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Friday, Feb 147:29 AM
Friday, Feb 147:29 AM| Comment!
- Aveo Oncology (AVEO) and Japan's Astellas Pharma (ALPMF) are ending their agreement to develop Aveo's lead drug Tivozanib and they will halt a Phase II study testing its use in colon cancer.
- The move comes after Aveo said in January that it would end a similar-stage trial of Tivozanib as a treatment for breast cancer because of poor enrollments. In July, the drug was rejected as a treatment for kidney cancer because of inconsistent study results.
Thursday, Jan 307:46 AM
Thursday, Jan 307:46 AM| Comment!
- Aveo Oncology (AVEO) and Japanese partner Astellas Pharma (ALPMF) plan to end a Phase II study of the Tivozanib drug for treating breast cancer after not being able to enroll enough patients in the trial.
- The latest blow to Aveo comes after the FDA rejected Tivozanib as a treatment for kidney cancer in June, due to inconsistent study results. (PR)
Friday, Dec 132013, 11:06 AM
Friday, Dec 132013, 11:06 AM| Comment!
- 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.
Friday, Nov 12013, 3:29 PM
Friday, Nov 12013, 3:29 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 222013, 10:19 AM
Tuesday, Oct 222013, 10:19 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)
Tuesday, Sep 242013, 7:05 AM|Tuesday, Sep 242013, 7:05 AM| Comment!
Thursday, Aug 12013, 3:40 PM
Thursday, Aug 12013, 3:40 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.
Thursday, Aug 12013, 8:21 AM
Thursday, Aug 12013, 8:21 AM| Comment!
- Astellas Pharma (ALPMY.PK) reports FQ1 consolidated net sales of ¥275.8B (.pdf), up 13.4% Y/Y.
- Net sales of Xtandi — the prostate cancer treatment developed and commercialized with partner Medivation (MDVN) — were $82M for the period, below Street estimates of $83.7M. (supplemental documents)
- Xtandi faces what some say is looming threat from Janssen's acquisition of Aragon and the company's ARN-509.
Wednesday, Jun 262013, 9:05 AMMedivation (MDV) and Astellas (ALPMF.PK) enroll the first patient in a Phase II trial for enzalutamide, a treatment for triple-negative breast cancer, for which "there are no approved targeted therapies." The trial will recruit approximately 80 patients, who will take enzalutamide orally once a day. (PR) |Wednesday, Jun 262013, 9:05 AM| Comment!
Tuesday, Jun 252013, 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) |Tuesday, Jun 252013, 8:18 AM| Comment!
Monday, Jun 32013, 8:06 AM
Wednesday, May 292013, 8:05 AMAmgen (AMGN -0.6%) forms a JV with Japan's Astellas Pharma (ALPMF.PK) to develop and sell five new drugs in the latter's home country, with the hope being to launch the first medicine in 2016. The JV should help Amgen partly fill what it has described as "a noticeable gap" - its absence from China and Japan. (PR) |Wednesday, May 292013, 8:05 AM| Comment!
Friday, Apr 262013, 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) |Friday, Apr 262013, 11:12 AM| 1 Comment
Monday, Jul 232012, 9:07 AMThe combination of Tarceva and Nexavar tablets to treat liver cancer didn't improve survival rates compared with Nexavar on its own in a Phase III trial. Nexavar is jointly produced by Bayer and Onyx (ONXX -0.45%), while Tarceva, which is already used in lung cancer, is sold by Astellas Pharma and Roche unit Genentech. |Monday, Jul 232012, 9:07 AM| Comment!
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