Astex Pharma (ASTX) Higher on Positive CHMP Call for DACOGEN
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Astex Pharmaceuticals, Inc. (Nasdaq: ASTX), is popping higher Friday following a positive CHMP recommendation for its DACOGEN AML treatment.
Shares are up 4.5 percent on the session, with volatility increased 28 percent from Thursday's close.
From the release:
"[Astex] announced that Janssen-Cilag International NV was notified that the Committee for Medical Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted a positive opinion recommending approval of DACOGEN® (decitabine) for Injection in the treatment of adult patients (age 65 years and above) with newly diagnosed de novo or secondary acute myeloid leukemia (AML), according to the World Health Organization (WHO) classification who are not candidates for standard induction chemotherapy. Janssen is the licensee for DACOGEN in territories outside of the United States, Canada and Mexico.
The CHMP is the committee responsible for the scientific assessment of products seeking centralized marketing authorization throughout the European Union. The CHMP's positive opinion is now referred for approval to the European Commission. Janssen anticipates receiving the regulatory decision from the Commission in the end of the third quarter of 2012.
The CHMP positive opinion is based on data from the DACO-016 trial, the largest AML trial to date in this population of older patients. This randomized, open-label, multi-center phase 3 clinical trial compared DACOGEN versus patient's choice with physician's advice of either supportive care or low-dose cytarabine in patients 65 years and older with newly diagnosed de novo or secondary acute myeloid leukemia and poor- or intermediate-risk cytogenetics. DACOGEN was administered at 20 mg/m2 as a 1-hour intravenous infusion once daily for five consecutive days, repeated every four weeks, continued as long as the patient derived benefit. Key results from this study were published in the Journal of Clinical Oncology in June 20121."
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Shares are up 4.5 percent on the session, with volatility increased 28 percent from Thursday's close.
From the release:
"[Astex] announced that Janssen-Cilag International NV was notified that the Committee for Medical Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted a positive opinion recommending approval of DACOGEN® (decitabine) for Injection in the treatment of adult patients (age 65 years and above) with newly diagnosed de novo or secondary acute myeloid leukemia (AML), according to the World Health Organization (WHO) classification who are not candidates for standard induction chemotherapy. Janssen is the licensee for DACOGEN in territories outside of the United States, Canada and Mexico.
The CHMP is the committee responsible for the scientific assessment of products seeking centralized marketing authorization throughout the European Union. The CHMP's positive opinion is now referred for approval to the European Commission. Janssen anticipates receiving the regulatory decision from the Commission in the end of the third quarter of 2012.
The CHMP positive opinion is based on data from the DACO-016 trial, the largest AML trial to date in this population of older patients. This randomized, open-label, multi-center phase 3 clinical trial compared DACOGEN versus patient's choice with physician's advice of either supportive care or low-dose cytarabine in patients 65 years and older with newly diagnosed de novo or secondary acute myeloid leukemia and poor- or intermediate-risk cytogenetics. DACOGEN was administered at 20 mg/m2 as a 1-hour intravenous infusion once daily for five consecutive days, repeated every four weeks, continued as long as the patient derived benefit. Key results from this study were published in the Journal of Clinical Oncology in June 20121."
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