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Tuesday, Mar 189:12 AM
Tuesday, Mar 189:12 AM| Comment!
- Medivation (MDVN +2% premarket) and Astellas Pharma (ALPMF) have filed a request with the FDA to widen the use of their Xtandi product to treat men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy.
- Xtandi is already approved for the treatment of patients with mCRPC who have received Docetaxel chemotherapy.
- The companies intend to file a similar request in the EU later this year. (PR)
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, 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, 1:49 PM
Thursday, Aug 12013, 1:49 PM| Comment!
- Astellas Pharma (ALPMY.PK +1.2%) corrects a translation error in its FQ1 conference call earlier, confirming that interim analysis on its Prevail study of Xtandi will actually occur this year.
- The company became aware of an error in the English translation, which cited incorrect timing of the interim analysis.
- Guidance has not changed.
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, Jul 312013, 11:24 AM
Wednesday, Jul 312013, 11:24 AM| Comment!
- AstraZeneca (AZN +0.9%) inks a collaboration deal to develop an oral anemia drug with privately held U.S. biotechnology company FibroGen that could potentially be worth more than $815M.
- The collaboration includes the development and commercialization of FG-4592, a drug that mimics the body's response to being at high altitude, which stimulates production of red blood cells and would be used to treat anemia.
- AZN's is making an initial $350M payment to FibroGen, will could rise to as much as $815M if development milestones are reached, and possibly even exceed that with royalty payments on future sales in the low 20% range.
- AZN has made $2.8B worth of acquisition and collaboration deals in the last six months alone in a bid to counteract the revenue-sapping effect of generic competition.
- The deal is limited to the U.S., China and a few other markets, but excludes Europe, Japan and other markets where FibroGen already has an agreement with Astellas Pharma (ALPMY.PK).
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, May 242013, 7:58 AMAstellas (ALPMY.PK) and Medivation (MDVN) say a marketing approval application for enzalutamide (its friends call it XTANDI and it's FDA approved) has been submitted to Japan's Ministry of Health, Labour, and Welfare for the treatment of prostate cancer. (PR) |Friday, May 242013, 7:58 AM| Comment!
Thursday, May 232013, 6:21 PMAVEO Pharmaceuticals (AVEO) has been informed by its partner, Astellas Pharma (ALPMY.PK), that it no longer intends to submit a Marketing Authorization Application to the European Medicines Agency for tivozanib, its treatment for advanced renal cell carcinoma, nor does not intend to fund any future trials under its strategic collaboration agreement. AVEO says it's evaluating the impact of the news and its options for the drug going forward. AVEO -14.7% AH. |Thursday, May 232013, 6:21 PM| Comment!
Monday, May 132013, 8:44 PMJapanese stocks move higher in early trading after a record finish for the S&P 500 overnight. The Nikkei Average gained 0.3% to 14,822, extending its gains after finishing at its highest level yesterday since December 2007. Big gainers include: Hino Motors (HINOY.PK +2.2%), Isuzu Motors (ISUZY.PK +1.7%) and Astellas Pharma (ALPMY.PK +3.9%). |Monday, May 132013, 8:44 PM| 1 Comment