Astellas Pharma, Inc. ADROTCPK - Current
Mon, Sep. 19, 9:16 AM
- Thinly traded nano cap Vical (NASDAQ:VICL) slumps 22% premarket on increased volume in response to its announcement that a Phase 2 clinical trial assessing its CMV vaccine candidate ASP0113 failed to meet its primary endpoint of a statistically valid proportion of patients achieving CMV viremia (viral load of at least 1,000 IU/mL at Year 1 after the first injection of study drug). The aim of the study was assess the safety and efficacy of ASP0113 in kidney transplant patients who received an organ from a CMV-seropositive donor.
- ASP0113 also failed to beat placebo in the secondary endpoints of the incidence of CMV-associated disease and incidence of CMV-specific antiviral therapy.
- On the plus side, the safety profiles were similar between the treatment groups.
- Results from a Phase 3 study in hematopoietic cell transplant (HCT) patients are expected in Q4 2017.
- Vical is developing Orphan Drug-tagged ASP0113 with collaboration partner Astellas (OTCPK:ALPMF)(OTCPK:ALPMY).
Thu, Sep. 8, 8:09 AM
- Cytokinetics (NASDAQ:CYTK) earns a $2M milestone payment from collaboration partner Astellas (OTCPK:ALPMF)(OTCPK:ALPMY) triggered by the initiation of IND-enabling studies for a next-generation fast skeletal muscle activator.
- The companies formed their partnership in 2013 with the primary aim of developing novel therapies for disorders associated with muscle impairment and weakness. That year, Astellas acquired the right to co-develop and co-commercialize CK-2127107, a fast skeletal troponin activator, in non-neuromuscular indications. In 2014, the collaboration was expanded to include certain neuromuscular indications, including spinal muscular atrophy. In 2016, the partnership was expanded further to include amyotrophic lateral sclerosis (ALS). Concurrently, Cytokinetics granted Astellas an option to develop and commercialize tirasemtiv worldwide excluding North America.
Wed, Aug. 3, 7:32 PM| Wed, Aug. 3, 7:32 PM
Tue, Jul. 26, 10:00 AM
- FibroGen (FGEN +0.6%) and development partner Astellas Pharma (OTCPK:ALPMF)(OTCPK:ALPMY) announce the dosing of the first patient in Phase 3 studies in Japan assessing roxadustat for the treatment of anemia in patients with chronic kidney disease (CKD). The event triggers a $10M milestone payment to FibroGen from Astellas. The Phase 3 trials follow two successful Phase 2s there.
- FibroGen is collaborating with Astellas on the development and commercialization of roxadustat for anemia in CKD patients in Japan, the Commonwealth of Independent States, the Middle East and South Africa. FibroGen is partnering with AstraZeneca (AZN -0.2%) in the U.S., China and other markets.
- Roxadustat is an orally administered small molecule inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase. HIF is a protein transcription factor that "turns on" the production of red blood cells (erythropoiesis). Its value proposition is the ability to maintain hemoglobin levels in CKD patients without affecting inflammation and potentially avoiding the need for ongoing intravenous iron repletion therapy as needed with epoetin alfa [Janssen's Procrit].
Tue, Jul. 26, 8:43 AM
- Thinly traded micro cap Tokai Pharmaceuticals (NASDAQ:TKAI) craters 70% premarket on higher-than-normal volume in response to its announcement that it will stop its Phase 3 clinical trial, ARMOR3-SV, assessing lead product candidate galeterone compared to enzalutamide (XTANDI) in treatment-naive men with metastatic castration-resistant prostate cancer (mCRPC) whose tumors express the androgen receptor splice variant AR-V7. The company made its decision based on the recommendation from the independent Data Monitoring Committee that the trial was unlikely to meet its primary efficacy endpoint.
- Tokai intends to evaluate its ongoing ARMOR2 expansion in mCRPC patients with acquired resistance to enzalutamide and its planned study in patients who rapidly progress on either enzalutamide or abiraterone acetate (ZYTIGA).
- Galeterone is an orally available small molecule that disrupts the androgen receptor (NYSE:AR) signaling pathway by degrading AR, blocking the binding of testosterone or dihydrotestosterone with AR and inhibiting CYP17, an enzyme that plays a key role in the synthesis of testosterone. Prostate cancer is stoked by androgens acting through the androgen receptor.
