Dec. 13, 2013, 11:06 AM
- Aveo Pharma (AVEO -15.1%) says its lead experimental drug tivozanib was unlikely to succeed in a mid-stage colon cancer study that was testing if the drug was superior to an approved treatment.
- Partner Astellas (ALPMF, ALPMY) was testing the drug in combination with standard chemotherapy against cancer drug bevacizumab with standard chemotherapy, for use in previously untreated patients with advanced colorectal cancer.
- Aveo has seen a string of failures associated with the drug; the FDA denied approval for the drug's use in renal cell carcinoma in June, citing inconsistent patient survival data.
Nov. 1, 2013, 3:29 PM
- Astellas Pharma (ALPMY) reports H1 consolidated net sales ( ¥ millions) of ¥556,702, up 16.7% Y/Y.
- Net income ( ¥ millions) for H1 falls 16% Y/Y to ¥48.195. (full results)
- Xtandi U.S. sales of ~$190M for April-September. (supplementary documents)
- Backing out FQ1 sales of $82M gets ~$108M in U.S. Xtandi sales for FQ2.
- These numbers are likely behind the rally in shares of Medivation (MDVN +10.1%), Astellas' Xtandi partner.
Oct. 22, 2013, 10:19 AM
- After observing benefits in OS and radiographic PFS (co-primary endpoints), the IDMC for Medivation (MDVN +3.7%) and Astellas Pharma's (ALPMF +0.9%) Phase 3 PREVAIL trial of enzalutamide in metastatic prostate cancer recommends "the study be stopped and patients treated with placebo be offered enzalutamide."
- Enzalutamide reduced the risk of death by 30% (Hazard Ratio .70), and patients saw an 81% reduction in risk of radiographic progression or death (Hazard Ratio 0.19).
- Here's Dr. Tomasz Beer, professor of medicine and deputy director of the Knight Cancer Institute: "To my knowledge, the benefits in overall survival and radiographic progression-free survival reported in today's PREVAIL trial results are unprecedented in this patient population." (PR)
Aug. 1, 2013, 3:40 PM
- As reported here earlier, Astellas Pharma's (ALPMY.PK +1%) quarterly report showed Xtandi sales of $82M. That's short of consensus and bad news for partner Medivation (MDVN -1.3%).
- More color: William Blair's forecast was for sales of $85.2M (so a big miss there) — Astellas' full year Xtandi sales guidance of $400M is well below the firm's estimate of $459M.
Jun. 25, 2013, 8:18 AMCytokinetics (CYTK +9.8%) grants Astellas (ALPMF.PK) an exclusive license to co-develop and commercialize Cytokinetics' CK-2127107 treatment for muscle weakness, which is in Phase I trials. Cytokinetics will receive $16M up front and is eligible to receive over $24M in reimbursements during the first two years. Astellas could also pay $450M in R&D and sales milestones and royalties, as well as make other milestone payments. (8-K) | Comment!
Apr. 26, 2013, 11:12 AMMedivation (MDVN +0.6%) and Astellas Pharma (ALPMF.PK) say the Committee for Medicinal Products for Human Use (CHMP) has recommended approval for the oral androgen receptor inhibitor XTANDI (approved in the U.S.) for adult men with progressed metastatic castration-resistant prostate cancer. Other CHMP news: Pfizer's (PFE -1.1%) arthritis pill Xeljanz is rejected (appeal to come), Roche (RHHBY.OB +0.2%) and Curis' (CRIS +4.5%) Erivedge for basal cell carcinoma gets a recommendation, and Vivus' (VVUS +3.7%) ED drug Spedra gets a positive review. (See also: AVNR and CELG get thumbs up from EU regulators) | 1 Comment
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