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Sunesis Pharmaceuticals Announces European Patent Covering Vosaroxin Combination Use in AML and Other Hematologic Malignancies
1 hour 10 minutes ago - DJNF
Sunesis Pharmaceuticals Announces European Patent Covering Vosaroxin Combination Use in AML and Other Hematologic Malignancies
SOUTH SAN FRANCISCO, Calif., Nov. 30, 2015 (GLOBE NEWSWIRE) -- Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced that the European Patent Office (EPO) has granted European Patent No. 2 049 109 B1, claiming certain combined uses of vosaroxin and cytarabine, at doses of 10-120 mg/m(2) and 5-1500 mg/m(2) , respectively, for the treatment of acute myelogenous leukemia and acute myeloblastic leukemia. The patent further provides for combinations of vosaroxin and cytarabine with other therapies, such as radiation, or other chemotherapeutics, including anti-cancer agents, in hematologic disorders, whether administered simultaneously or sequentially. Sunesis is proceeding to validate this patent in multiple EPO member states. The resulting national patents would expire in the third quarter of 2027, but could be eligible for supplementary patent term in EPO member states beyond this date. Related patent applications are pending in several countries, including the United States and Japan.
"This patent adds important value to a European commercial opportunity for vosaroxin, as it covers a wide range of its contemplated commercial use with cytarabine out to 2027," said Eric Bjerkholt, Executive Vice President, Corporate Development and Finance of Sunesis. "Granting of this European patent is particularly timely, as we prepare to file a European Marketing Authorization Application for vosaroxin in combination with cytarabine in AML by year end. It also provides us with greater certainty in pursuing the full clinical and commercial potential of vosaroxin using various therapeutic combinations in AML and other hematologic malignancies."
About QINPREZO(TM) (vosaroxin)
QINPREZO(TM) (vosaroxin) is an anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Preclinical data demonstrate that vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the U.S. Food and Drug Administration (FDA) and European Commission have granted orphan drug designation to vosaroxin for the treatment of AML. Additionally, vosaroxin has been granted fast track designation by the FDA for the potential treatment of relapsed or refractory AML in combination with cytarabine. Vosaroxin is an investigational drug that has not been approved for use in any jurisdiction.
The trademark name QINPREZO is conditionally accepted by the FDA and the EMA as the proprietary name for the vosaroxin drug product candidate.
About Sunesis Pharmaceuticals
Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the potential treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to advancing its lead product candidate, vosaroxin, in multiple indications to improve the lives of people with cancer.
For additional information on Sunesis, please visit http://www.sunesis.com.
SUNESIS and the logos are trademarks of Sunesis Pharmaceuticals, Inc.
This press release contains forward-looking statements, including statements related to Sunesis' estimated timelines for regulatory interactions and regulatory progress, including the anticipated submission of the MAA for vosaroxin with the EMA and plans to gain marketing approval of vosaroxin in the U.S., Sunesis' overall strategy, the design, conduct and results of clinical trials, including the expected progress in its kinase inhibitor pipeline, estimated new cases of AML, its prevalence across major global markets, prognosis for patients with AML, the need for and the role of vosaroxin as a potential new treatment option, and Sunesis' clinical development of vosaroxin, including the analysis of the results from the VALOR clinical trial. Words such as "anticipates," "estimates," "expect," "intends," "plan," "potential," "will" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Sunesis' current expectations. Forward-looking statements involve risks and uncertainties. Sunesis' actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the risk that Sunesis may not be able to submit timely the MAA to the EMA, the risk that Sunesis' clinical studies for vosaroxin may not lead to regulatory approval in the U.S. or Europe, that Sunesis' development activities for vosaroxin could be otherwise halted or significantly delayed for various reasons, the risk that Sunesis' clinical studies for vosaroxin or other product candidates may not demonstrate safety or efficacy or lead to regulatory approval, the risk that data to date and trends may not be predictive of future data or results, risks related to the conduct of Sunesis' clinical trials, risks related to Sunesis' need for substantial additional funding to complete the development and commercialization of vosaroxin, and risks related to Sunesis' ability to raise the capital that it believes to be accessible and is required to fully finance the development and commercialization of vosaroxin. These and other risk factors are discussed under "Risk Factors" and elsewhere in Sunesis' Quarterly Report on Form 10-Q for the quarter ended September 30, 2015. Sunesis expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Sunesis' expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
CONTACT: Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
(MORE TO FOLLOW) Dow Jones Newswires
November 30, 2015 07:00 ET (12:00 GMT)
Sunesis Pharmaceuticals Announces European Patent Covering Vosaroxin Combination Use in AML and Other Hematologic Malignancies
1 hour 10 minutes ago - DJNF
Sunesis Pharmaceuticals Announces European Patent Covering Vosaroxin Combination Use in AML and Other Hematologic Malignancies
SOUTH SAN FRANCISCO, Calif., Nov. 30, 2015 (GLOBE NEWSWIRE) -- Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced that the European Patent Office (EPO) has granted European Patent No. 2 049 109 B1, claiming certain combined uses of vosaroxin and cytarabine, at doses of 10-120 mg/m(2) and 5-1500 mg/m(2) , respectively, for the treatment of acute myelogenous leukemia and acute myeloblastic leukemia. The patent further provides for combinations of vosaroxin and cytarabine with other therapies, such as radiation, or other chemotherapeutics, including anti-cancer agents, in hematologic disorders, whether administered simultaneously or sequentially. Sunesis is proceeding to validate this patent in multiple EPO member states. The resulting national patents would expire in the third quarter of 2027, but could be eligible for supplementary patent term in EPO member states beyond this date. Related patent applications are pending in several countries, including the United States and Japan.