- Related tickers: (NASDAQ:MDVN)(OTCPK:ALPMF)(OTCPK:ALPMY)(NYSE:JNJ)
Thu, Jun. 9, 1:04 PM
- Thinly traded nano cap SCYNEXIS (SCYX -23.8%) slumps on a 17x surge in volume, albeit on turnover of only 674K shares, in response to its announcement of results from a Phase 2 clinical trial assessing lead product candidate, Fast Track- and QIDP-tagged SCY-078, for the treatment of patients with acute vulvovaginal candidiasis (VVC), commonly known as vaginal yeast infection.
- The study randomized 96 women with moderate-to-severe VVC 1:1:1 to receive either of two dose regimens of SCY-078 or fluconazole, the standard-of-care prescription oral medication.
- Data from the Intent-to-Treat population all favored SCY-078, but the cure rate, defined by a negative culture, was only slightly better than fluconazole (70.3% versus 68.8%). The therapeutic cure rate, defined as a negative culture and the resolution of symptoms without further antifungal treatment (clinical cure), was identical (56.3%) for both.
- One significant negative was the "considerably higher rate of GI-related adverse events (diarrhea, nausea, vomiting, abdominal pain) in the SCY-078 arms compared to fluconazole. According to the company, they were "mild to moderate and transient in nature" with the majority lasting no more than one day after initiating SCY-078.
- SCY-078 inhibits an enzyme called glucan synthase. Its value proposition is comparable activity to echinocandins [e.g., Astellas' (OTCPK:ALPMF)(OTCPK:ALPMY) Mycamine (micafungin sodium) for injection] but available in an oral formulation and active against multi-drug-resistant pathogens, including those resistant to echinocandins.
Thu, Jun. 9, 8:31 AM
- FibroGen (NASDAQ:FGEN) announces that collaboration partner Astellas Pharma (OTCPK:ALPMF)(OTCPK:ALPMY) has initiated a Phase 3 clinical trial in Japan evaluating roxadustat for the treatment of anemia in patients with chronic kidney disease (CKD) on hemodialysis. The action triggers a $10M milestone payment to FibroGen.
- Under FibroGen's 2004 license agreement with Yamanouchi (predecessor to Astellas), Astellas is responsible for the development costs of roxadustat in Japan and makes payments to FibroGen based on the achievement of certain milestones.
- Roxadustat is an orally administered small molecule inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase. HIF is a protein transcription factor that "turns on" the production of red blood cells (erythropoiesis). Its value proposition is the ability to maintain hemoglobin levels in CKD patients without affecting inflammation and potentially avoiding the need for ongoing intravenous iron repletion therapy as needed with epoetin alfa [Janssen's (NYSE:JNJ) Procrit]
Fri, Jun. 3, 7:37 AM
- Bayer (OTCPK:BAYRY) and Espoo, Finland-based Orion expand their 2014 agreement to jointly develop BAY-1841788 (ODM-201) in prostate cancer, currently in Phase 3 development (ARAMIS study) for the treatment of high-risk non-metastatic castration-resistant prostate cancer.
- The new indication will be for the treatment of newly diagnosed metastatic hormone-sensitive prostate cancer, in combination with docetaxel, in men who are starting first-line hormone therapy.
- A Phase 3 study, called ARASENS, will begin enrolling patients in late Q4. The double-blind, placebo-controlled trial will randomize ~1,300 subjects 1:1 to receive either BAY-1841788 (ODM-201) or placebo in combination with an androgen deprivation therapy of the investigator's choice started no more than 12 weeks before randomization. The primary endpoint is overall survival.
- BAY-1841788 is an oral androgen receptor antagonist.
- Prostate cancer-related tickers: (NASDAQ:MDVN)(OTCPK:ALPMY)(NYSE:VRX)(NASDAQ:TTHI)(NASDAQ:EDAP)(NASDAQ:TKAI)(NYSE:JNJ)(NASDAQ:TSRO)(NYSE:AZN)(NASDAQ:EGRX)(NASDAQ:OGXI)
Thu, Jun. 2, 10:12 AM
- Medivation (MDVN -0.7%) and collaboration partner Astellas Pharma (OTCPK:ALPMY) announce the initiation of a Phase 3 clinical trial, called ENDEAR, assessing Xtandi (enzalutamide), as monotherapy or in combination with paclitaxel, for the treatment of triple-negative breast cancer (TNBC). Patient enrollment will begin in Q4. Medivation will the lead the effort.
