Thu, May 21, 9:59 AM
- Astellas Pharma (OTCPK:ALPMY -0.1%) finalizes the enrollment of 150 kidney transplant patients a year ahead of schedule in a Phase 2 study evaluating its therapeutic cytomegalovirus (CMV) vaccine candidate ASP0113. The randomized, double-blind, placebo-controlled trial will assess ASP0113 in CMV-seronegative kidney transplant patients receiving a kidney from a CMV-seropositive donor.
- The primary endpoint will compare the efficacy of ASP0113 + 100 days of valganciclovir to placebo + 100 days of valganciclovir in reducing the incidence of CMV viremia (virus is in the blood) for one year following the first vaccination. Top-line results are expected in H2 2016.
- Under current standard of care, about half of D+/R- kidney transplant recipients experience CMV viremia and ~35% experience CMV disease with one year after transplantation.
- Astellas licensed the Orphan Drug-designated product candidate from Vical (VICL +1.1%).
- CMV is a type of herpes virus that most people come in contact with in their lifetimes. It is asymptomatic in healthy individuals but presents mononucleosis-type symptoms in those with weakened immune systems.
Wed, Apr. 22, 9:54 AM
- Astellas Pharma (OTCPK:ALPMY) and privately-held Potenza Therapeutics enter into an exclusive research and development collaboration to advance a portfolio of cancer programs with novel mechanisms of action targeting immune checkpoint pathways, co-stimulatory signals and regulatory T cells. The agreement includes an option for Astellas to acquire Potenza at the end of the collaboration period.
- Under the terms of the agreement, Potenza will lead drug discovery and deliver development candidates to Astellas, which will be responsible for clinical development and commercialization. Financial terms are undisclosed but include an equity investment, option fee, research funding and potential future acquisition and milestone payments.
Thu, Apr. 2, 8:56 AM
- A second Phase 2 study, called STRIVE, comparing Xtandi (enzalutamide) to bicalutamide in men with non-metastatic or metastatic castration-resistant prostate cancer achieved its primary efficacy endpoint of a statistically significant increase in progression-free survival (PFS) in the enzalutamide arm versus the bicalutamide arm (p<0.0001). Median PFS in the enzalutamide group was 19.4 months compared to 5.7 months in the bicalutamide group.
- Median time on treatment was 14.7 months for enzalutamide patients vs. 8.4 months for those treated with bicalutamide. Serious adverse events were reported in 29.4% of enzalutamide subjects compared to 28.3% in bicalutamide subjects.
- Another comparative Phase 2, called TERRAIN, was also successful.
- Xtandi is being developed and commercialized by Medivation (NASDAQ:MDVN) and Astellas Pharma (OTCPK:ALPMY) in a collaboration that began in 2009. It is currently cleared for sale in the U.S. for the treatment of metastatic castration-resistant prostate cancer.
- Previously: Xtandi beats bicalutamide in Phase 2 CRPC trial (March 24)
Tue, Mar. 24, 9:28 AM
- A Phase 2 study comparing Xtandi (enzalutamide) to bicalutamide in patients with metastatic castration-resistant prostate cancer (CRPC) met its primary efficacy endpoint of a statistically significant increase in progression-free survival (PFS). Median PFS in the enzalutamide arm was 9.9 months longer than the bicalutamide arm (15.7 months vs. 5.8 months; p<0.0001). In addition, the median time to PSA progression was 13.6 months longer with enzalutamide (19.4 months vs. 5.8 months; p<0.0001). The data were presented at the European Association of Urology Congress in Madrid, Spain.
- Xtandi is being developed and commercialized by Medivation (NASDAQ:MDVN) and Astellas Pharma (OTCPK:ALPMF) (OTCPK:ALPMY) in a collaboration that began in October 2009.
Fri, Mar. 20, 9:59 AM
- Amgen Astellas BioPharma K.K., a joint venture between Amgen (AMGN +1.1%) and Astellas Pharma (OTCPK:ALPMF) (OTCPK:ALPMY), files a regulatory application with the Japanese Ministry of Health, Labour and Welfare seeking clearance for Repatha (evolocumab) for the treatment of high cholesterol.
- Repatha is a PCSK9 inhibitor that works by freeing up more low density lipoprotein (LDL) receptors on the surface of liver cells so more LDL-C can be removed from the blood. PCSK9 inhibitors represent the next generation of cholesterol-lowering medicines after statins. Approximately 50% of Japanese patients on statin therapy fail to reach their LDL-C goal so the market opportunity is substantial.
- Previously: Japanese study shows Amgen's evolocumab lowers bad cholesterol in high risk patients (March 14)
Fri, Mar. 6, 2:46 PM
- The FDA approves Astellas Pharma's (OTCPK:ALPMF) (OTCPK:ALPMY) QIDP-designated Cresemba (isavuconazonium sulfate) for the treatment of adult patients with invasive aspergillosis and invasive mucormycosis.
- Aspergillus is a fungus whose spores are present in the air we breathe. It's normally harmless but can cause disease in people with weakened immune systems, damaged lungs or allergies. The variety of these disease is called aspergillosis.
- Mucormycosis is caused by fungi in the order Mucorales. It can affect multiple parts of the body and is characterized by a variety of symptoms such as headache, facial pain, fever and nasal congestion that progresses to black discharge.
- Both conditions are rare, but serious.
- The agency designated Cresemba a Qualified Infectious Disease Product for the treatment of invasive aspergillosis in 2013. In addition to reaping the benefits of Fast Track review, it will have an additional five-year period of market exclusivity.
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)
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