"This patent adds important value to a European commercial opportunity for vosaroxin, as it covers a wide range of its contemplated commercial use with cytarabine out to 2027," said Eric Bjerkholt, Executive Vice President, Corporate Development and Finance of Sunesis. "Granting of this European patent is particularly timely, as we prepare to file a European Marketing Authorization Application for vosaroxin in combination with cytarabine in AML by year end. It also provides us with greater certainty in pursuing the full clinical and commercial potential of vosaroxin using various therapeutic combinations in AML and other hematologic malignancies."
About QINPREZO(TM) (vosaroxin)
QINPREZO(TM) (vosaroxin) is an anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Preclinical data demonstrate that vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the U.S. Food and Drug Administration (FDA) and European Commission have granted orphan drug designation to vosaroxin for the treatment of AML. Additionally, vosaroxin has been granted fast track designation by the FDA for the potential treatment of relapsed or refractory AML in combination with cytarabine. Vosaroxin is an investigational drug that has not been approved for use in any jurisdiction.
The trademark name QINPREZO is conditionally accepted by the FDA and the EMA as the proprietary name for the vosaroxin drug product candidate.
About Sunesis Pharmaceuticals
Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the potential treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to advancing its lead product candidate, vosaroxin, in multiple indications to improve the lives of people with cancer.
For additional information on Sunesis, please visit http://www.sunesis.com.
SUNESIS and the logos are trademarks of Sunesis Pharmaceuticals, Inc.
This press release contains forward-looking statements, including statements related to Sunesis' estimated timelines for regulatory interactions and regulatory progress, including the anticipated submission of the MAA for vosaroxin with the EMA and plans to gain marketing approval of vosaroxin in the U.S., Sunesis' overall strategy, the design, conduct and results of clinical trials, including the expected progress in its kinase inhibitor pipeline, estimated new cases of AML, its prevalence across major global markets, prognosis for patients with AML, the need for and the role of vosaroxin as a potential new treatment option, and Sunesis' clinical development of vosaroxin, including the analysis of the results from the VALOR clinical trial. Words such as "anticipates," "estimates," "expect," "intends," "plan," "potential," "will" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Sunesis' current expectations. Forward-looking statements involve risks and uncertainties. Sunesis' actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the risk that Sunesis may not be able to submit timely the MAA to the EMA, the risk that Sunesis' clinical studies for vosaroxin may not lead to regulatory approval in the U.S. or Europe, that Sunesis' development activities for vosaroxin could be otherwise halted or significantly delayed for various reasons, the risk that Sunesis' clinical studies for vosaroxin or other product candidates may not demonstrate safety or efficacy or lead to regulatory approval, the risk that data to date and trends may not be predictive of future data or results, risks related to the conduct of Sunesis' clinical trials, risks related to Sunesis' need for substantial additional funding to complete the development and commercialization of vosaroxin, and risks related to Sunesis' ability to raise the capital that it believes to be accessible and is required to fully finance the development and commercialization of vosaroxin. These and other risk factors are discussed under "Risk Factors" and elsewhere in Sunesis' Quarterly Report on Form 10-Q for the quarter ended September 30, 2015. Sunesis expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Sunesis' expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
CONTACT: Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
(MORE TO FOLLOW) Dow Jones Newswires
November 30, 2015 07:00 ET (12:00 GMT)
I'm in it to win it!
NASDAQ DIP and RIP
Here is the best word that describes what i do here.
Intuitive;
means having the ability to understand or know something without any direct evidence or reasoning process.
I was born with it, I'm truly blessed!
Alway's searching for winners'
NASDAQ DIP and RIP
Here is the best word that describes what i do here.
Intuitive;
means having the ability to understand or know something without any direct evidence or reasoning process.
I was born with it, I'm truly blessed!
Alway's searching for winners'
