business.”
“Filing of an MAA by our partner EUSA Pharma is an important step toward the potential commercialization of tivozanib in territories around the world,” said Michael Bailey, President and Chief Executive Officer of AVEO. “We continue to leverage strong partnerships to advance our pipeline, including tivozanib in areas outside of North America and oncology, while we focus on the development and regulatory path forward for tivozanib in North America. We look forward to making progress on this path in the near-term, including the potential initiation of a Phase 3 trial of tivozanib in third line RCC to potentially enable registration in the first- and third-lines in the U.S.”
cooles Bild..wenn in paar monaten der kurs noch steigt umso besser :-)
wird schon :-)
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tja, nutzt alles nix, hier wir des andere news brauchen.
NEWS !!!
AVEO Announces Acceptance of Registration Dossier for Tivozanib in RCC by the Ministry of Health of the Russian Federation
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
AVEO Oncology (AVEO) today announced that a registration dossier seeking to obtain marketing authorization of tivozanib as a first line treatment of advanced renal cell carcinoma (“RCC”) has been accepted by the Ministry of Health (“MoH”) of the Russian Federation. The dossier was submitted in December 2015 by Pharmstandard Group, the largest Russian pharmaceutical group (“Pharmstandard”). In August 2015, AVEO licensed Pharmstandard rights to the development, manufacture and commercialization of tivozanib in the territories of Russia, Ukraine and the Commonwealth of Independent States (CIS), for all indications other than non-oncologic diseases or conditions of the eye.
Marketing authorization is being sought by Pharmstandard based upon results from TIVO-1, AVEO’s global, randomized, controlled Phase 3 trial evaluating tivozanib compared to sorafenib in patients with advanced RCC. AVEO is eligible to receive $7.5 million in connection with the first marketing authorization of tivozanib in Russia, provided that Russian regulatory authorities grant marketing approval based on the results from TIVO-1. If Russian regulatory authorities require additional studies to be performed prior to approval, the amount potentially payable to AVEO upon approval would be $3.0 million. AVEO is also eligible to receive a high single-digit royalty on net sales, if any, in the above mentioned territories. A percentage of any milestone and royalty payments received by AVEO are due to Kyowa Hakko Kirin as a sublicensing fee.
“Acceptance of a registration dossier marks an important step toward potential approval of tivozanib in RCC in territories outside the United States,” said Michael Bailey, president and chief executive officer of AVEO. “We look forward to MoH review of the dossier as we work toward submitting a marketing authorization application to the European Medicines Agency with our partner EUSA Pharma. In parallel, we continue to work toward the potential initiation of a Phase 3 trial of tivozanib in third line RCC to potentially enable registration in the first- and third-lines in the U.S., as well as the potential initiation of a combination study with a checkpoint inhibitor. Both studies may provide important strategic datasets in a rapidly evolving treatment landscape in RCC.”
About Tivozanib
Tivozanib is an oral, once-daily, investigational vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI). It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications. Tivozanib has been evaluated in several tumors types, including renal cell, colorectal and breast cancers.
About AVEO
AVEO Oncology (AVEO) is a biopharmaceutical company dedicated to advancing a broad portfolio of targeted therapeutics for oncology and other areas of unmet medical need. The company is focused on developing and commercializing its lead candidate tivozanib, a potent, selective, long half-life inhibitor of vascular endothelial growth factor 1, 2 and 3 receptors, in North America as a treatment for renal cell carcinoma and other cancers. AVEO is leveraging multiple partnerships to develop and commercialize tivozanib in non-oncologic indications worldwide and oncology indications outside of North America, as well as to progress its pipeline of novel therapeutic candidates in cancer and cachexia (wasting syndrome). For more information, please visit the company’s website at www.aveooncology.com.
AVEO Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of AVEO within the meaning of The Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. The words “anticipate,” “believe,” “expect,” “intend,” “may,” “plan,” “could,” “should,” “seek,” or the negative of these terms or other similar expressions, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about: the potential for tivozanib to obtain regulatory approval in RCC in territories outside the United States; expected payments from Pharmstandard; expected benefits of the Pharmstandard license agreement; expected submission of a marketing authorization application to the European Medicines Agency; and AVEO’s plans to initiate a Phase 3 trial of tivozanib to potentially enable registration in first- and third-line therapy in the U.S., as well as the potential initiation of a combination study with a checkpoint inhibitor and the potential for both studies to provide an important strategic dataset in RCC. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that AVEO makes due to a number of important factors, including risks relating to: AVEO’s ability to maintain its licensing agreements, including with Pharmstandard and EUSA Pharma, and its ability, and the ability of its licensees, to achieve development and commercialization objectives under these arrangements; AVEO’s ability, and the ability of its licensees, to demonstrate to the satisfaction of applicable regulatory agencies the safety, efficacy and clinically meaningful benefit of AVEO’s product candidates; AVEO’s ability to successfully implement its strategic plans; AVEO’s ability to successfully enroll and complete clinical trials of its product candidates; AVEO’s ability to achieve and maintain compliance with all regulatory requirements applicable to its product candidates; AVEO’s ability to obtain and maintain adequate protection for intellectual property rights relating to its product candidates and technologies; developments, expenses and outcomes related to AVEO’s ongoing shareholder litigation and SEC investigation; AVEO’s ability to raise the substantial additional funds required to achieve its near term strategic plans, including U.S. clinical trials of tivozanib; unplanned capital requirements; adverse general economic and industry conditions; competitive factors; and those risks discussed in the section titled “Risk Factors” in AVEO’s most recent Annual Report on Form 10-K, its quarterly reports on Form 10-Q and its other filings with the SEC. The forward-looking statements in this press release represent AVEO’s views as of the date of this press release. AVEO anticipates that subsequent events and developments may cause its views to change. While AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing AVEO’s views as of any date other than the date of this press release.