- TNBC, lacking three receptors [estrogen, progesterone and human growth factor receptor 2 (ER-/PR-/HER2-)] known to fuel most breast cancers, represents 15 - 20% of breast cancer cases. These patients have a poor prognosis. There are no currently available therapies specifically for TNBC.
- ENDEAR will randomize ~780 patients with advanced diagnostic-positive TNBC who are treatment-naive or have received one prior line of systemic therapy. The primary endpoint is progression-free survival (PFS). Subjects in the test arm will receive 160 mg of enzalutamide daily as monotherapy or with 90 mg/m2 of paclitaxel administered once per week for 16 weeks.
- Xtandi was approved by the FDA for the treatment of prostate cancer in August 2012.
Thu, Apr. 28, 11:37 AM
- Credit Suisse claims Medivation (MDVN +8%) is worth $55 a share, ~5% above Sanofi's (SNY -1.1%) unsolicited bid of $52.50. It says much of the attention has focused on the prospects of prostate cancer drug XTANDI (enzalutamide), approved by the FDA in August 2012, which generated $1.15B in the U.S. last year as reported by development and commercialization partner Astellas Pharma (OTCPK:ALPMF)(OTCPK:ALPMY). What appears to be underrepresented is the value of the company's pipeline, led by late-stage PARP inhibitor talazoparib.
- According to the analyst, other potential bidders include AstraZeneca (AZN -0.5%), Roche (OTCQX:RHHBY -0.5%) and Celgene (CELG +0.9%).
- AstraZeneca reportedly has held internal talks about an offer. Medivation rejected Sanofi's first approach several weeks ago, so the bidding could turn hostile if the board rejects $52.50, a likely scenario.
- Citi says Sanofi's offer is a bit light considering MDVN's 52-week high of $66.39, hit in June of last year. The board might reject the offer based purely on technical grounds.
- Previously: Medivation +9% AH on reported Sanofi takeover effort (April 12)
- Previously: Report: AstraZeneca held talks for Medivation bid (April 18)
Wed, Mar. 30, 8:22 AM
- The FDA designates Vical's (NASDAQ:VICL) VL-2397 for Fast Track review for the treatment of invasive aspergillosis, an infection caused by inhaling the ubiquitous Aspergillus fungus. It is inconsequential in people with a normally functioning immune system, but can be dangerous in those with weakened immunity such as those undergoing hematopoietic stem cell transplantation, chemotherapy for leukemia or with AIDS.
- VL-2397, based on an isolate from a leaf litter fungus Acremonium species collected in Malaysia, was initially developed by strategic partner Astellas Pharma (OTCPK:ALPMF) (OTCPK:ALPMY). A Phase 1 study was recently initiated.
- The FDA designated it a Qualified Infectious Disease Product in August 2015 and an Orphan Drug in January of this year.
- Shares are up 16% premarket on increased volume.
Thu, Mar. 24, 8:31 AM
- The first patient has been dosed in a Phase 3 clinical trial, ARCHES, evaluating the safety and efficacy of enzalutamide with androgen deprivation therapy (ADT) compared to placebo with ADT in metastatic hormone-sensitive prostate cancer (mHSPC) patients. The global, double-blind, placebo-controlled study will randomize ~1,100 mHSPC patients to receive a once-daily 160 mg oral dose of enzalutamide or placebo, administered with ADT. The primary efficacy endpoint is radiographic progression-free survival up to four years.
- According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint is April 2020. The estimated study completion date is December 2023.
- Enzalutamide, branded as Xtandi, is an androgen receptor inhibitor developed at UCLA by a team led by Distinguished Professor of Chemistry and Biochemistry Michael Jung. It was licensed to Medivation (NASDAQ:MDVN) in 2005 who sublicensed it to Astellas Pharma (OTCPK:ALPMF)(OTCPK:ALPMY) in 2009. The FDA approved it in 2012. Xtandi generated $1.15B in sales last year for Astellas.
