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Friday, Nov 13:29 PMAstellas reports Xtandi sales, Medivation rallies
Friday, Nov 13:29 PM| Comment!
- 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.
Tuesday, Oct 2210:19 AMMedivation, Astellas announce positive results from enzalutamide trial
Tuesday, Oct 2210:19 AM| Comment!
- 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)
Thursday, Aug 13:40 PMXtandi sales weigh on Medivation
Thursday, Aug 13:40 PM| Comment!
- 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.
Tuesday, Jun 258:18 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) |Tuesday, Jun 258:18 AM| Comment!
Friday, Apr 2611:12 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) |Friday, Apr 2611:12 AM| 1 Comment