AVEO Announces Acceptance of Registration Dossier for Tivozanib in RCC by the Ministry of Health of the Russian Federation
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
AVEO Oncology (AVEO) today announced that a registration dossier seeking to obtain marketing authorization of tivozanib as a first line treatment of advanced renal cell carcinoma (“RCC”) has been accepted by the Ministry of Health (“MoH”) of the Russian Federation. The dossier was submitted in December 2015 by Pharmstandard Group, the largest Russian pharmaceutical group (“Pharmstandard”). In August 2015, AVEO licensed Pharmstandard rights to the development, manufacture and commercialization of tivozanib in the territories of Russia, Ukraine and the Commonwealth of Independent States (CIS), for all indications other than non-oncologic diseases or conditions of the eye.
Marketing authorization is being sought by Pharmstandard based upon results from TIVO-1, AVEO’s global, randomized, controlled Phase 3 trial evaluating tivozanib compared to sorafenib in patients with advanced RCC. AVEO is eligible to receive $7.5 million in connection with the first marketing authorization of tivozanib in Russia, provided that Russian regulatory authorities grant marketing approval based on the results from TIVO-1. If Russian regulatory authorities require additional studies to be performed prior to approval, the amount potentially payable to AVEO upon approval would be $3.0 million. AVEO is also eligible to receive a high single-digit royalty on net sales, if any, in the above mentioned territories. A percentage of any milestone and royalty payments received by AVEO are due to Kyowa Hakko Kirin as a sublicensing fee.
“Acceptance of a registration dossier marks an important step toward potential approval of tivozanib in RCC in territories outside the United States,” said Michael Bailey, president and chief executive officer of AVEO. “We look forward to MoH review of the dossier as we work toward submitting a marketing authorization application to the European Medicines Agency with our partner EUSA Pharma. In parallel, we continue to work toward the potential initiation of a Phase 3 trial of tivozanib in third line RCC to potentially enable registration in the first- and third-lines in the U.S., as well as the potential initiation of a combination study with a checkpoint inhibitor. Both studies may provide important strategic datasets in a rapidly evolving treatment landscape in RCC.”
About Tivozanib
Tivozanib is an oral, once-daily, investigational vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI). It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications. Tivozanib has been evaluated in several tumors types, including renal cell, colorectal and breast cancers.
About AVEO
AVEO Oncology (AVEO) is a biopharmaceutical company dedicated to advancing a broad portfolio of targeted therapeutics for oncology and other areas of unmet medical need. The company is focused on developing and commercializing its lead candidate tivozanib, a potent, selective, long half-life inhibitor of vascular endothelial growth factor 1, 2 and 3 receptors, in North America as a treatment for renal cell carcinoma and other cancers. AVEO is leveraging multiple partnerships to develop and commercialize tivozanib in non-oncologic indications worldwide and oncology indications outside of North America, as well as to progress its pipeline of novel therapeutic candidates in cancer and cachexia (wasting syndrome). For more information, please visit the company’s website at www.aveooncology.com.
AVEO Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of AVEO within the meaning of The Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. The words “anticipate,” “believe,” “expect,” “intend,” “may,” “plan,” “could,” “should,” “seek,” or the negative of these terms or other similar expressions, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about: the potential for tivozanib to obtain regulatory approval in RCC in territories outside the United States; expected payments from Pharmstandard; expected benefits of the Pharmstandard license agreement; expected submission of a marketing authorization application to the European Medicines Agency; and AVEO’s plans to initiate a Phase 3 trial of tivozanib to potentially enable registration in first- and third-line therapy in the U.S., as well as the potential initiation of a combination study with a checkpoint inhibitor and the potential for both studies to provide an important strategic dataset in RCC. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that AVEO makes due to a number of important factors, including risks relating to: AVEO’s ability to maintain its licensing agreements, including with Pharmstandard and EUSA Pharma, and its ability, and the ability of its licensees, to achieve development and commercialization objectives under these arrangements; AVEO’s ability, and the ability of its licensees, to demonstrate to the satisfaction of applicable regulatory agencies the safety, efficacy and clinically meaningful benefit of AVEO’s product candidates; AVEO’s ability to successfully implement its strategic plans; AVEO’s ability to successfully enroll and complete clinical trials of its product candidates; AVEO’s ability to achieve and maintain compliance with all regulatory requirements applicable to its product candidates; AVEO’s ability to obtain and maintain adequate protection for intellectual property rights relating to its product candidates and technologies; developments, expenses and outcomes related to AVEO’s ongoing shareholder litigation and SEC investigation; AVEO’s ability to raise the substantial additional funds required to achieve its near term strategic plans, including U.S. clinical trials of tivozanib; unplanned capital requirements; adverse general economic and industry conditions; competitive factors; and those risks discussed in the section titled “Risk Factors” in AVEO’s most recent Annual Report on Form 10-K, its quarterly reports on Form 10-Q and its other filings with the SEC. The forward-looking statements in this press release represent AVEO’s views as of the date of this press release. AVEO anticipates that subsequent events and developments may cause its views to change. While AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing AVEO’s views as of any date other than the date of this press release.
man braucht extrem viel sitzfleisch hier
kurs wie festgenagelt bei der 1 :-/
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