- Previously: UCLA sells Xtandi royalty rights to Royalty Pharma for $1.14B (March 4)
Fri, Mar. 4, 11:18 AM
- Privately held Royalty Pharma acquires UCLA's royalty interest in the prostate cancer drug Xtandi (enzalutamide) for $1.14B in cash. The rights were jointly owned by the university, researchers working at UCLA at the time of the discoveries and a research organization. UCLA will use its share, ~$520M, to support research programs, undergraduate scholarships and graduate student fellowships.
- Enzalutamide, an androgen receptor inhibitor, was developed at UCLA by a team led by Distinguished Professor of Chemistry and Biochemistry Michael Jung. It was licensed to Medivation (MDVN +7.1%) in 2005 who sublicensed it to Astellas Pharma (OTCPK:ALPMF)(OTCPK:ALPMY) in 2009. The FDA approved it in 2012.
- Xtandi generated $1.15B in sales last year as reported by Astellas.
Mon, Feb. 29, 8:25 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Boehringer Ingelheim's Giotrif (afatinib) for the treatment of patients with advanced squamous cell carcinoma of the lung whose disease has progressed on or after treatment with platinum-based chemo.
- The data supporting the application was generated in the LUX-Lung 8 study that showed a 19% improvement in progression-free survival in patients treated with afatinib compared to Genentech (OTCQX:RHHBY) and Astellas' (OTCPK:ALPMF)(OTCPK:ALPMY) Tarceva (erlotinib).
- Giotrif is currently approved for the treatment of EGFR mutation-positive non-small cell lung cancer.
- A final decision from the European Commission usually takes ~60 days.
Wed, Feb. 24, 8:39 AM
- Ironwood Pharmaceuticals (NASDAQ:IRWD) earns a $15M milestone payment from development and commercialization partner Astellas Pharma (OTCPK:ALPMF)(OTCPK:ALPMY) triggered by the latter's filing of a new drug application in Japan seeking clearance of linaclotide for the treatment of adults with irritable bowel syndrome with constipation (IBS-C). The milestone was stipulated in the companies' 2009 licensing agreement for the development of the product in Japan.
- Linaclotide, marketed in the U.S. under the band name Linzess, is a guanylate cyclase-C (GCC) receptor agonist. GCC is a key receptor for enterotoxins that cause diarrhea.
Tue, Feb. 16, 11:53 AM
- Data from a Phase 2 clinical trial assessing FibroGen's (FGEN +4.9%) oral agent roxadustat for the treatment of anemia in patients with chronic kidney disease (CKD) showed that patients on hemodialysis who were previously receiving epoetin alfa [Amgen's (AMGN +1.1%) EPOGEN or J&J's (JNJ +0.3%) PROCRIT] but switched to roxadustat maintained hemoglobin (Hb) levels regardless of iron deletion status, degree of inflammation or prior iron regimen over six or 19 weeks. The results were published in the American Journal of Kidney Disease.
- In the first part of the study, lasting six weeks, lowest dose roxadustat (1.0 mg/kg 3x/week) maintained hemoglobin levels on par with epoetin alfa. Some separation was seen at higher doses of at least 1.5 mg/kg with 79% of patients showing a hemoglobin response compared to 33% for epoetin alfa.
- In the second part of the study, 51% of the roxadustat cohort achieved a Hb level of at least 11.0 g/dL compared to 36% for epoetin alfa (normal range is 13.5 - 17.5 for men and 12.0 - 15.5 for women). In addition, maintenance dosing of roxadustat was not correlated with levels of the inflammatory biomarker C-reactive protein (CRP). Decreases in cholesterol and hepcidin (key regulator of iron) were also observed in the roxadustat group.
- Roxadustat is an orally administered small molecule inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase. HIF is a protein transcription factor that "turns on" the production of red blood cells (erythropoiesis). Its value proposition is the ability to maintain hemoglobin levels in CKD patients without affecting inflammation and potentially avoiding the need for ongoing intravenous iron repletion therapy as needed with epoetin alfa.
- It is currently in Phase 3 development through collaborations with AstraZeneca (NYSE:AZN) and Astellas Pharma (OTCPK:ALPMF) (OTCPK:ALPMY).
- Previously: Data from mid-stage study show CKD patients with anemia respond to FibroGen's roxadustat in dose-related manner (Aug. 13, 2015)