SA News • Thu, Jan. 22
Astellas' Isavuconazonium Should Pass Ad Comm Meeting For 2 Indications
- Briefing documents show isavuconazonium is safe and effective for treating invasive aspergillosis and mucormycosis.
- There may be stronger antifungals on the market, but due to resistance and tolerability issues, isavuconazonium fills an unmet need and Ad Comm will recommend that it be approved.
- Isavuconazonium's place in therapy will be behind generics but ahead of Noxafil, which has a more limited spectrum of activity.
Astellas Proposes to Acquire CV Therapeutics for $1Billion
Thu, Jan. 22, 3:13 PM
- The FDA's Anti-Infective Drugs Advisory Committee votes 11 - 0 in favor of Astellas Pharma's (OTCPK:ALPMF) (OTCPK:ALPMY) isavuconazonium sulfate for the treatment of aspergillosis and 8 - 2 (1 abstention) in favor for the treatment of mucormycosis.
- Previously: Ad Comm meets today to review Astellas NDA for antifungal med (Jan. 22)
Thu, Jan. 22, 8:51 AM
- The FDA's Anti-Infective Drugs Advisory Committee meets today to review the New Drug Application (NDA) from Astellas Pharma (OTCPK:ALPMF) (OTCPK:ALPMY) for isavuconazonium sulfate capsules and isavuconazonium sulfate for injection for the treatment of patients with invasive aspergillosis and mucormycosis.
- Briefing doc
- Astellas briefing doc
Thu, Jan. 22, 8:34 AM
- A Phase 2 clinical trial measuring progression-free survival (PFS) in patients with metastatic castration-resistant prostate cancer receiving Xtandi (enzalutamide) or bicalutamide met its primary endpoint of a statistically significant increase in PFS for enzalutamide.
- Median PFS for the enzalutamide cohort was 15.7 months versus 5.8 months for the bicalutamide group (p<0.0001), although the median time on treatment was twice as long for the enzalutamide group (11.7 months) compared to the bicalutamide group (5.8 months).
- Data from the trial will be presented at a future medical conference.
- Enzalutamide is being co-developed by Medivation (NASDAQ:MDVN) and Astellas Pharma (OTCPK:ALPMF) (OTCPK:ALPMY).
- Related ticker: (NYSE:AZN)
Mon, Jan. 19, 5:26 PM
- As expected, the European Commission approves Boehringer Ingelheim's OFEV (nintedanib) for the treatment of patients with idiopathic pulmonary fibrosis (IPF). The Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion in November backing approval.
- Previously: Europe Ad Comm supports approval for BI pulmonary fibrosis drug (Nov. 21, 2014)
- IPF-related tickers: (NYSE:BMY) (OTCQX:RHHBY) (NASDAQ:FGEN) (NYSE:AZN) (OTCPK:ALPMF) (OTCPK:ALPMY)
Dec. 23, 2014, 8:28 AM
- Cytokinetics (NASDAQ:CYTK) and Astellas Pharma (OTCPK:ALPMF) (OTCPK:ALPMY) expand their collaboration agreement focused on the research, development and commercialization of skeletal muscle activators to include the development of CK-2127107, a fast skeletal troponin activator, in spinal muscular atrophy (SMA) as well as other neuromuscular indications. Cytokinetics will conduct a Phase 2 trial of CK-2127107 in patients with SMA that will commence in 2015. The companies will jointly develop and may jointly commercialize CK-2127107 as well as other fast skeletal troponin activators.
- Under the terms of the amended contract, Cytokinetics will receive $55M from Astellas ($30M upfront, $10M purchase of CYTK common stock, $15M milestone for the Phase 2 study of CK-2127107) and ~$20M for reimbursement of R&D expenses over the next two years. In addition, CYTK is eligible to receive over $600M in pre-commercialization and commercialization milestones which includes ~$100M for CK-2127107 in each of SMA and other neuromuscular indications. CYTK will also receive escalating royalties on increased sales.
- CYTK is up 19% premarket on moderately higher volume.
Nov. 20, 2014, 9:31 AM
- The enrollment of the first patient in a Phase 3 trial in Japan to evaluate linaclotide for the treatment of irritable bowel syndrome triggers a $15M milestone payment to Ironwood Pharmaceuticals (NASDAQ:IRWD) from partner Astellas Pharma (OTCPK:ALPMF) (OTCPK:ALPMY).
- Under the terms of their 2009 license agreement, Astellas paid Ironwood a $30M upfront licensing fee and will pay an additional $30M in milestones for the linaclotide regulatory submission ($15M) and regulatory approval ($15M).
Nov. 10, 2014, 1:46 PM
- San Francisco, CA-based FibroGen (Pending:FGEN) is on deck for its IPO of 7.1M shares of common stock at $16 - 19.
- The biopharmaceutical company focuses on fibrosis and hypoxia-inducible factor (HIF) biology. Its lead product is roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylases currently in Stage 3 development, for the treatment of anemia in patients with chronic kidney disease. Its second product candidate is FG-3019, a monoclonal antibody in Phase 2 development for the treatment of idiopathic pulmonary fibrosis.
- The company's development and commercialization partners for roxadustat are Astellas Pharma (OTCPK:ALPMF) (OTCPK:ALPMY) (Japan, Europe, CIS, Middle East, South Africa) and AstraZeneca (AZN +0.6%) (U.S., China, ROW ex. Astellas territories).
- 2013 Performance ($M): Revenues: 102.2 (+55.1%); Operating Expenses: 110.1 (+18.1%); Net Loss: (14.9) (+54.3%); CF Ops: 25.9 (+562.5%).
- 2014 Performance (9 mo.): Revenues: 121.5 (+35.3%); Operating Expenses: 123.6 (+69.8%); Net Loss: (8.9) (-175.4%); CF Ops: 46.2 (-4.9%).
- ETFs: IBB, BIB, BIS (NYSEARCA:IPO)
Nov. 3, 2014, 12:44 PM
- The FDA designates Astellas' (OTCPK:ALPMF) (OTCPK:ALPMY) isavuconazole an Orphan Drug for the treatment of invasive candidiasis. Among the benefits of the label is a seven-year post approval period of market exclusivity. The agency previously designated isavuconazole an Orphan Drug for the treatment of invasive aspergillosis and invasive mucormycosis.
- The investigational drug is also a Qualified Infectious Disease Product for invasive candidiasis. Among the benefits of this tag is a five-year extension of market exclusivity.
Oct. 24, 2014, 10:14 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supporting the label expansion of Xtandi (enzalutamide) to include the treatment of adult men with metastatic castrate-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen-deprivation therapy in whom chemotherapy is not yet clinically indicated.
- CHMP's positive recommendation is based on the Phase 3 Prevail study where enzalutamide reduced the risk of death by 29% compared to placebo. Treated patients also experienced a 17-month delay in the time to initiation of chemotherapy versus placebo.
- Xtandi's current indication is for the treatment of adult men with mCRPC whose disease has progressed on or after docetaxel therapy.
- Enzalutamide was developed by Medivation (MDVN +2%) in collaboration with Astellas Pharma (OTCPK:ALPMF) (OTCPK:ALPMY).
- A final decision by the European Commission typically takes about 60 days.
Mar. 18, 2014, 9:12 AM
- 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)
Feb. 14, 2014, 7:29 AM
- 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.
Jan. 30, 2014, 7:46 AM
- 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)
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)
Sep. 24, 2013, 7:05 AM| Comment!
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